StemCell Therapy

TORONTO, March 31, 2020 /CNW/ - The Gairdner Foundation is pleased to announce the 2020 Canada Gairdner Award laureates, recognizing some of the world's most significant biomedical research and discoveries. During these challenging times, we believe it is important to celebrate scientists and innovators from around the world and commend them for their tireless efforts to conduct research that impacts human health.

2020 Canada Gairdner International AwardThe five 2020 Canada Gairdner International Award laureates are recognized for seminal discoveries or contributions to biomedical science:

Dr. Masatoshi TakeichiSenior Visiting Scientist, RIKEN Center for Biosystems Dynamics Research, Kobe, Japan; Professor Emeritus, Kyoto University, Kyoto, Japan

Dr. Rolf KemlerEmeritus Member and Director, Max Planck Institute of Immunobiology and Epigenetics, Freiburg, Germany

Awarded "For their discovery, characterization and biology of cadherins and associated proteins in animal cell adhesion and signalling."

Dr. Takeichi

The Work: The animal body is made up of numerous cells. Dr. Takeichi was investigatinghow animal cells stick together to form tissues and organs, and identified a key protein which he named 'cadherin'.Cadherin is present on the surface of a cell and binds to the same cadherin protein on the surface of another cell through like-like interaction, thereby binding the cells together. Without cadherin, cell to cell adhesion becomes weakened and leads to the disorganization of tissues. Dr. Takeichi found that there are multiple kinds of cadherin within the body, each of which are made by different cell types, such as epithelial and neuronal cells. Cells with the same cadherins tend to cluster together, explaining the mechanism of how different cells are sorted out and organized to form functional organs.

Further studies by Dr. Takeichi's group showed that cadherin function is supported by a number of cytoplasmic proteins, includingcatenins, and their cooperation is essential for shaping of tissues. His studies also revealed that the cadherin-dependent adhesion mechanism is involved in synaptic connections between neurons, which are important for brain wiring.

Dr. Kemler

The Work: Dr. Kemler, using an immunological approach, developed antibodies directed against surface antigens of early mouse embryos. These antibodies were shown to prevent compaction of the mouse embryo and interfered with subsequent development. Both Dr. Kemler and Dr. Takeichi went on to clone and sequence the gene encoding E-cadherin and demonstrate that it was governing homophilic cell adhesion.

Dr. Kemler also discovered the other proteins that interact with the cadherins, especially the catenins, to generate the machinery involved in animal cell-to-cell adhesion. This provided the first evidence of their importance in normal development and diseases such as cancer. It has been discovered that cadherins and catenins are correlated to the formation and growth of some cancers and how tumors continue to grow. Beta catenin is linked to cell adhesion through interaction with cadherins but is also a key component of the Wnt signalling pathway that is involved in normal development and cancer. There are approximately 100 types of cadherins, known as the cadherin superfamily.

Dr. Takeichi

The Impact: The discovery of cadherins, which are found in all multicellular animalspecies, has allowed us to interpret how multicellular systems are generated and regulated. Loss of cadherin function has been implicated as the cause of certain cancers, as well as in invasiveness of many cancers. Mutations in special types of cadherin result in neurological disorders, such as epilepsy and hearing loss. The knowledge of cadherin function is expected to contribute to the development of effective treatments against such diseases.

Dr. Kemler

The Impact: Human tumors are often of epithelial origin. Given the role of E-cadherin for the integrity of an epithelial cell layer, the protein can be considered as a suppressor of tumor growth. The research on the cadherin superfamily has had great impact on fields as diverse as developmental biology, cell biology, oncology, immunology and neuroscience. Mutations in cadherins/catenins are frequently found in tumors. Various screens are being used to identify small molecules that might restore cell adhesion as a potential cancer therapy.

Dr. Roel NusseProfessor & Chair, Department of Developmental Biology; Member, Institute for StemCell Biology andRegenerativeMedicine, Stanford University, School of Medicine.Virginia and Daniel K. Ludwig Professor of Cancer Research. Investigator, Howard Hughes Medical Institute

Awarded"For pioneering work on the Wnt signaling pathway and its importance in development, cancer and stem cells"

The Work: Dr. Nusse's research has elucidated the mechanism and role of Wnt signaling, one of the most important signaling systems in development. There is now abundant evidence that Wnt signaling is active in cancer and in control of proliferation versus differentiation of adult stem cells, making the Wnt pathway one of the paradigms for the fundamental connections between normal development and cancer.

Among Dr. Nusse's contributions is the original discovery of the first Wnt gene (together with Harold Varmus) as an oncogene in mouse breast cancer. Afterwards Dr. Nusse identified the Drosophila Wnt homolog as a key developmental gene, Wingless. This led to the general realization of the remarkable links between normal development and cancer, now one of the main themes in cancer research. Using Drosophila genetics, he established the function of beta-catenin as a mediator of Wnt signaling and the Frizzleds as Wnt receptors (with Jeremy Nathans), thereby establishing core elements of what is now called the Wnt pathway. A major later accomplishment of his group was the first successful purification of active Wnt proteins, showing that they are lipid-modified and act as stem cell growth factors.

The Impact: Wnt signaling is implicated in the growth of human embryos and the maintenance of tissues. Consequently, elucidating the Wnt pathway is leading to deeper insights into degenerative diseases and the development of new therapeutics. The widespread role of Wnt signaling in cancer is significant for the treatment of the disease as well. Isolating active Wnt proteins has led to the use of Wnts by researchers world-wide as stem cell growth factors and the expansion of stem cells into organ-like structures (organoids).

Dr. Mina J. Bissell Distinguished Senior Scientist, Biological Systems and Engineering Division, Lawrence Berkeley National Laboratory; Faculty; Graduate Groups in Comparative Biochemistry, Endocrinology, Molecular Toxicology and Bioengineering, University of California Berkeley, Berkeley, CA, USA

Awarded "For characterizing "Dynamic Reciprocity" and the significant role that extracellular matrix (ECM) signaling and microenvironment play in gene regulation in normal and malignant cells, revolutionizing the fields of oncology and tissue homeostasis."

The Work: Dr. Mina Bissell's career has been driven by challenging established paradigms in cellular and developmental biology. Through her research, Dr. Bissell showed that tissue architecture plays a dominant role in determining cell and tissue phenotype and proposed the model of 'dynamic reciprocity' (DR) between the extracellular matrix (ECM) and chromatin within the cell nucleus. Dynamic reciprocity refers to the ongoing, bidirectional interaction between cells and their microenvironment. She demonstrated that the ECM could regulate gene expression just as gene expression could regulate ECM, and that these two phenomena could occur concurrently in normal or diseased tissue.

She also developed 3D culture systems to study the interaction of the microenvironment and tissue organization and growth, using the mammary gland as a model.

The Impact:Dr. Bissell's model of dynamic reciprocity has been proven and thoroughly established since its proposal three decades ago and the implications have permeated every area of cell and cancer biology, with significant implications for current and future therapies. Dr. Bissell's work has generated a fundamental and translationally crucial paradigm shift in our understanding of both normal and malignant tissues.

Her findings have had profound implications for cancer therapy by demonstrating that tumor cells can be influenced by their environment and are not just the product of their genetic mutations. For example, cells from the mammary glands grown in two-dimensional tissue cultures rapidly lose their identity, but once placed in proper three-dimensional microenvironments, they regain mammary form and function. This work presages the current excitement about generation of 3D tissue organoids and demonstrates Dr. Bissell's creative and innovative approach to science.

Dr. Elaine FuchsHoward Hughes Medical Institute Investigator and Rebecca C. Lancefield Professor and Head of the Robin Chemers Neustein Laboratory of Mammalian Cell Biology and Cell Biology; The Rockefeller University, New York, NY, USA

Awarded"For her studies elucidating the role of tissue stem cells in homeostasis, wound repair, inflammation and cancer."

The Work: Dr. Fuchs has used skin to study how the tissues of our body are able to replace dying cells and repair wounds. The skin must replenish itself constantly to protect against dehydration and harmful microbes. In her research, Fuchs showed that this is accomplished by a resident population of adult stem cells that continually generates a shell of indestructible cells that cover our body surface.

In her early research, Fuchs identified the proteins---keratinsthat produce the iron framework of the skin's building blocks, and showed that mutations in keratins are responsible for a group of blistering diseases in humans. In her later work, Fuchs identified the signals that prompt skin stem cells to make tissue and when to stop. In studying these processes, Fuchs learned that cancers hijack the fundamental mechanisms that tissue stem cells use to repair wounds. Her team pursued this parallel and isolated and characterized the malignant stem cells that are responsible for propagating a type of cancer called "squamous cell carcinoma." In her most recent work, she showed that these cells can be resistant to chemotherapies and immunotherapies and lead to tumor relapse.

The Impact: All tissues of our body must be able to replace dying cells and repair local wounds. Skin is particularly adept at performing these tasks. The identification and characterization of the resident skin stem cells that make and replenish the epidermis, sweat glands and hair provide important insights into this fountain of youth process and hold promise for regenerative medicine and aging. In normal tissues, the self-renewing ability of stem cells to proliferate is held in check by local inhibitory signals coming from the stem cells' neighbours. In injury, stimulatory signals mobilize the stem cells to proliferate and repair the wound. In aging, these normal balancing cues are tipped in favour of quiescence. In inflammatory disorders, stem cells become hyperactivated. In cancers, the wound mechanisms to mobilize stem cells are hijacked, leading to uncontrolled tissue growth. Understanding the basic mechanisms controlling stem cells in their native tissue is providing new strategies for searching out refractory tumor cells in cancer and for restoring normalcy in inflammatory conditions.

2020 John Dirks Canada Gairdner Global Health AwardThe 2020 John Dirks Canada Gairdner Global Health Award laureate is recognized for outstanding achievements in global health research:

Professor Salim S. Abdool KarimDirector of CAPRISA (Centre for the AIDS Program of Research in South Africa), the CAPRISA Professor in Global Health at Columbia University, New York and Pro Vice-Chancellor (Research) at the University of KwaZulu-Natal, Durban, South Africa

Professor Quarraisha Abdool KarimAssociate Scientific Director of CAPRISA, Professor in Clinical Epidemiology, Columbia University, New York and Professor in Public Health at the Nelson Mandela Medical School and Pro Vice-Chancellor (African Health) at the University of KwaZulu-Natal, Durban, South Africa

Awarded"For their discovery that antiretrovirals prevent sexual transmission of HIV, which laid the foundations for pre-exposure prophylaxis (PrEP), the HIV prevention strategy that is contributing to the reduction of HIV infection in Africa and around the world."

The Work: UNAIDS estimates that 37 million people were living with HIV and 1.8 million people acquired HIV in 2017. In Africa, which has over two thirds of all people with HIV, adolescent girls and young women have the highest rates of new HIV infections. ABC (Abstinence, Be faithful, and use Condoms) prevention messages have had little impact - due to gender power imbalances, young women are often unable to successfully negotiate condom use, insist on mutual monogamy, or convince their male partners to have an HIV test.

In responding to this crisis, Salim and Quarraisha Abdool Karim started investigating new HIV prevention technologies for women about 30 years ago. After two unsuccessful decades, their perseverance paid off when they provided proof-of-concept that antiretrovirals prevent sexually acquired HIV infection in women. Their ground-breaking CAPRISA 004 trial showed that tenofovir gel prevents both HIV infection and genital herpes. The finding was ranked inthe "Top 10 Scientific Breakthroughs of 2010" by the journal, Science. The finding was heralded by UNAIDS and the World Health Organization (WHO) as one of the most significant scientific breakthroughs in AIDS and provided the first evidence for what is today known as HIV pre-exposure prophylaxis (PrEP).

The Abdool Karims have also elucidated the evolving nature of the HIV epidemic in Africa, characterising the key social, behavioural and biological risk factors responsible for the disproportionately high HIV burden in young women. Their identification of the "Cycle of HIV Transmission", where teenage girls acquire HIV from men about 10 years older on average, has shaped UNAIDS policies on HIV prevention in Africa.

The impact: CAPRISA 004 and several clinical trials of oral tenofovir led tothe WHO recommending a daily tenofovir-containing pill for PrEP as a standard HIV prevention tool for all those at high risk a few years later. Several African countries are among the 68 countries across all continents that are currently making PrEP available for HIV prevention. The research undertaken in Africa by this South African couple has played a key role in shaping the local and global response to the HIV epidemic.

2020 Canada Gairdner Wightman AwardThe 2020 Canada Gairdner Wightman Award laureate is a Canadian scientist recognized for outstanding leadership in medicine and medical science throughout their career:

Dr. Guy Rouleau Director of the Montreal Neurological Institute-Hospital (The Neuro); Professor & Chair of the Department of Neurology and Neurosurgery, McGill University; Director of the Department of Neuroscience, McGill University Health Center

Awarded "For identifying and elucidating the genetic architecture of neurological and psychiatric diseases, including ALS, autism and schizophrenia, and his leadership in the field of Open Science."

The Work: Dr. Rouleau has identified over 20 genetic risk factors predisposing to a range of brain disorders, both neurological and psychiatric, involving either neurodevelopmental processes or degenerative events. He has defined a novel disease mechanism for diseases related to repeat expansions that are at play in some of the most severe neurodegenerative conditions. He has significantly contributed to the understanding of the role of de novo variants in autism and schizophrenia. In addition, he has made important advances for various neuropathies, in particular for amyotrophic lateral sclerosis (ALS) where he was involved in the identification of the most prevalent genetic risk factors -which in turn are now the core of innumerable ALS studies worldwide.

Dr. Rouleau has also played a pioneering role in the practice of Open Science (OS), transforming the Montreal Neurological Institute-Hospital (The Neuro) into the first OS institution in the world. The Neuro now uses OS principles to transform research and careand accelerate the development of new treatments for patients through Open Access, Open Data, Open Biobanking, Open Early Drug Discovery and non-restrictive intellectual property.

The Impact: The identification of genetic risk factors has a number of significant consequences. First, allowing for more accurate genetic counselling, which reduces the burden of disease to affected individuals, parents and society. A revealing case is Andermann syndrome, a severe neurodevelopmental and neurodegenerative condition that was once relatively common in the Saguenay-Lac-St-Jean region of Quebec. Now this disease has almost disappeared from that population. Second, identifying the causative gene allows the development of treatments. For instance, his earlier work on a form of ALS linked to the superoxide dismutase-1 gene (SOD1) opened up studies which are now the focal point of phase 2 clinical studies showing great promise.

Byactingasalivinglabforthelast coupleofyears,TheNeuroisspearheading the practice of OpenScience (OS).TheNeurois alsoengagingstakeholdersacross Canadawiththegoal of formalizinganational OSallianceforthe neurosciences.Dr.Rouleau'sworkinOScontributesfundamentallytothetransformationoftheveryecosystemofsciencebystimulatingnewthinkingandfosteringcommunitiesofsharing.InspiredbyTheNeuro'svision,theglobalsciencecommunityisreflecting oncurrentresearchconventionsandcollaborativeprojects,andthemomentumforOSisgainingafootholdinorganizationsandinstitutionsinallcornersoftheearth.

About the Gairdner Foundation:

The Gairdner Foundation was established in 1957 by Toronto stockbroker, James Gairdner to award annual prizes to scientists whose discoveries have had major impact on scientific progress and on human health. Since 1959 when the first awards were granted, 387scientists have received a Canada Gairdner Award and 92 to date have gone on to receive the Nobel Prize.The Canada Gairdner Awards promote a stronger culture of research and innovation across the country through our Outreach Programs including lectures and research symposia. The programs bring current and past laureates to a minimum of 15 universities across Canada to speak with faculty, trainees and high school students to inspire the next generation of researchers. Annual research symposia and public lectures are organized across Canada to provide Canadians access to leading science through Gairdner's convening power.

http://www.gairdner.org

SOURCE Gairdner Foundation

View original content to download multimedia: http://www.newswire.ca/en/releases/archive/March2020/31/c7291.html

Go here to see the original:
2020 Canada Gairdner Awards Recognize World-renowned Scientists for Transformative Contributions to Research That Impact Human Health - Benzinga

The following article is part of conference coverage from the American College of Cardiology (ACC.20) /World Congress of Cardiology. The Cardiology Advisors staff is reporting on research conducted by leading experts in cardiology. Check back for the latest news from the ACC.20.

Renal insufficiency may be linked to reduced circulating progenitor cell (CPC) counts, a factor indicative of impaired regenerative capacity in older adults with coronary artery disease (CAD), according to study results intended to be presented at the annual meeting of the American College of Cardiology (ACC 2020).

Anurag Mehta, MBBS, from the Emory University School of Medicine, Atlanta, Georgia, and colleagues estimated the number of CPCs with flow cytometry. CPCs were CD45med+ cells with a single nucleus expressing epitopes for CD34 and CD133. The samples of 1281 patients with CAD (mean age, 66 years; 39% women; 21% black) were analyzed. The association between renal insufficiency (ie, estimated glomerular filtration rate <60 mL/min/1.73 m2) and log-transformed CPC counts was examined using adjusted linear regression models. Furthermore, using adjusted Cox models, the investigators assessed the predictive value of CPC counts for cardiovascular death or myocardial infarction during a 3.5-year median follow-up period.

In unadjusted analyses renal insufficiency wasfound to be associated with lower counts of CD34+ cells (-10.1%; 95%CI, -16.9% to -2.8%; P =.008) and withlower counts of CD34+/CD133+ cells (-11.4%; 95% CI,-19.4% to -2.6%; P =.13) in 446patients.

After adjusting for age, renal insufficiencywas independently associated with lower counts of CD34+ cells (14.5%;95% CI, -24.4% to -3.4%; P =.012) andwith lower counts of CD34+/CD133+ cells (-15.7%; 95% CI,-28.7% to -0.4%; P =.045) in patients70 years. Patients with renal insufficiency who had counts below the medianfor CD34+ or CD34+/CD133+ cells were found tobe at a higher risk for adverse events (adjusted hazard ratio, 1.76; 95% CI,1.24-2.52 and adjusted hazard ratio, 1.80; 95% CI, 1.26-2.56, respectively).Notably, patients with renal insufficiency and CPC counts above the medianvalue had a similar risk for cardiovascular death or myocardial infarctioncompared with patients without renal insufficiency.

The investigators concluded, Impairedregenerative capacity in patients with CAD and [renal insufficiency] independentlypredicts cardiovascular risk.

Reference

Mehta A, Tahhan AS, Liu C, et al. Impaired regenerative capacity predicts outcomes in patients with coronary artery disease and renal insufficiency. Intended to be presented at: American College of Cardiology 69th Annual Scientific Session; March 28-30, 2020; Chicago, IL. Presentation 915-07. Accessed March 24, 2020.

Visit The Cardiology Advisors conference section for coverage intended to be presented at the annual meeting of the American College of Cardiology (ACC.20)/World Congress of Cardiology

See the original post:
Renal Insufficiency May Be Associated With Impaired Regenerative Capacity in CAD - The Cardiology Advisor

NEW YORK, March 30, 2020 (GLOBE NEWSWIRE) -- Results from a sub-study of 70 patients with end-stage ischemic heart failure and a Left Ventricular Assist Device (LVAD), of 159 randomized patients who received either Mesoblasts allogeneic mesenchymal precursor cell (MPC) product candidate Revascor or saline, were presented on March 28 at the American College of Cardiology (ACC) Virtual Scientific Sessions. The full results from these 70 patients will be published in a peer-reviewed journal.

When compared to controls, in MPC recipients:

The conclusions were:

End-stage ischemic heart failure patients with LVADs are older and have co-morbidities such as diabetes, thereby closely resembling the majority of patients in Mesoblasts 566-patient Phase 3 trial for advanced chronic heart failure, planned to readout in mid-2020.

Revascor is being developed for use in end-stage ischemic heart failure patients with LVADs under existing FDA Regenerative Medicine Advanced Therapy (RMAT) and Orphan Drug Designations.

About Mesoblast Mesoblast Limited (Nasdaq:MESO; ASX:MSB) is a world leader in developing allogeneic (off-the-shelf) cellular medicines. The Company has leveraged its proprietary mesenchymal lineage cell therapy technology platform to establish a broad portfolio of commercial products and late-stage product candidates. Mesoblasts proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide.

Mesoblast has filed a Biologics License Application to the United States Food and Drug Administration (FDA) to seek approval of its product candidate RYONCIL (remestemcel-L) for steroid-refractory acute graft versus host disease (acute GvHD). Remestemcel-L is also being developed for other rare diseases. Mesoblast is completing Phase 3 trials for its product candidates for advanced heart failure and chronic low back pain. If approved, RYONCIL is expected to be launched in the United States in 2020 for pediatric steroid-refractory acute GVHD. Two products have been commercialized in Japan and Europe by Mesoblasts licensees, and the Company has established commercial partnerships in Europe and China for certain Phase 3 assets.

Mesoblast has a strong and extensive global intellectual property (IP) portfolio with protection extending through to at least 2040 in all major markets. This IP position is expected to provide the Company with substantial commercial advantages as it develops its product candidates for these conditions.

Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see http://www.mesoblast.com, LinkedIn: Mesoblast Limited and Twitter: @Mesoblast

Forward-Looking Statements This announcement includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward- looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward- looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. Forward-looking statements include, but are not limited to, statements about the timing, progress and results of Mesoblasts preclinical and clinical studies; Mesoblasts ability to advance product candidates into, enroll and successfully complete, clinical studies; the timing or likelihood of regulatory filings and approvals; and the pricing and reimbursement of Mesoblasts product candidates, if approved. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblasts actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise.

Release authorized by the Chief Executive.

For further information, please contact:

See the article here:
Clinical Outcomes Of Mesoblast's Cell Therapy In End-stage Ischemic Heart Failure Presented At American College Of Cardiology Virtual Scientific...

Covington-based CTIClinical Trial and Consulting Services has partnered with California-based Humanigen, Inc. on a study for the treatment of novel coronavirus 2019 (COVID-19).

Humanigen, Inc., (HGEN) (Humanigen), a clinical-stage biopharmaceutical company focused on preventing and treating cytokine storm with lenzilumab, the companys proprietary Humaneered anti-human-granulocyte-macrophage colony-stimulating factor (GM-CSF) monoclonal antibody, announced that the company has submitted an initial protocol synopsis to the FDA in support of the companys plans to initiate a multi-center, US, Phase III study in COVID-19 patients.

The study, if approved, will be a randomized, controlled, clinical trial with lenzilumab for the prevention of ARDS and/or death in hospitalized patients with pneumonia associated with coronavirus 2 (SARS-CoV-2) infection in COVID-19.

The study will be conducted in partnership with CTI, which specializes in complex programs for critically and chronically ill patients.

Humanigen, Inc. is developing its portfolio of clinical and pre-clinical therapies for the treatment of cancers and infectious diseases via its novel, cutting-edge GM-CSF neutralization and gene-knockout platforms.

Humanigen has pioneered the field of GM-CSF neutralization and, unlike others, has already conducted two Phase I and two Phase II studies, including in patients with severe respiratory conditions, with excellent safety results, said Dr. Cameron Durrant, chief executive officer of Humanigen. We have been working on prevention of cytokine storm for nearly three years. Lenzilumab has an excellent safety and tolerability profile and has not been associated with serious adverse events, including in patients who are immunosuppressed or with severe asthma. Subject to discussion and agreement with regulatory authorities, we intend to progress as quickly as possible with this study.

More details on the companys programs in COVID-19 can be found on the companys websiteunder the COVID-19 tab.

CTI Clinical Trial and Consulting Services is a global, privately held, full-service contract research organization (CRO).

It delivers a complete spectrum of clinical trial and consulting services throughout the lifecycle of development, from concept to commercialization.

CTIs focused therapeutic approach provides pharmaceutical, biotechnology, and medical device firms with clinical and disease area expertise in rare diseases, regenerative medicine/gene therapy, immunology, transplantation, nephrology, hematology/oncology, neurology, infectious diseases, hepatology, cardiopulmonary, and pediatric populations.

Schroeder

The COVID-19 pandemic demands an unprecedented response from the pharmaceutical and biotechnology communities, requiring innovation, collaboration, and prioritization of speed without the cost of safety, remarked Tim Schroeder, founder and CEO of CTI. We are proud to have the opportunity to collaborate on such a response with the Humanigen team and to work together to develop an effective treatment solution for those hardest hit by COVID-19.

CTI also offers a fully integrated multi-specialty clinical research site that conducts phase I-IV trials. CTI has a passion for helping life-changing therapies succeed in chronically and critically ill patient populations. With clinical trial experience across 6 continents, CTI partners with research sites, patients, and sponsors to fulfill unmet medical needs. CTI is headquartered in the Greater Cincinnati, OH area, with operations across North America, Europe, Latin America, and Asia-Pacific.

For more information on CTI, click here.

Study to tackle leading cause of death in COVID-19 patients

Lenzilumab, a monoclonal antibody that neutralizes granulocyte macrophage colony stimulating factor (GM-CSF)

GM-CSF is up-regulated in COVID-19 patients and may cause a harmful immune response leading to acute respiratory distress syndrome (ARDS)

Clinical evidence suggests that this harmful immune response contributes to cytokine storm in COVID-19 patients at risk of developing ARDS

Company plans to study lenzilumab in COVID-19 patients to prevent ARDS and mortality with CTI Clinical Trial and Consulting Services (CTI)

COVID-19 is an infectious disease caused by SARS-CoV-2. COVID-19 has become a global pandemic, with over 460,000 confirmed cases and over 21,000 deaths reported to date. Patients with severe cases of COVID-19 experience severe viral pneumonia that can progress to acute respiratory distress syndrome (ARDS) and death.

ARDS is an acute, life-threatening inflammatory lung injury characterized by hypoxia a lack of oxygen to the tissue and stiff lungs due to increased pulmonary vascular permeability. ARDS necessitates hospitalization and mechanical ventilation. A rapid increase in patients with ARDS presents a major challenge for the global public health system given limited hospital beds and ventilators. When implementing standard of care, including mechanical ventilation, ARDS has an overall mortality rate of greater than 40 percent.

Humanigen, Inc. study is focused on the belief that its GM-CSF neutralization and gene-editing platform technologies have the potential to reduce the inflammatory cascade associated with coronavirus infection as well as the serious and potentially life-threatening CAR-T therapy-related side effects while preserving and potentially improving the efficacy of the CAR-T therapy itself, thus breaking the efficacy/toxicity linkage.

The companys immediate focus is to prevent or minimize the cytokine storm that precedes severe lung dysfunction and ARDS in cases of pneumonia-associated SARS-CoV-2 infection and also in combining FDA-approved and development stage CAR-T therapies with lenzilumab, the companys proprietary Humaneered anti-human-GM-CSF immunotherapy, which is its lead product candidate.

CTI

Originally posted here:
Covington-based CTI partners with Humanigen for study of Lenzilumab for treatment of Coronavirus - User-generated content

TORONTO , March 31, 2020 /CNW/ - The Gairdner Foundation is pleased to announce the 2020 Canada Gairdner Award laureates, recognizing some of the world's most significant biomedical research and discoveries. During these challenging times, we believe it is important to celebrate scientists and innovators from around the world and commend them for their tireless efforts to conduct research that impacts human health.

2020 Canada Gairdner International AwardThe five 2020 Canada Gairdner International Award laureates are recognized for seminal discoveries or contributions to biomedical science:

Dr. Masatoshi Takeichi Senior Visiting Scientist, RIKEN Center for Biosystems Dynamics Research, Kobe, Japan ; Professor Emeritus, Kyoto University , Kyoto, Japan

Dr. Rolf Kemler Emeritus Member and Director, Max Planck Institute of Immunobiology and Epigenetics, Freiburg, Germany

Awarded "For their discovery, characterization and biology of cadherins and associated proteins in animal cell adhesion and signalling."

Dr. Takeichi

The Work: The animal body is made up of numerous cells. Dr. Takeichi was investigatinghow animal cells stick together to form tissues and organs, and identified a key protein which he named 'cadherin'.Cadherin is present on the surface of a cell and binds to the same cadherin protein on the surface of another cell through like-like interaction, thereby binding the cells together. Without cadherin, cell to cell adhesion becomes weakened and leads to the disorganization of tissues. Dr. Takeichi found that there are multiple kinds of cadherin within the body, each of which are made by different cell types, such as epithelial and neuronal cells. Cells with the same cadherins tend to cluster together, explaining the mechanism of how different cells are sorted out and organized to form functional organs.

Further studies by Dr. Takeichi's group showed that cadherin function is supported by a number of cytoplasmic proteins, includingcatenins, and their cooperation is essential for shaping of tissues. His studies also revealed that the cadherin-dependent adhesion mechanism is involved in synaptic connections between neurons, which are important for brain wiring.

Dr. Kemler

The Work: Dr. Kemler, using an immunological approach, developed antibodies directed against surface antigens of early mouse embryos. These antibodies were shown to prevent compaction of the mouse embryo and interfered with subsequent development. Both Dr. Kemler and Dr. Takeichi went on to clone and sequence the gene encoding E-cadherin and demonstrate that it was governing homophilic cell adhesion.

Dr. Kemler also discovered the other proteins that interact with the cadherins, especially the catenins, to generate the machinery involved in animal cell-to-cell adhesion. This provided the first evidence of their importance in normal development and diseases such as cancer. It has been discovered that cadherins and catenins are correlated to the formation and growth of some cancers and how tumors continue to grow. Beta catenin is linked to cell adhesion through interaction with cadherins but is also a key component of the Wnt signalling pathway that is involved in normal development and cancer. There are approximately 100 types of cadherins, known as the cadherin superfamily.

Dr. Takeichi

The Impact: The discovery of cadherins, which are found in all multicellular animalspecies, has allowed us to interpret how multicellular systems are generated and regulated. Loss of cadherin function has been implicated as the cause of certain cancers, as well as in invasiveness of many cancers. Mutations in special types of cadherin result in neurological disorders, such as epilepsy and hearing loss. The knowledge of cadherin function is expected to contribute to the development of effective treatments against such diseases.

Dr. Kemler

The Impact: Human tumors are often of epithelial origin. Given the role of E-cadherin for the integrity of an epithelial cell layer, the protein can be considered as a suppressor of tumor growth. The research on the cadherin superfamily has had great impact on fields as diverse as developmental biology, cell biology, oncology, immunology and neuroscience. Mutations in cadherins/catenins are frequently found in tumors. Various screens are being used to identify small molecules that might restore cell adhesion as a potential cancer therapy.

Dr. Roel Nusse Professor & Chair, Department of Developmental Biology; Member, Institute for StemCell Biology andRegenerativeMedicine, Stanford University , School of Medicine. Virginia and Daniel K. Ludwig Professor of Cancer Research. Investigator, Howard Hughes Medical Institute

Awarded"For pioneering work on the Wnt signaling pathway and its importance in development, cancer and stem cells"

The Work: Dr. Nusse's research has elucidated the mechanism and role of Wnt signaling, one of the most important signaling systems in development. There is now abundant evidence that Wnt signaling is active in cancer and in control of proliferation versus differentiation of adult stem cells, making the Wnt pathway one of the paradigms for the fundamental connections between normal development and cancer.

Among Dr. Nusse's contributions is the original discovery of the first Wnt gene (together with Harold Varmus) as an oncogene in mouse breast cancer. Afterwards Dr. Nusse identified the Drosophila Wnt homolog as a key developmental gene, Wingless. This led to the general realization of the remarkable links between normal development and cancer, now one of the main themes in cancer research. Using Drosophila genetics, he established the function of beta-catenin as a mediator of Wnt signaling and the Frizzleds as Wnt receptors (with Jeremy Nathans ), thereby establishing core elements of what is now called the Wnt pathway. A major later accomplishment of his group was the first successful purification of active Wnt proteins, showing that they are lipid-modified and act as stem cell growth factors.

The Impact: Wnt signaling is implicated in the growth of human embryos and the maintenance of tissues. Consequently, elucidating the Wnt pathway is leading to deeper insights into degenerative diseases and the development of new therapeutics. The widespread role of Wnt signaling in cancer is significant for the treatment of the disease as well. Isolating active Wnt proteins has led to the use of Wnts by researchers world-wide as stem cell growth factors and the expansion of stem cells into organ-like structures (organoids).

Dr. Mina J. Bissell Distinguished Senior Scientist, Biological Systems and Engineering Division, Lawrence Berkeley National Laboratory; Faculty; Graduate Groups in Comparative Biochemistry, Endocrinology, Molecular Toxicology and Bioengineering, University of California Berkeley , Berkeley, CA , USA

Awarded "For characterizing "Dynamic Reciprocity" and the significant role that extracellular matrix (ECM) signaling and microenvironment play in gene regulation in normal and malignant cells, revolutionizing the fields of oncology and tissue homeostasis."

The Work: Dr. Mina Bissell's career has been driven by challenging established paradigms in cellular and developmental biology. Through her research, Dr. Bissell showed that tissue architecture plays a dominant role in determining cell and tissue phenotype and proposed the model of 'dynamic reciprocity' (DR) between the extracellular matrix (ECM) and chromatin within the cell nucleus. Dynamic reciprocity refers to the ongoing, bidirectional interaction between cells and their microenvironment. She demonstrated that the ECM could regulate gene expression just as gene expression could regulate ECM, and that these two phenomena could occur concurrently in normal or diseased tissue.

She also developed 3D culture systems to study the interaction of the microenvironment and tissue organization and growth, using the mammary gland as a model.

The Impact:Dr. Bissell's model of dynamic reciprocity has been proven and thoroughly established since its proposal three decades ago and the implications have permeated every area of cell and cancer biology, with significant implications for current and future therapies. Dr. Bissell's work has generated a fundamental and translationally crucial paradigm shift in our understanding of both normal and malignant tissues.

Her findings have had profound implications for cancer therapy by demonstrating that tumor cells can be influenced by their environment and are not just the product of their genetic mutations. For example, cells from the mammary glands grown in two-dimensional tissue cultures rapidly lose their identity, but once placed in proper three-dimensional microenvironments, they regain mammary form and function. This work presages the current excitement about generation of 3D tissue organoids and demonstrates Dr. Bissell's creative and innovative approach to science.

Dr. Elaine Fuchs Howard Hughes Medical Institute Investigator and Rebecca C. Lancefield Professor and Head of the Robin Chemers Neustein Laboratory of Mammalian Cell Biology and Cell Biology; The Rockefeller University , New York, NY , USA

Awarded"For her studies elucidating the role of tissue stem cells in homeostasis, wound repair, inflammation and cancer."

The Work: Dr. Fuchs has used skin to study how the tissues of our body are able to replace dying cells and repair wounds. The skin must replenish itself constantly to protect against dehydration and harmful microbes. In her research, Fuchs showed that this is accomplished by a resident population of adult stem cells that continually generates a shell of indestructible cells that cover our body surface.

In her early research, Fuchs identified the proteins---keratinsthat produce the iron framework of the skin's building blocks, and showed that mutations in keratins are responsible for a group of blistering diseases in humans. In her later work, Fuchs identified the signals that prompt skin stem cells to make tissue and when to stop. In studying these processes, Fuchs learned that cancers hijack the fundamental mechanisms that tissue stem cells use to repair wounds. Her team pursued this parallel and isolated and characterized the malignant stem cells that are responsible for propagating a type of cancer called "squamous cell carcinoma." In her most recent work, she showed that these cells can be resistant to chemotherapies and immunotherapies and lead to tumor relapse.

The Impact: All tissues of our body must be able to replace dying cells and repair local wounds. Skin is particularly adept at performing these tasks. The identification and characterization of the resident skin stem cells that make and replenish the epidermis, sweat glands and hair provide important insights into this fountain of youth process and hold promise for regenerative medicine and aging. In normal tissues, the self-renewing ability of stem cells to proliferate is held in check by local inhibitory signals coming from the stem cells' neighbours. In injury, stimulatory signals mobilize the stem cells to proliferate and repair the wound. In aging, these normal balancing cues are tipped in favour of quiescence. In inflammatory disorders, stem cells become hyperactivated. In cancers, the wound mechanisms to mobilize stem cells are hijacked, leading to uncontrolled tissue growth. Understanding the basic mechanisms controlling stem cells in their native tissue is providing new strategies for searching out refractory tumor cells in cancer and for restoring normalcy in inflammatory conditions.

2020 John Dirks Canada Gairdner Global Health AwardThe 2020 John Dirks Canada Gairdner Global Health Award laureate is recognized for outstanding achievements in global health research:

Professor Salim S. Abdool Karim Director of CAPRISA (Centre for the AIDS Program of Research in South Africa), the CAPRISA Professor in Global Health at Columbia University , New York and Pro Vice-Chancellor (Research) at the University of KwaZulu-Natal, Durban, South Africa

Professor Quarraisha Abdool KarimAssociate Scientific Director of CAPRISA, Professor in Clinical Epidemiology, Columbia University , New York and Professor in Public Health at the Nelson Mandela Medical School and Pro Vice-Chancellor (African Health) at the University of KwaZulu-Natal, Durban, South Africa

Awarded"For their discovery that antiretrovirals prevent sexual transmission of HIV, which laid the foundations for pre-exposure prophylaxis (PrEP), the HIV prevention strategy that is contributing to the reduction of HIV infection in Africa and around the world."

The Work: UNAIDS estimates that 37 million people were living with HIV and 1.8 million people acquired HIV in 2017. In Africa, which has over two thirds of all people with HIV, adolescent girls and young women have the highest rates of new HIV infections. ABC (Abstinence, Be faithful, and use Condoms) prevention messages have had little impact - due to gender power imbalances, young women are often unable to successfully negotiate condom use, insist on mutual monogamy, or convince their male partners to have an HIV test.

In responding to this crisis, Salim and Quarraisha Abdool Karim started investigating new HIV prevention technologies for women about 30 years ago. After two unsuccessful decades, their perseverance paid off when they provided proof-of-concept that antiretrovirals prevent sexually acquired HIV infection in women. Their ground-breaking CAPRISA 004 trial showed that tenofovir gel prevents both HIV infection and genital herpes. The finding was ranked inthe "Top 10 Scientific Breakthroughs of 2010" by the journal, Science. The finding was heralded by UNAIDS and the World Health Organization (WHO) as one of the most significant scientific breakthroughs in AIDS and provided the first evidence for what is today known as HIV pre-exposure prophylaxis (PrEP).

The Abdool Karims have also elucidated the evolving nature of the HIV epidemic in Africa , characterising the key social, behavioural and biological risk factors responsible for the disproportionately high HIV burden in young women. Their identification of the "Cycle of HIV Transmission", where teenage girls acquire HIV from men about 10 years older on average, has shaped UNAIDS policies on HIV prevention in Africa .

The impact: CAPRISA 004 and several clinical trials of oral tenofovir led tothe WHO recommending a daily tenofovir-containing pill for PrEP as a standard HIV prevention tool for all those at high risk a few years later. Several African countries are among the 68 countries across all continents that are currently making PrEP available for HIV prevention. The research undertaken in Africa by this South African couple has played a key role in shaping the local and global response to the HIV epidemic.

2020 Canada Gairdner Wightman AwardThe 2020 Canada Gairdner Wightman Award laureate is a Canadian scientist recognized for outstanding leadership in medicine and medical science throughout their career:

Dr. Guy Rouleau Director of the Montreal Neurological Institute-Hospital (The Neuro); Professor & Chair of the Department of Neurology and Neurosurgery, McGill University ; Director of the Department of Neuroscience, McGill University Health Center

Awarded "For identifying and elucidating the genetic architecture of neurological and psychiatric diseases, including ALS, autism and schizophrenia, and his leadership in the field of Open Science."

The Work: Dr. Rouleau has identified over 20 genetic risk factors predisposing to a range of brain disorders, both neurological and psychiatric, involving either neurodevelopmental processes or degenerative events. He has defined a novel disease mechanism for diseases related to repeat expansions that are at play in some of the most severe neurodegenerative conditions. He has significantly contributed to the understanding of the role of de novo variants in autism and schizophrenia. In addition, he has made important advances for various neuropathies, in particular for amyotrophic lateral sclerosis (ALS) where he was involved in the identification of the most prevalent genetic risk factors -which in turn are now the core of innumerable ALS studies worldwide.

Dr. Rouleau has also played a pioneering role in the practice of Open Science (OS), transforming the Montreal Neurological Institute-Hospital (The Neuro) into the first OS institution in the world. The Neuro now uses OS principles to transform research and careand accelerate the development of new treatments for patients through Open Access, Open Data, Open Biobanking, Open Early Drug Discovery and non-restrictive intellectual property.

The Impact: The identification of genetic risk factors has a number of significant consequences. First, allowing for more accurate genetic counselling, which reduces the burden of disease to affected individuals, parents and society. A revealing case is Andermann syndrome, a severe neurodevelopmental and neurodegenerative condition that was once relatively common in the Saguenay-Lac-St-Jean region of Quebec . Now this disease has almost disappeared from that population. Second, identifying the causative gene allows the development of treatments. For instance, his earlier work on a form of ALS linked to the superoxide dismutase-1 gene (SOD1) opened up studies which are now the focal point of phase 2 clinical studies showing great promise.

Byactingasalivinglabforthelast coupleofyears,TheNeuroisspearheading the practice of OpenScience (OS).TheNeurois alsoengagingstakeholdersacross Canadawiththegoal of formalizinganational OSallianceforthe neurosciences.Dr.Rouleau'sworkinOScontributesfundamentallytothetransformationoftheveryecosystemofsciencebystimulatingnewthinkingandfosteringcommunitiesofsharing.InspiredbyTheNeuro'svision,theglobalsciencecommunityisreflecting oncurrentresearchconventionsandcollaborativeprojects,andthemomentumforOSisgainingafootholdinorganizationsandinstitutionsinallcornersoftheearth.

About the Gairdner Foundation:

The Gairdner Foundation was established in 1957 by Toronto stockbroker, James Gairdner to award annual prizes to scientists whose discoveries have had major impact on scientific progress and on human health. Since 1959 when the first awards were granted, 387scientists have received a Canada Gairdner Award and 92 to date have gone on to receive the Nobel Prize.The Canada Gairdner Awards promote a stronger culture of research and innovation across the country through our Outreach Programs including lectures and research symposia. The programs bring current and past laureates to a minimum of 15 universities across Canada to speak with faculty, trainees and high school students to inspire the next generation of researchers. Annual research symposia and public lectures are organized across Canada to provide Canadians access to leading science through Gairdner's convening power.

http://www.gairdner.org

SOURCE Gairdner Foundation

View original content to download multimedia: http://www.newswire.ca/en/releases/archive/March2020/31/c7291.html

Read more from the original source:
2020 Canada Gairdner Awards Recognize World-renowned Scientists for Transformative Contributions to Research That Impact Human Health - Yahoo Finance

Tissue Regenix Group (AIM:TRX) ('Tissue Regenix' or the 'Company') the regenerative medical devices company, today provides an update in relation to its working capital position and an initial assessment of the impact to its business following the outbreak of COVID-19.

Following the trading update announced on 22 January 2020, Tissue Regenix has successfully implemented various cost control measures, resulting in the Board's belief that the Company's available cash runway will now continue to support its working capital requirements until at least the end of the second week of May 2020.

As previously announced, the Board is endeavouring to secure necessary funding for the Company. The Board is encouraged by a number of ongoing discussions with potential investors which the Board is working to conclude in the near future. However, there is no guarantee that any such discussions will result in near-term funding being made available to the Company. Should this funding not be forthcoming before the Company's available cash runway expires (not expected by the Board to be before the end of the second week of May) then the Board will be required to take action to protect the interests of creditors and which, if necessary, is likely to result in a material reduction in any resulting value attributable to shareholders.

COVID-19

Further announcements will be made at the appropriate time.

For more Information

The person responsible for this announcement is, Gareth Jones, Interim CEO.

About Tissue Regenix

Tissue Regenix is a leading medical devices company in the field of regenerative medicine. Tissue Regenix was formed in 2006 when it was spun-out from the University of Leeds, UK. The company's patented decellularisation ('dCELL') technology removes DNA and other cellular material from animal and human soft tissue leaving an acellular tissue scaffold which is not rejected by the patient's body and can then be used to repair diseased or worn out body parts. Current applications address many critical clinical needs such as sports medicine, heart valve replacement and wound care.

In November 2012 Tissue Regenix Group plc set up a subsidiary company in the United States - 'Tissue Regenix Wound Care Inc.', January 2016 saw the establishment of joint venture GBM-V, a multi- tissue bank based in Rostock, Germany.

In August 2017 Tissue Regenix acquired CellRight Technologies, a biotech company that specializes in regenerative medicine and is dedicated to the development of innovative osteoinductive and wound care scaffolds that enhance healing opportunities of defects created by trauma and disease. CellRight's human osteobiologics may be used in spine, trauma, general orthopedic, foot & ankle, dental, and sports medicine surgical procedures.

See more here:
IP : Tissue Regenix Group plc - Update in relation to working capital position and impact of COVID-19 pandemic - Marketscreener.com

The report on the Global Regenerative Medicine Market has been prepared after conducting a comprehensive research through a systematized methodology. These skills are useful for scrutinizing the market on the terms of outlined research guidelines. Mainly, global Regenerative Medicine market research report covers all the information about the target audience, manufactures, vendors, research papers, products and many more.

Request a sample of this report @ https://www.orbispharmareports.com/sample-request/13701

Keeping a focus on the overall market aspects, and perceptions, this report vastly covers profiles of the companies who have made it big in this particular field along with their sales data and other data. It also suggests the business models, innovations, growth and every information about the big manufacturers that will be present the future market estimates. Every market consists of set of manufacturers, vendors and consumers that gives a definition to the market, its each and every move, achievements. All these are the important subjects required to study the analysis of the global Regenerative Medicine market. It also includes the major market conditions across the globe such as the product profit, price, production, capacity, demand, supply, as well as market growth structure. In addition, this report offers significant data through the SWOT analysis, investment return data, and investment feasibility analysis.

Top Companies Analysis:

J & J (DePuy Synthes)MedtronicZimmerBiometStrykerAllergan(Acelity)MiMedx GroupOrganogenesisFujifilm Cellular DynamicsOsiris TherapeuticsVcanbioCCBCCytoriCelgeneVericel CorporationGuanhao BiotechMesoblastAMAG Pharmaceuticals (CBR)ViaCordCordLifeIntegra LifeSciencesNuvasiveCook BiotechJapan Tissue Engineering

Browse the complete report @ https://www.orbispharmareports.com/global-regenerative-medicine-market-2019-present-status-and-future-opportunities-by-major-companies-typs-and-applications-2024/

The global Regenerative Medicine market report also features a comprehensive quantitative and qualitative evaluation by analysing information collected from market experts and industry participants in the major points of the market value chain. The data offered in global Regenerative Medicine market report is gathered based on the latest industry news, trends, as well as opportunities. This study offers a separate analysis of the major trends in the existing market, mandates and regulations, micro & macroeconomic indicators is also comprised in this report. By doing so, the study estimated the attractiveness of every major segment during the prediction period.

Segmentation by Type:

Cell TherapyTissue EngineeringOthers

Segmentation by Application:

DermatologyCardiovascularCNSOrthopedicOthers

Moreover, the report comprises the analysis of opportunities available in the Regenerative Medicine market on the global level. It also includes the major market conditions across the globe such as the product profit, price, production, capacity, demand, supply, as well as market growth structure.The annual progression for the global Regenerative Medicine market in different regions cannot always be listed down as it will keep changing, thus studying and reviewing markets occasionally becomes vital. In addition, the Regenerative Medicine market report provides a detailed information about the key market players along with the strategies they implemented to gain market existence and develop themselves. The report includes precise market estimations depending on current market status and future market forecasts.

Make an enquiry of this report @ https://www.orbispharmareports.com/enquiry-before-buying/13701

About Us :

Orbis Research (orbisresearch.com) is a single point aid for all your market research requirements. We have vast database of reports from the leading publishers and authors across the globe. We specialize in delivering customized reports as per the requirements of our clients. We have complete information about our publishers and hence are sure about the accuracy of the industries and verticals of their specialization. This helps our clients to map their needs and we produce the perfect required market research study for our clients.

Contact Us :

Hector CostelloSenior Manager Client Engagements4144N Central Expressway,Suite 600, Dallas,Texas 75204, U.S.A.Phone No.: +1 (972)-362-8199; +91 895 659 5155

Link:
Global Regenerative Medicine Market 2019 Present Status and Future Opportunities by Major Companies Typs and Applications 2024 - The Fuel Fox

Regenerative Medicine Market: Snapshot

Regenerative medicine is a part of translational research in the fields of molecular biology and tissue engineering. This type of medicine involves replacing and regenerating human cells, organs, and tissues with the help of specific processes. Doing this may involve a partial or complete reengineering of human cells so that they start to function normally.

Get Sample Copy of the Report @https://www.tmrresearch.com/sample/sample?flag=B&rep_id=1889

Regenerative medicine also involves the attempts to grow tissues and organs in a laboratory environment, wherein they can be put in a body that cannot heal a particular part. Such implants are mainly preferred to be derived from the patients own tissues and cells, particularly stem cells. Looking at the promising nature of stem cells to heal and regenerative various parts of the body, this field is certainly expected to see a bright future. Doing this can help avoid opting for organ donation, thus saving costs. Some healthcare centers might showcase a shortage of organ donations, and this is where tissues regenerated using patients own cells are highly helpful.

There are several source materials from which regeneration can be facilitated. Extracellular matrix materials are commonly used source substances all over the globe. They are mainly used for reconstructive surgery, chronic wound healing, and orthopedic surgeries. In recent times, these materials have also been used in heart surgeries, specifically aimed at repairing damaged portions.

Cells derived from the umbilical cord also have the potential to be used as source material for bringing about regeneration in a patient. A vast research has also been conducted in this context. Treatment of diabetes, organ failure, and other chronic diseases is highly possible by using cord blood cells. Apart from these cells, Whartons jelly and cord lining have also been shortlisted as possible sources for mesenchymal stem cells. Extensive research has conducted to study how these cells can be used to treat lung diseases, lung injury, leukemia, liver diseases, diabetes, and immunity-based disorders, among others.

Global Regenerative Medicine Market: Overview

The global market for regenerative medicine market is expected to grow at a significant pace throughout the forecast period. The rising preference of patients for personalized medicines and the advancements in technology are estimated to accelerate the growth of the global regenerative medicine market in the next few years. As a result, this market is likely to witness a healthy growth and attract a large number of players in the next few years. The development of novel regenerative medicine is estimated to benefit the key players and supplement the markets growth in the near future.

Global Regenerative Medicine Market: Key Trends

The rising prevalence of chronic diseases and the rising focus on cell therapy products are the key factors that are estimated to fuel the growth of the global regenerative medicine market in the next few years. In addition, the increasing funding by government bodies and development of new and innovative products are anticipated to supplement the growth of the overall market in the next few years.

On the flip side, the ethical challenges in the stem cell research are likely to restrict the growth of the global regenerative medicine market throughout the forecast period. In addition, the stringent regulatory rules and regulations are predicted to impact the approvals of new products, thus hampering the growth of the overall market in the near future.

Global Regenerative Medicine Market: Market Potential

The growing demand for organ transplantation across the globe is anticipated to boost the demand for regenerative medicines in the next few years. In addition, the rapid growth in the geriatric population and the significant rise in the global healthcare expenditure is predicted to encourage the growth of the market. The presence of a strong pipeline is likely to contribute towards the markets growth in the near future.

Global Regenerative Medicine Market: Regional Outlook

In the past few years, North America led the global regenerative medicine market and is likely to remain in the topmost position throughout the forecast period. This region is expected to account for a massive share of the global market, owing to the rising prevalence of cancer, cardiac diseases, and autoimmunity. In addition, the rising demand for regenerative medicines from the U.S. and the rising government funding are some of the other key aspects that are likely to fuel the growth of the North America market in the near future.

Furthermore, Asia Pacific is expected to register a substantial growth rate in the next few years. The high growth of this region can be attributed to the availability of funding for research and the development of research centers. In addition, the increasing contribution from India, China, and Japan is likely to supplement the growth of the market in the near future.

Request TOC of the Report @https://www.tmrresearch.com/sample/sample?flag=T&rep_id=1889

Global Regenerative Medicine Market: Competitive Analysis

The global market for regenerative medicines is extremely fragmented and competitive in nature, thanks to the presence of a large number of players operating in it. In order to gain a competitive edge in the global market, the key players in the market are focusing on technological developments and research and development activities. In addition, the rising number of mergers and acquisitions and collaborations is likely to benefit the prominent players in the market and encourage the overall growth in the next few years.

Some of the key players operating in the regenerative medicine market across the globe areVericel Corporation, Japan Tissue Engineering Co., Ltd., Stryker Corporation, Acelity L.P. Inc. (KCI Licensing), Organogenesis Inc., Medtronic PLC, Cook Biotech Incorporated, Osiris Therapeutics, Inc., Integra Lifesciences Corporation, and Nuvasive, Inc.A large number of players are anticipated to enter the global market throughout the forecast period.

About TMR Research:

TMR Research is a premier provider of customized market research and consulting services to business entities keen on succeeding in todays supercharged economic climate. Armed with an experienced, dedicated, and dynamic team of analysts, we are redefining the way our clients conduct business by providing them with authoritative and trusted research studies in tune with the latest methodologies and market trends.

Visit link:
Regenerative Medicine Market Demand, Growth, Opportunities and Analysis Of Top Key Player Forecast To 2025 - Daily Science

FAYETTEVILLE, N.C., March 26, 2020 /PRNewswire/ -- Cyto CBD, the CBD company that created precision medical dosing, is partnering with Cumberland Medical Associates and Purple Lotus Aesthetics to help transition patients from opioid-focused treatments to Cannabidiol (CBD) for chronic pain management.

A highly anticipated study, published in January 2020, in Postgraduate Medicine Journal showed that 53% of chronic pain patients that were on opioids for over a year at least were able to reduce their opioid usage and/or completely discontinue opioids with daily supplementation of CBD in just eight weeks. This is why Dr. Sanjiv Dalvi and his wife, Dr. Sumedha Dalvi, who are both certified Addiction and Regenerative Medicine Specialists, started integrating Cyto CBD into their practice at Cumberland Medical.

"The potential benefits of CBD are undeniable, as we are seeing more and more data to support its use in our chronic pain patients. Additionally, given the holistic nature of the product, we are seeing an improvement in overall quality of life, as patients are getting better sleep and experiencing lower stress levels," said Dr. Sanjiv Dalvi, MD, PhD. "We use Cyto CBD because it is a medical grade product with research to confirm its quality. The company owns the entire production chain, including the farm where the hemp is cultivated, and their pharmaceutical approach to quality gives us confidence in recommending it and using it with our patients."

Cumberland Medical focuses on holistic health, pain management, mental health and sleep medicine. The clinic now serves as a hub where patients can access Cyto CBD products through their team of specialists and/or by purchasing the products in office, for personal use.

"With all of the attention that CBD is getting, it is important to remember that this is a product that is ultimately being ingested or applied to our bodies. That is why CBD products should be no less than medical grade and the reason Cyto CBD is manufactured at facilities that are cGMP certified and fully registered with the FDA," said Dr. Cohin Kakar, Chief Marketing Officer of Cyto CBD. "We are thrilled to bring an alternative therapy to the community in North Carolina that we can confidently endorse as safe with high purity."

Cyto CBD is now available at Cumberland Medical and will be available at their upcoming partner practice, Purple Lotus Aesthetics, scheduled to open in the summer of 2020. To schedule an appointment or learn more, please contact Cumberland Medical at (910) 864-0689 or visit their practice located at 5085 Morganton Road, Suite 100, Fayetteville, NC 28314.

About Cyto CBD Headquartered in Los Angeles, California and part of The Anthos Group, Cyto CBD is exclusively available at clinics and pharmacies that focus on health and medical care. Cyto CBD has pharmacists and physicians on staff, endorsements from physicians all over the world, and they serve on the National Cannabis Industry Association (NCIA) Board. Cyto CBD also won the Global Health & Pharma Award for Most Innovative CBD Company in 2019. Cyto CBD is an educator in the industry, as the team hosts regular educational webinars, keeping the medical community updated and informed around new science in CBD and cannabinoids.

For more on Cyto CBD visit cytocbd.com, and follow on Facebook, Twitter, Instagram.

Go here to see the original:
Cumberland Medical & Purple Lotus Aesthetics Partner With Cyto CBD To Address Opioid Epidemic In North Carolina - The Mountaineer

By A. Rahman Ford, PNN Columnist

No group is more worthy of the revolutionary benefits of stem cell therapy than Americas military veterans. While the U.S. Department of Veterans Affairs (VA) thinks the field is in its infancy and much more research is needed before stem cells are offered as treatment, brave practitioners are stepping forward to help veterans NOW.

Dr. Joseph Kanan and his staff at the Tullahoma Chiropractic Center are providing free stem cell therapy for veterans who suffer from chronic pain. Kanan in partnership with Veterans in Pain recently performed his first pro bono procedure on a veteran named Ryan, who has severe hip pain. Stem cell injections into Ryans hip, which are not covered by insurance, normally would have cost $6,500. Ryan got them for free.

I think veterans do a lot for our country and there are very few doctors that are performing medical procedures like this, Kanan told The Tullahoma News. We were very glad to be able to do this for him.

Kanan says his Tennessee clinic performs stem cell therapy for veterans twice a month and has had good results so far. One patient was able to avoid a knee replacement and reported consistent improvement one year after the procedure. Patients can expect to experience 10 percent improvement every month for 10 months.

Veterans in Pain is a non-profit that connects military veterans with civilian physicians who provide free regenerative medicine treatments for chronic pain. VIP has provided $250,000 worth of services since 2019.

VIP founder and president Micaela Bensko is herself a stem cell therapy recipient. She spent years in a wheelchair after an accident in her driveway left her with severe spine damage that led to arachnoiditis, a chronic inflammation of spinal nerves. A friend suggested stem cell therapy, which inspired Bensko to establish VIP as a resource for veterans.

Veterans in Pain connects each veteran with a volunteer physician in their area. If one cannot be located, the cost of transportation and accommodations are covered for treatments, as they were for Ryan. Veterans associated with VIP visit schools, organizations and corporations sharing their story of recovery. Most of VIPs funding is provided by small individual donations, grants and grassroots fundraising.

According to the National Institutes of Health, nearly two-thirds of veterans report having chronic pain, with about 9% having severe pain. Chronic pain among veterans is closely associated with mental health conditions such as depression, anxiety, poor sleep and substance abuse disorders. Many veterans suffer from more than one condition.

Because of red tape and a shortage of pain management specialists at the VA, many veterans suffering from chronic pain are left devoid of proper diagnosis and treatment, causing many to self-medicate or search for answers on their own.Chronic pain can lead to substance abuse, a common and growing trend among veterans. A 2017 study found that 30% of military suicides were preceded by alcohol or drug abuse.

The dire plight of military veterans suffering from chronic pain is yet another compelling reason for the FDA to loosen its regulation of stem cell therapy. Our heroes are counting on it.

A. Rahman Ford, PhD, is a lawyer and research professional. He is a graduate of Rutgers University and the Howard University School of Law, where he served as Editor-in-Chief of the Howard Law Journal. Rahman lives with chronic inflammation in his digestive tract and is unable to eat solid food. He has received stem cell treatmentin China.

See the original post here:
Non-Profit Offers Free Stem Cell Therapy to Veterans - Pain News Network

Yewei Jia,1,* Wei He,1,* Hanxiao Zhang,2 Lei He,1 Yanben Wang,1 Tan Zhang,1 Jiaxuan Peng,3 Peng Sun,2 Yu Qian1

1Department of Orthopaedics, Shaoxing Hospital, Zhejiang University School of Medicine, Shaoxing, Zhejiang 312000, Peoples Republic of China; 2The Second Affiliated Hospital and Yuying Childrens Hospital of Wenzhou Medical University, Wenzhou, Zhejiang 325000, Peoples Republic of China; 3Guangxi Key Laboratory of Regenerative Medicine, Guangxi Medical University, Guangxi 530021, Peoples Republic of China

*These authors contributed equally to this work

Correspondence: Yu QianDepartment of Orthopaedics, Shaoxing Hospital, Zhejiang University School of Medicine, Shaoxing, Zhejiang 312000, Peoples Republic of ChinaTel +86 13905754033Email doctor120@hotmail.com

Purpose: Osteoarthritis (OA) is one of the most common degenerative joint diseases in the world, characterized primarily by the progressive degradation of articular cartilage. Accumulating evidence has shown that Morusin, a flavonoid derived from the root bark of Morus alba (mulberry) plants, exerts unique protective properties in several diseases. However, its effects on OA, specifically, have not yet been characterized.Methods: In this study, we evaluated the anti-inflammatory effect of Morusin on mouse chondrocytes and its underlying mechanism in vitro. In addition, the protective effect of Morusin on destabilization of the medial meniscus (DMM) model was also explored in vivo.Results: In vitro, IL-1-induced activation of inflammatory factors (TNF-, IL-6, INOS and COX2) was dramatically suppressed by Morusin. Further, Morusin treatment inhibited the expression of ADAMTS5 and metalloproteinase (MMPs), both of which regulate extracellular matrix degradation. Morusin also decreased IL-1-induced p65 phosphorylation and IB degradation. In vivo, degradation of the articular cartilage following surgical DMM, which mimicked OA pathology, was abrogated following treatment with Morusin, thus demonstrating a protective effect in the DMM model.Conclusion: Herein, we demonstrate that Morusin reduces the OA inflammatory response in vitro and protects against articular cartilage degradation in vivo potentially via regulation of the NF-B pathway. Hence, Morusin may prove to be an effective candidate for novel OA therapeutic strategies.

Keywords: osteoarthritis, chondrocytes, Morusin, IL-1, NF-B pathway

This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License.By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.

Link:
Morusin Ameliorates IL-1-Induced Chondrocyte Inflammation and Os | DDDT - Dove Medical Press

GOLDEN, CO / ACCESSWIRE / March 26, 2020 / Vitro Diagnostics, Inc. (OTC:VODG), dba Vitro Biopharma, announced its 1st quarter ended January 31st, 2020 financial results of operations.

Vitro Diagnostics Inc. ("Vitro Biopharma") is pleased to announce a record 1st comparative quarter in Total Revenues. Vitro Biopharma recorded 1st quarter revenues of $225,921 vs $192,895 an increase of 17% over the same comparative quarter last year. In addition, Stem Cell treatments accounted for 74% of the revenues up from 71% of the revenues in the prior comparative quarter last year. Current quarter stem cell revenues were $167,750 for the 1st quarter ended January 31, 2020 vs $137,123 for the first quarter ended January 31, 2019.

The company's gross profit margins improved to 75% up from 73% in the comparative prior year's quarter. Gross margin improvement is in line with the strategic direction of the company to expand the market of its flagship product AlloRx Stem Cells. The company's clean-room lab expansion last year and expanded Stem Cell manufacturing using its patent-pending cell line, has increased efficiencies and lowered production costs.

Overall operating expenses increased in the quarter to $193,385 from $147,398 in the prior year's comparative quarter. The increase in expenses reflects additional investment as the Company expands its capability to service its strategic direction of offshore Stem Cell treatments while also expanding into US markets. The company expended additional resources on external consultants supporting our regulatory status in maintaining ISO9001 & ISO13485 certifications, expanding our efforts to approach US markets through FDA filings and advancement of existing patent filings.

The company's first quarter is its most seasonal quarter as the period between Thanksgiving and the New Year is slow for all the company's revenue lines of Nutra Vivo/STEMulize, AlloRx Stem Cells, private labeled InfiniVive-MD Stem Cell Serum and our core research products.

During the quarter the company achieved and pursed the following company objectives

During the quarter the company commenced a Series A Convertible Preferred Stock offering to accredited investors under the SEC Regulation D exemption. The preferred Stock is priced at $25 per share which is convertible at $0.25 cents per share for a total of 100 shares. The minimum investment is $50,000 per unit. The company sold $450,000 of the Series A Convertible Preferred Stock during the quarter. The company has additional interest in the offering and subsequent to the quarter has sold an additional $50,000 unit for a total to date of $500,000. The company has additional interested parties for approximately $200,000. The offering is for a total of $1,000,000.

Our partnership with DVC. Stem in the Cayman Islands continued to advance through treatment of new & previous patients. This IRB-approved protocol targets patients with inflammatory conditions including multiple sclerosis, systemic inflammation and new indications including Chrohn's disease, Alzheimer's disease and COPD. To date we have treated 60 patients including repeat treatments. There have been no serious adverse events and we continue to gain evidence of efficacy. One of the initial MS patients has now received a second transplant of our AlloRx Stem Cells and he has reported significant therapeutic benefits of both the initial and subsequent therapy. He had received an earlier transplant of adipose-derived MSCs that was effective, but the improvement lasted 3 months while AlloRx Stem Cell therapy lasted 18 months. We had predicted such a clinical outcome based on significantly higher potency of umbilical cord MSCS compared to those derived from adipose tissue or bone marrow. The Chrohn's disease patient showed significant improvement as did both the AD & COPD patients.

The strategic development of our stem cell therapies involves pursuit of both offshore and domestic markets. The partnership with DVC Stem, our IRB-approved trial in the Bahamas together with other strategic opportunities represent offshore operations & prospects. During Q1 2020, we initiated expansion into US therapeutic markets through development of an Investigational New Drug (IND) application for submission to FDA. Once approved, an IND allows the conduct of clinical trials for specific medical conditions in the US.

Given the current COVID-19 pandemic, our initial IND application is for use of AlloRx Stem Cells in treatment of Coronavirus infections. This is supported by clinical studies showing that 17 critically ill patients responded favorably to IV infusion of umbilical cord-derived MSCs. All patients were receiving assisted ventilation but 3 days following stem cell therapy, were removed from ventilators and subsequently discharged from the hospital. We are pursuing discussions with FDA to establish the appropriate regulatory pathway and expedited review options given the current emergency circumstances. (See Subsequent Events, below, for additional discussion of our COVID-19 response.) Once our initial IND is in place, we have plans for additional INDs for stem cell therapy of musculoskeletal conditions and Alzheimer's disease.

We have received an initial order of AlloRx Stem Cells for testing purposes by PR Medica located in Cabo San Lucas. Given successful test results, we anticipate subsequent new revenue generation from this customer.

Vitro Biopharma's cosmetic topical stem cell serum is being distributed by InfiniVive MD into cosmetic clinics that are providing the topical treatment as a beautification product. To date the company's product is being offered in 10 cosmetic clinics.

Our partner, Dr Jack Zamora, MD was a keynote speaker at a master session at the American Academy of Cosmetic Surgery annual meeting in late February. The topic of his presentation was "Topical Stem Cells, Exosomes and Conditioned Media Serums in Aesthetics." This was the official launch of the InfiniVive-MD platform including: Dailey Serum, Stem Cell Serum 2.0 & Exosomes within the product line. Vitro Biopharma will manufacture & private label these new products for distribution in the US. We anticipate InfiniVive MD growth, development and revenues to mirror the development of Apyx subdermal plasma skin tightening as a cosmetic treatment and technique that has gone global.

http://www.jackzamoramd.com http://www.infinivivemd.com

Our core research product sales continued to expand in Q1 2020. Our facility expansion continued with addition of manufacturing capacity and development of plans to add operational facility to increase outputs further by 100% or more. We were also in discussions with the USPTO regarding our pending patents for our novel stem cell therapy and stem cell activation technology. We continue to work closely with our examiner and have established communication channels to facilitate awards of these patents.

The COVD-19 pandemic is a significant obstacle for all business. However, Vitro Biopharma is uniquely positioned since we have a potential effective therapy. This is based on 3 independent reports showing efficacy of stem cell therapy in 17 COVID-19 patients. All were treated with IV umbilical cord MSCs comparable to AlloRx Stem Cells and all 17 required respiratory assistance but within 3-4 days of treatment, were able to breath without ventilators and were discharged within 14 days. https://www.scmp.com/news/china/society/article/3053080/coronavirus-critically-ill-chinese-patient-saved-stem-cell On the contrary, untreated patients on ventilators have death rates of 50% or more. We have received a formal request to supply AlloRx Stem Cells for compassionate use from a major university medical center and several other potential clinical partners have also expressed interest in using our cells to treat COVID-19 patients. We are presently working with the FDA to gain authority to begin clinical testing in the US. We are currently assessing the overall financial impact of the COVID-19 pandemic on our business, but this depends on overall control of the pandemic. There have been no staff layoffs and our workers are considered essential since we conduct essential research to the COVID-19 response.

Dr. Jim Musick, CEO of Vitro Biopharma, said, "We are very pleased with the increased revenue growth during our first quarter 2020 compared to the prior year However all our resources are currently focused on the emergency response to the COVID-19 pandemic and increasing our inventory of AlloRx to satisfy anticipated emergency demand to treat critically ill COVID-19 patients." The Company is working to get expedited clinical trial approvals to sell our AlloRx Stem Cells to hospitals coping with the pandemic. Vitro is pleased to have recently been recognized by Bioinformant as "a Company Tracking the Coronavirus". https://bioinformant.com/product/coronavirus-covid-19-report/ We anticipate clinical progress in the effectiveness of our stem cell therapies while expecting to see a reduction in our offshore and cosmetic revenues for the next quarter or two. The company is in a good cash position to weather this storm and simultaneously advance its AlloRx stem cell therapies into clinical trials.

In summary, Vitro Biopharma is advancing as a key player in regenerative medicine with 10- years' experience in the development and commercialization of stem cell products for research, recognized by a Best in Practice Technology Innovation Leadership award for Stem Cell Tools and Technology and a growing track record of successful translation to therapy. We are leveraging our proprietary technology platform to the establishment of international Stem Cell Centers of Excellence and regulatory approvals in the US and worldwide.

Sincerely yours,

James R. Musick, PhD.President, CEO & Chairman of the Boardwww.vitrobiopharma.com

Forward-Looking Statements

Statements herein regarding financial performance have not yet been reported to the SEC nor reviewed by the Company's auditors. Certain statements contained herein and subsequent statements made by and on behalf of the Company, whether oral or written may contain "forward-looking statements". Such forward looking statements are identified by words such as "intends," "anticipates," "believes," "expects" and "hopes" and include, without limitation, statements regarding the Company's plan of business operations, product research and development activities, potential contractual arrangements, receipt of working capital, anticipated revenues and related expenditures. Factors that could cause actual results to differ materially include, among others, acceptability of the Company's products in the market place, general economic conditions, receipt of additional working capital, the overall state of the biotechnology industry and other factors set forth in the Company's filings with the Securities and Exchange Commission. Most of these factors are outside the control of the Company. Investors are cautioned not to put undue reliance on forward-looking statements. Except as otherwise required by applicable securities statutes or regulations, the Company disclaims any intent or obligation to update publicly these forward-looking statements, whether as a result of new information, future events or otherwise.

CONTACT:

Dr. James MusickChief Executive OfficerVitro BioPharma(303) 999-2130 Ext. 3E-mail: jim@vitrobiopharma.comwww.vitrobiopharma.com

The company provides its financial information for investor purposes only, the results published are not audited or necessarily SEC or GAAP compliant

The company provides its financial information for investor purposes only, the results published are not audited or necessarily SEC or GAAP compliant

The company provides its financial information for investor purposes only, the results published are not audited or necessarily SEC or GAAP compliant.

The company provides its financial information for investor purposes only, the results published are not audited or necessarily SEC or GAAP compliant.

SOURCE: Vitro Diagnostics, Inc.

View source version on accesswire.com: https://www.accesswire.com/582759/Vitro-Biopharma-First-Quarter-ended-January-31-2020-Financial-Results-of-Operations

Read the original post:
Vitro Biopharma First Quarter ended January 31, 2020 Financial Results of Operations - Benzinga

Newswise When smartphones and social media became ubiquitous for students, cyberbullying rates went up. This makes sense, of course, because there was now an almost limitless number of potential targets and aggressors, said Sameer Hinduja, Ph.D., a professor in the School of Criminology and Criminal Justice within FAUs College for Design and Social Inquiry, and co-director of the Cyberbullying Research Center. Well, during this unprecedented time when theyre all stuck at home, those same students will be using apps even more than they already do with them being forced to use online platforms for learning, regardless of their level of comfort or proficiency. Teachers are delivering education not just in learning management systems like Canvas, Blackboard, and Moodle, but even on Roblox, Twitch, and YouTube, among others.

In the midst of major crises where everyone is already on edge, Hinduja says hostility toward others tends to escalate along with self-preserving and self-defensive behaviors. This may manifest even more so between students in their online interactions their posts, comments, pictures and videos. Some of it will be mild, and some of it will be severe. Some of it will be what students are used to and will not bother them, but some of it will be brand new and a jarring, wounding experience. This may be especially true for those who are not used to learning and interacting in online-only spaces (and may also disproportionately affect more vulnerable populations of youth).

Hinduja cautions that many cyberbullying targets will hesitate to get help from their parents. When it happens, they may suffer silently since there will not be any visual cues for educators to see or investigate because the student is not physically at school. In addition, with everyone now receiving instruction online, students cannot readily stop by the guidance counselors office, chat with a teacher after class, or let their coach know about what is troubling them and affecting their ability to play sports (since youth sports also are shut down). Those opportunities for meaningful, connective conversations and check-ins largely will not happen organically.

Its also very possible that xenophobic/racist cyberbullying may go up. Some continue to call COVID-19 a foreign virus and parents have complained that their children are being accused as carriers just because they are Asian, said Hinduja. Im Asian and have dealt with my share of bullying based on race/ethnicity, and so I am particularly sensitive to this issue and simply do not want to see it spiral out of control.

Hinduja provides a number of suggestions for educators:

Students also are going to struggle with feelings of isolation because they are not able to go to school and connect and interact with their peers in person, said Hinduja.

He also suggests that parents need to be creative to make sure that their children do not suffer from extremes of social isolation:

With intentionality, graciousness, and good will, we dont have to just survive through this crisis. We can actually thrive, and our relationships with the youth we care for can be better off than they were before all of this even began, asserts Hinduja.

Additional information and tips can be found at the Cyberbullying Research Center.

- FAU -

About Florida Atlantic University: Florida Atlantic University, established in 1961, officially opened its doors in 1964 as the fifth public university in Florida. Today, the University, with an annual economic impact of $6.3 billion, serves more than 30,000 undergraduate and graduate students at sites throughout its six-county service region in southeast Florida. FAUs world-class teaching and research faculty serves students through 10 colleges: the Dorothy F. Schmidt College of Arts and Letters, the College of Business, the College for Design and Social Inquiry, the College of Education, the College of Engineering and Computer Science, the Graduate College, the Harriet L. Wilkes Honors College, the Charles E. Schmidt College of Medicine, the Christine E. Lynn College of Nursing and the Charles E. Schmidt College of Science. FAU is ranked as a High Research Activity institution by the Carnegie Foundation for the Advancement of Teaching. The University is placing special focus on the rapid development of critical areas that form the basis of its strategic plan: Healthy aging, biotech, coastal and marine issues, neuroscience, regenerative medicine, informatics, lifespan and the environment. These areas provide opportunities for faculty and students to build upon FAUs existing strengths in research and scholarship. For more information, visit fau.edu.

Read more here:
Another Unintended Consequence of COVID-19: Cyberbullying Could Increase - Newswise

With reliable and impactful research methodologies, Regenerative Medicine Market Research provides critical information pertaining to the growth of the global Regenerative Medicine market. Our team of analysts monitor the ongoing developments within the Regenerative Medicine space and provide an unbiased assessment of the global Regenerative Medicine market. The data included in the report are procured from reliable and trustworthy primary and secondary sources.

According to the findings of the report, the value of the global Regenerative Medicine market in 2018 was ~US$ XX (Mn/Bn) and expected to attain a value of ~US$ XX (Mn/Bn) by the end of 2029. In addition, the report reveals that the global Regenerative Medicine market is likely to grow at a CAGR of XX% during the forecast period (2019-2029).

Request Sample Report @ https://www.marketresearchhub.com/enquiry.php?type=S&repid=2042766&source=atm

Some of the leading companies profiled in the market study include:

The presented market study includes a brief introduction of the Regenerative Medicine market to enhance the reading experience of our users. Further, a thorough quantitative and qualitative analysis of each of these segments is provided in the report along with graphs, tables, and figures to support the data.

The following manufacturers are covered in this report:ABS Protection GmbHMammutClarus CorporationBackcountry AccessScottOrtovoxARVAOsprey PacksThe North FaceDakineMystery RanchMillet(Calida Group)MotorfistDeuter

Regenerative Medicine Breakdown Data by TypeMono Avalanche AirbagsDual Avalanche AirbagsRegenerative Medicine Breakdown Data by ApplicationSkiingClimbingHikingOthers

Regenerative Medicine Production by RegionUnited StatesEuropeChinaJapanSouth KoreaIndiaOther Regions

Regenerative Medicine Consumption by RegionNorth AmericaUnited StatesCanadaMexicoAsia-PacificChinaIndiaJapanSouth KoreaAustraliaIndonesiaMalaysiaPhilippinesThailandVietnamEuropeGermanyFranceUKItalyRussiaRest of EuropeCentral & South AmericaBrazilRest of South AmericaMiddle East & AfricaGCC CountriesTurkeyEgyptSouth AfricaRest of Middle East & Africa

Make An EnquiryAbout This Report @ https://www.marketresearchhub.com/enquiry.php?type=E&repid=2042766&source=atm

Key information drawn from the Regenerative Medicine market study

The market report aims to address the following queries:

You can Buy This Report from Here @ https://www.marketresearchhub.com/checkout?rep_id=2042766&licType=S&source=atm

Originally posted here:
Regenerative Medicine Market Report 2019: With Essential Analysis of Market, Industry News and Policies by Regions, Top Manufacturers, Types and...

Paul Bisaro and Gail Naughton, Ph.D., Appointed as Independent Directors

On behalf of the Board of Directors of TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative, leading womens healthcare company, Chairman Tommy G. Thompson today announced the appointments of Paul Bisaro and Gail Naughton, Ph.D., to the Companys Board of Directors. The appointments fill two of the vacancies created by the resignations from the Board of Brian Bernick, M.D., John C.K. Milligan, IV and Nicholas Segal. Dr. Bernick will continue to serve as a Co-Founder of TherapeuticsMD on a full-time basis, supporting the Companys outreach with healthcare providers. Mr. Milligan will continue to serve as the President of TherapeuticsMD on a full-time basis, leading the Companys infrastructure and critical operations.

"We are very pleased to add Paul and Gail as the newest independent directors to our Board. Each has a wealth of experience as both directors and members of senior management at successful organizations," said former Governor and Secretary of Health and Human Services, Thompson. "This is an exciting time in our companys growth and development, and we believe that Paul and Gails respective skill sets will complement our recent transformation to a commercial organization."

"On behalf of the TherapeuticsMD Board of Directors, I would like to thank Brian, John and Nick for their service to our company," said Thompson. "Brians passion for innovation and persistence in solving patient needs are the reasons we have world-class products. Brian will continue to serve as our Co-Founder and play a key role in our outreach to healthcare providers. Johns commitment and can-do attitude built the infrastructure and critical operations that our Company has today. John will continue to serve as our President and lead our infrastructure and critical operations. Nick and his family were among our early investors and without their vision and commitment we would not be where we are today. We are excited to welcome Paul and Gail to the TherapeuticsMD Board of Directors. Each of them brings significant experience that we believe will activate our next stage of growth."

"I am very pleased and honored to be joining the TherapeuticsMD Board of Directors," said Mr. Bisaro. "I believe TherapeuticsMDs portfolio of differentiated products meets many of the significant unmet needs facing women today. In addition, I believe the Companys vitaCare platform which was created to remove the hassle and lack of visibility that patients often face when dealing with their insurance coverage, reimbursement and supply is a unique capability that supports TherapeuticsMDs patients. I look forward to working with the Board and management team to use these assets to help our patients while continuing to focus on creating long-term value for our shareholders."

Mr. Bisaro is an accomplished global business leader with more than 25 years of generic and branded pharmaceutical experience, and a track record of driving company growth through operational execution and corporate transformation. He has served as Executive Chairman of Allergan, plc (formerly Actavis, plc), President, Chief Executive Officer and a member of the Board of Directors of Actavis (and its predecessor firm Watson Pharmaceuticals, Inc.), Executive Chairman of Amneal Pharmaceuticals, Inc., and President, Chief Executive Officer and a member of the Board of Directors of Impax Laboratories, Inc. until its acquisition by Amneal. He also served as President, Chief Operating Officer and a member of the Board of Directors of Barr Pharmaceuticals, Inc.

"I am honored and delighted to be joining the Board of Directors of TherapeuticsMD. The directors and executives have created innovative products that are poised to greatly enhance womens health and I share in their vision in continuing to develop solutions that will be transformative to healthcare worldwide," said Dr. Naughton.

Dr. Naughton is an accomplished life sciences executive and researcher. Dr. Naughton founded two regenerative medicine companies and is the holder of more than 105 U.S. and foreign patents. She served as the Dean of the College of Business at San Diego State University from 2002-2011. Her current venture, Histogen, is focused on the development of novel solutions based on the products of cells grown under simulated embryonic conditions. She currently serves as Histogens Chief Scientific Officer and Chief Business Development Officer and is the inventor of its core technology. Dr. Naughton has brought several tissue engineered products to market including a product for severe burns (TransCyte), a dermal replacement for diabetic ulcers (Dermagraft), an aesthetic dermal filler (Cosmederm/Cosmeplast) and SkinMedicas TNS product for skin care. Dr. Naughton has been extensively published and is a frequent speaker in the field of tissue engineering and regenerative medicine. In 2000, Dr. Naughton received the 27th Annual National Inventor of the Year award by the Intellectual Property Owners Association in honor of her pioneering work in the field of tissue engineering.

Story continues

"We are thankful to each of Brian, John and Nick for their years of service on our Board and look forward to continuing to work with Brian and John as key members of our leadership team," concluded TherapueticsMD Chief Executive Officer Robert G. Finizio. "As TherapeuticsMD looks to the future, adding two seasoned experts in Mr. Bisaro and Dr. Naughton to the Board while continuing to utilize two proven performers in Dr. Bernick and Mr. Milligan, is an ideal scenario."

About TherapeuticsMD

TherapeuticsMD, Inc. is an innovative, leading healthcare company, focused on developing and commercializing novel products exclusively for women. Our products are designed to address the unique changes and challenges women experience through the various stages of their lives with a therapeutic focus in family planning, reproductive health, and menopause management. The Company is committed to advancing the health of women and championing awareness of their healthcare issues. To learn more about TherapeuticsMD, please visit http://www.therapeuticsmd.com or follow us on Twitter: @TherapeuticsMD and on Facebook: TherapeuticsMD.

Forward-Looking Statements

This press release by TherapeuticsMD, Inc. may contain forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to TherapeuticsMDs objectives, plans and strategies as well as statements, other than historical facts, that address activities, events or developments that the company intends, expects, projects, believes or anticipates will or may occur in the future. These statements are often characterized by terminology such as "believes," "hopes," "may," "anticipates," "should," "intends," "plans," "will," "expects," "estimates," "projects," "positioned," "strategy" and similar expressions and are based on assumptions and assessments made in light of managements experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and the company undertakes no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties, many of which are outside of the companys control. Important factors that could cause actual results, developments and business decisions to differ materially from forward-looking statements are described in the sections titled "Risk Factors" in the companys filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, as well as reports on Form 8-K, and include the following: the effects of the COVID-19 pandemic; the companys ability to maintain or increase sales of its products; the companys ability to develop and commercialize IMVEXXY, ANNOVERA, BIJUVA and its hormone therapy drug candidates and obtain additional financing necessary therefor; whether the company will be able to comply with the covenants and conditions under its term loan facility, including the conditions to draw an additional tranche thereunder and whether the lender will make such tranche available; the potential of adverse side effects or other safety risks that could adversely affect the commercialization of the companys current or future approved products or preclude the approval of the companys future drug candidates; whether the FDA will approve the efficacy supplement for the lower dose of BIJUVA; the companys ability to protect its intellectual property, including with respect to the Paragraph IV notice letters the company received regarding IMVEXXY and BIJUVA; the length, cost and uncertain results of future clinical trials; the companys reliance on third parties to conduct its manufacturing, research and development and clinical trials; the ability of the companys licensees to commercialize and distribute the companys products; the ability of the companys marketing contractors to market ANNOVERA; the availability of reimbursement from government authorities and health insurance companies for the companys products; the impact of product liability lawsuits; the influence of extensive and costly government regulation; the volatility of the trading price of the companys common stock and the concentration of power in its stock ownership. PDF copies of the companys historical press releases and financial tables can be viewed and downloaded at it website: http://www.therapeuticsmd.com/pressreleases.aspx.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200324005366/en/

Contacts

Investor Contact Nichol OchsnerVice President, Investor Relations561-961-1900, ext. 2088Nochsner@TherapeuticsMD.com

Read more:
TherapeuticsMD Strengthens Board with Appointment of Industry Leaders - Yahoo Finance

The positioning of the Global Cell Culture Market vendors in FPNV Positioning Matrix are determined by Business Strategy (Business Growth, Industry Coverage, Financial Viability, and Channel Support) and Product Satisfaction (Value for Money, Ease of Use, Product Features, and Customer Support) and placed into four quadrants (F: Forefront, P: Pathfinders, N: Niche, and V: Vital).

New York, March 25, 2020 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Global Cell Culture Market - Premium Insight, Competitive News Feed Analysis, Company Usability Profiles, Market Sizing & Forecasts to 2025" - https://www.reportlinker.com/p05872141/?utm_source=GNW

The report deeply explores the recent significant developments by the leading vendors and innovation profiles in the Global Cell Culture Market including are Becton, Dickinson and Company, Cellgenix, Corning, Danaher, Eppendorf, Fujifilm Irvine Scientific, GE Healthcare, Hi-Media Laboratories, Invivogen, Lonza Group AG, Merck KGaA, Miltenyi Biotec, Promocell, and Sartorius AG.

On the basis of Product, the Global Cell Culture Market is studied across Consumables and Equipment.

On the basis of Application , the Global Cell Culture Market is studied across Biopharmaceutical Production, Diagnostics, Drug Screening and Development, Stem Cell Research, and Tissue Engineering & Regenerative Medicine.

On the basis of End User , the Global Cell Culture Market is studied across Cell Banks, Hospitals and Diagnostic Laboratories, Pharmaceutical & Biotechnology Companies, and Research Institutes.

For the detailed coverage of the study, the market has been geographically divided into the Americas, Asia-Pacific, and Europe, Middle East & Africa. The report provides details of qualitative and quantitative insights about the major countries in the region and taps the major regional developments in detail.

In the report, we have covered two proprietary models, the FPNV Positioning Matrix and Competitive Strategic Window. The FPNV Positioning Matrix analyses the competitive market place for the players in terms of product satisfaction and business strategy they adopt to sustain in the market. The Competitive Strategic Window analyses the competitive landscape in terms of markets, applications, and geographies. The Competitive Strategic Window helps the vendor define an alignment or fit between their capabilities and opportunities for future growth prospects. During a forecast period, it defines the optimal or favorable fit for the vendors to adopt successive merger and acquisitions strategies, geography expansion, research & development, new product introduction strategies to execute further business expansion and growth.

Research Methodology:Our market forecasting is based on a market model derived from market connectivity, dynamics, and identified influential factors around which assumptions about the market are made. These assumptions are enlightened by fact-bases, put by primary and secondary research instruments, regressive analysis and an extensive connect with industry people. Market forecasting derived from in-depth understanding attained from future market spending patterns provides quantified insight to support your decision-making process. The interview is recorded, and the information gathered in put on the drawing board with the information collected through secondary research.

The report provides insights on the following pointers:1. Market Penetration: Provides comprehensive information on sulfuric acid offered by the key players in the Global Cell Culture Market 2. Product Development & Innovation: Provides intelligent insights on future technologies, R&D activities, and new product developments in the Global Cell Culture Market 3. Market Development: Provides in-depth information about lucrative emerging markets and analyzes the markets for the Global Cell Culture Market 4. Market Diversification: Provides detailed information about new products launches, untapped geographies, recent developments, and investments in the Global Cell Culture Market 5. Competitive Assessment & Intelligence: Provides an exhaustive assessment of market shares, strategies, products, and manufacturing capabilities of the leading players in the Global Cell Culture Market

The report answers questions such as:1. What is the market size of Cell Culture market in the Global?2. What are the factors that affect the growth in the Global Cell Culture Market over the forecast period?3. What is the competitive position in the Global Cell Culture Market?4. Which are the best product areas to be invested in over the forecast period in the Global Cell Culture Market?5. What are the opportunities in the Global Cell Culture Market?6. What are the modes of entering the Global Cell Culture Market?Read the full report: https://www.reportlinker.com/p05872141/?utm_source=GNW

About ReportlinkerReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place.

__________________________

Story continues

Clare: clare@reportlinker.comUS: (339)-368-6001Intl: +1 339-368-6001

Originally posted here:
The Global Cell Culture Market is expected to grow from USD 14,923.23 Million in 2018 to USD 35,236.23 Million by the end of 2025 at a Compound Annual...

Lake Forest Mar 27, 2020 (Thomson StreetEvents) -- Edited Transcript of CryoPort Inc earnings conference call or presentation Thursday, March 5, 2020 at 10:00:00pm GMT

* Jerrell W. Shelton

Cryoport, Inc. - Chairman, President & CEO

* Mark W. Sawicki

Cryoport, Inc. - Chief Commercial Officer

* Robert S. Stefanovich

Cryoport, Inc. - CFO, Treasurer & Corporate Secretary

B. Riley FBR, Inc., Research Division - Senior Analyst

Janney Montgomery Scott LLC, Research Division - MD, Head of Healthcare Research & Senior Equity Research Analyst

SVB Leerink LLC, Research Division - MD of Life Science Tools & Diagnostics and Senior Research Analyst

Kanan, Corbin, Schupak & Aronow, Inc. - Managing Partner

Welcome to the Cryoport, Inc. Full Year 2019 Earnings Conference Call. (Operator Instructions) And the conference is being recorded. (Operator Instructions)

I would now like to turn the conference over to Todd Fromer, the Managing Partner, KCSA. Please go ahead.

Todd Fromer, Kanan, Corbin, Schupak & Aronow, Inc. - Managing Partner [2]

Thank you, operator. Before we begin today, I would like to remind everyone that this conference call contains certain forward-looking statements. All statements that address our operating performance, events or developments that we expect or anticipate occurring in the future are forward-looking statements. These forward-looking statements are based on management's beliefs and assumptions and not on information currently available to our management team. Our management team believes these forward-looking statements are reasonable as and when made. However, you should not place undue reliance on any such forward-looking statements because such statements speak only as of the date when made. We do not undertake any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

In addition, forward-looking statements are subject to certain risks and uncertainties that could cause actual results, events and developments to differ materially from our historical experiences and our present expectations or projections. These risks and uncertainties include, but are not limited to, those described in Item 1A, Risk Factors and elsewhere in our annual report on Form 10-K filed with the Securities and Exchange Commission and those described from time to time in other reports, which we file with the Securities and Exchange Commission.

I would now like to turn the call over to Mr. Jerrell Shelton, Chief Executive Officer of Cryoport. Jerry, the floor is yours.

Jerrell W. Shelton, Cryoport, Inc. - Chairman, President & CEO [3]

Thank you, Todd. Good afternoon, ladies and gentlemen. Thank you for joining us today. With me this afternoon is our Chief Financial Officer, Mr. Robert Stefanovich; and our Chief Commercial Officer, Dr. Mark Sawicki.

As a reminder, we've uploaded our 2019 Year in Review document to our website. It can be found in the Investor Relations section under Events & Presentations. This document provides a review of our recent financial and operational performance and a general business outlook. So if you have not had a chance to read it, I would encourage you to go to the website and download it.

As with previous quarters, on this conference call, we will provide you with a brief general update. And then we'll move to the question-and-answer session, where we will address your queries regarding our company's results.

Now for the update. We reported record revenues of $33.9 million for fiscal year 2019, an increase of 73% from fiscal year 2018. This strong result was driven partly by our commercial agreements supporting Gilead's YESCARTA and Novartis' KYMRIAH, which contributed $8.3 million in the 12-month period, an increase of 295% or $6.2 million compared with the prior year. Revenue from our commercial agreements is expected to continue to grow throughout 2020 and will include revenue from the commercial launch of bluebird bio's ZYNTEGLO, commencing during the first quarter of 2020.

A record total of 5 Cryoport-supported Marketing Authorization Applications and Biologics Licensing Applications were filed during the fourth quarter of 2019. We expect approximately 10 additional Cryoport-supported MAAs and BLAs to be filed in 2020 based on internal information and forecasts from the Alliance for Regenerative Medicine.

As the number of cell and gene therapies and clinical trials increased, we secured new clients and expanded our market share with the global regenerative medicine market. During our fourth quarter, we added a net total of 11 clinical trials, bringing the total number of regenerative therapy clinical trials supported by Cryoport to a record 436, of which 56 are currently in Phase III compared with 357 trials at the end of 2018, of which 47 were in Phase III.

During the year, to further advance our leadership position, we invested in enhancing our platform by entering the biostorage market with the acquisition of Cryogene and launching the first ever Cryoport Express Advanced Therapy Shipper product line, which guarantees each shipper has been used only for human use, is cleaned with 99.9999% effectiveness and provides complete traceability of all equipment, components and commodities. As a result of these investments last year, we're now providing our global clients with an expanded platform of critical solutions that include both highly differentiated temperature-controlled logistics and biostorage services.

With the regenerative medicine market growing rapidly, Cryoport is developing the network of partners, processes and systems that support a Compliance Unified Ecosystem within the life sciences industry. We have successfully secured several top-tier partnerships, including Lonza, Vineti, McKesson, EVERSANA and further integrating other solutions into the life sciences industry by providing scalable, standardized and compliant solutions focused on the supply chain of regenerative therapies.

In 2020, we are continuing to expand our global supply chain network and platform of advanced therapies for life sciences, including through the build-out of Global Supply Chain Centers in Morris Plains, New Jersey; and Houston, Texas. We believe that Cryoport's strong business model and balance sheet has us well positioned for both continued organic and acquisitive growth. Our market-leading position and superior technology platforms also give us the ability to scale our operations and to expand our support of the global regenerative medicine ecosystem as the market continues to demonstrate rapid and accelerating growth.

Now I'll turn the call over to the operator to open the telephone lines for your questions and our answers.

================================================================================

Questions and Answers

--------------------------------------------------------------------------------

Operator [1]

--------------------------------------------------------------------------------

(Operator Instructions) Our first question comes from Brandon Couillard with Jefferies.

--------------------------------------------------------------------------------

Unidentified Analyst, [2]

--------------------------------------------------------------------------------

This is [Matt] on for Brandon. First one, if we look at the clinical trial revenues or the noncommercial biopharma revenues, essentially flat in the second half of the year versus the first half of the year, even though you added more than 20 new clinical trials in the -- versus the first half. Can you just help us reconcile the trend of your ongoing growth in supported clinical trials across the 3 phases? Is it simply timing issues as the trials transition and ramp from their various clinical phases? And then as a follow-up to that, are the ballpark revenue ranges or bands you have historically laid out by clinical trial phases still relevant today?

--------------------------------------------------------------------------------

Jerrell W. Shelton, Cryoport, Inc. - Chairman, President & CEO [3]

--------------------------------------------------------------------------------

Yes. So there's not all of that in the answer, but I'm going to turn that over to Mark Sawicki to answer the question.

--------------------------------------------------------------------------------

Mark W. Sawicki, Cryoport, Inc. - Chief Commercial Officer [4]

--------------------------------------------------------------------------------

Yes, thanks. So the bottom line on clinical trial activity and associated revenue is that we use clinical trials as a pipeline for ultimately commercial revenue, which has by far a larger revenue basis associated with a given program and cycle. Clinical does, in its inherent nature, have more volatility. And volatility can be associated with interruptions in trials, holds between phases or terminations due to lack of progression, which obviously, we outlined in the earnings release.

--------------------------------------------------------------------------------

Unidentified Analyst, [5]

--------------------------------------------------------------------------------

And then on the biostorage side, you made some progress cross-selling to your existing customer base there and recently onboarded several clients to the Cryogene platform. Curious if you can just kind of provide any initial feedback, what it is about their offering that's resonating with your customers? And then anything you're penciling in for 2020 in terms of revenue synergies from Cryogene?

--------------------------------------------------------------------------------

Jerrell W. Shelton, Cryoport, Inc. - Chairman, President & CEO [6]

--------------------------------------------------------------------------------

You want to take that, Mark?

--------------------------------------------------------------------------------

Mark W. Sawicki, Cryoport, Inc. - Chief Commercial Officer [7]

--------------------------------------------------------------------------------

Sure. So we're absolutely seeing crossover between the Cryoport and Cryogene businesses, which is one of the reasons we moved forward with the acquisition last year. And we do believe that, that will accelerate in this fiscal year. The primary driver behind that is folks moving towards an integrated or a single-supplier supply chain, so they want to not only be able to support the distribution aspects through our supply chain logistics platform, but also storage.

--------------------------------------------------------------------------------

Operator [8]

--------------------------------------------------------------------------------

The next question comes from Puneet Souda with SVB Leerink.

--------------------------------------------------------------------------------

Puneet Souda, SVB Leerink LLC, Research Division - MD of Life Science Tools & Diagnostics and Senior Research Analyst [9]

--------------------------------------------------------------------------------

So Jerry, first one for you and maybe

Mark can chime in into it too. Wanted to understand why commercial revenue was stepping down here when revenue for both the commercial therapies were up. Can you provide maybe how much of that was ASP driven? Or is there some other dynamic that we're unclear on? And just wanted to understand if -- how is that shaping up in the first quarter.

--------------------------------------------------------------------------------

Jerrell W. Shelton, Cryoport, Inc. - Chairman, President & CEO [10]

--------------------------------------------------------------------------------

Yes. Yes, that is a good question, Puneet. The commercial revenues that we report are divided into 2 primary categories. One of these is patient and shipping-related revenues. And the second category is services, where, for example, our customers asked us for consulting or lane validations or custom secondary packaging or program management and that sort of thing. So in the fourth quarter, there was a bit of a drop from the third quarter revenue as a result of the nonshipping services-related revenue dropping.

--------------------------------------------------------------------------------

Puneet Souda, SVB Leerink LLC, Research Division - MD of Life Science Tools & Diagnostics and Senior Research Analyst [11]

--------------------------------------------------------------------------------

And would you expect that to recover again here in the first quarter? Or what's your expectation on that revenue? Or is that something we should expect to decline through the year?

--------------------------------------------------------------------------------

Jerrell W. Shelton, Cryoport, Inc. - Chairman, President & CEO [12]

--------------------------------------------------------------------------------

It's a constant flow. It just had a drop in that last quarter. But it's -- there's constantly activity in these areas. There's always a need here.

This is evolving -- this is an evolving space. And so it's just -- it's going to continue to develop.

--------------------------------------------------------------------------------

Mark W. Sawicki, Cryoport, Inc. - Chief Commercial Officer [13]

--------------------------------------------------------------------------------

Yes. Puneet, it's -- as Jerry has said -- yes, the numbers will rebound.

--------------------------------------------------------------------------------

Puneet Souda, SVB Leerink LLC, Research Division - MD of Life Science Tools & Diagnostics and Senior Research Analyst [14]

--------------------------------------------------------------------------------

Sorry, I didn't catch that. Can you repeat?

--------------------------------------------------------------------------------

Mark W. Sawicki, Cryoport, Inc. - Chief Commercial Officer [15]

--------------------------------------------------------------------------------

I said -- yes, I said the numbers will rebound.

--------------------------------------------------------------------------------

Jerrell W. Shelton, Cryoport, Inc. - Chairman, President & CEO [16]

--------------------------------------------------------------------------------

Mark said the same thing I said in a different way. He just simply said, the numbers will come back if we just had a drop for a quarter in those numbers.

--------------------------------------------------------------------------------

Puneet Souda, SVB Leerink LLC, Research Division - MD of Life Science Tools & Diagnostics and Senior Research Analyst [17]

--------------------------------------------------------------------------------

Okay. All right. And then on clinical trials, I have a bigger question. I mean I appreciate there were 2 high-volume trials that were impacting the quarter. But wanted to get a view into what you're seeing so far in the year. Was that sort of onetime phenomena, one-off phenomena that you saw here? And I understand these are large clinical trials, but any sense that you're getting in 2020 so far on any other trials or a recovery in -- for Phase III trials?

Continued here:
Edited Transcript of CYRX earnings conference call or presentation 5-Mar-20 10:00pm GMT - Yahoo Finance

MIAMI, March 19, 2020 /PRNewswire/ --The American Academy of Stem Cell Physicians has Recommendations for the Treatment of COVID-19. Treatment plans were sent to the WHO representatives and DirectorDr. Tedros Adhanom earlier today.

The following are recommendations of The American Academy of Stem Cell Physicians for treatment of COVID-19:

For Hospitalized Patients (Based on 70KG weight):

1. Intravenous Vitamin C 50 grams QD (Need to check patients for G6PD deficiency before high dose IVC.)2. Zinc 8mg IV QD3. Vitamin D3 100000-150000 IU Intramuscularly QD4. Chloroquine 10mg/kg bid5. Umbilical Cord Blood - 1 million MNC/kg QD6. Nebulizer with Amniotic fluid derived Exosomes 1 Billion/Kg Q4h.

Please note the vitamins and minerals are given at a higher dose than are normally recommended and physicians should do prophylaxis for gastrointestinal protection and add probiotics.

Non-Hospitalized Patients:

1. Zinc 40 mg BID2. Vitamin C 5000mg/day3. Chloroquine 500mg BID initial loading dose of 1000mg4. Vitamin D 5000 IU QD5. Oral iodine 300mg PO bid

6. Dietary and lifestyle recommendations:a. 8oz of water/hourb. No sugarc. More vegetables at each meal.d. Exercise 30 minutes per day.e. Meditate.f. Sleep minimum of 7-8 hours/day.

A spokesman for The American Academy of Stem Cell Physicians, Dr. A.J. Farshchian said earlier today,"The AASCP members have been working on the above protocol this past week. We have to thank all the physicians contributing to this protocol in particular."

Thephysicians are :

Kristine Salter, M.D.Sunny Kim, M.D.Pedro Abrantes, DPMTom Yarema, M.D.Robert Hamilton, M.D.

This protocol is to be tailored for each individual patient. Physicians from around the world are welcome to contact us, as we will continuously be updating this protocol.

For updates, check The American Academy of Stem Cell Physicians website: http://www.aascp.net.

About AASCP

The American Academy of Stem Cell Physicians (AASCP) is an organization created to advance research and the development of therapeutics in regenerative medicine, including diagnosis, treatment, and prevention of disease related to or occurring within the human body. The AASCP aims to serve as an educational resource for physicians, scientists, and the public.

Contact Marie Barba at AASCP.net or305-891-4686.

Related Images

aascp-recommendations-to-treat.jpeg AASCP recommendations to treat Covid-19 AASCP recommendation memo

SOURCE The American Academy of Stem Cell Physicians

Home

The rest is here:
The American Academy of Stem Cell Physicians Recommends a Treatment Protocol for COVID-19 to the WHO - PRNewswire

Global Regenerative Medicine Market was valued US$ XX Bn in 2018 and is expected to reach US$ XX Bn by 2026, at a XX %CAGR of around 24.3% during a forecast period.

Regenerative medicine is an interdisciplinary field of medicine that is used for developing methods to grow, replace or repair diseased or damaged cells, organs, and tissues. Regenerative medicine contains the generation and use of therapeutic stem cells, tissue engineering and the production of artificial organs.

The report covers all the trends and technologies playing a major role in the growth of the regenerative medicine market over the forecast period. It highlights the drivers, restraints, and opportunities expected to influence market growth during 2019-2026.

Global Regenerative Medicine Market

Regenerative medicines are expected to have a major impact on healthcare to treat specific indications and chronic conditions. Therefore, a high prevalence of cancer, neurodegenerative, orthopedic, and other ageing-associated disorders coupled with increasing worldwide geriatric population is driving the market growth. Additionally, increasing prevalence of inheritable genetic diseases is anticipated to fuel the demand in the field of the biotechnology field. However, high treatment costs, operative inefficiency, stringent government regulations, and lack of awareness will restrict the global market for regenerative medicine.

REQUEST FOR FREE SAMPLE REPORT: https://www.maximizemarketresearch.com/request-sample/35229/

The report on global regenerative medicine market covers segments such as type, application and region. Based on application, oncology segment is estimated to witness the fastest XX% CAGR over the forecast period. Many government organizations, as well as private companies, have made high investments in cancer research and development of regenerative & advanced cell therapies. Global efforts to reduce the cancer burden is expected to support the lucrative growth of the oncology segment.North America is the dominating region in the market for regenerative medicine. The major factors promoting regenerative medicine market growth in this region are growing awareness for the use of these medicines to treat various diseases and rising funding line for developing the product line by the private and government organizations.

However, the APAC is considered to grow at a faster rate during the forecast period because of the increasing focus on research and development on regenerative medicine, various government have taken initiative to treat many diseases with the help of regenerative medicines. The report gives a recent development in the market for regenerative medicine like in 2018, Novartis AG received EU approval for one-time gene therapy Luxturna, which has been developed to restore visualization in people with rare and genetically-associated retinal disease. Additionally, in 2017, Integra LifeSciences launched its product, Integra Dermal Regeneration Template Single Layer Thin for dermal repair faults reconstruction in a one-step procedure.

The objective of the report is to present a comprehensive assessment of the market and contains thoughtful insights, facts, historical data, industry-validated market data and projections with a suitable set of assumptions and methodology. The report also helps in understanding Global Regenerative Medicine Market dynamics, structure by identifying and analyzing the market segments and project the global market size. Further, the report also focuses on the competitive analysis of key players by product, price, financial position, product portfolio, growth strategies, and regional presence. The report also provides PEST analysis, PORTERs analysis, and SWOT analysis to address the question of shareholders to prioritizing the efforts and investment shortly to the emerging segment in the Global Regenerative Medicine Market.Scope of the Global Regenerative Medicine Market

DO INQUIRY BEFORE PURCHASING REPORT HERE: https://www.maximizemarketresearch.com/inquiry-before-buying/35229/

Global Regenerative Medicine Market, By Type

Cell-Based Immunotherapy & Cell Therapy Productso Allogeneic Productso Autologous Products Tissue-Engineered Products Gene Therapy ProductsGlobal Regenerative Medicine Market, By Application

Musculoskeletal Disorders Wound Care Oncology Ocular Disorders Diabetes OtherGlobal Regenerative Medicine Market, By Region

North America Europe Asia Pacific Middle East & Africa South AmericaKey Players operating in the Global Regenerative Medicine Market

Integra LifeSciences Corporation Astellas Pharma Inc. Ocata Therapeutics, Inc. Corline Biomedical AB Cook Biotech, Inc. Bayer BV BlueRock Therapeutics AstraZeneca MedImmune F. Hoffmann-La Roche Ltd Pfizer Inc. Merck & Co., Inc. Sigma-Aldrich Co. LLC Abbott St. Jude Medical, Inc. Vericel Corporation Novartis AG Alcon GlaxoSmithKline plc. Baxter. Synovis Micro Companies Alliance Inc Amgen Inc. Eli Lilly and Company Bristol-Myers Squibb Company iPierian, Inc Nuvasive, Inc. Organogenesis, Inc. NuTech MiMedx Group, Inc. Stability, LLC. Takara Bio Inc. Caladrius Biosciences, Inc. U.S. Stem Cell, Inc. Cesca Therapeutics Osiris Therapeutics, Inc

MAJOR TOC OF THE REPORT

Chapter One: Regenerative Medicine Market Overview

Chapter Two: Manufacturers Profiles

Chapter Three: Global Regenerative Medicine Market Competition, by Players

Chapter Four: Global Regenerative Medicine Market Size by Regions

Chapter Five: North America Regenerative Medicine Revenue by Countries

Chapter Six: Europe Regenerative Medicine Revenue by Countries

Chapter Seven: Asia-Pacific Regenerative Medicine Revenue by Countries

Chapter Eight: South America Regenerative Medicine Revenue by Countries

Chapter Nine: Middle East and Africa Revenue Regenerative Medicine by Countries

Chapter Ten: Global Regenerative Medicine Market Segment by Type

Chapter Eleven: Global Regenerative Medicine Market Segment by Application

Chapter Twelve: Global Regenerative Medicine Market Size Forecast (2019-2026)

Browse Full Report with Facts and Figures of Regenerative Medicine Market Report at: https://www.maximizemarketresearch.com/market-report/global-regenerative-medicine-market/35229/

About Us:

Maximize Market Research provides B2B and B2C market research on 20,000 high growth emerging technologies & opportunities in Chemical, Healthcare, Pharmaceuticals, Electronics & Communications, Internet of Things, Food and Beverages, Aerospace and Defense and other manufacturing sectors.

Contact info:

Name: Lumawant Godage

Organization: MAXIMIZE MARKET RESEARCH PVT. LTD.

Email: sales@maximizemarketresearch.com

Contact: +919607065656/ +919607195908

Website: http://www.maximizemarketresearch.com

Read more:
Global Regenerative Medicine Market: Industry Analysis and Forecast (2019-2026): By Type, Application and Region. - Stock Market Herald

HAIFA, Israel, March 17, 2020 (GLOBE NEWSWIRE) -- Pluristem Therapeutics Inc. (PSTI) (PSTI), a leading regenerative medicine company developing a platform of novel biological products, today announced that the Israeli Ministry of Health has approved Pluristems request to seek approvals to treat COVID-19 coronavirus patients under the per-patient compassionate use framework in Israel. The Israeli Ministry of Health may approve proposed treatments on a per-patient basis for the use of PLX cell therapy including intra-muscular (IM) administration of PLX-PAD for the proposed treatment of severe pneumonia resulting from COVID-19 and preventing the deterioration of patients towards Acute Respiratory Distress Syndrome (ARDS) and sepsis. Pluristem has not yet submitted any such request for treatment of a specific COVID-19 patient, and there is no assurance that any such request will be approved by Israeli Ministry of Health.

Pluristem recently announced a collaborative agreement with the BIH Center for Regenerative Therapy (BCRT) and the Berlin Center for Advanced Therapies (BeCAT) at Charit University of Medicine Berlin to evaluate the therapeutic effects of PLX cell product candidates for the potential treatment of the respiratory and inflammatory complications associated with the COVID-19 coronavirus.

Pluristem is highly committed to use its technology, knowledge and expertise in order to attempt to provide a better outcome to patients infected by complications associated with COVID-19. We hope and believe that the ease of use of our PLX cell product candidates, and their being readily available, may play an important role in case there is a need to treat large numbers of patients with respiratory complications. Our collaborative research with Charit of Berlin on our PLX COVID-19 program enables us to accelerate the implementation of our cell therapies candidates towards this indication, as we continue our efforts to expand the program to additional countries, stated Pluristem President and CEO Yaky Yanay.

PLX cells are available off-the-shelf and once commercialized, can be manufactured in large scale quantities, offering a key advantage in addressing a global pandemic. PLX cells are allogeneic mesenchymal-like cells that have immunomodulatory properties that induce the immune systems natural regulatory T cells and M2 macrophages, and thus may prevent or reverse the dangerous overactivation of the immune system. Accordingly, PLX cells may potentially reduce the incidence andor severity of COVID-19 pneumonia and pneumonitis leading hopefully to a better prognosis for the patients. Previous pre-clinical findings of PLX cells revealed therapeutic benefit in animal studies of pulmonary hypertension, lung fibrosis, acute kidney injury and gastrointestinal injury which are potential complications of the severe COVID-19 infection. Clinical data using PLX cells demonstrated the strong immunomodulatory potency of PLX cells in patients post major surgery. Taken together, PLX cells potential capabilities with the safety profile observed from clinical trials involving hundreds of patients worldwide potentially position them as a therapy for mitigating the tissue-damaging effects of COVID-19.

About Pluristem TherapeuticsPluristem Therapeutics Inc. is a leading regenerative medicine company developing novel placenta-based cell therapy product candidates. The Company has reported robust clinical trial data in multiple indications for its patented PLX cell product candidates and is currently conducting late stage clinical trials in several indications. PLX cell product candidates are believed to release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders and radiation damage. The cells are grown using the Company's proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching. Pluristem has a strong intellectual property position; a Company-owned and operated GMP-certified manufacturing and research facility; strategic relationships with major research institutions; and a seasoned management team.

Safe Harbor Statement

This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws. For example, Pluristem is using forward-looking statements when it discusses the potential use of its PLX cell product candidates for the proposed treatment of severe pneumonia resulting from COVID-19 and preventing the deterioration of patients towards ARDS, sepsis and death, its commitment to use its technology, knowledge and expertise in order to attempt to provide a better outcome to patients afflicted by complications associated with COVID-19, its hope and belief that the ease of use of its PLX cell product candidates and their being readily available, may play an important role in case there is a need to treat large numbers of patients with respiratory complications, that its collaborative research with Charit of Berlin on the PLX COVID-19 program enables Pluristem to accelerate the implementation of its cell therapies candidates towards this indication, its intention to continue efforts to expand its PLX COVID-19 program to additional countries, the belief that PLX cells being available off-the-shelf and can be manufactured in large scale quantities, may offer a potential key advantage in addressing a global pandemic and the belief that PLX cells may potentially reduce the incidence andor severity of COVID-19 induced pneumonia and pneumonitis. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristems products may not be approved by regulatory agencies, Pluristems technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristems process; Pluristems products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristems patents may not be sufficient; Pluristems products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem's reports filed from time to time with the Securities and Exchange Commission.

Story continues

Originally posted here:
Israeli Ministry of Health Clears a Path to Allow Per Patient Compassionate Use Treatment of Covid-19 Patients with Pluristems PLX Cells - Yahoo...