StemCell Therapy

'); jQuery('.cart-remove-box a').on('click', function(){ link = jQuery(this).attr('href'); jQuery.ajax({ url: link, cache: false }); jQuery('.cart-remove-box').remove(); setTimeout(function(){window.location.reload();}, 800); }); }); //jQuery('#ajax_loader').hide(); // clear being added addToCartButton.text(defaultText).removeAttr('disabled').removeClass('disabled'); addToCartButton.parent().find('.disabled-blocker').remove(); loadingDots.remove(); clearInterval(loadingDotId); jQuery('body').append(""); setTimeout(function () {jQuery('.add-to-cart-success').slideUp(500)}, 5000); }); } try { jQuery.ajax( { url : url, dataType : 'json', type : 'post', data : data, complete: function(){ if(jQuery('body').hasClass('product-edit') || jQuery('body').hasClass('wishlist-index-configure')){ jQuery.ajax({ url: "https://www.stemcell.com/meigeeactions/updatecart/", cache: false }).done(function(html){ jQuery('header#header .top-cart').replaceWith(html); }); jQuery('#ajax_loader').hide(); jQuery('body').append(""); setTimeout(function () {jQuery('.add-to-cart-success').slideUp(500)}, 5000); } }, success : function(data) { if(data.status == 'ERROR'){ jQuery('body').append(''); }else{ ajaxComplete(); } } }); } catch (e) { } // End of our new ajax code this.form.action = oldUrl; if (e) { throw e; } } }.bind(productAddToCartForm); productAddToCartForm.submitLight = function(button, url){ if(this.validator) { var nv = Validation.methods; delete Validation.methods['required-entry']; delete Validation.methods['validate-one-required']; delete Validation.methods['validate-one-required-by-name']; if (this.validator.validate()) { if (url) { this.form.action = url; } this.form.submit(); } Object.extend(Validation.methods, nv); } }.bind(productAddToCartForm); function setAjaxData(data,iframe,name,image){ if(data.status == 'ERROR'){ jQuery('body').append(''); }else{ if(data.sidebar && !iframe){ if(jQuery('.top-cart').length){ jQuery('.top-cart').replaceWith(data.sidebar); } if(jQuery('.sidebar .block.block-cart').length){ if(jQuery('#cart-sidebar').length){ jQuery('#cart-sidebar').html(jQuery(data.sidebar).find('#mini-cart')); jQuery('.sidebar .block.block-cart .subtotal').html(jQuery(data.sidebar).find('.subtotal')); }else{ jQuery('.sidebar .block.block-cart p.empty').remove(); content = jQuery('.sidebar .block.block-cart .block-content'); jQuery('').appendTo(content); jQuery('').appendTo(content); content.find('#cart-sidebar').html(jQuery(data.sidebar).find('#mini-cart').html()); content.find('.actions').append(jQuery(data.sidebar).find('.subtotal')); content.find('.actions').append(jQuery(data.sidebar).find('.actions button.button')); } cartProductRemove('#cart-sidebar li.item a.btn-remove', { confirm: 'Are you sure you would like to remove this item from the shopping cart?', submit: 'Ok', calcel: 'Cancel' }); } jQuery.fancybox.close(); jQuery('body').append(''); }else{ jQuery.ajax({ url: "https://www.stemcell.com/meigeeactions/updatecart/", cache: false }).done(function(html){ jQuery('header#header .top-cart').replaceWith(html); jQuery('.top-cart #mini-cart li.item a.btn-remove').on('click', function(event){ event.preventDefault(); jQuery('body').append('Are you sure you would like to remove this item from the shopping cart?OkCancel'); jQuery('.cart-remove-box a').on('click', function(){ link = jQuery(this).attr('href'); jQuery.ajax({ url: link, cache: false }); jQuery('.cart-remove-box').remove(); setTimeout(function(){window.location.reload();}, 800); }); }); jQuery.fancybox.close(); jQuery('body').append(''); }); } } setTimeout(function () {jQuery('.add-to-cart-success').slideUp(500)}, 5000); } // The EasySep Human B Cell Enrichment Kit is designed to isolate B cells from fresh or previously frozen peripheral blood mononuclear cells by negative selection. Unwanted cells are targeted for removal with Tetrameric Antibody Complexes recognizing non-B cells and dextran-coated magnetic particles. The labeled cells are separated using an EasySep magnet without the use of columns. Desired cells are poured off into a new tube.

For even faster cell isolations, we recommend the new EasySep Human B Cell Isolation Kit (17954), which isolates cells in just 9 minutes.

Advantages:

Fast, easy-to-use and column-free Up to 99% purity Untouched, viable cells

Magnet Compatibility:

EasySep Magnet (Catalog #18000)

The Big Easy EasySep Magnet (Catalog #18001)

Easy 50 EasySep Magnet (Catalog #18002)

EasyPlate EasySep Magnet (Catalog 18102)

EasyEights EasySep Magnet (Catalog #18103)

RoboSep-S (Catalog #21000)

Subtype:

Cell Isolation Kits

Sample Source:

Leukapheresis; PBMC

Selection Method:

Negative

Application:

Cell Isolation

Area of Interest:

Immunology

Document Type

Product Name

Catalog #

Lot #

Language

Yes. The EasySep kits use either a negative selection approach by targeting and removing unwanted cells or a positive selection approach targeting desired cells. Depletion kits are also available for the removal of cells with a specific undesired marker (e.g. GlyA).

Magnetic particles are crosslinked to cells using Tetrameric Antibody Complexes (TAC). When placed in the EasySep Magnet, labeled cells migrate to the wall of the tube. The unlabeled cells are then poured off into a separate fraction.

The EasySep procedure is column-free. That's right - no columns!

The Product Information Sheet provided with each EasySep kit contains detailed staining information.

Yes. RoboSep, the fully automated cell separator, automates all EasySep labeling and cell separation steps.

Yes. We recommend a cell concentration of 2x108 cells/mL and a minimum working volume of 100 L. Samples containing 2x107 cells or fewer should be suspended in 100 L of buffer.

Yes, the EasySep particles are flow cytometry-compatible, as they are very uniform in size and about 5000X smaller than other commercially available magnetic beads used with column-free systems.

No, but due to the small size of these particles, they will not interfere with downstream applications.

Yes; however, this may impact the kit's performance. The provided EasySep protocols have already been optimized to balance purity, recovery and time spent on the isolation.

Yes, the purity of targeted cells will increase with additional rounds of separations; however, cell recovery will decrease.

If particle binding is a key concern, we offer two options for negative selection. The EasySep negative selection kits can isolate untouched cells with comparable purities, while RosetteSep can isolate untouched cells directly from whole blood without using particles or magnets.

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This product is designed for use in the following research area(s) as part of the highlighted workflow stage(s). Explore these workflows to learn more about the other products we offer to support each research area.

Research Area Workflow Stages for

Workflow Stages

Figure 1. FACS Histogram Results With EasySep Human B Cell Enrichment Kit

Starting with frozen mononuclear cells, the CD19+ cell content of the enriched fraction typically ranges from 95% - 99%.

D. G. W. Alanine et al.

The Plasmodium falciparum reticulocyte-binding protein homolog 5 (PfRH5) is the leading target for next-generation vaccines against the disease-causing blood-stage of malaria. However, little is known about how human antibodies confer functional immunity against this antigen. We isolated a panel of human monoclonal antibodies (mAbs) against PfRH5 from peripheral blood B cells from vaccinees in the first clinical trial of a PfRH5-based vaccine. We identified a subset of mAbs with neutralizing activity that bind to three distinct sites and another subset of mAbs that are non-functional, or even antagonistic to neutralizing antibodies. We also identify the epitope of a novel group of non-neutralizing antibodies that significantly reduce the speed of red blood cell invasion by the merozoite, thereby potentiating the effect of all neutralizing PfRH5 antibodies as well as synergizing with antibodies targeting other malaria invasion proteins. Our results provide a roadmap for structure-guided vaccine development to maximize antibody efficacy against blood-stage malaria.

K. Kwak et al.

Protective antibody responses to vaccination or infection depend on affinity maturation, a process by which high-affinity germinal center (GC) B cells are selected on the basis of their ability to bind, gather, and present antigen to T follicular helper (Tfh) cells. Here, we show that human GC B cells have intrinsically higher-affinity thresholds for both B cell antigen receptor (BCR) signaling and antigen gathering as compared with na{{i}}ve B cells and that these functions are mediated by distinct cellular structures and pathways that ultimately lead to antigen affinity- and Tfh cell-dependent differentiation to plasma cells. GC B cells bound antigen through highly dynamic actin- and ezrin-rich pod-like structures that concentrated BCRs. The behavior of these structures was dictated by the intrinsic antigen affinity thresholds of GC B cells. Low-affinity antigens triggered continuous engagement and disengagement of membrane-associated antigens whereas high-affinity antigens induced stable synapse formation. The pod-like structures also mediated affinity-dependent antigen internalization by unconventional pathways distinct from those of na{"{i}}ve B cells. Thus intrinsic properties of human GC B cells set thresholds for affinity selection."""

D. G. Gonzalez et al.

We examined the unique contributions of the cytokines IL-21 and IL-4 on germinal center (GC) B cell initiation and subsequent maturation in a murine model system. Similar to other reports, we found T follicular helper cell expression of IL-21 begins prior to T follicular helper cell migration into the B cell follicle and precedes that of IL-4. Consistent with this timing, IL-21 signaling has a greater influence on the perifollicular pre-GC B cell transition to the intrafollicular stage. Notably, Bcl6hi B cells can form in the combined absence of IL-21R- and STAT6-derived signals; however, these nascent GC B cells cease to proliferate and are more prone to apoptosis. When B cells lack either IL-21R or STAT6, aberrant GCs form atypical centroblasts and centrocytes that differ in their phenotypic maturation and costimulatory molecule expression. Thus, IL-4 and IL-21 play nonredundant roles in the phased progression of GC B cell development that can initiate in the combined absence of these cytokine signals.

Pé et al.

Type 1 diabetes (T1D) is characterized by a chronic, progressive autoimmune attack against pancreas-specific antigens, effecting the destruction of insulin-producing -cells. Here we show interleukin-2 (IL-2) is a non-pancreatic autoimmune target in T1D. Anti-IL-2 autoantibodies, as well as T cells specific for a single orthologous epitope of IL-2, are present in the peripheral blood of non-obese diabetic (NOD) mice and patients with T1D. In NOD mice, the generation of anti-IL-2 autoantibodies is genetically determined and their titre increases with age and disease onset. In T1D patients, circulating IgG memory B cells specific for IL-2 or insulin are present at similar frequencies. Anti-IL-2 autoantibodies cloned from T1D patients demonstrate clonality, a high degree of somatic hypermutation and nanomolar affinities, indicating a germinal centre origin and underscoring the synergy between cognate autoreactive T and B cells leading to defective immune tolerance.

Carroll VA et al.

HIV-1 infection is associated with increased risk for B-cell lymphomas. How HIV infection promotes the development of lymphoma is unclear, but it may involve chronic B-cell activation, inflammation, and/or impaired immunity, possibly leading to a loss of control of oncogenic viruses and reduced tumor immunosurveillance. We hypothesized that HIV structural proteins may contribute to lymphomagenesis directly, because they can persist long term in lymph nodes in the absence of viral replication. The HIV-1 transgenic mouse Tg26 carries a noninfectious HIV-1 provirus lacking part of the gag-pol region, thus constituting a model for studying the effects of viral products in pathogenesis. Approximately 15% of Tg26 mice spontaneously develop leukemia/lymphoma. We investigated which viral proteins are associated with the development of leukemia/lymphoma in the Tg26 mouse model, and performed microarray analysis on RNA from spleen and lymph nodes to identify potential mechanisms of lymphomagenesis. Of the viral proteins examined, only expression of HIV-1 matrix protein p17 was associated with leukemia/lymphoma development and was highly expressed in bone marrow before disease. The tumor cells resembled pro-B cells, and were CD19(+)IgM(-)IgD(-)CD93(+)CD43(+)CD21(-)CD23(-)VpreB(+)CXCR4(+) Consistent with the pro-B-cell stage of B-cell development, microarray analysis revealed enrichment of transcripts, including Rag1, Rag2, CD93, Vpreb1, Vpreb3, and Igll1 We confirmed RAG1 expression in Tg26 tumors, and hypothesized that HIV-1 matrix protein p17 may directly induce RAG1 in B cells. Stimulation of human activated B cells with p17 enhanced RAG1 expression in three of seven donors, suggesting that intracellular signaling by p17 may lead to genomic instability and transformation.

STEMCELL TECHNOLOGIES INC.S QUALITY MANAGEMENT SYSTEM IS CERTIFIED TO ISO 13485. PRODUCTS ARE FOR RESEARCH USE ONLY AND NOT INTENDED FOR HUMAN OR ANIMAL DIAGNOSTIC OR THERAPEUTIC USES UNLESS OTHERWISE STATED.

Internal Search Keywords: 19054|19054RF|19054C.2|19014|14054 |B cell isolation|Easy sep B cell

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EasySep Human B Cell Enrichment Kit

Phase 1 Clinical Study to Evaluate Multiple Doses of FT538 as Monotherapy for Acute Myeloid Leukemia and in Combination with Anti-CD38 Monoclonal Antibody Therapy for Multiple Myeloma

Off-the-shelf NK Cell Product Candidate Derived from Clonal Master iPSC Line Engineered with Three Functional Components to Enhance Innate Immunity

SAN DIEGO, May 20, 2020 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, announced today that the U.S. Food and Drug Administration (FDA) has cleared the Companys Investigational New Drug (IND) application for FT538, the first CRISPR-edited, iPSC-derived cell therapy. FT538 is an off-the-shelf natural killer (NK) cell cancer immunotherapy that is derived from a clonal master induced pluripotent stem cell (iPSC) line engineered with three functional components to enhance innate immunity: a novel high-affinity, non-cleavable CD16 (hnCD16) Fc receptor; an IL-15/IL-15 receptor fusion (IL-15RF); and the elimination of CD38 expression. The Company plans to initiateclinical investigation of three once-weekly doses of FT538as a monotherapy in acute myeloid leukemia (AML) and in combination with daratumumab, a CD38-directed monoclonal antibody therapy, for the treatment of multiple myeloma.

We are very pleased to expand the clinical application of our proprietary iPSC product platform to multiple myeloma, where rates of relapse remain high, said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. Clinical data suggest that deficiencies in NK cell-mediated immunity, which are evident even at the earliest stages of myeloma, continue to accumulate through disease progression. We believe administration of FT538 to patients can restore innate immunity, and that the anti-cancer effect of certain standard of care treatments, such as monoclonal antibodies, can be more effective when combined with the engineered functionality of FT538.

The three functional components of FT538 are designed to boost the innate immune response in cancer patients, where endogenous NK cells are typically diminished in both number and function due to prior treatment regimens and tumor suppressive mechanisms. In preclinical studies, FT538 has shown superior NK cell effector function, as compared to endogenous NK cells, with the potential to confer significant anti-tumor activity to patients through multiple mechanisms of action including:

The first-in-human, multi-center, dose-escalation Phase 1 clinical trial of FT538 is designed to determine the maximum tolerated dose (MTD) of three once-weekly doses of FT538 in up to 105 adult patients across four dose cohorts (100M cells per dose; 300M cells per dose; 900M cells per dose; and 1.5B cells per dose). The study will assess two treatment regimens: Regimen A as a monotherapy in patients with relapsed / refractory AML; and Regimen B in combination with daratumumab, an FDA-approved anti-CD38 monoclonal antibody, in patients with relapsed / refractory multiple myeloma who have failed at least two lines of therapy. In addition, the Company may initiate a third treatment regimen in combination with elotuzumab, an FDA-approved anti-SLAMF7 monoclonal antibody, in patients with relapsed / refractory multiple myeloma who have failed at least two lines of therapy starting at one dose level below the MTD of Regimen B. For all regimens, multiple indication- or dose-specific dose-expansion cohorts of up to 15 patients per cohort may be enrolled to further evaluate the clinical activity of FT538.

FT538 is the fourth off-the-shelf, iPSC-derived NK cell product candidate from the Companys proprietary iPSC product platform cleared for clinical investigation by the FDA. The Company has initiated clinical manufacture of FT538 at its GMP facility in San Diego, CA.

About Fate Therapeutics iPSC Product PlatformThe Companys proprietary induced pluripotent stem cell (iPSC) product platform enables mass production of off-the-shelf, engineered, homogeneous cell products that can be administered with multiple doses to deliver more effective pharmacologic activity, including in combination with cycles of other cancer treatments. Human iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Companys first-of-kind approach involves engineering human iPSCs in a one-time genetic modification event and selecting a single engineered iPSC for maintenance as a clonal master iPSC line. Analogous to master cell lines used to manufacture biopharmaceutical drug products such as monoclonal antibodies, clonal master iPSC lines are a renewable source for manufacturing cell therapy products which are well-defined and uniform in composition, can be mass produced at significant scale in a cost-effective manner, and can be delivered off-the-shelf for patient treatment. As a result, the Companys platform is uniquely capable of overcoming numerous limitations associated with the production of cell therapies using patient- or donor-sourced cells, which is logistically complex and expensive and is subject to batch-to-batch and cell-to-cell variability that can affect clinical safety and efficacy. Fate Therapeutics iPSC product platform is supported by an intellectual property portfolio of over 300 issued patents and 150 pending patent applications.

Story continues

About Fate Therapeutics, Inc.Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for cancer and immune disorders. The Company has established a leadership position in the clinical development and manufacture of universal, off-the-shelf cell products using its proprietary induced pluripotent stem cell (iPSC) product platform. The Companys immuno-oncology product candidates include natural killer (NK) cell and T-cell cancer immunotherapies, which are designed to synergize with well-established cancer therapies, including immune checkpoint inhibitors and monoclonal antibodies, and to target tumor-associated antigens with chimeric antigen receptors (CARs). The Companys immuno-regulatory product candidates include ProTmune, a pharmacologically modulated, donor cell graft that is currently being evaluated in a Phase 2 clinical trial for the prevention of graft-versus-host disease, and a myeloid-derived suppressor cell immunotherapy for promoting immune tolerance in patients with immune disorders. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit http://www.fatetherapeutics.com.

Forward-Looking StatementsThis release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 including statements regarding the advancement of and plans related to the Company's product candidates and clinical studies, the Companys progress, plans and timelines for the clinical investigation of its product candidates, the therapeutic potential of the Companys product candidates including FT538, and the Companys clinical development strategy for FT538. These and any other forward-looking statements in this release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk of difficulties or delay in the initiation of any planned clinical studies, or in the enrollment or evaluation of subjects in any ongoing or future clinical studies, the risk that the Company may cease or delay preclinical or clinical development of any of its product candidates for a variety of reasons (including requirements that may be imposed by regulatory authorities on the initiation or conduct of clinical trials or to support regulatory approval, difficulties in manufacturing or supplying the Companys product candidates for clinical testing, and any adverse events or other negative results that may be observed during preclinical or clinical development), the risk that results observed in preclinical studies of FT538 may not be replicated in ongoing or future clinical trials or studies, and the risk that FT538 may not produce therapeutic benefits or may cause other unanticipated adverse effects. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Companys actual results to differ from those contained in the forward-looking statements, see the risks and uncertainties detailed in the Companys periodic filings with the Securities and Exchange Commission, including but not limited to the Companys most recently filed periodic report, and from time to time in the Companys press releases and other investor communications.Fate Therapeutics is providing the information in this release as of this date and does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise.

Contact:Christina TartagliaStern Investor Relations, Inc.212.362.1200christina@sternir.com

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Fate Therapeutics Announces FDA Clearance of IND Application for FT538, First CRISPR-edited, iPSC-derived Cell Therapy - Yahoo Finance

President Trump announced on Wednesday that the United States will pull out from the major 35-nation arms control treaty that allows nations to operate reconnaissance flights over other territoriesa critical agreement for building trust and maintaining peace between countries. The official withdrawal from the post-Cold War Open Skies agreement will reportedly happen in six months in accordance with the treatys exit policy. The move was prompted by several instances where Russia refused to comply with the pact, which poses a threat to the U.S. military and cybersecurity, The New York Times reports.

It will be the third major arms control agreement Trump has chosen to exitafter the Iran nuclear deal and the Intermediate Nuclear Forces treatyand reportedly indicates that he may also choose to pull out from the U.S.-Russia nuclear pact START. During the course of this review it has become abundantly clear that it is no longer in Americas interests to remain a party to the Open Skies treaty, a top U.S. official told Reuters.

Link:
Trump Moves to Withdraw From Yet Another Arms Control Treaty - The Daily Beast

Any company in Michigan that allows Donald Trump inside its facilities without wearing a face mask could face legal action, the states attorney general has warned ahead of the presidents Thursday visit. Trump is due in the state to look around a Ford facility in Ypsilanti that has been repurposed to make ventilators for coronavirus patients. The president has refused to wear a mask in public so farbut thats not something state officials will take lightly. Michigan Attorney General Dana Nessel told CNN early Thursday: Honestly, if [Trump] fails to wear a mask, hes going to be asked not to return to any enclosed facilities inside our state. She added: I think were going to take action against any company or any facility that allows him inside those facilities and puts our workers at risk. We simply cant afford it here in our state. Rep. Debbie Dingell (D-MI), who represents the district that includes the Ford plant, also told CNN: Leaders need to lead... I hope the president will follow the protocols because people will see the importance of wearing those masks. It matters. Michigan has been hard-hit by the pandemic, with more than 52,000 cases and more than 5,000 deaths.

See the article here:
Michigan Will Sue Companies That Let Trump Inside Unmasked, Warns State AG - The Daily Beast

Ontario Announces First Phase of Research Projects to Fight COVID-19Ontario-Based Solutions Contribute to the Global Effort against the Outbreak

Ontario is funding the following research on preventing, detecting and treating COVID-19. These projects focus on important areas of research, including vaccine development, diagnostics, drug trials and development, and social sciences.

A Randomized Open-Label Trial of CONvalescent Plasma for Hospitalized Adults with Acute COVID-19 Respiratory Illness (CONCOR-1)Donald Arnold, Principal InvestigatorMcMaster University

CONCOR-1 is a clinical trial that will collect blood plasma from individuals who have recovered from COVID-19, known as COVID-19 convalescent plasma. Convalescent plasma contains COVID-19 antibodies, proteins that help fight the virus. Convalescent plasma will be injected into patients currently fighting the infection, to test whether this is an effective treatment for the virus. This clinical trial will enrol patients 16 years of age and older admitted to hospital with COVID-19 and who require supplemental oxygen for respiratory illness.

Partners include 60 hospitals across Canada and three hospitals in New York City, the Canadian Blood Services and Hma-Qubec and the New York Blood Center.

Research and Deployment of Rapid High-Throughput Diagnostic Testing for COVID-19Marek Smieja, Principal InvestigatorSt Joseph's Healthcare Hamilton

This project will increase Ontario's COVID-19 testing capacity by deploying robotic liquid handling technology, specimen pooling, and efficient sample preparation, while reducing biological risk and ensuring reliable results. The Disease Diagnostics & Development group in the Research Institute of St Joe's Hamilton (RSJH) is collaborating with the Hamilton Regional Laboratory Medicine Program (HRLMP) and other clinical laboratories across the province to quickly develop, validate, and deliver high-throughput, COVID-19 testing, with the goal of testing up to 6,000 samples per lab daily.

Assay Development for SARS-CoV-2 Sero-SurveillanceJennifer Gommerman, Principal InvestigatorUniversity of Toronto

This study will provide a better understanding of the immune response to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19. This approach aims to measure the level and/or types of antibodies induced by SARS-CoV-2 infection in the blood of acute and convalescent patients. In addition, measuring these antibodies in the saliva of asymptomatic infected subjects identified through contact tracing will provide insights into what the early immune response to the virus looks like, and how this may correlate with clinical outcome. This knowledge, as well as the development of a robust serosurveillance platform, represents a powerful weapon in our fight against COVID-19.

Multivalent Antibody Scaffold to Deliver an Exceptionally Potent and Broad Antiviral Against SARS-CoV-2Jean-Philippe Julien, Principal InvestigatorThe Hospital for Sick Children

This project has the potential to develop a unique antibody-based molecule for protection and treatment against COVID-19. Molecular technology will allow these researchers to decipher the vulnerabilities of the virus with the goal of developing a potent and broad antiviral that neutralizes SARS-CoV-2 and prevents associated COVID-19 symptoms.

Developing Prophylactic Virus-Vectored Vaccines for COVID-19Byram Bridle, Leonardo Susta and Sarah Wootton (Co-Principal Investigators, University of Guelph); Darwyn Kobasa, National Microbiology Laboratory, Public Health Agency of Canada (Collaborator) University of Guelph

This research aims to develop a vaccination strategy for COVID-19. By developing avian avulavirus (AAvV-1) and adenovirus viral-vectored vaccines expressing the SARS-CoV-2 spike protein as a target antigen, researchers will test these vaccines in mice to identify a way to induce robust protective mucosal (respiratory, gastrointestinal and urogenital tract) and systemic immunity. Mucosal immunity plays a significant role in preventing pathogens from getting into the body. Systemic immunity clears any pathogens that bypass mucosal barriers. After optimization, these vaccines will be evaluated in a hamster challenge model at the National Microbiology Laboratory in Winnipeg.

The RAPID COVID Study - Application of Point-of-Care COVID-19 Testing to Optimize Patient Care, Resource Allocation and Safety for Frontline StaffDerek So, Principal InvestigatorUniversity of Ottawa Heart Institute

This study will determine the role of point-of-care testing (POC) as a tool to improve care of COVID-19 patients and conserve resources. A major obstacle facing hospitals during the COVID-19 outbreak is the inability to quickly diagnose who is infected with the virus. Delayed test results could mean that patients, who ultimately test negative, are treated for days utilising resources that could be better deployed elsewhere. An immediate diagnosis of COVID-19 among carriers could provide more expedient treatment, prevent clinical deterioration and help health care workers avoid unnecessary risk of exposure.

In collaboration with Spartan Biosciences, which has developed a novel point-of-care 45-minute bedside COVID-19 test, and a team of specialists from six centres in Ontario, this research will evaluate the efficacy of POC testing to determine when, how and to who it can be applied.

A Prospective, Observational Research Study on the Diagnosis of COVID-19 Infection from Stool Samples of Children and AdultsNikhil Pai, Jeff Pernica, Marek Smieja (Co-Principal Investigators)McMaster University

Through the development and use of a novel test to diagnose COVID-19 from stool samples, this team will assess up to 4,500 stool samples collected from outpatient clinics, emergency departments and inpatient wards across eight major Hamilton region hospitals and clinics. This work will improve COVID-19 disease detection in children and adults who lack respiratory symptoms, are asymptomatic, or are presumed to have "recovered" from past infection. The researchers hope to expand COVID-19 testing options across Canada and ultimately, better identify patients who carry high risk of community transmission than traditional respiratory testing alone.

Cellular Immuno-Therapy for COVID-19 Induced Acute Respiratory Distress Syndrome: The CIRCA-19 TrialDuncan Stewart, Principal InvestigatorOttawa Hospital Research Institute

Through a series of trials, this research will rapidly evaluate the safety and efficacy of using mesenchymal stromal/stem cells, or MSCs, to help treat patients with COVID-19 related acute respiratory distress syndrome (ARDS). Up to 25 percent of all patients admitted to hospital require admission to an intensive care unit, and as many as 40 percent develop severe difficulty breathing due to ARDS.

In total, 27 patients will undergo three sequential trials. The first trial, called the Vanguard study, is designed to quickly determine the optimal dosing strategy of MSCs derived from bone marrow to treat patients experiencing ARDS. The next two trials will use the optimal dose of cells determined by the Vanguard trial, but will administer MSCs derived from the umbilical cord, which is an abundant and readily available source.

Rapid Identification of Immunogenic and T-cell Epitopes to Enable Serologic Testing, Passive Immunotherapy, and Epitope Vaccine for COVID-19Shawn Li, Principal InvestigatorWestern University

To curb the COVID-19 outbreak caused by the SARS-CoV-2 virus, researchers are looking to solve three critical challenges as quickly as possible - detection, treatment, and vaccination. This project will address these challenges by developing a point-of-care blood test to identify infected individuals, including those without symptoms, devising strategies for the production of virus-neutralizing antibodies to treat the severely ill, and identifying viral epitopes to inform epitope-vaccine development.

The Impact of the Coronavirus Pandemic on Children with Medical Complexity Technology Dependency: A Novel Research Cohort StudyAudrey Lim, Principal InvestigatorMcMaster University

This study addresses how to effectively manage pediatric patients remotely by identifying the barriers and facilitators of virtual clinics. COVID-19 is placing strain on families of children with medical complexity, medical fragility and technology dependency. Many of these children are dependent on life sustaining technology such as tracheostomy, home mechanical ventilation, and/or enteral feeding tubes. Though accounting for less than 1 percent of all children in Ontario, this group is at increased risk of multiple and prolonged hospitalizations and poorer health outcomes. Normally, these children are seen at a hospital to address their multiple complex needs, however due to COVID-19, all in-person clinic appointments have been replaced by virtual clinics. Parental satisfaction with virtual clinic healthcare teams will also be assessed using a quality improvement tool developed for this study. This research has the potential to advance virtual medicine, beyond COVID-19.

Food Retail Environment Surveillance for Health and Economic Resiliency: FRESHER OntarioJason Gilliland, Principal InvestigatorWestern University

The Food Retail Environment Surveillance for Health & Economic Resiliency (FRESHER) project is a rapid response to the widespread closures of, and modified operating conditions for, many retail food outlets. The FRESHER project will examine the economic and social impacts of COVID-19 in Southwestern Ontario by identifying what businesses modified their operations, temporarily closed or permanently closed during the outbreak and how the outbreak has affected businesses and their employees. This study will help inform policies and programs that will maintain Ontario's food security, incentivize economic growth during the recovery period, and improve resiliency among businesses during future pandemics and emergencies.

Protective Immunity in Individuals Infected with COVID-19Ishac Nazy, Principal InvestigatorMcMaster University

The goal of this research is to determine the makeup, concentration, strength and viral properties of anti-SARS-CoV-2 antibodies to provide insights into the immune response of individuals infected with COVID-19. Working with Dr. Arnold (CONCOR-1 study on convalescent plasma therapy), this team will use samples from recovered patients to test whether antibodies exist, and if they are able to bind and neutralize the virus. This research will determine whether immunity is longstanding or if it wanes over time; and will inform researchers how immune-based treatments work to fight off the virus, including convalescent plasma or future vaccines.

Clinical Research on the Therapeutic Benefits of Annexin A5 in Severe COVID-19 PatientsClaudio Martin, Principal InvestigatorLawson Health Research Institute

There are currently no proven therapies to treat COVID-19. In the most severe cases, the disease is complicated by sepsis acute respiratory distress syndrome (ARDS), and multiorgan failure. Sepsis is a life-threatening condition caused by the body's response to an infection. While the body normally releases chemicals to fight an infection, sepsis occurs when the body's response to these chemicals is out of balance, triggering systemic inflammation that can damage multiple organs. Many critically ill COVID-19 patients develop sepsis 1-2 days before ARDS, suggesting that sepsis is a major contributor to the development of organ and respiratory failure.

This clinical trial will examine the effects of Annexin A5, in treating critically ill COVID-19 patients who develop sepsis. Annexin A5 is a human protein that has potent anti-inflammatory, anti-apoptotic (cell death prevention) and moderate anticoagulant (blood clot prevention) properties. The ultimate goal of the trial is to use Annexin A5 to treat sepsis and prevent respiratory and multi-organ failure.

Novel Coronavirus Antiviral Drug Discovery Using High-Throughput ScreeningJean-Simon Diallo, Principal InvestigatorOttawa Hospital Research Institute

Using a novel bio-sensor that detects drugs that disrupt the attachment of coronaviruses to cells, this research will test approximately 1,200 approved drugs to better understand their potential to prevent viral infection in cells and their ability to block the interaction between COVID-19 and its receptor. A second phase of this study will attempt to identify novel antivirals from a small (>220,000) molecule library.

Canada's COVID-19 Pandemic Response and Impact in Low-Income and Homeless or At-Risk for Homelessness Populations in Ottawa (Canada): A Mixed Method StudySmita Pakhale, Principal InvestigatorThe Ottawa Hospital Research Institute

Vulnerable populations face numerous social and health inequities that are exacerbated during times of crises. Lessons learned from previous public health crises suggest that inappropriate communication strategies jeopardize risk reduction for vulnerable populations. The objective of this research is to measure the impacts of COVID-19 public health emergency response efforts and communication strategies on Ottawa's low-income, homeless or at-risk for homelessness populations. The findings could help inform public health messaging strategies and pandemic approaches for vulnerable populations.

More:
Ontario Announces First Phase of Research Projects to Fight COVID-19 - Government of Ontario News

If these were normal circumstances, Yuki Bhambri would probably be back on the grind of the tennis tour trying to qualify for a Grand Slam again. It would be a far cry from his breakthrough 2018 season, where he crossed top 100 and played all four Majors, but at least he would be back and fighting on court.

However as things stand, the former India No 1 has not played a competitive match since October 2018 after battling a debilitating knee injury that wasnt correctly diagnosed for months and led to a layoff that is 18 months and counting now.

From a career-best ranking of 83 in April 2018 to losing his ranking and being tagged as inactive on the official ATP charts, it has been a period of difficulty and confusion for the 27-year-old, who has been a junior world No 1 and Grand Slam champion.

Its been a pain a struggle. The [past] 18 months have felt like five years. From not being able to really put any load on my knee, I think its a big achievement to be able to finally get back to playing tennis and do even the basic exercises, Bhambri told Scroll.in.

But even then, there are two ways to look at the long time away from the sport due to injury and now an extended break due to the coronavirus pandemic. The positive is, of course, a shutdown of the entire tennis tour means that the timeline for recovery is extended. Does he see this time off, although due to a negative reason, as beneficial?

Yes, it does for me and for everyone whos been out injured because you dont miss out on the tour. Everyone in the same situation, everyone comes back without hitting a tennis ball for months. Ill not be missing the Grand Slams or any events and it gives me time to come back. So for the few ones, like me, Roger Federer, Juan Martin del Potro, this is a good time. Of course, you dont want it to happen due to a pandemic, he added.

The Indian has been spending time at home in Delhi, trying to get whatever fitness training he can at home with the tennis courts shut amid the nationwide lockdown but he knows its not enough.

Its difficult and different, no matter how much you train at home, its not the same. Youre obviously doing it for your career, for tennis and Im not able to play it and theres only a certain amount that you can really do at home. For me, its really just about being active and doing bits and pieces so that I dont have to start from scratch when I get back on the court, he added.

I was already following a bunch of exercises I need to for my knee rehab. But sometimes modifications are needed and Im in constant touch with my team. Theres only so much you know you can do but I think Ive been good enough in being active, said the Indian who is coached by Stephen Koon from the Impact Tennis Academy in Thailand.

Bhambri admitted that he is unsure if he would be a 100% if the tour were to restart.

Its pretty good but I am not match-fit. I made a lot of progress and if I had to, even right now Id give myself a 70% chance. I need to get out there and practice because I havent done anything in regards to my physical fitness for about over a year and a half now.

The body takes some time to get used to it again and for that Id have to be on the court I presume for at least a couple of months, to be able to get back to running and being able to take the load of a match. I had just started to do that and get into a routine when the lockdown happened. Once its over Ill get back to practice but looking at things, we may not have a tennis season this year he added.

As candid as Bhambri is while talking about the past few months, the toll becomes evident when he describes the excruciating details of his injury and the experimental treatment. He was injured in mid-2018 but it was only in September 2019 when he consulted with Dr Angel Ruiz Cortorro, who has worked with many top injured tennis players including Rafael Nadal, that Bhambri got a clear idea of the problem.

From what I understand of the diagnosis I have a small, partial tear in the medial part of my knee. Because it was tiny and in the middle of the tendon, no one could really figure it out and I was somewhere stuck in between because surgery would have been too big a step to repair it and the basic modern medication and therapy werent working. So I had to try different kinds of treatments, different injections to help heal the tendon, he said.

I was seeing doctors in the US and getting different opinions. But a few of them had the same idea, which was an experimental treatment called stem cell. This procedure was more advanced in Spain and there are very few countries that actually do it; they dont even do it in the States. Since I was getting different opinions, I decided to get in touch with Dr Cortorro just to have another opinion and went with him because hes the one who has treated a lot of tennis players who had knee trouble, Bhambri added.

The decision paid off because after almost a year of taking different injections and waiting for months to see if they made a difference, he finally made progress in late 2019. Around the new year is when I got back on court to hit the ball and I have seen improvement every week, which is a good sign.

Also read: Yuki Bhambri on building up the ammo to fire his way to the top

In his career so far, Bhambri is no stranger to injuries or fighting back from them, but even then one needs immense self-belief to be able to deal with this long and complicated rehab process.

There havent been too many positives, he laughed, but admitted that his success in 2017-18 was a reminder of what he is capable of.

I needed to keep reminding myself that I want to come back and continue playing to get back at the level I was at. I think having tasted success of finally playing the Slams, my first Wimbledon, winning a few matches at the Masters 1000 in Indian Wells and Miami, pushed me as well to try. Wanting to play those events again kept me going, he said.

Coming from a family of tennis players also helped the 27-year-old. His sister Ankita is the Indian Fed Cup coach while other sister Sanaa and cousin Prerna are all pro tennis players.

Theyre always on the lookout, helping out; specially both my sisters who have been helping with the research, making sure I am finishing training and not being lazy my parents coming in and asking if Ive iced my knee or not. So theyve all been actively involved and try to help it in whatever way they can, he said.

Read the original:
Indian tennis: For injury-plagued Yuki Bhambri, the lockdown is both a chance and another challenge - Scroll.in

Three arms of this trial will be leronlimab, remdesivir, and leronlimab + remdesivir

VANCOUVER, Washington, May 18, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (CytoDyn or the Company), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, today announced it will be submitting a protocol to the U.S. Food and Drug Administration (FDA) for a factorial design trial to compare effectiveness of leronlimab versus remdesivir and in combination with remdesivir for the treatment of COVID-19.

Leronlimab was administered to more than sixty patients with COVID-19 under emergency Investigational New Drug (eINDs) authorizations granted by the FDA. Preliminary results from this patient population led to CytoDyns Phase 2b/3 clinical trial for 390 patients, which is randomized, placebo-controlled with 2:1 ratio (active drug to placebo ratio). CytoDyn has also been granted a Phase 2 randomized clinical trial study in the U.S. for a Phase 2 randomized clinical trial for mild-to-moderate COVID-19 population in the U.S. CytoDyn plans to update the public regarding current eIND results later this week.

We believe the randomized head-to-head comparison of leronlimab to remdesivir and in combination will provide answers to the lingering question regarding effective treatment options for patients suffering from COVID-19. We look forward to working both in the United States and with potential international sites to help provide effective treatment options for COVID-19, said Jacob Lalezari, M.D., Chief Science Officer of CytoDyn.

Unfortunately, COVID-19 remains a global public health challenge, and its economic impact continues to devastate the world economy. With a second wave of potential cases threatening to surface in the fall and winter of 2020, it is more important than ever to be sure successful treatment options are available to protect the lives of patients. CytoDyn has assurance from its manufacturer that it will have available over 1 million vials this year and could ramp up production to 2-3 million vials this year alone, said, Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn.

About Coronavirus Disease 2019CytoDyn is currently enrolling patients in two clinical trials for COVID-19, a Phase 2 randomized clinical trial for mild-to-moderate COVID-19 population in the U.S. and a Phase 2b/3 randomized clinical trial for severe and critically ill COVID-19 population in several hospitals throughout the country.

SARS-CoV-2 was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China. The origin of SARS-CoV-2 causing the COVID-19 disease is uncertain, and the virus is highly contagious. COVID-19 typically transmits person to person through respiratory droplets, commonly resulting from coughing, sneezing, and close personal contact. Coronaviruses are a large family of viruses, some causing illness in people and others that circulate among animals. For confirmed COVID-19 infections, symptoms have included fever, cough, and shortness of breath. The symptoms of COVID-19 may appear in as few as two days or as long as 14 days after exposure. Clinical manifestations in patients have ranged from non-existent to severe and fatal. At this time, there are minimal treatment options for COVID-19.

About Leronlimab (PRO 140) and BLA Submission for the HIV Combination TherapyThe FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for deadly diseases. The first as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer.Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH.Leronlimab has completed nine clinical trials in over 800 people, including meeting its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.

The Company filed its BLA for Leronlimab as a Combination Therapy for Highly Treatment Experienced HIV Patients with the FDA on April 27, 2020, and submitted additional FDA requested clinical datasets on May 11, 2020. After the BLA submission is deemed completed, the FDA sets a PDUFA goal date. CytoDyn has Fast Track designation for leronlimab and a rolling review for its BLA, as previously assigned by the FDA, and the Company plans to request a priority review for the BLA. A priority review designation means the FDAs goal is to take action on the marketing application within six months of receipt (compared with 10 months under standard review).

In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting aPhase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted orphan drug designation to leronlimab for the prevention of GvHD.

About CytoDynCytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells.The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH. CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. CytoDyn filed its BLA in April 2020 to seek FDA approval for leronlimab as a combination therapy for highly treatment experienced HIV patients, and submitted additional FDA requested clinical datasets on May 11, 2020. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV. No drug-related serious site injection reactions reported in about 800 patients treated with leronlimab and no drug-related SAEs reported in patients treated with 700 mg dose of leronlimab. Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than five years. CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is atwww.cytodyn.com.

Forward-Looking StatementsThis press releasecontains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as believes, hopes, intends, estimates, expects, projects, plans, anticipates and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Forward-looking statements specifically include statements about leronlimab, its ability to have positive health outcomes, the possible results of clinical trials, studies or other programs or ability to continue those programs, the ability to obtain regulatory approval for commercial sales, and the market for actual commercial sales. The Companys forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i)the sufficiency of the Companys cash position, (ii)the Companys ability to raise additional capital to fund its operations, (iii) the Companys ability to meet its debt obligations, if any, (iv)the Companys ability to enter into partnership or licensing arrangements with third parties, (v)the Companys ability to identify patients to enroll in its clinical trials in a timely fashion, (vi)the Companys ability to achieve approval of a marketable product, (vii)the design, implementation and conduct of the Companys clinical trials, (viii)the results of the Companys clinical trials, including the possibility of unfavorable clinical trial results, (ix)the market for, and marketability of, any product that is approved, (x)the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Companys products, (xi)regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii)general economic and business conditions, (xiii)changes in foreign, political, and social conditions, and (xiv)various other matters, many of which are beyond the Companys control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form10-K, and any risk factors or cautionary statements included in any subsequent Form10-Q or Form8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.

CYTODYN CONTACTSInvestors: Dave Gentry, CEORedChip CompaniesOffice: 1.800.RED.CHIP (733.2447)Cell: 407.491.4498dave@redchip.com

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CytoDyn to Prepare a Phase 3 Protocol to Submit to the FDA for a Three-Arm Comparative and Combination Trial of Leronlimab and Remdesivir -...

The study is anticipated to consist of approximately thirty patients with potential involvement of the NIH of Mexico in other CytoDyn trials

VANCOUVER, Washington, May 19, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (CytoDyn” or the Company”), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, today announced it will be coordinating with the NIH of Mexico and providing leronlimab for a trial for the severe/critical COVID-19 population in Mexico with the potential to collaborate on further CytoDyn COVID-19 trials.

CytoDyn is currently enrolling a Phase 2b/3 clinical trial for 390 patients, which is a randomized, placebo-controlled with 2:1 ratio (active drug to placebo ratio). CytoDyn is also enrolling a Phase 2 randomized clinical trial with 75 patients in the mild-to-moderate COVID-19 population. CytoDyn has been granted more than sixty emergency Investigational New Drug (eIND) authorizations by the U.S. Food and Drug Administration (FDA) and plans to provide clinical updates for this patient population later in the week.

We look forward to evaluating leronlimab as a treatment option for patients of COVID-19. We have seen the devastation of this disease on the citizens of Mexico and are looking forward to providing effective treatment options to mitigate the devastation of COVID-19,” said Dr. Gustavo Reyes Tern, head of the Coordinating Commission of National Institutes of Health and High Specialty Hospitals of Mexico, an organization that coordinates the main institutions of medical care and public research in the country.

The NIH of Mexico is committed to help alleviate human suffering and mortality of Mexican citizens. The Metropolitan Area of the Valley of Mexico has a population of approximately 21.5 million people and the contagious nature of COVID-19 is relentless. We look forward to working with the NIH of Mexico to rapidly commence with the proposed study. We also believe that this study results, along with the ongoing Phase 2 study, could establish a path for quick approval in Mexico for use of leronlimab in COVID-19 patients,” said Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn.

About Coronavirus Disease 2019 CytoDyn is currently enrolling patients in two clinical trials for COVID-19, a Phase 2 randomized clinical trial for mild-to-moderate COVID-19 population in the U.S. and a Phase 2b/3 randomized clinical trial for severe and critically ill COVID-19 population in several hospitals throughout the country.

SARS-CoV-2 was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China. The origin of SARS-CoV-2 causing the COVID-19 disease is uncertain, and the virus is highly contagious. COVID-19 typically transmits person to person through respiratory droplets, commonly resulting from coughing, sneezing, and close personal contact. Coronaviruses are a large family of viruses, some causing illness in people and others that circulate among animals. For confirmed COVID-19 infections, symptoms have included fever, cough, and shortness of breath. The symptoms of COVID-19 may appear in as few as two days or as long as 14 days after exposure. Clinical manifestations in patients have ranged from non-existent to severe and fatal. At this time, there are minimal treatment options for COVID-19.

About Leronlimab (PRO 140) and BLA Submission for the HIV Combination Therapy The FDA has granted a Fast Track” designation to CytoDyn for two potential indications of leronlimab for deadly diseases. The first as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer. Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH. Leronlimab has completed nine clinical trials in over 800 people, including meeting its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.

The Company filed its BLA for Leronlimab as a Combination Therapy for Highly Treatment Experienced HIV Patients with the FDA on April 27, 2020, and submitted additional FDA requested clinical datasets on May 11, 2020. After the BLA submission is deemed completed, the FDA sets a PDUFA goal date. CytoDyn has Fast Track designation for leronlimab and a rolling review for its BLA, as previously assigned by the FDA, and the Company plans to request a priority review for the BLA. A priority review designation means the FDA’s goal is to take action on the marketing application within six months of receipt (compared with 10 months under standard review).

In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting a Phase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted orphan drug” designation to leronlimab for the prevention of GvHD.

About CytoDyn CytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells. The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH. CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. CytoDyn filed its BLA in April 2020 to seek FDA approval for leronlimab as a combination therapy for highly treatment experienced HIV patients, and submitted additional FDA requested clinical datasets on May 11, 2020. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV. No drug-related serious site injection reactions reported in about 800 patients treated with leronlimab and no drug-related SAEs reported in patients treated with 700 mg dose of leronlimab. Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than five years. CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is at http://www.cytodyn.com.

Forward-Looking Statements This press release contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as believes,” hopes,” intends,” estimates,” expects,” projects,” plans,” anticipates” and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Forward-looking statements specifically include statements about leronlimab, its ability to have positive health outcomes, the possible results of clinical trials, studies or other programs or ability to continue those programs, the ability to obtain regulatory approval for commercial sales, and the market for actual commercial sales. The Company’s forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i) the sufficiency of the Company’s cash position, (ii) the Company’s ability to raise additional capital to fund its operations, (iii) the Company’s ability to meet its debt obligations, if any, (iv) the Company’s ability to enter into partnership or licensing arrangements with third parties, (v) the Company’s ability to identify patients to enroll in its clinical trials in a timely fashion, (vi) the Company’s ability to achieve approval of a marketable product, (vii) the design, implementation and conduct of the Company’s clinical trials, (viii) the results of the Company’s clinical trials, including the possibility of unfavorable clinical trial results, (ix) the market for, and marketability of, any product that is approved, (x) the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Company’s products, (xi) regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii) general economic and business conditions, (xiii) changes in foreign, political, and social conditions, and (xiv) various other matters, many of which are beyond the Company’s control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, and any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.

CYTODYN CONTACTS Investors: Dave Gentry, CEO RedChip Companies Office: 1.800.RED.CHIP (733.2447) Cell: 407.491.4498 dave@redchip.com

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CytoDyn and the Mexican National Institutes of Health Participate in a Collaborative Study of Leronlimab for the Treatment of Severe/Critical COVID-19...

Magnifier Research has offered the latest report titled Global Canine Arthritis Treatment Market Size, Status and Forecast 2020-2026 which facilitates clients with the changing trends in various markets, regions, and consumers in the global market. The report exhibits on current market analysis scenario, upcoming as well as future opportunities, revenue growth, pricing, and profitability. It gives business summary which includes an examination of the current and past market, analysis of major players dominating the global Canine Arthritis Treatment market, their revenue, their business summary, product segmentation, as well as market size, share, growth, trends analysis, segment and forecasts from 2020-2026.

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Global Canine Arthritis Treatment Market 2020 Manufacturer Landscape, Revenue and Volume Analysis and Segment Information upto 2026 - Cole of Duty

University Health System physicians say each scent offers a unique effect.

SAN ANTONIO Over the past few months most of us have gotten used to wearing masks, whether it is in the grocery store, outside, or for some at all times, and in many cases it just isn't comfortable.

Dr. Jan Patterson, the Medical Director of the Integrative Medicine Program and an Infectious Disease Physician at University Health System, and Professor of Medicine and Infectious Diseases at UT Health San Antonio, spoke to KENS 5 about the study among UHS where they found essential oils to improve mask comfort.

"When COVID happened we realized we had to shift some of our focus to the staff with universal masking which we are very grateful for because it helps us protect each other," she said. "We started in early April with our hospital staff and went to different departments. We are doing both clinical staff and non-clinical staff. More recently weve open it up to patients, some of our patients who are in the clinics who are here for quite a while for infusions and so forth. We would like to try it and see if it makes a difference for them as well."

Rebekah Kendrick, a nurse specializing in pain management told us, "People are feeling different effects from wearing these all day so we wanted to offer them something that might alleviate some of those complaints. Essential oils are really becoming a new thing, so theres new interest in it."

Some of the most common mask complaints include anxiety, fatigue, poor mental focus, headaches, and shortness of breath. Dr. Patterson said, "We know that essential oils, not only do they smell good, but they can affect us very positively in terms of our mood."

The oils go directly to the brain through the olfactory nerve or smell nerve, and they can also affect the respiratory system by opening up the lungs, making breathing easier. The doctors say each scent does something different.

The doctors told us, "Lavender would be great for that to help alleviate some of the anxiety with that and mental focus. The orange oil, we call it happy oil, which is a very happy and calming oil. The lemon oil is brightening and cleansing. People get their headaches relieved through peppermint oil and it can help with mental focus fatigue and breathing. Eucalyptus it's a strong oil we like to say it opens the mind as well as the lungs."

Dr. Patterson spoke about how you apply the oil and said, "Once we choose an oil we simply get a very small drop and put it on the outer edge of the inner mask."

But the ones you get online could be stronger and have a more pleasant effect than the ones you get at the grocery store

Dr. Patterson said, "The ones you get at the grocery store or drugstore or at a lower price point, so sometimes they are diluted and have synthetics in them but you may still get a positive affect. We wanted to use some very pure oils that are what we call therapeutic grade, because we think it has a better affect because they are purer and they last longer.

Dr. Kendrick added, "We have a lot of different options that can help make it a little more of a pleasant experience."

Dr. Patterson also told us how the study they are conducting works. She said, "The survey simply ask things like whats bothering you and how is the mask affecting your anxiety level your mood your fatigue your mental focus. We go through that survey and we help them choose an essential oil that we think is best for them."

Make sure to start with one drop and if you need more add one at a time.

For more information about family health call 210-358-3045. You can also find the rest of Wear The Gown stories, just go to WearTheGown.com.

The rest is here:
Wear The Gown: Using essential oils to improve mask comfort - KENS5.com

A quiz.

Q. You are walking on one side of a sidewalk. Someone strolling toward you veers within six feet of you. You dont have any room to move but the other person does. You call out through your mask, Six feet!

The correct action for that person is:

a. Pretend not to hear and stay the course.

b. Give you the finger and swerve a little.

c. Create some distance by moving away.

The right answer is c.

As some of our COVID-19 pandemic lockdown rules in Illinois are easing and the spring weather is bringing us outside more frequently to walk, run and bike, Ive been navigating the new normal while social distancing. There is no best practices manual for this.

Im a speed walker. I aim at five miles a day. As I roam around, Ive made it a point to observe social or physical distancing behavior who among us tries to observe the six feet; who doesnt; and whether lapses appear willful or the result of being oblivious. Ive become a student of the various tactics people are using and developing some of my own.

Without getting into the heavier political issues associated with wearing masks and social distancing as President Donald Trump ignores both I want to share my evolving rules of the road for folks finding themselves sharing the same sidewalks, paths and streets.

In writing this column, I consulted with two specialists at Northwestern University working on caution fatigue behavior during this pandemic: Dr. Melinda Ring, executive director of the Osher Center for Integrative Medicine, and her colleague, Jacqueline Gollan, associate professor of psychiatry and behavioral sciences at the Asher Center for the Study and Treatment of Depressive Disorders at the Feinberg School of Medicine.

Caution fatigue, Ring said, is a loss of interest in following the recommended guidelines due to mental or physical exhaustion.

Gollan told me in an email, Caution fatigue can influence our ability to comply (with) the new rules. This occurs when people show low motivation or energy to comply with safety guidelines. We may become impatient with the warnings, or we dont believe the warnings to be real or relevant (or) we interpret the risk incorrectly. We may stop safety behaviors, like washing our hands and social distancing.

Caution fatigue occurs because we become desensitized to warnings or risk. Initially, when we hear pandemic warnings, we become fearful and take action. But being intensely fearful is highly taxing on the brain. We adjust psychologically to reduce the fear and desensitize to the pandemic information.

And with that, here are the Sweet Outdoor Rules of the Road:

1. Its on me.

Social distancing is key to avoiding the spread of COVID-19. There are all sorts of persuasion messaging and advertising campaigns ongoing to convince people to stay six feet apart. Yet people dont. Maybe its a spatial dissonance thing? A political statement? Youthful rebellion? Entitlement? Free floating hostility? Ignorance? Doesnt matter why.

Since I care more than you may do about this six-feet thing, its on me to get out of your way.

In general, what we know is, Ring said, you cant change another persons behavior. You can only change your own.

2. Make peace with doing the easiest thing to create the six feet: cross the street, take a turn, whatever. Remember we are living in difficult times.

We are seeing a rise in depression, anxiety, PTSD, Ring said. Add to that people struggling with financial and relationship burdens.

3. Maintain situational awareness. Do not stop in the middle of a sidewalk or path to read your email or chat on the phone. Move off the sidewalk or path.

4. Its also on you.

When you are walking, running or biking behind someone who doesnt know you are there, it is your responsibility to create the six feet of space. Slow down, which, for heavens sake, is not the end of the world. Please call out something like on your left so I can scramble out of your way.

5. End the blockades. Dont be a sidewalk hog. No, you cant always walk or run three abreast with a dog if the path is crowded. Single file.

6. Distance shaming can backfire. Reserve calling out six feet when there is no alternative.

It sounds like a mother scolding a kid, Ring said.

7. Signal. This is for walkers. Sidewalk hogs get a warning when you stick out your arm to create some safe distance and flap it up and down a little. The nonverbal cue is effective in getting folks to fall into single file. Yes, I look a little crazy.

Many folks are great. I zig, they zag, and it works out. Dont get worked up. Said Ring, take some deep belly breaths beneath your mask and move on.

Continued here:
Exercising while social distancing: Rules of the road for walking, running and biking - Chicago Sun-Times

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Section 2: Global Pulse Oximeters Industry Segmentation by Type, Application and Research Region;

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Pulse Oximeters Market To Witness The Highest Growth Globally In Coming Years 2020-2026 - News Distinct

Dr David Glass - MBChB, FCOG (SA)

Last week we gave a brief history lesson describing the origins of the fibre hypothesis as basic to human health. This was based on the research of three icons of medicine in Africa Drs Denis Burkitt, (Uganda), Hugh Trowell (Kenya) and ARP Walker (South Africa). All originated from the UK, but spent many years in Africa as clinicians but also perceptive researchers.

ALSO READ: Turning the Tide: The importance of fibre in your diet

Today we will cover a somewhat controversial subject, leaky gut syndrome, which has a connection to the fibre hypothesis. It has long been propounded by alternative and integrative medicine practitioners, and more recently by functional medicine practitioners. However there are some gastroenterologists who now also recognise the condition, although perhaps would not blame this condition as the cause of as many diseases as the former practitioners would.

In our first article in this series on the GIT, we noted that the intestines are lined with a single layer of cells, spread out across finger-like villi and microvilli to increase the surface area through which nutrients can be absorbed. Just under the surface is an extensive capillary network which provides transport of these absorbed nutrients into the portal system which directs all blood from the intestines into the liver. The liver detoxifies harmful substances, and processes all nutrients into basic chemicals available for bodily functions. It is important for many reasons that this single layer of cells remains intact.

Although the lining of the gut is inside the body, it nevertheless is a vast area exposed to the outside world.

What happens when the integrity of this delicate barrier is breached through holes or tears? It is claimed partially digested foods, bacteria and toxins are allowed to pass directly into the blood stream where they can cause inflammation and chronic illness, including auto-immune diseases. Much of the research on this condition has been done in laboratories as basic science, rather than clinical research. It is still very controversial. Read an overview of the condition from Harvard Health, written by Dr Marcelo Campos HERE

I do believe the most important intervention to ensure a healthy gut comes from providing a healthy diet, which in particular includes fibre-rich plant foods. Other interventions include adequate exercise, control of stress through meditation and spiritual activities, avoidance of alcohol and dietary or environmental toxins.

Unfortunately many of the strong proponents of the leaky gut theory are also pedlars of all manner of supplements and fad diets. Many have blamed gluten or wheat or antibiotics or fruit as the cause.

In a later article we will address the gluten/wheat theory and also discuss the importance of fibre in both gut and general health.

One of the bright lights in the world in gut health is Dr Will Bulsiewicz a doubly qualified specialist physician and gastroenterologist who has written a just released book Fiber Fueled which is getting rave reviews in the lifestyle medicine circles. We will use some of the information from his book in future blogs to give a balanced view on gastrointestinal health.

In the mean time HERE is a really exciting interview with Dr B discussing gut health and Covid-19. It is over an hour long but so full of scientifically sound and rational information, all so very pertinent to our present crisis.

Next week we will introduce the subject of fibre and the microbiome. I wish I could share information directly from Dr Bs book, but we will have to rely on interviews with him for pertinent facts given the fact that access to books from the USA is limited, and it is selling like hot cakes.

Continue your good preventive habits. Until next week. Dave Glass

Dr David Glass MBChB, FCOG (SA)

Dr David Glass graduated from UCT in 1975. He spent the next 12 years working at a mission hospital in Lesotho, where much of his work involved health education and interventions to improve health, aside from the normal busy clinical work of an under-resourced mission hospital.

He returned to UCT in 1990 to specialise in obstetrics/gynaecology and then moved to the South Coast where he had the privilege of, amongst other things, ushering 7000 babies into the world. He no longer delivers babies but is still very clinically active in gynaecology.

An old passion, preventive health care, has now replaced the obstetrics side of his work. He is eager to share insights he has gathered over the years on how to prevent and reverse so many of the modern scourges of lifestyle obesity, diabetes, ischaemic heart disease, high blood pressure, arthritis, common cancers, etc.

He is a family man, with a supportive wife, and two grown children, and four beautiful grandchildren. His hobbies include walking, cycling, vegetable gardening, bird-watching, travelling and writing. He is active in community health outreach and deeply involved in church activities. He enjoys teaching and sharing information.

See the original post here:
Turning the Tide A healthy gut comes from a healthy diet - South Coast Herald

First things first: You do not need expensive superfoods or packaged supplements to better your health or immunity during the quarantine. In fact, you never did! According to Luke Coutinho, Holistic Lifestyle Coach - Integrative Medicine, Getting in a wholesome balanced diet with the right quality and quantity of fruits, vegetables, nuts, seeds, pulses, whole grains, common kitchen spices, herbs and good fats are all you need to boost your immunity at a cellular level. These food groups also have numerous fringe benefits on your health and mental well-being.

For example, if you are vulnerable to stress, foods such as bananas, nuts and seeds, chamomile tea and tulsi or holy basil tea will help relax your body and mind. However, the two things that'll not necessarily help are your daily cup of joe and sugar. We are exposed to negative news, today, more than ever and a constant exposure to it can induce fear in us. It can make us feel anxious, hyperactive, etc. On top of that if we add stimulants such as sugar and coffee in our diet we prevent our body from coming back to a state of homeostasis and balance. Though coffee in itself is not the problem, putting it in a system that's already stressed and is churning cortisol to keep up with the stress, causes problems, he says.

You can also include endorphin-boosting foods in your diet, or better yet endorphin-boosting activities in your work-from-home schedule to keep stress at bay. Endorphin is a happy hormone that brings about a feel-good factor. Foods such as chocolates and smells such as that of lavender stimulate the release of endorphins. However, the most reliable sources of an endorphin boost are exercise, laughter and good sex, he explains. If you have the liberty to run a couple of laps on your terrace, do that too. A cardio activity is known to give us an endorphin rush which is as good as a high from a stimulant.

1

Use this time to bring about positive changes in your overall lifestyle the way you eat, sleep, move, breathe and think.

2

Start eating an early dinner to maintain a gap between your dinner and bedtime. This will allow your body enough time to digest and detoxify at night.

3

Spend a part of your mornings doing Yoga, pranayama, gratitude journaling and meditation.

4

Learn healthy cooking from scratch. This skill is going to save you from calling for junk food from restaurants when we resume our normal living.

5

Have free time? Watch a funny movie or documentary with your family! Research shows that laughter has a connection with strong immunity as it boosts levels of natural killer cells.

We can use this time to either worry about what is going to happen next or cultivate a lifestyle and a strong immune system thatll help us sail through this. Choose the latter.

NOW READ

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4 simple mango recipes that are perfect for this summer during the lockdown

3 easy-to-make chocolate recipes you should try during lockdown

More on Food

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Stressed, anxious or nervous during the lockdown? These foods can help - GQ India

The best way to avoid caffeine withdrawal symptoms is to slowly reduce your intake instead of quitting cold turkey, recommends holistic psychiatrist Ellen Vora, M.D.

There are a couple of ways you can do this effectively. Selhub recommends taking away half a cup of caffeine every week for about six weeks. "You can replace regular coffee with decaf, but I recommend drinking more water," she says.

If you're comforted by sipping something warm, Vora recommends this method: "Turn a few cups a day into half-caf, then transition those to black tea...to green tea...to just a few sips." Eventually, your caffeine intake will be so low, you should be able to quit altogether.

One study shows exercise may help manage symptoms of caffeine withdrawal, as well. Selhub explains that exercise can increase dopamine and serotonin levels, which may have dropped with your caffeine decrease. Getting quality sleep and spending time in nature can have similar positive effects.

Selhub also recommends eating a balanced diet, full of antioxidants. "A little bit of dark chocolate might also help," she says. Now that's a recommendation we can get behind.

See the original post here:
Caffeine Withdrawal Is Very Real: Here Are The Symptoms & How To Deal - mindbodygreen.com

KNS

By : KNS | Srinagar,Publish Date: Friday, May 22, 2020 6:04:10 PM|Updated Date : Friday, May 22, 2020 6:04:10 PM

Srinagar, May 22 (KNS): The Jammu and Kashmir government is bringing in far reaching measures to minimize the economic fallout of Covid -19 pandemic on Agriculture and allied sectors.As part of these measures, the government has issued detailed guidelines for the elimination of intermediary brokers and ease down certain other problems faced by the farmers.The decongestion of major fruit and vegetable Mandies across Jammu & Kashmir and timely marketing of Agricultural and Horticultural produce are other crucial areas of governments focus.The Agriculture Production Department, in view of COVID-19 situation, has allowed Deputy Commissioners to notify the places in their respective jurisdictions, where farmers can bring their produce for marketing without any intermediary interference.The guidelines said that collection or aggregation centre in the proximity of production areas may be set up by a person after getting it registered by the concerned Market Administrative Committees. The person will have to comply with a set of guidelines, particularly refraining from any kind of hoarding, under Essential Commodities Act.All the Market Administrative Committees of the UT have been asked to allow and facilitate functioning of such Collection and Sale Centres without any hindrance.Similarly, the principal agriculture product of the UT, Jammu, Basmati rice has been certified as Safe for Pesticides Residual Limits by Quality Control & Quality Assurance Division of Indian Institute Of Integrative e-Medicine (CSIR). The CSIR collected 184 samples of Basmati Rice from Basmati growers of Jammu, Samba and Kathua districts and confirmed the purity of prestigious Jammu Basmati Rice.A report issued by IIIM in this regard will be shared with Agriculture and Processed Products Export Development Authority (APEDA) and other relevant forums for promoting and popularizing the Jammu Basmati and further removing the bottlenecks in trouble-free export of Basmati-370.In another major move to reduce Covid-19 pandemic distress among the farmers, JK Industries is going to procure 60,000 Kg of Grade A and B grade Cocoon from Jammu division and 50,000 kg from Kashmir division.Meanwhile, concerted efforts are underway to develop horticulture and related activities in Jammu region by way of several ongoing government interventions.The potential taping High Density and Ultra High Density plantation for Apple, Kiwi, Peach, Grapes and Walnut is main focus of the government. These fruits have huge potential in hilly areas like Kishtwar, Doda, Poonch, Rajouri and hilly areas of Udhampur, Reasi, Ramban and Kathua.The services of Centre for Excellence for Horticulture are being utilized to promote the fruit growing in all types of regions of Jammu division.Upgrading of the infrastructure of Fruit and Vegetable Market, for developing it on modern lines replete with all the necessary facilities has been prioritized.The State Level Project Screening Committee (SLPSC) on Rashtriya Krishi Vikas Yojana (RKVY-RAFTAR), has recently approved the Annual Action Plan envisaging mobilization of Farmers Producer Organizations (FPOs) and promotion of local specialty crops, value addition, organic farming, farm mechanization and promoting agri-business entrepreneurship. Aadhar seeding and 100% assistance transfer through DBT for all beneficiary oriented schemes has also been stressed upon. (KNS)

Go here to read the rest:
Covid -19 pandemic: JK Govt brings in far reaching measures to lessen economic impact on Agriculture, allied sectors - Kashmir News Service

The results of a new clinical trial published in the journal STEM CELLS Translational Medicine demonstrate how a topical solution made up of stem cells leads to the regrowth of hair for people with a common type of baldness.1

Unfortunately, there are only a few FDA-approved medications to treat hair loss, and these carry a myriad of associated side effects including a negative impact on sexual functioning. There is therefore a pertinent need to develop anti-hair loss treatments that lack such side effects.

Emerging research has demonstrated the potential application of stem cells, particularly adipose tissue-derived stem cells (ADSCs), in this space. ADSCs are a type of mesenchymal stem cell that secrete several growth hormones that facilitate cell development and proliferation.

As previous research has demonstrated that growth factors such as hepatocyte growth factor, vascular endothelial growth factor, insulin-like growth factor and platelet-derived growth factor increase the size of hair follicles during hair development, scientists have explored whether ADSCs can promote hair growth in men and women with alopecia.2,3 The results of such research have been positive, however, a randomized, placebo-controlled trial of such a therapeutic approach in AGA did not exist until now.

"Recent studies have shown that ADSCs promote hair growth in both men and women with alopecia. However, no randomized, placebo-controlled trial in humans has explored the effects and safety of adipose-derived stem cell constituent extract (ADSC-CE) in AGA," says Sang Yeoup Lee, M.D., Ph.D., of the Family Medicine Clinic and Research Institute of Convergence of Biomedical Science and Technology, Pusan National University Yangsan Hospital. "We aimed to assess the efficacy and tolerability of ADSC-CE in middle-aged patients with AGA in our study, hypothesizing that it is an effective and safe treatment agent."

Participants were instructed to apply 2mL of solution to the area in which they experienced hair loss, twice every day for a total of 16 weeks, massaging the solution into their scalp using their fingers. Each subjected visited the research center four times in total throughout the study, and were requested to keep a diary to record when they were using the solution.

To measure whether the solution was significantly impacting hair growth, the scientists measured changes in total hair number and hair thickness as confirmed by close contract photographs using a standardized technique. This was the primary efficacy variable. Photographs were taken at baseline, eight weeks and 16 weeks after using the product. At baseline, participants received a dot tattoo over their scalp to ensure that the photographs were taken at the same spot at each follow up. The secondary efficacy variables of the study included analysis of global photographs of the participants' scalps by an investigator, and self-evaluation of hair growth by the participants.

Whilst these results are promising, the authors note several limitations to the study. When assessing the secondary efficacy outcomes, the researchers found that the improvement score provided by the investigator was higher in the intervention group than the control, but this was not a significant increase. Additionally, the evaluation provided by the subject was lower in the intervention group. The scientists suggest that a contributing factor here could be the study duration, positing the idea that the length of time in which the participants were involved in the trial may not have been sufficient for them to notice a visual improvement. Furthermore, the self-report assessment could have been limited in validity as subjects may have been impacted by their own expectations towards the intervention. A solution to consider going forward could be to ask participants about their expectations regarding the magnitude of improvement at baseline.

Lee adds, "Our findings suggest that the application of the ADSC-CE topical solution has enormous potential as an alternative therapeutic strategy for hair regrowth in patients with AGA, by increasing both hair density and thickness while maintaining adequate treatment safety. The next step should be to conduct similar studies with large and diverse populations in order to confirm the beneficial effects of ADSC-CE on hair growth and elucidate the mechanisms responsible for the action of ADSC-CE in humans."

"For the millions of people who suffer from male-pattern baldness, this small clinical trial offers hope of a future treatment for hair regrowth," says Anthony Atala, M.D., Editor-in-Chief ofSTEM CELLS Translational Medicineand director of the Wake Forest Institute for Regenerative Medicine. "The topical solution created from proteins secreted by stem cells found in fat tissue proves to be both safe and effective. We look forward to further findings that support this work."

References:

1. Tak, Lee, Cho and Kim. (2020). A randomized, doubleblind, vehiclecontrolled clinical study of hair regeneration using adiposederived stem cell constituent extract in androgenetic alopecia. Stem Cells Translational Medicine. DOI: https://doi.org/10.1002/sctm.19-0410.

2. Ramdasi S, Tiwari SK. (2016). Growth factors and cytokines secreted in conditioned media by mesenchymal stem cells-promising possible therapeutic approach for hair regeneration. J Stem Cells. https://www.ncbi.nlm.nih.gov/pubmed/28296872.

3. Lee et al. (2001). Hepatocyte growth factor (HGF) activator expressed in hair follicles is involved in in vitro HGF-dependent hair follicle elongation. J Dermatol Sci. 25:156-163.

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Clinical Trial Shows Topical Stem Cell Treatment Leads to Hair Regrowth in Common Type of Baldness - Technology Networks

CUBIQ Foods is aiming to replace animal-based fats with vegan and cultured ingredients.

Founded in 2018 by Dr. Raquel Revilla and Andrs Montefeltro, the Barcelona-based food tech startup promotes sustainability, human health, and animal welfare.

One of the companys products, the vegan SMART FAT, enhances the flavor of low-fat vegetable, animal, or cultivated proteins. It contains less saturated fat and fewer calories than traditional emulsions and uses 100 percent sustainable ingredients. SMART FAT is designed to replace unhealthy fats in meat, dairy, flexitarian, and vegan products.

CUBIQ also produces vegan-friendly SMART Omega-3, which carries a concentrated and encapsulated form of the polyunsaturated fatty acid.

The highly concentrated essential oils maintain their properties for use within even the most demanding industrial recipes. This can assist food producers to include recommended daily amounts of omega-3 in affordable and healthy products.

Sustainable omega-3 and vegan healthier fats inspire our team and partners, said Montefeltro. We are ready to deliver a new generation of nutritious, healthy, and accessible products at an industrial scale by the end of this year.

The company just received 5 million in funding from Blue Horizon Ventures and Moira Capital Partners SGEIC.

This new wave of funding will help CUBIQ produce its sustainable fats on an industrial scale, ready to launch at the end of 2020. The company is the first of its kind to produce such products on this scale. It is also the first cultivated fat cell platform to produce such high-quality omega-3s in this way.

CUBIQ Foods also uses cultured fat to produce oil-enriched omega-3.

In an email sent to LIVEKINDLY, Montefeltro explained that the company uses duck stem cells to produce DHA and EPA enriched oils. Montefeltro said the process is more sustainable than fish oil, a traditional source of omega-3.

Proponents of lab-grown food believe that growing ingredients from cell culture can be less resource-intensive than traditional methods. Cultivated animal products can provide a low-impact and clean alternative to conventional animal agriculture.

Traditional animal agriculture is responsible for 14.5 percent of global greenhouse gas emissions globally.The production of food from cell culture, in the form of tissue, will undoubtedly be the most efficient and scalable way to meet the food needs we will face in the coming years, said Montefeltro.

Summary

Article Name

This Food Tech Startup Is Replacing Animal Fats With Plants

Description

Barcelona-based CUBIQ Foods produces sustainable, healthy food ingredients, including vegan and cultured fat and concentrated omega-3.

Author

Liam Pritchett

Publisher Name

LIVEKINDLY

Publisher Logo

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This Food Tech Startup Is Replacing Animal Fats With Plants - LIVEKINDLY

It will be made in a similar way to brewing beer, says Lavanya Anandan. She is not talking about a new kind of drink, however, but describing a new industry aiming to grow meat in the lab. This new food is known as clean meat, cultured meat or cultivated meat.

Demand for meat has never been higher, but the way we produce it today is unsustainable and, for some, ethically dubious. So scientists around the world are learning to grow meat and seafood in their labs without the need for farms or livestock.

They have had considerable success the worlds first lab-grown beef burger was cooked and tasted in London in 2013, albeit at a price of around $250,000 and costs have dropped by orders of magnitude since. The challenge now is to turn these lab-based successes into food that can be sold on supermarket shelves at reasonable prices.

Thats how Anandan fits in. Leading a new Innovation Field on this topic and based in Silicon Valley, Anandan works for Merck KGaA, Darmstadt, Germany, a leading science and technology company in Healthcare, Life Science and Performance Materials with a 350-year record of innovation. The companys strategy and transformation team is working on new products and technologies for the future. One of their goals is to provide the technology platforms and infrastructure that will enable the cultured meat revolution.

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This revolution is desperately needed. The worlds population is growing, with another 2 billion expected by 2050. Demand for meat is expected to grow by 70 per cent, significantly increasing the pressure on limited resources such as land and water. This in turn will drive climate change. Today, livestock farming is responsible for 15 per cent of global greenhouse gas emissions and is a key cause of deforestation. If you look at the numbers, theyre quite staggering, says Anandan.

If meat could be grown in the lab instead of on farms, it could create an alternative to traditionally-produced meat and help reduce the environmental footprint for meat production. Additionally, by reducing or eliminating the use of antibiotics and hormones, cultured meat could also have positive health aspects.

Cultured meat is produced using some of the same technologies biologists have used for decades to grow animal cells. First, muscle cells are taken from live animals as a small biopsy from which stem cells are isolated and then cultured in the lab.

The next stage is more difficult, however. The cultured cells must then be grown and differentiated into a form of tissue comprising of muscle, fat and other cells that is suitable for food processing and consumption. This takes place inside bioreactors where the cells are trapped and supported in a scaffold of fibres, just as in animal tissue, and submerged in a cocktail of nutrients called a growth media. Finally, this tissue must be processed and formed into products such as burgers patties, sausages or shrimp mince.

Currently, around 60 start-ups around the world are developing and improving the cultured meat process to make different meats and seafood. Most of them are growing its own special cells that require bespoke growth media and cellular scaffolding. And they are all looking to scale up production while bringing down costs.

This is where the expertise of Merck KGaA, Darmstadt, Germany, comes in. The techniques used to culture meat are the same for the biologics and cell therapy industry and, as a leading life sciences company, weve helped solve similar challenges, says Anandan.

The company is not aiming to grow its own meat but to develop the materials and technologies that will accelerate its development. And it is already working with start-ups, non-profits and academics. We are taking our existing expertise and trying to come up with innovative solutions and technologies such as reagents and analytical tools to solve problems for the clean meat sector, she says.

One important goal is to find the right formulation for the growth media. This is a cocktail of 50 to 100 ingredients such as sugars, salts, amino acids, micronutrients and growth factor. Each cell line is going to require a specific optimised formula, says Anandan.

This growth medium must also not contain animal-derived compounds and economical enough to make lab-grown meat affordable. Cost is an important hurdle that has to be overcome, she says. Currently, culture media costs hundreds of dollars per litre, but for clean meat production to scale this needs to drop to around $1 a litre.

Other challenges for the industry are to develop the tissue scaffolds needed to support growth of the cells, and to engineer the specialised bioreactors needed to scale-up production.

So when will the fruits of this cellular agriculture reach the supermarket shelves? In the next few years we can expect a few launches of small-scale products in high end restaurants. It will be a pretty expensive burger in a restaurant in Hong Kong or San Francisco says Anandan. My prediction is that by 2030 you might see them on supermarket shelves at a decent price.

To find out more:In the US, click hereIn the UK, Europe and RoW, click here

Free online eventThe global demand for meat is expected to rise nearly 70% by 2050. Cultured Meat could help to feed this growing hunger for animal protein with less negative impact on the environment. But which technology hurdles do scientists have to overcome before cultured meat becomes mainstream?When: 10 June 2020, from 16:30 to 17:30 BSTWhere: onlineIn the US, register for free hereIn the UK, Europe and RoW, register for free here

What if medicines could be 3D printed? Or plants grown in agricultural tunnels using nanotechnology that fine-tunes sunlight to boost yields? Or cultured meat grown in bioreactors? These ideas have the potential to transform industries but they need a helping hand to come to fruition. This is exactly the aim of the Innovation Centers of Merck KGaA, Darmstadt, Germany.

The Innovation Center is a playground for scientists and entrepreneurs to explore new fields and develop new businesses beyond the companys current scope. These teams are now operating at the companys headquarters in Darmstadt, Germany, with additional hubs in Silicon Valley and China, with involvement from colleagues around the world. Our innovation projects operate like startups, says Lavanya Anandan, who is coordinating the clean meat innovation field at the California site. The Innovation Center and Innovation Hubs are building an ecosystem where we can grow viable new businesses with the backing and know-how of a big company.

In addition to the clean meat research, the Innovation Center is working on a laser-adjustable lens replacements for people with cataracts, new technologies for structure analysis on a sub-microgram scale and many other challenges.

Find out more.In the US, go to: innovationcenter.emdgroup.comIn the UK, Europe and RoW go to: innovationcenter.merckgroup.com

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Accelerating the cultured meat revolution - New Scientist

The idea is hard to stomach at first: animal meat grown in a lab.

But proponents of "cell-based meat" say the emerging technology has the potential to tackle two global problems at once. Lab-grown beef patties, chicken cutlets and even exotic proteins could help satisfy the world's growing appetite for meat, they argue. And it could be done in a way that cuts down on the tremendous environmental impact of animal agriculture.

Standing in the way is a long list of challenges including regulatory obstacles, sky-high production costs and the ever-present ick factor.

Still, advocates say lab-grown meat could hit store shelves as soon as 2025 if not earlier.

One proponent is Krijn de Nood, the chief executive of Meatable, a Netherlands-based company that is producing animal tissue by mimicking the cellular growth that typically happens inside rather than outside of living organisms. In an interview, de Nood said Meatable is "mission driven" and that it aims to address issues from climate change to animal welfare.

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The company is among dozens of startups worldwide that are racing to scale technology they claim produces "real meat" not plant-based alternatives from companies such as Impossible Foods and Beyond Meat (Climatewire, Oct. 21, 2019).

That's possible, they say, because most cultured protein products originate as stem cells from real animals. Some companies make a point to say that no animals are harmed in the process.

Here's how it typically works. Engineers obtain an animal stem cell sample and isolate "cell lines" with the strongest genetic material. The cells are then placed in an environment like a petri dish or bioreactor that encourages rapid growth, and later differentiation. The resulting fat and muscle tissue is then harvested, structured and processed to create a final product.

De Nood said Meatable already has produced small quantities of meat using this process. And the whole thing took just three weeks a far faster timeline, Meatable notes, than it takes to raise an animal for slaughter. The company plans to host its first public taste testing of a pork prototype in September.

Several other companies already have allowed outsiders to sample their products. Those include Memphis Meats, Peace of Meat and Mosa Meat, which are based in the U.S., Belgium and the Netherlands, respectively.

In fact, one of the first cultured meat tastings dates back to 2013, when Maastricht University physiologist Mark Post presented the world with a beef patty that was produced in a petri dish.

At the time, that single slab of meat cost a whopping 250,000 to produce; Google co-founder Sergey Brin picked up the tab. Several years later, Post co-founded Mosa Meat.

More recently, in March, Peace of Meat hosted an event where attendees sampled a chicken nugget.

Tasting aside, co-founder David Brandes underscored that the startup has a different ambition than many other companies. Rather than producing consumer-facing products, Peace of Meat aims to eventually grow more than 100,000 tons of pure, cultured fat per year. The startup plans to sell the fat to other companies as a key ingredient to enhance the taste and texture of alternative meat products, including those that are plant-based.

"We don't want to make the most fancy-looking piece of food, we don't want to work on exotic species," said Brandes. "You need to produce massive amounts of meat if you really want to have an impact."

Animal agriculture is responsible for a whopping 14.5% of planet-warming emissions, according to the Food and Agriculture Organization of the United Nations. That figure includes greenhouse gases attributable to meat processing, meat-related transportation and manure storage. Then there's the issue of belching cattle which itself is responsible for 65% of the livestock sector's emissions.

Paul Mozdziak, who serves as Peace of Meat's chief scientific officer, was among those who said a central goal of cellular agriculture is to satisfy the world's staggering, and still rising, demand for animal protein but without relying on supply chains that scientists say are environmentally fraught and highly vulnerable to marketplace disruptions.

As an example, Mozdziak pointed to the novel coronavirus crisis, which in recent weeks has temporarily shuttered meat packing plants, forced farmers to cull tens of thousands of animals and spurred fears of a nationwide protein shortage (Greenwire, May 4).

"I absolutely think the pandemic supports the need for this," said Mozdziak, who also directs North Carolina State University's graduate physiology program.

"It's another way to produce food. It's another way to produce protein. It's another way to increase food security," he added. "What if something [else] happens? ... [W]here's the protein going to come from? How are we going to eat?"

But even Mozdziak, who has pondered cultured meat since the early 1990s, acknowledged the obstacles ahead. Despite entrepreneurs' ambitions, he said, the field remains deep in research and development and far from supermarket shelves.

De Nood, of Meatable, highlighted that same issue. "It's all about the scalability of the process," he said, noting that his company is working to drive down costs and move its operations from "small environments" to large bioreactors that would require major processing factories.

Peace of Meat's Brandes agreed. But he said that even if production costs fall, there's the possibility that cultured meat would not meaningfully impact the carbon footprint of the global food system.

"When it comes to greenhouse gas emissions, I think there is a big potential," said Brandes. But producing large quantities of cultured meat would inevitably require substantial amounts of energy, too, "so it really depends where you draw the energy from," Brandes said.

Despite those obstacles and more, some projections have named cultured meat as a key driver of a revolutionary shift away from animal agriculture. Independent think tank RethinkX, for instance, predicts that cell-based meat and plant-based alternatives could render industrial cow farming "obsolete" in the U.S. entirely.

Ermias Kebreab, who is a climate and animal agriculture expert at the University of California, Davis, disagreed with that assessment.

Even as the world becomes more invested in exploring alternatives to conventional protein, Kebreab said, researchers and traditional farmers are actively developing strategies like feeding seaweed to cows to cut the sector's environmental footprint.

In his eyes, sustainable agriculture, rather than cellular agriculture, is what will ultimately enhance food security in developing countries where most future population growth is predicted to occur.

"I'd rather have beef" from cows, said Kebreab, adding that cell-based meat also raises other issues for him, like the products' overall nutritional value. He said he's wary of "highly, highly processed food."

Mozdziak, of Peace of Meat, agreed in part. He doesn't see cellular agriculture putting meat companies out of business.

But "at the same time," he said, "let me vehemently state that I think cultured meat is really important. ... [I]f we're going to have a billion more people on the planet in 30 years, we're going to have to find a way to feed them."

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BUSINESS: Can lab-grown meat save the planet and dinner? - E&E News