StemCell Therapy

Millions of Americans have chronic kidney disease. Hundreds of thousands will progress to end stage kidney disease requiring either dialysis or kidney transplant. But research is underway to keep people from reaching that point.

Our goal is to take a look at how we can repair the diabetic kidney in terms of delaying the rate of progression of kidney failure, says LaTonya Hickson, M.D., a Mayo Clinic nephrologist.

Dr. Hickson is part of the research team looking at using stem cells to help regenerate failing kidneys.

We take these cells from our abdominal fat and we can inject them back into the body for them to do good, says Dr. Hickson. They basically tell the kidney or other organ systems that are impaired to wake up and get back to work and help heal that organ system.

While theres a lot more research ahead, Dr. Hickson is excited about the possibilities.

Listen to the Mayo Clinic Radio Health Minute and learn more about stem cells and chronic kidney disease in the video below:

Tags: chronic kidney disease, Dr. LaTonya Hickson, Mayo Clinic Center for Regenerative Medicine, Medical Research, Research, stem cells

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Stem Cells and Chronic Kidney Disease | Mayo Clinic Center ...

Current treatment options often fail due to the progression of renal disease. The pathology involves tubulointerstitial fibrosis, oxidative damage, glomerular fibrosis, and microvascular rarefaction. The kidneys have intrinsic regenerative capacity, which allows them to recover after minimal injury. The regenerative potential of these organs is limited, however.

Stem cell infusions are now being used to treat kidney failure with positive outcomes. Mesenchymal stem cells (MSCs) produce cytokines and growth factors that support hematopoiesis. These cells can transform into renal epithelial cells, functional mesangial cells, and tubular cells. Research shows that each stem cell viability is 95%, and injections work 99% of the time. MSCs have ability to reduce inflammatory response, reduce apoptosis, and increase renal function recovery.

Most chronic kidney disease patients are treated with stem cells and show improvement in the following areas:

Research:

Stem cells at R3 Stem Cell are harvested in a very safe process from consenting donors after a scheduled c-section. No babies or mother are harmed during the process. These cells possess unique immunomodulatory properties that relieve inflammation, and they can facilitate renal tissue repair. Several clinical studies have proved that stem cells are safe and effective for treating renal failure. Some research suggests that stem cells can change into ectodermal and endodermal lineages, and secrete growth factors, cytokines, and chemokines.

In a recent clinical study, researchers found that stem cells possessed a high potential for angiogenesis (vessel re-growth). In addition, investigators noted local tissue turnover and repair of kidney damage after stem cell therapy. The cells were also noted to go to the site of kidney injury. The stem cells are known to release dozens of active biological factors that act on local cell dynamics, reduce inflammation, lessen fibrosis, and recruit resident progenitor cells.

A phase 1 research study involved stem cell infusions given one week after kidney transplant surgery. The researchers found that they decreased graft rejection, and both patients had excellent kidney function at the 1-year follow-up evaluation. The patients also recovered faster from surgery, had less complications, and few adverse effects. Another similar study involving five people with renal failure involved administration of stem cell injections. Six months after transplant, a noted immunomodulatory effect was noted.

Another clinical study showed feasibility and safety of stem cell infusion for the treatment of renal disease. The study involved several cohort patients, as well as a control group. The stem cells were infused through the renal artery. At the 1-year follow-up, researchers noted a beneficial effect and reduced dosage requirement of immunosuppressive drugs. These clinical trials prove effectiveness and safety of stem cell therapy for renal diseases. Notable findings include improved resolution of tubular atrophy and interstitial fibrosis, as well as decreased risk of infection, positive effects of infusion, and lower incidence of acute rejection.

References:

Peired AJ, Sisti A, & Romagnani P (2016). Mesenchymal Stem Cell-Based Therapy for Kidney Disease: A Review of Clinical Evidence. Stem Cells Int, 4798639.

Perico N, Casiraghi F, Introna M, Gotti E, Todeschini M, Cavinato RA, et al. Autologous mesenchymal stromal cells and kidney transplantation: a pilot study of safety and clinical feasibility.Clin J Am Soc Nephrol.2011;6:412422

Reinders ME, de Fijter JW, Roelofs H, Bajema IM, de Vries DK, Schaapherder AF, et al. Autologous bone marrow-derived mesenchymal stromal cells for the treatment of allograft rejection after renal transplantation: results of a phase I study.Stem Cells Transl Med.

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Kidney Failure | Stem Cell Treatment in Tijuana Mexico

NEW YORK, April 08, 2020 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB) today announced that its allogeneic mesenchymal stem cell (MSC) product candidate remestemcel-L will be formally evaluated in a randomized, placebo-controlled trial in 240 patients with acute respiratory distress syndrome (ARDS) caused by coronavirus infection (COVID-19). This multi-center Phase 2/3 trial will be conducted as a public-private partnership in a collaboration with the Cardiothoracic Surgical Trials Network (CTSN), which was established by the United States National Institutes of Healths National Heart, Lung and Blood Institute (NHLBI) as a flexible platform for conducting collaborative trials. Mesoblast holds an Investigational New Drug (IND) Application from the United States Food and Drug Administration (FDA) for use of remestemcel-L in the treatment of patients with COVID-19 ARDS, and will provide investigational product for the trial.

Mesoblast Chief Executive Dr Silviu Itescu stated: This significant public-private partnership is a prime example of how the combined resources of industry and government can be leveraged to evaluate in a most efficient and rigorous manner the potential of innovative therapies to make a meaningful difference to patient outcomes.

CTSN Chairman Dr A. Marc Gillinov said: We are excited to work with Mesoblast to make a real impact on the high mortality associated with COVID-19. Thisrandomized controlled trialis in line with our mandate torigorously evaluate novel therapies forpublic health imperatives.

Professor and System Chair of Population Health Science and Policy and the Edmond A. Guggenheim Professor of Health Policy at the Icahn School of Medicine at Mount Sinai, Dr Annetine Gelijns, said: The COVID-19 pandemic has resulted in very large numbers of people suffering with ARDS requiring ventilation in hospital intensive care units, with dismal outcomes, placing an enormous burden on the United States health system.We are committed to evaluating whether Mesoblasts mesenchymal stem cell product candidate for ARDS has the potential to make an impact on this unprecedented health crisis.

ARDS occurs due to an excessive immune response against the COVID-19 virus in the lungs, with the inflammatory cytokines produced by the immune cells (cytokine storm) destroying the lung tissue. These inflammatory cytokines also can cause damage to other organs such as liver, kidney, and heart.

Remestemcel-L is being developed for various inflammatory conditions, and is believed to counteract the inflammatory processes implicated in these diseases by down-regulating the production of pro-inflammatory cytokines, increasing production of anti-inflammatory cytokines, and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues.The safety and therapeutic effects of remestemcel-L intravenous infusions have been evaluated in over 1,100 patients in various clinical trials.

Remestemcel-L was successful in a Phase 3 trial for steroid-refractory acute graft versus host disease (aGVHD) in children, a potentially fatal inflammatory condition due to a similar cytokine storm process as is seen in COVID-19 ARDS.Additionally, a post-hoc analysis of a randomized, placebo-controlled study in 60 patients with chronic obstructive pulmonary disease demonstrated that remestemcel-L significantly improved respiratory function in patients with the same elevated inflammatory biomarkers that are also observed in patients with COVID-19 ARDS. Together, these outcomes provide the rationale for evaluating remestemcel-L in patients with COVID-19 ARDS.

Mesoblast Chief Medical Officer Dr Fred Grossman said: The mortality rate in moderate to severe ARDS due to COVID-19 can be as high as 80%. Remestemcel-L has demonstrated safety, efficacy and significant survival benefit in aGVHD where inflammation is at the core, similar to ARDS from COVID-19. The mechanism of action of remestemcel-L demonstrated in aGVHD supports the evaluation of remestemcel-L to safely tame a similar cytokine storm in the lungs that leads to the high mortality in patients with COVID-19.

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

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

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

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

Forward-Looking StatementsThis announcement includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements include, but are not limited to, statements about the initiation, timing, progress and results of Mesoblast and its collaborators clinical studies; Mesoblast and its collaborators ability to advance product candidates into, enroll and successfully complete, clinical studies; the timing or likelihood of regulatory filings and approvals; and the pricing and reimbursement of Mesoblasts product candidates, if approved; the potential benefits of strategic collaboration agreements and Mesoblasts ability to maintain established strategic collaborations; Mesoblasts ability to establish and maintain intellectual property on its product candidates and Mesoblasts ability to successfully defend these in cases of alleged infringement; the scope of protection Mesoblast is able to establish and maintain for intellectual property rights covering its product candidates and technology. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblasts actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise.

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MESOBLAST PARTNERS WITH THE CARDIOTHORACIC SURGICAL TRIALS NETWORK ESTABLISHED BY THE U.S. NATIONAL INSTITUTES OF HEALTHS NATIONAL HEART, LUNG AND...

Supplemental Biologics License Application (sBLA) Accepted for KEYTRUDA Monotherapy in Patients Whose Tumors Are Tumor Mutational Burden-High (TMB-H) Who Have Progressed Following Prior Treatment

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for a new supplemental Biologics License Application (sBLA) for KEYTRUDA, Merck's anti-PD-1 therapy. The application seeks accelerated approval of KEYTRUDA monotherapy for the treatment of adult and pediatric patients with unresectable or metastatic solid tumors with tissue tumor mutational burden-high (TMB-H) 10 mutations/megabase, as determined by an FDA-approved test, who have progressed following prior treatment and who have no satisfactory alternative treatment options. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of June 16, 2020.

"From the start, biomarker research has been a critical aspect of our clinical program evaluating KEYTRUDA monotherapy," said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. "TMB has been an area of scientific interest to help identify patients most likely to benefit from KEYTRUDA. We look forward to working with the FDA throughout the review process to help bring KEYTRUDA monotherapy to patients with cancer in the second-line or higher treatment setting, where options remain limited."

The application was based in part on results from the Phase 2 KEYNOTE-158 trial, which also supported Merck's 2017 FDA approval for KEYTRUDA as the first cancer treatment based on a biomarker, regardless of cancer type, in microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors. MSI-H is on the highest end of the TMB spectrum. Data from KEYNOTE-158 on the TMB-H patient population were presented at the European Society for Medical Oncology (ESMO) 2019 Congress.

About KEYNOTE-158

KEYNOTE-158 (NCT02628067) is a multicenter, multi-cohort, non-randomized, open-label trial evaluating KEYTRUDA (200 mg every three weeks) in patients with solid tumors. Tissue TMB status was determined using the Foundation Medicine, Inc. FoundationOneCDx assay. Tumor response was assessed every nine weeks per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by independent, central, blinded radiographic review. The major efficacy outcome measures were objective response rate (ORR) and duration of response (DOR) as assessed by blinded independent central review (BICR) according to RECIST v1.1, modified to follow a maximum of 10 target lesions and a maximum of five target lesions per organ.

About KEYTRUDA (pembrolizumab) Injection, 100 mg

KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the body's immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industry's largest immuno-oncology clinical research program. There are currently more than 1,200 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected KEYTRUDA (pembrolizumab) Indications

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.

KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.

Non-Small Cell Lung Cancer

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) 1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS 1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

Small Cell Lung Cancer

KEYTRUDA is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Head and Neck Squamous Cell Cancer

KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS) 1] as determined by an FDA-approved test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after 3 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Primary Mediastinal Large B-Cell Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

Urothelial Carcinoma

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 [combined positive score (CPS) 10], as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Microsatellite Instability-High (MSI-H) Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.

Gastric Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Esophageal Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS 10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.

Cervical Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Hepatocellular Carcinoma

KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Merkel Cell Carcinoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Renal Cell Carcinoma

KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

Selected Important Safety Information for KEYTRUDA

Immune-Mediated Pneumonitis

KEYTRUDA can cause immune-mediated pneumonitis, including fatal cases. Pneumonitis occurred in 3.4% (94/2799) of patients with various cancers receiving KEYTRUDA, including Grade 1 (0.8%), 2 (1.3%), 3 (0.9%), 4 (0.3%), and 5 (0.1%). Pneumonitis occurred in 8.2% (65/790) of NSCLC patients receiving KEYTRUDA as a single agent, including Grades 3-4 in 3.2% of patients, and occurred more frequently in patients with a history of prior thoracic radiation (17%) compared to those without (7.7%). Pneumonitis occurred in 6% (18/300) of HNSCC patients receiving KEYTRUDA as a single agent, including Grades 3-5 in 1.6% of patients, and occurred in 5.4% (15/276) of patients receiving KEYTRUDA in combination with platinum and FU as first-line therapy for advanced disease, including Grades 3-5 in 1.5% of patients.

Monitor patients for signs and symptoms of pneumonitis. Evaluate suspected pneumonitis with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 or recurrent Grade 2 pneumonitis.

Immune-Mediated Colitis

KEYTRUDA can cause immune-mediated colitis. Colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 2 (0.4%), 3 (1.1%), and 4 (<0.1%). Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold KEYTRUDA for Grade 2 or 3; permanently discontinue KEYTRUDA for Grade 4 colitis.

Immune-Mediated Hepatitis (KEYTRUDA) and Hepatotoxicity (KEYTRUDA in Combination With Axitinib)

Immune-Mediated Hepatitis

KEYTRUDA can cause immune-mediated hepatitis. Hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.4%), and 4 (<0.1%). Monitor patients for changes in liver function. Administer corticosteroids for Grade 2 or greater hepatitis and, based on severity of liver enzyme elevations, withhold or discontinue KEYTRUDA.

Hepatotoxicity in Combination With Axitinib

KEYTRUDA in combination with axitinib can cause hepatic toxicity with higher than expected frequencies of Grades 3 and 4 ALT and AST elevations compared to KEYTRUDA alone. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased ALT (20%) and increased AST (13%) were seen. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider more frequent monitoring of liver enzymes as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed.

Immune-Mediated Endocrinopathies

KEYTRUDA can cause adrenal insufficiency (primary and secondary), hypophysitis, thyroid disorders, and type 1 diabetes mellitus. Adrenal insufficiency occurred in 0.8% (22/2799) of patients, including Grade 2 (0.3%), 3 (0.3%), and 4 (<0.1%). Hypophysitis occurred in 0.6% (17/2799) of patients, including Grade 2 (0.2%), 3 (0.3%), and 4 (<0.1%). Hypothyroidism occurred in 8.5% (237/2799) of patients, including Grade 2 (6.2%) and 3 (0.1%). The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC (16%) receiving KEYTRUDA, as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. Hyperthyroidism occurred in 3.4% (96/2799) of patients, including Grade 2 (0.8%) and 3 (0.1%), and thyroiditis occurred in 0.6% (16/2799) of patients, including Grade 2 (0.3%). Type 1 diabetes mellitus, including diabetic ketoacidosis, occurred in 0.2% (6/2799) of patients.

Monitor patients for signs and symptoms of adrenal insufficiency, hypophysitis (including hypopituitarism), thyroid function (prior to and periodically during treatment), and hyperglycemia. For adrenal insufficiency or hypophysitis, administer corticosteroids and hormone replacement as clinically indicated. Withhold KEYTRUDA for Grade 2 adrenal insufficiency or hypophysitis and withhold or discontinue KEYTRUDA for Grade 3 or Grade 4 adrenal insufficiency or hypophysitis. Administer hormone replacement for hypothyroidism and manage hyperthyroidism with thionamides and beta-blockers as appropriate. Withhold or discontinue KEYTRUDA for Grade 3 or 4 hyperthyroidism. Administer insulin for type 1 diabetes, and withhold KEYTRUDA and administer antihyperglycemics in patients with severe hyperglycemia.

Immune-Mediated Nephritis and Renal Dysfunction

KEYTRUDA can cause immune-mediated nephritis. Nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.1%), and 4 (<0.1%) nephritis. Nephritis occurred in 1.7% (7/405) of patients receiving KEYTRUDA in combination with pemetrexed and platinum chemotherapy. Monitor patients for changes in renal function. Administer corticosteroids for Grade 2 or greater nephritis. Withhold KEYTRUDA for Grade 2; permanently discontinue for Grade 3 or 4 nephritis.

Immune-Mediated Skin Reactions

Immune-mediated rashes, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) (some cases with fatal outcome), exfoliative dermatitis, and bullous pemphigoid, can occur. Monitor patients for suspected severe skin reactions and based on the severity of the adverse reaction, withhold or permanently discontinue KEYTRUDA and administer corticosteroids. For signs or symptoms of SJS or TEN, withhold KEYTRUDA and refer the patient for specialized care for assessment and treatment. If SJS or TEN is confirmed, permanently discontinue KEYTRUDA.

Other Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue in patients receiving KEYTRUDA and may also occur after discontinuation of treatment. For suspected immune-mediated adverse reactions, ensure adequate evaluation to confirm etiology or exclude other causes. Based on the severity of the adverse reaction, withhold KEYTRUDA and administer corticosteroids. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Based on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with corticosteroid use, administration of other systemic immunosuppressants can be considered. Resume KEYTRUDA when the adverse reaction remains at Grade 1 or less following corticosteroid taper. Permanently discontinue KEYTRUDA for any Grade 3 immune-mediated adverse reaction that recurs and for any life-threatening immune-mediated adverse reaction.

The following clinically significant immune-mediated adverse reactions occurred in less than 1% (unless otherwise indicated) of 2799 patients: arthritis (1.5%), uveitis, myositis, Guillain-Barr syndrome, myasthenia gravis, vasculitis, pancreatitis, hemolytic anemia, sarcoidosis, and encephalitis. In addition, myelitis and myocarditis were reported in other clinical trials, including classical Hodgkin lymphoma, and postmarketing use.

Treatment with KEYTRUDA may increase the risk of rejection in solid organ transplant recipients. Consider the benefit of treatment vs the risk of possible organ rejection in these patients.

Infusion-Related Reactions

KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis, which have been reported in 0.2% (6/2799) of patients. Monitor patients for signs and symptoms of infusion-related reactions. For Grade 3 or 4 reactions, stop infusion and permanently discontinue KEYTRUDA.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Immune-mediated complications, including fatal events, occurred in patients who underwent allogeneic HSCT after treatment with KEYTRUDA. Of 23 patients with cHL who proceeded to allogeneic HSCT after KEYTRUDA, 6 (26%) developed graft-versus-host disease (GVHD) (1 fatal case) and 2 (9%) developed severe hepatic veno-occlusive disease (VOD) after reduced-intensity conditioning (1 fatal case). Cases of fatal hyperacute GVHD after allogeneic HSCT have also been reported in patients with lymphoma who received a PD-1 receptorblocking antibody before transplantation. Follow patients closely for early evidence of transplant-related complications such as hyperacute graft-versus-host disease (GVHD), Grade 3 to 4 acute GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease (VOD), and other immune-mediated adverse reactions.

In patients with a history of allogeneic HSCT, acute GVHD (including fatal GVHD) has been reported after treatment with KEYTRUDA. Patients who experienced GVHD after their transplant procedure may be at increased risk for GVHD after KEYTRUDA. Consider the benefit of KEYTRUDA vs the risk of GVHD in these patients.

Increased Mortality in Patients With Multiple Myeloma

In trials in patients with multiple myeloma, the addition of KEYTRUDA to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of these patients with a PD-1 or PD-L1 blocking antibody in this combination is not recommended outside of controlled trials.

Embryofetal Toxicity

Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. Advise women of this potential risk. In females of reproductive potential, verify pregnancy status prior to initiating KEYTRUDA and advise them to use effective contraception during treatment and for 4 months after the last dose.

Adverse Reactions

In KEYNOTE-006, KEYTRUDA was discontinued due to adverse reactions in 9% of 555 patients with advanced melanoma; adverse reactions leading to permanent discontinuation in more than one patient were colitis (1.4%), autoimmune hepatitis (0.7%), allergic reaction (0.4%), polyneuropathy (0.4%), and cardiac failure (0.4%). The most common adverse reactions (20%) with KEYTRUDA were fatigue (28%), diarrhea (26%), rash (24%), and nausea (21%).

In KEYNOTE-002, KEYTRUDA was permanently discontinued due to adverse reactions in 12% of 357 patients with advanced melanoma; the most common (1%) were general physical health deterioration (1%), asthenia (1%), dyspnea (1%), pneumonitis (1%), and generalized edema (1%). The most common adverse reactions were fatigue (43%), pruritus (28%), rash (24%), constipation (22%), nausea (22%), diarrhea (20%), and decreased appetite (20%).

In KEYNOTE-054, KEYTRUDA was permanently discontinued due to adverse reactions in 14% of 509 patients; the most common (1%) were pneumonitis (1.4%), colitis (1.2%), and diarrhea (1%). Serious adverse reactions occurred in 25% of patients receiving KEYTRUDA. The most common adverse reaction (20%) with KEYTRUDA was diarrhea (28%).

In KEYNOTE-189, when KEYTRUDA was administered with pemetrexed and platinum chemotherapy in metastatic nonsquamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 20% of 405 patients. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonitis (3%) and acute kidney injury (2%). The most common adverse reactions (20%) with KEYTRUDA were nausea (56%), fatigue (56%), constipation (35%), diarrhea (31%), decreased appetite (28%), rash (25%), vomiting (24%), cough (21%), dyspnea (21%), and pyrexia (20%).

In KEYNOTE-407, when KEYTRUDA was administered with carboplatin and either paclitaxel or paclitaxel protein-bound in metastatic squamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 15% of 101 patients. The most frequent serious adverse reactions reported in at least 2% of patients were febrile neutropenia, pneumonia, and urinary tract infection. Adverse reactions observed in KEYNOTE-407 were similar to those observed in KEYNOTE-189 with the exception that increased incidences of alopecia (47% vs 36%) and peripheral neuropathy (31% vs 25%) were observed in the KEYTRUDA and chemotherapy arm compared to the placebo and chemotherapy arm in KEYNOTE-407.

In KEYNOTE-042, KEYTRUDA was discontinued due to adverse reactions in 19% of 636 patients with advanced NSCLC; the most common were pneumonitis (3%), death due to unknown cause (1.6%), and pneumonia (1.4%). The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia (7%), pneumonitis (3.9%), pulmonary embolism (2.4%), and pleural effusion (2.2%). The most common adverse reaction (20%) was fatigue (25%).

In KEYNOTE-010, KEYTRUDA monotherapy was discontinued due to adverse reactions in 8% of 682 patients with metastatic NSCLC; the most common was pneumonitis (1.8%). The most common adverse reactions (20%) were decreased appetite (25%), fatigue (25%), dyspnea (23%), and nausea (20%).

Adverse reactions occurring in patients with SCLC were similar to those occurring in patients with other solid tumors who received KEYTRUDA as a single agent.

In KEYNOTE-048, KEYTRUDA monotherapy was discontinued due to adverse events in 12% of 300 patients with HNSCC; the most common adverse reactions leading to permanent discontinuation were sepsis (1.7%) and pneumonia (1.3%). The most common adverse reactions (20%) were fatigue (33%), constipation (20%), and rash (20%).

In KEYNOTE-048, when KEYTRUDA was administered in combination with platinum (cisplatin or carboplatin) and FU chemotherapy, KEYTRUDA was discontinued due to adverse reactions in 16% of 276 patients with HNSCC. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonia (2.5%), pneumonitis (1.8%), and septic shock (1.4%). The most common adverse reactions (20%) were nausea (51%), fatigue (49%), constipation (37%), vomiting (32%), mucosal inflammation (31%), diarrhea (29%), decreased appetite (29%), stomatitis (26%), and cough (22%).

In KEYNOTE-012, KEYTRUDA was discontinued due to adverse reactions in 17% of 192 patients with HNSCC. Serious adverse reactions occurred in 45% of patients. The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia, dyspnea, confusional state, vomiting, pleural effusion, and respiratory failure. The most common adverse reactions (20%) were fatigue, decreased appetite, and dyspnea. Adverse reactions occurring in patients with HNSCC were generally similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy, with the exception of increased incidences of facial edema and new or worsening hypothyroidism.

In KEYNOTE-087, KEYTRUDA was discontinued due to adverse reactions in 5% of 210 patients with cHL. Serious adverse reactions occurred in 16% of patients; those 1% included pneumonia, pneumonitis, pyrexia, dyspnea, GVHD, and herpes zoster. Two patients died from causes other than disease progression; 1 from GVHD after subsequent allogeneic HSCT and 1 from septic shock. The most common adverse reactions (20%) were fatigue (26%), pyrexia (24%), cough (24%), musculoskeletal pain (21%), diarrhea (20%), and rash (20%).

In KEYNOTE-170, KEYTRUDA was discontinued due to adverse reactions in 8% of 53 patients with PMBCL. Serious adverse reactions occurred in 26% of patients and included arrhythmia (4%), cardiac tamponade (2%), myocardial infarction (2%), pericardial effusion (2%), and pericarditis (2%). Six (11%) patients died within 30 days of start of treatment. The most common adverse reactions (20%) were musculoskeletal pain (30%), upper respiratory tract infection and pyrexia (28% each), cough (26%), fatigue (23%), and dyspnea (21%).

In KEYNOTE-052, KEYTRUDA was discontinued due to adverse reactions in 11% of 370 patients with locally advanced or metastatic urothelial carcinoma. Serious adverse reactions occurred in 42% of patients; those 2% were urinary tract infection, hematuria, acute kidney injury, pneumonia, and urosepsis. The most common adverse reactions (20%) were fatigue (38%), musculoskeletal pain (24%), decreased appetite (22%), constipation (21%), rash (21%), and diarrhea (20%).

In KEYNOTE-045, KEYTRUDA was discontinued due to adverse reactions in 8% of 266 patients with locally advanced or metastatic urothelial carcinoma. The most common adverse reaction resulting in permanent discontinuation of KEYTRUDA was pneumonitis (1.9%). Serious adverse reactions occurred in 39% of KEYTRUDA-treated patients; those 2% were urinary tract infection, pneumonia, anemia, and pneumonitis. The most common adverse reactions (20%) in patients who received KEYTRUDA were fatigue (38%), musculoskeletal pain (32%), pruritus (23%), decreased appetite (21%), nausea (21%), and rash (20%).

In KEYNOTE-057, KEYTRUDA was discontinued due to adverse reactions in 11% of 148 patients with high-risk NMIBC. The most common adverse reaction resulting in permanent discontinuation of KEYTRUDA was pneumonitis (1.4%). Serious adverse reactions occurred in 28% of patients; those 2% were pneumonia (3%), cardiac ischemia (2%), colitis (2%), pulmonary embolism (2%), sepsis (2%), and urinary tract infection (2%). The most common adverse reactions (20%) were fatigue (29%), diarrhea (24%), and rash (24%).

Adverse reactions occurring in patients with gastric cancer were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy.

Adverse reactions occurring in patients with esophageal cancer were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy.

In KEYNOTE-158, KEYTRUDA was discontinued due to adverse reactions in 8% of 98 patients with recurrent or metastatic cervical cancer. Serious adverse reactions occurred in 39% of patients receiving KEYTRUDA; the most frequent included anemia (7%), fistula, hemorrhage, and infections [except urinary tract infections] (4.1% each). The most common adverse reactions (20%) were fatigue (43%), musculoskeletal pain (27%), diarrhea (23%), pain and abdominal pain (22% each), and decreased appetite (21%).

Adverse reactions occurring in patients with hepatocellular carcinoma (HCC) were generally similar to those in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy, with the exception of increased incidences of ascites (8% Grades 3-4) and immune-mediated hepatitis (2.9%). Laboratory abnormalities (Grades 3-4) that occurred at a higher incidence were elevated AST (20%), ALT (9%), and hyperbilirubinemia (10%).

Among the 50 patients with MCC enrolled in study KEYNOTE-017, adverse reactions occurring in patients with MCC were generally similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy. Laboratory abnormalities (Grades 3-4) that occurred at a higher incidence were elevated AST (11%) and hyperglycemia (19%).

Read the original post:
Merck Receives Priority Review from FDA for Second Application for KEYTRUDA (pembrolizumab) Based on Biomarker, Regardless of Tumor Type - Benzinga

Well, unlike many news organisations, we have no sponsors, no corporate or ideological interests. We don't put up a paywall we believe in free public access to information. Although underresourced & primarily volunteer-based, we endeavour to provide the community with real-time access to true unfiltered news firsthand from primary sources. Our goal and mission is to provide free and alternative access to impartial information, fighting media monopolization and adhering to honesty, neutrality, fairness, transparency and independence in collection and dissemination of information. It is a bumpy road with all sorties of difficulties. (Media ownership in Australia is one of the most concentrated in the world (more on this!). Since the trend of consolidation is and has historically been upward, fewer and fewer individuals or organizations control increasing shares of the mass media in our country. According to independent assessment, about 98% of the media sector is held by three conglomerates. This tendency is not only totally unacceptable, but also to a degree frightening). Learn moreWe can only achieve this goal together. Our website is open to any citizen journalists and organizations who want to contribute, publish high-quality insights or send media releases to improve public access to impartial information. You and we have the right to know, learn, read, hear what and how we deem appropriate.If you like what we do & would like to buy us a coffee (or lots of coffees), please know it's greatly appreciated. All donations are kept completely private and confidential.Thank you very much in advance!

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Weizmann Institute of Science Began to Conduct Coronavirus Testing Today - Mirage News

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After more than 20 years of research, we are now witnessing a breakthrough of small interfering RNA (siRNA)-based therapies. In 2018, the first-ever siRNA drug, Onpattro, reached the market, followed by the approval of Givlaari in 2019, and many other clinical trials are in progress.

Holding the potential to treat a wide range of diseases from cancer to immunological disorders, siRNA therapeutics have received plenty of attention. With the support of a suitable delivery system, they can be directed to downregulate a specific target gene. Both approved siRNA drugs Onpattro and Givlaari are only able to reach the liver, however. Other organs that can be treated by loco-regional administration, such as the lung, are, in principle, good targets for siRNA therapies as well.

In this view, siRNA-baseddrugs could not only act as an ally in the battle against the current COVID-19pandemic but also against other severe lung diseases such as asthma. Despitethe great advances in asthma treatment, this disease still represents an unmetmedical need in about 510% of patients.Moreover, most of the available drugs work symptomatically rather than causally.

In a recent article published in WIREs Nanomedicine and Nanobiotechnology, Domizia Baldassi and Tobias Keil, graduate students in Prof. Olivia Merkels research group at the University of Munich, discuss the groups advances towards developing a nanocarrier that can deliver siRNA into T cells in the lung.

The aim of T-cell delivery is downregulation of GATA-3, the transcription factor of T helper 2 (TH2) cells overexpressed in asthmatic patients, which is recognized as a key factor in the asthmatic inflammatory cascade. Based on their observation that transferrin receptor is overexpressed in activated T cells, the researchers sought to find a virus-like tool to target activated TH2 cells specifically and efficiently in a receptor-mediated manner.

They accomplishedthis goal by creating a conjugate formed by transferrin and low-molecular-weightpolyethylenimine (Tf-PEI). On the one hand, they used a well-known cationic polymerto electrostatically interact with the negatively charged siRNA and protect itfrom degradation during the journey through the airways. And on the other hand,transferrin served as a targeting moiety to mediate a specific, targeteddelivery of siRNA only to activated T cells.

Since theendosomal escape is considered the rate-limiting step in cytoplasmaticdelivery of nanoparticle-based therapies, improving this aspect of theformulation was the focus, and Tf-PEI was blended with a second conjugatecomposed of melittin and PEI (Mel-PEI). Melittin is a well-known membranolyticagent from bee venom that was chemically modified to react in a pH-dependentmanner.

The researchersexploited the intrinsic lytic characteristic of the peptide to improve therelease of siRNA into the cytosol, reaching knockdown levels as high as 70% exvivo. But further steps such as the validation of these results in vivo on anasthma mouse model are needed, as well as possible alternative polymericmaterials.

In the process of developing a new pharmaceutical product, it is crucial to keep the administration route in mind. Spray drying is the most straightforward technique to produce inhalable particles for pulmonary delivery, according to the researchers. In a proof-of-concept study, they obtained nano-in-microparticles by spray drying PEI-pDNA polyplexes together with a cryoprotectant agent. After seeing promising results, their studies to obtain a dry powder formulation of siRNA-based polyplexes are ongoing.

Ultimately, both research fields will be combined and hopefully result in a new therapy for the treatment of severe, uncontrolled asthma and many other lung diseases, concluded Baldassi, Keil, and Merkel.

Reference: Tobias W. M. Keil et al. T-cell targeted pulmonary siRNA delivery for the treatment of asthma. WIREs Nanomedicine and Nanobiotechnology (2020). DOI: 10.1002/10.1002/wnan.1634

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A new, inhaled siRNA therapeutic option for asthma - Advanced Science News

Global Nano Therapy Market was valued US$ XX Mn in 2019 and is expected to reach US$ XX Mn by 2027, at a CAGR of 8.6% during a forecast period.

Global Nano Therapy Market

Market Dynamics

Nanotechnology is the manipulation of matter on an atomic, molecular, and supramolecular scale. Nanotherapy is a branch of Nano medicine that includes using nanoparticles to deliver a drug to a given target location in the body so as to treat the disease through a process called as targeting.

This report provides insights into the factors that are driving and restraining the global Nano Therapy market. Nanotherapy is also referred to as targeted therapy, which offers to transport the molecules to the affected cells to treat the disease without affecting other negative effects on the healthy cells. Nanoparticles allow for multiple functional groups to be added to the surface. Each of the functional groups contributes to the effectiveness of this method of therapy and deliver its components in a controlled way once it gets to the target cells/tissue. Nano therapy is considered as recent technology for some diseases, which are implemented with the help of submicron-sized molecular devices or nanoparticles. Nanoparticles can improve the drug accessibility in the body with strength, drag out the medication, and can upsurge the half-life of plasma and boost the drug specificity. These are the factors driving the growth of the Nano therapy market.

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As compared to the conventional methods, this method has increased more popularity owing to its high accuracy when it comes to administering therapeutic formulations. The market is thriving, with around 250 Nano-medical products being verified or used for humans. Though, with Nano therapy, the carrier is protected from degradations, which allows it to reach given target cells in the body for a local reaction. Nano therapy is considerably used in the treatment of diseases like cancer, diabetes, and cardiovascular diseases. A recent study by the Journal of Diabetes and Metabolic diseases has stated that the incidence of MS ranged from 30.5 to 31.5% in China and 35.8 to 45.3% in India.

However, an absence of controlling standards in the examination of Nano therapy and high expenditure of treatment are several of the major factors that are restraining the growth of the Nano therapy market during the forecast period.

Global Nano Therapy Market Segment analysis

Based on Type, the Nanomaterial segment is anticipated to grow at a CAGR of 20.8% during the forecast period. The nanomaterial is the materials with at least one exterior dimension in the size range of nearly 1 to 100 nanometers. The nanomaterial is intended for developing novel characteristics and has the potential to improve quality of life. The nanomaterial is generally used in cosmetics, healthcare, electronics, and other areas currently. Unceasing development and innovation in the field are impelling the growth of the global nanomaterials market. The amazing chemical and physical properties of materials at the nanometer scale allow novel applications. For instance, energy conservation and structural strength improvement to antimicrobial properties and self-cleaning surfaces. Nanotechnology is being increasingly efficient by spending mainly on R&D activities which are resulting in the development of current technologies and innovations with reference to the new materials.

Global Nano Therapy Market Regional analysis

North America region dominated the Nano therapy market with US$ XX Mn in 2019. The availability of technology, increasing healthcare spending, and government funding for research and development are some of the factors boosting the growth of the Nano therapy market in the region. Europe is expected to follow the Americas and bring in the second leading market share for Nano therapy throughout the forecast period. Europe is mainly driven by awareness and improvement in the nanotechnology sector.

Recent Developments

In 08 May 2019- Cisplatin cis-(diammine) dichloridoplatinum (II) (CDDP) is the first platinum based complex approved by the food and drug administration (FDA) of the United States (US). Cisplatin is the first line chemotherapeutic agent used alone or combined with radiations or other anti-cancer agents for a broad range of cancers such as lung, head and neck.

In May 2019- A new study conducted by scientists from the Indian Institute of Technology, Bombay, have designed hybrid nanoparticles to treat cancer. These nanoparticles are made from gold and lipids. These nanoparticles respond to light and can be directed inside the body to release drugs to a targeted area, and are biocompatible, meaning theyre not toxic to a human body.

In September 2019, researchers at Finlands University of Helsinki, in partnership with the bo Akademi University and Chinas Huazhong University of Science and Technology developed an anti-cancer nanomedicine useful for targeted cancer chemotherapy.

The objective of the report is to present a comprehensive analysis of the Global Nano Therapy Market including all the stakeholders of the industry. The past and current status of the industry with forecasted market size and trends are presented in the report with the analysis of complicated data in simple language. The report covers all the aspects of the industry with a dedicated study of key players that includes market leaders, followers and new entrants. PORTER, SVOR, PESTEL analysis with the potential impact of micro-economic factors of the market have been presented in the report. External as well as internal factors that are supposed to affect the business positively or negatively have been analyzed, which will give a clear futuristic view of the industry to the decision-makers.The report also helps in understanding Global Nano Therapy Market dynamics, structure by analyzing the market segments and project the Global Nano Therapy Market size. Clear representation of competitive analysis of key players by Application, price, financial position, Product portfolio, growth strategies, and regional presence in the Global Nano Therapy Market make the report investors guide.Scope of the Global Nano Therapy Market

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Global Nano Therapy Market, By Type

Nanomaterial and Biological Device Nano Electronic Biosensor Molecular Nanotechnology Implantable Cardioverter-DefibrillatorsGlobal Nano Therapy Market, By Application

Cardiovascular Disease Cancer Therapy Diabetes Treatment Rheumatoid ArthritisGlobal Nano Therapy Market, By Regions

North America Europe Asia-Pacific South America Middle East and Africa (MEA)Key Players operating the Global Nano Therapy Market

Selecta Biosciences Inc. Cristal Therapeutics Sirnaomics Inc. Nanobiotix Luna CytImmune Science Inc. NanoBio Corporation Nanospectra Biosciences Inc. Nanoprobes Inc. NanoBioMagnetics.n.nu Smith and Nephew NanoMedia Solutions Inc. Nanosphere Inc. DIM Parvus Therapeutics Tarveda Therapeutics

MAJOR TOC OF THE REPORT

Chapter One: Nano Therapy Market Overview

Chapter Two: Manufacturers Profiles

Chapter Three: Global Nano Therapy Market Competition, by Players

Chapter Four: Global Nano Therapy Market Size by Regions

Chapter Five: North America Nano Therapy Revenue by Countries

Chapter Six: Europe Nano Therapy Revenue by Countries

Chapter Seven: Asia-Pacific Nano Therapy Revenue by Countries

Chapter Eight: South America Nano Therapy Revenue by Countries

Chapter Nine: Middle East and Africa Revenue Nano Therapy by Countries

Chapter Ten: Global Nano Therapy Market Segment by Type

Chapter Eleven: Global Nano Therapy Market Segment by Application

Chapter Twelve: Global Nano Therapy Market Size Forecast (2019-2026)

Browse Full Report with Facts and Figures of Nano Therapy Market Report at: https://www.maximizemarketresearch.com/market-report/global-nano-therapy-market/54507/

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Global Nano Therapy Market- Industry Analysis and Forecast (2020-2027) - Publicist360

As we all are learning to cope with our current, ever-changing new normal I want to offer some musings and things I have learned through this coronavirus pandemic crisis. It is my sincerest hope that as you read this column, you, too, are overcome with love and compassion for our collective, human and animal suffering and rebounding resilience.

Veterinary medicine has always been touted as a career for animal lovers. However, anyone who remains in the field knows that to be successful one must enjoy interacting with people. After all, pets are always accompanied by their owners.

One of the things I have always loved about general practice is the ability to develop bonds not only with my patients but also their families. I enjoy hearing about the familys joys and triumphs. I have always tried to focus my interactions not only on presenting facts, guidance, and honesty; but also through a lens compassion and understanding for the family.

COVID 19 has shown me that I never realized how much I would miss these interactions until I couldnt be there for my clients in person.

I never realized how much I would miss being able to hug a client during a euthanasia or when were trying to make a difficult decision.

I miss being able to introduce myself to new clients by shaking their hand and inviting them into the exam room.

I miss being able to spend time in the exam room with clients talking them through my exam findings in real time. I miss helping seniors carry their pets to their cars. I even miss letting kids use my stethoscope to listen to their pets heartbeats.

Because at the end of the day yes my job is to do medicine, it is to be a veterinarian. But the best part of my job has, and always will be, interacting with clients and their pets.

The best part is that I get to help maintain and foster a deeper human animal bond through teaching the importance of what were trying to do.

Please know that our curbside check-ins and the way we are structuring appointments is to maintain public health and safety.

However, we feel the absence and change too. May we never take for granted again the power of a hug, a handshake and in-person conversation. I, for one, never will again.

Danielle Carey, a doctor of veterinary medicine, is an associate veterinarian at the Animal Clinic of Walla Walla.

Read the original post:
Scope of veterinary medicine embraces animals and their people - Walla Walla Union-Bulletin

NHS trusts are recruiting vets to help relieve pressure on health service staff as hospitals struggle to cope with the coronavirus pandemic.

About 150 vets are volunteering as respiratory assistants with Torbay and South Devon NHS foundation trust, while Hampshire hospitals NHS foundation trust has invited vets, veterinary nurses and dentists to apply for jobs.

Hospitals are being stretched by the scale of the outbreak, which has yet to reach its peak. Pressures are being exacerbated by staff absences due to healthcare workers having contracted the virus or self-isolating because of a suspicion they may have it.

The respiratory assistants at Torbay and South Devon will be unpaid, according to the Health Service Journal, which first reported their recruitment. The Guardian understands they were undergoing training via Zoom on Thursday. They will not be making decisions about triage, intubation or withdrawal of medical treatment, the trust confirmed.

A spokesperson said: We have received many offers of voluntary help from veterinary staff who have valuable skills that can be used to support frontline staff who are dealing with respiratory problems.

A job advert for bedside support workers at Hampshire trust, whose recruitment drive was first reported by Vet Times, says that successful applicants will be paid between 17,000 and 42,000, with vets, veterinary surgeons and dentists in a higher salary band than veterinary or dental nurses.

A spokesperson for the trust said: Following a number of offers of help from skilled professionals working outside the NHS, such as vets and dentists, we have developed a bespoke role called a bedside support worker.

This is a role we have created in response to the coronavirus pandemic, which will support our brilliant staff in critical care and on medical wards, who are all working tirelessly to respond to this unprecedented challenge.

Patient care remains our top priority, and only those who are assessed to have the appropriate transferable skills, education and training will temporarily join our team.

Vets have been contributing to the crisis effort in other ways. On Thursday, Willow Farm vets, a team that works across northern England, said it had donated 4,000 protective gowns, amid concerns about a shortage of personal protective equipment for hospital staff. It followed VetPartners, based in York, which said on Monday that it was donating masks, aprons, gloves and ventilators to the health service.

Dr Rachel Dean, director of clinical research and excellence in practice at VetPartners, said some ventilators used on animals were the same as those used on humans, particularly on children.

The Royal College of Veterinary Surgeons issued advice to its members on Wednesday about how they could best help during the Covid-19 pandemic, recommending that they consider assisting the livestock production, meat hygiene and food import/export industries before volunteering with the NHS.

The colleges registrar, Eleanor Ferguson, said: If local NHS trusts do choose to employ veterinary professionals to undertake roles that are not reserved by law to licensed doctors, nurses or other regulated professionals, they must be satisfied that the individual has the skills and competencies to do that role.

However, any veterinary professionals employed in these roles should not misrepresent their position to patients and must be careful not to hold themselves out as a licensed medical doctor or nurse.

Read more from the original source:
Vets recruited to work in UK hospitals during coronavirus outbreak - The Guardian

Michigan State Universitys College of Veterinary Medicine was ranked eighth in the world and third in the United States among veterinary schools in the latest global ranking from educational data specialists Quacquarelli Symonds, or QS.

At a time when everyone is being challenged by the COVID-19 pandemic and good news is a hot commodity, our college takes special pride in the high-quality of education we deliver to our students, said Birgit Puschner, dean of the College of Veterinary Medicine. Our DVM program is a testament not just to our students and educators, but to our entire community alumni, donors, staff, and our health and research partners that supports us, no matter the context or conditions we face.

The veterinary colleges prominent ranking continues on its upward trajectory the college was ranked eleventh in 2019 and 2018, 12th in 2017 and 15th in 2016.

MSU also retains its number one rank among the six colleges of veterinary medicine in the Big Ten, a union of world-class academic institutions that share a common mission of research, graduate, professional and undergraduate teaching and public service. Six of the 30 veterinary programs in the United States are in the Big Ten.

Original post:
MSU veterinary school ranks third in the nation, top 10 in the world - MSUToday

Since first hearing about the COVID-19 outbreak in China, media outlets around the world have reported on strains of the virus originating in animals, on pets testing positive for the virus and most recently, on a tiger testing positive for COVID-19 at the Bronx Zoo.

Annette OConnor chairperson of the Department of Large Animal Clinical Sciences and professor of Epidemiology at Michigan State Universitys College of Veterinary Medicine says that there are seven different types of coronaviruses and that the Centers for Disease Control doesnt believe the COVID-19 strain can be transmitted to domestic animals.

However, OConnor explains that since COVID-19 is a new virus, its critical for humans to take extra precautions around animals and pets since there isnt a wealth of research about the virus.

OConnor answers common questions related to COVID-19 and pets:

Can my pets get sick from COVID-19?

At this time, we have very limited information about animals and COVID-19 because it is too new of a virus. However, if pets do get sick, we would expect them to have signs such as diarrhea, vomiting or respiratory problems, like trouble breathing. If you are concerned about your pet, you should do what you would usually do: isolate them and contact your veterinarian.

Am I at risk for catching COVID-19 from an animal?

The transmission we see currently see of COVID-19 is human-to-human transmission. We do continue to see rare reports of cats and dogs that live with COVID-infected patients being infected.

To date, we have no evidence that owners can catch the virus from cats or dogs because we have no evidence that naturally infected cats and dogs shed the virus.

However, as this is a very new virus, pet owners need to continue to follow routine practices for pet hygiene recommended by the American Veterinary Medical Association. These guidelines include washing your hands after petting animals, avoiding touching your face, dont kiss your pet, and dont share dishes, drinking glasses, cups, eating utensils, towels or bedding with other people or pets.

So what about the tiger at the Bronx zoo who tested positive?

The detection of the virus that causes COVID-19 in the tiger is interesting, because it appears to be an example of the transmission from humans to tiger a very rare event. This finding has highlighted the concern for our wild animal populations, and staff at zoos have adopted practices that will protect these valuable populations.

If I have or someone I know has COVID-19, can my pet catch it?

If an owner is ill with COVID-19, as suggested by the CDC, they should isolate themselves from the pets and have another household member care for them.

If isolation of the pet isnt possible, continue to use frequent hand washing and avoid touching your face. Also remember: if your pet requires veterinary care, make sure you inform your veterinarian that you or a household member is ill with COVID-19. That information will allow your veterinarian to take adequate precautions.

Can my pets catch the virus that causes COVID-19 from other pets?

There is evidence that cats can catch COVID-19 from other cats but there is only a small amount of evidence at this point. The largest study we have only involved 102 cats from Wuhan, China; of the 102 tested, only 11 had antibodies to COVID-19. None had evidence of the virus, so they were probably infected some time ago. In that study we also dont know how the cats became infected, perhaps they were infected from humans, or maybe cat-to-cat transmission does occur. We need to wait for more data.

Information and resources about the coronavirus, COVID-19 and animals is available through the College of Veterinary Medicine.

Read this article:
Ask the expert: pets and COVID-19 - MSUToday

College of Veterinary Medicine continues serving community and state

It has been a little under a month since COVID-19 was first recognized as a pandemic by the World Health Organization. Around the world, people from all walks of life have been asked to adapt to a new lifestyleone of constant change and social distancing.

Despite the upheaval, the University of Georgia College of Veterinary Medicine and its units continue to make daily contributions to the fight against COVID-19 providing vital equipment, research expertise and continued care to the communitys animals.

The Veterinary Teaching Hospital has remained open, operating on an emergency-only basis, with faculty and staff providing care for more than 575 patients since March 16. Likewise, our Diagnostic Laboratories in Tifton and Athens, our Poultry Diagnostic and Research Center, and the colleges other affiliated laboratories continue to provide critical services that ensure the health of animal companions and safeguard the food supply both around the globe and here at home.

Additionally, researchers in the college have been engaged by Gov. Brian P. Kemps task force to perform research on COVID-19, develop testing protocols, and test the vaccines that might one day make this virus a threat of the past. Eleven researchers from across the collegeincluding the Center for Vaccines and Immunology and four academic departmentsare actively engaged in projects related to the virus. This research is being conducted in the colleges Animal Health Research Center in conjunction with universities around the state.

The college has also donated equipment to various hospital and testing services around the state. The colleges single human-appropriate ventilator is currently at Piedmont Athens Regional Medical Center. Likewise, vital testing equipment and reagents have been donated to Emory University and Georgia State University and personal protective equipment, such as N95 masks, have been donated to the state for distribution as needed.

The mission of the college is to create a healthier world for animals and humans. In the face of adversity, the college has stepped up and stayed the coursein their own way contributing to the cause during these unprecedented times. Dean Lisa K. Nolan summed it up in a recent email: We do what we do because we provide certain services no one else in the state can and because our clients and referring veterinarians count on us being here, supporting them.

Read the original post:
Staying the course in the face of chaos - University of Georgia

LOS ANGELES, April 10, 2020 /PRNewswire/ --A telehealth announcement shocks veterinarians in California trying to safely treat their patients during the Coronavirus pandemic. While many states amended their telemedicine laws to account for stay-at-home mandates, the California Veterinary Medical Board has made it harder for a pet to be seen by video call. The board announced Thursday that telemedicine may only be used with existing patients for preexisting conditions. Veterinarians like Dr. Shea Cox with PetHospice say these measures directly violate the medical professional oath 'to do no harm.'

"Putting up barriers to healthcare is the opposite of what should be done to protect pets," said Cox. "Veterinarians should be allowed to use sound judgment regarding telemedicine without fear of repercussion."

The board released a statement Thursday saying, "Telemedicine may be conducted by a veterinarian only within an existing Veterinarian-Client-Patient Relationship (VCPR) and can be used only for specific medical conditions for which the animal patient has been previously examined and diagnosed by the veterinarian."

"Taking this vital tool away from pet parents is harmful - especially during the time of a pandemic," said Cox. "Telemedicine can address many issues, keeping people at home; asking pet parents to come into a clinic causes unnecessary exposure to all."

Veterinarians use telemedicine for triage, symptom management, and to offload nonemergency care from overburdened veterinarians. Many are operating with reduced staff to comply with social distancing. Now, veterinarians can't see telehealth patients referred from other vets until they can first physically touch the patient.

"Say you're out of the fluids that manage your dog's kidney disease. Now, I can't call in medicine for you unless I've physically examined your pet within the year even if I have the diagnosis from your primary veterinarian," said Cox. "I'd have to first send one of our vets into your home, which then leaves the humans more susceptible to COVID-19."

Veterinarians are frustrated, asking why California isn't following other states by making temporary changes to laws in order to better serve pets and their people. "We shouldn't have to make the choice between risking our lives or risking our license in order to treat pets," says Cox.

For telehealth information and photos visit the PetHospice Press Kit.

SOURCE PetHospice

http://www.pethospice.com

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Veterinarians in California risk losing their licenses if they treat new patients by video call during Pandemic - PRNewswire

Clinicians, staff, senior veterinary students are still doing rotations everyday

OLIVER MCKENNA | DAILY EVERGREEN FILE

Charlie Powell, public information officer for the college of veterinary medicine, said the veterinary hospital is still open and treating emergency and urgent cases.

During the COVID-19 pandemic, WSUs Veterinary Teaching Hospital is open to emergency and urgent cases.

Charlie Powell, public information officer for the College of Veterinary Medicine, said clinicians, staff and senior veterinary students are on clinical rotations everyday.

Animals are being taken care of with the highest standards, under federal law, all the time, regardless of what the current situation is, Powell said.

He said the veterinary school is not closed to the public and they are still treating critical cases. A lot of those cases begin with meeting animals in the parking lot before bringing them inside.

According to WSUs Insider website, the hospital has modified some of its operations in accordance with federal, state and regional public health recommendations.

The hospital took precautions early on and the hospital is fully stocked, according to the website. Staff and faculty are being encouraged to conserve supplies where possible as all human and animal care facilities.

The hospitals fee schedule will remain the same as it is during times of regular weekday, weekend and holiday operations, according to the website.

All in-patients will be cared for as usual until their normal discharge is indicated, according to the website.

Oliver, an 18-month-old Kunekune pig, was brought in from Spokane after he was vomiting and acting lethargic, according to the hospitals website,

Dr. Rachel Baumgardner and Dr. Marcie Logsdon located an unknown foreign object that was irritating his gastrointestinal tract, according to the website.

Oliver responded well to medical management and is now back home, according to the website.

Hospital Director Deb Sellon said the hospital is lacking resources such as basic cloth masks to protect employees and clients during the ongoing COVID-19 pandemic.

These masks will block droplet transmission if someone on the team is an asymptomatic carrier and help conserve our supply of surgical masks, Sellon said.

People who want to donate the masks are asked to leave them in the bin at the entrance of the hospital and call (509) 335-0711 when they do.

Original post:
Vet hospital still running amid COVID-19 pandemic - The Daily Evergreen

The Tennessee Veterinary Medical Association (TVMA) recently named its 2020-2021 executive board, comprised of veterinarians from across the state.

The newly elected officers are:

President Matt Povlovich, DVM, Tennessee Equine Hospital, Thompsons Station

President-Elect Tai Federico, DVM, Riverview Animal Hospital, Chattanooga

Vice President Bob Parker, DVM, Shelby Center Hospital for Animals, Bartlett

Secretary/Treasurer Margaret (Midge) Phillips, DVM, Clovercroft Veterinary Hospital, Franklin

Immediate Past President Danny Walker, DVM, University of Tennessee at Martin

Six members-at-large were also elected to represent East, West and Middle Tennessee. They are: Joanne Hibbs, DVM,Tazewell Pike Animal Clinic, Corryton; Robert Monin, DVM, Mountain Empire Large Animal Hospital, Johnson City; Lee Butler, DVM, Huntington Animal Clinic, Huntington; Lauren Dabney, DVM, Northside Animal Clinic, Humboldt; Beau House, DVM, Nashville Veterinary Specialists, Nashville; and Julie Buford, DVM, Nashville Veterinary Specialists, Nashville.

Deloris Green Gaines, CMP, serves as the executive director for the Tennessee Veterinary Medical Association.

About Tennessee Veterinary Medical Association

Since 1909, the Tennessee Veterinary Medical Association has been committed to advancing the science and art of veterinary medicine. More than 1,200 members work to ensure that laws and regulations promote the health and well-being of all animals and protect public health and human welfare. Large and small animal practitioners, students and veterinary school graduates make up TVMA membership. For additional information, visit http://www.tvmanet.org.

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Thompson's Station veterinarian named president of state executive board - williamsonherald.com

Dr. Bret McNabb has been appointed as director of the Large Animal Clinic at the UC Davis Veterinary Medical Teaching Hospital, effective April 1 for a five-year term.

An assistant professor of clinical livestock reproduction in the School of Veterinary Medicines Department of Population Health and Reproduction, McNabb has been service chief for the VMTHs Livestock Herd Health and Reproduction Service since 2013.

Well respected as a leader, McNabbs clinical acumen and dedication to patient care is widely acknowledged and he, along with his service colleagues, has contributed to rebuilding the VMTHs livestock herd health and reproduction caseload in recent years. He has offered expanded clinical services and is the attending veterinarian for multiple campus herds belonging to the undergraduate Department of Animal Science and two UC field stations.

We are thrilled to welcome McNabb as the leader of our Large Animal Clinic and a member of our dedicated hospital leadership team, said Dr. Jane Sykes, VMTH chief veterinary medical officer. He brings a wealth of experience in our hospital; a warm personality and positive outlook; a special ability to bring people together to create positive direction; and a dedication to supporting our students, clinicians, staff, clients, referring veterinarians and patients. His leadership will allow us to promote our cultural beliefs and maintain our reputation for excellence in teaching, clinical research and patient care.

McNabb is active in maintaining a public presence for the VMTH, providing veterinary services for many animal events throughout California, including the California State Fair and the Professional Bull Riders Tours annual event in Sacramento. McNabb has also contributed materially to the design process for the new Livestock and Field Service Center, as part of the future Veterinary Medical Center at UC Davis.

I am excited for the opportunity to serve the Large Animal Clinic, and strengthen our equine and livestock services, McNabb said. Working collaboratively with our faculty, I plan to continue our legacy of clinical excellence and fulfill the mission of the School of Veterinary Medicine.

As director of the Large Animal Clinic in conjunction with Sykes and the VMTH leadership team McNabb will be responsible for the professional, academic, and ethical affairs; financial health; personnel welfare; and operational efficiency of the Large Animal Clinic. He will be responsible for promoting a culture of clinical excellence; equity, diversity, and inclusion for all; and ensuring a supportive clinical learning environment for students, house officers, and other trainees.

Excerpt from:
McNabb named director of the Large Animal Clinic at the UC Davis - Red Bluff Daily News

Showers will break away Friday with a brief lull in activity. On Sunday, pay attention to the weather as severe weather is possible.

THE FORECAST:

Today and Tonight: Clouds and showers may linger Friday morning followed by some returning sun and cooler highs in the low 70s. With northeasterly winds, expect overnight lows in the low 50s beneath partly cloudy skies.

Up Next: Drier conditions will last through Saturday morning and then a period of active, perhaps impactful weather will begin. A warm front lifting through the area from south to north will return showers and thunderstorms to the area as early as Saturday afternoon. When the associated cold front and upper level energy move into the area on Sunday, some of the thunderstorms are expected to be severe. The Storm Prediction Center is using bolder language than usual saying an outbreak of severe thunderstorms appears possible on Sunday. The day three outlooks places areas north of I-12 in an unusual 4/5 moderate risk with the remainder of the area in a 3/5 enhanced risk for severe weather. Everything from damaging wind gusts to hail to tornadoes will be possible. In this time of staying home with loved ones, now is a great opportunity to identify or review your severe weather plan. Find the lowest and most interior place in your home to use as a safe place if a warning is issued. Mobile Home residents should find a nearby brick and mortar home of a family member or friend as it is recommended you prioritize the near term weather threat over social distancing. CLICK HERE for some ideas. Quiet weather and below average temperatures will persist Monday through Wednesday.

The Mississippi River: At Baton Rouge, major flood stage continues with a level of 42.7 as of Thursday morning. It is projected to crest near 43 this weekend. The high water is primarily an issue for river traffic and river islands, although some inundation will continue for a few spots north and south of Baton Rouge that are not protected by levees. Unprotected low-lying areas will be flooded and agricultural operations will be impacted on the west side of the river. The grounds of the older part of Louisiana State University's campus become soggy. This includes the area around the Veterinary Medicine building, the Veterinary Medicine Annex, the stadium and ball fields. The city of Baton Rouge and the main LSU campus are protected by levees at this level. This comes after a year where the gauge at Baton Rouge spent a record smashing run of 212 consecutive days above flood stage between January and August. Peaking at 44.1 on March 19, 2019 the river set its 7th highest recorded crest at Baton Rouge. The level is also high in New Orleans and the U.S. Army Corps of Engineers has opened the Bonnet Carre Spillway.

THE EXPLANATION:

Beyond morning showers, a lull in precipitation will come early Friday through early Saturday. Northerly winds will maintain cold air advection processes and keep below average temperatures in place through Saturday morning. A locations north of I-12 could even nip the upper 40s. An upper level low pressure system will advance out of the southwest U.S. on Saturday forcing a warm front to lift through the region. With warmer air surging northward, scattered showers and thunderstorms could develop late in the day. The deep upper level low pressure system will move over Texas by Sunday. As this occurs, it will begin to orient from northwest to southeast, this is called a negative tilt, and this is a reliable indicator for active weather. Rich low-level moisture will be drawn inland from the Gulf of Mexico in advance of a strengthening surface low that will move north of the local area dragging a cold front across the central Gulf Coast. Instability will work in tandem with a strong jet stream (winds aloft) to result in a very favorable environment for severe thunderstorms to develop. The combination is supportive of widespread damaging wind and strong, long-lived tornadoes. Timing is not yet clear, but will come into focus as we get closer. The front will clear to the east by Sunday night with cooler and drier conditions persisting into early next week. Please stay in touch.

--Josh

The WBRZ Weather Team is here for you, on every platform. Your weather updates can be found on News 2, wbrz.com, and the WBRZ WX App. on Apple and Android devices. Follow WBRZ Weather on Facebook and Twitter for even more weather updates while you are on the go.

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Prepare now, uncommon moderate risk of severe weather Sunday - WBRZ

From Our Archives Medical Author: Frederick Hecht, MD, FAAP, FACMG

Gene therapy is the treatment of disease by replacing, altering, or supplementing a gene that is absent or abnormal and whose absence or abnormality is responsible for the disease. Gene therapy may use the genetic material, DNA, itself as the means of treatment.

DNA or deoxyribonucleic acid is the very long molecule that encodes the genetic information. A gene is a stretch of DNA required to make a functional product such as part or all of a protein. People have about 100,000 to 150,000 genes. During gene therapy, DNA that codes for specific genes is delivered to individual cells in the body.

Most, if not all, diseases have a genetic factor. The genetic factor can be wholly or partially responsible for the disease. For example, in disorders such as cystic fibrosis, hemophilia, and muscular dystrophy, changes in a gene directly result in the condition. In other conditions such as high cholesterol and high blood pressure, genetic and environmental factors interact to cause disease. Disorders associated with aging often involve the loss of gene activity in specific types of cells. Even infections can be related to genes. In fact, they have two sets of genetic determinants: the genes of the infective agent and the genes of the person with the infection.

Uses of gene therapy

Gene therapy is being used in many ways. For example,to:

A large variety of genes are now being tested for use in gene therapy. Examples include: a gene for the treatment of cystic fibrosis (a gene called CFTR that regulates chloride); genes for factors VIII and IX, deficiency of which is responsible for classic hemophilia (hemophilia A) and another form of hemophilia (hemophilia B), respectively; genes called E1A and P53 that cause cancer cells to undergo cell death or revert to normal; AC6 gene which increases the ability of the heart to contract and may help in heart failure; and VEGF, a gene that induces the growth of new blood vessels (angiogenesis) of use in blood vessel disease.

A short synthetic piece of DNA (called an oligonucleotide) is being used by researchers to "pre-treat" veins used as grafts for heart bypass surgery. The piece of DNA seems to switch off certain genes in the grafted veins to prevent their cells from dividing and thereby prevent atherosclerosis.

Delivery of genes into cells

Gene delivery can be used in cells that have been removed from the body (ex vivo gene therapy) or in cells that are still in the body (in vivo gene therapy). Genes can be delivered into cells in different ways. The selection of a gene delivery system depends on the target cell, the duration of gene expression required for therapeutic effect, and the size of the piece of DNA to be used in the gene therapy.

Genes can be carried into cells by viruses. Viral vectors or carriers take advantage of the natural ability of a virus to enter a cell and deliver genetic material to the nucleus of the cell that contains its DNA. In developing virus carriers, the DNA coding for some or all of the normal genes of the virus to be used as a carrier are removed and replaced with a treatment gene. Most of these virus carriers are engineered so that they are able to enter cells, but they cannot reproduce themselves and so are innocuous.

Genes can also be delivered within tiny synthetic "envelopes" of fat molecules. Cell membranes contain a very high concentration of fat molecules. The fat molecule "envelope" can carry the therapeutic gene into the cell by being admitted through the cell membrane as if it were one of its own molecules.

Genes can also gain entrance into cells when an electrical charge is applied to the cell to create tiny openings in the membrane that surrounds a cells. This technique is called electroporation.

A "bionic chip"

A new "bionic chip" has been developed to help gene therapists using electroporation to slip fragments of DNA into cells. Electroporation was originally a hit-or-miss technique because there was no way to determine how much of an electrical jolt it took to open the cell membrane.

The "bionic chip" solves this problem. It contains a single living cell embedded in a tiny silicon circuit. The cell acts as a diode, or electrical gate. When it is hit with just the right charge, the cell membrane opens, allowing the electricity to pass from the top to the bottom of the bionic chip. By recording what voltage caused this phenomenon to occur, it is now posssible to determine precisely how much electricity it takes to pry open different types of cells.

Route of administration of gene therapy

The choice of route for gene therapy depends on the tissue to be treated and the mechanism by which the therapeutic gene exerts its effect. Gene therapy for cystic fibrosis, a disease which effects cells within the lung and airway, may be inhaled. Most genes designed to treat cancer are injected directly into the tumor. Proteins such as factor VIII or IX for hemophilia are also being introduced directly into target tissue (the liver).

The potential power of gene therapy

Most gene therapy for diseases such as cystic fibrosis and hemophilia has been designed only to ease, not to cure, the disease. However, the delivery of functional copies of genes provides a potential method to correct a disease at its most basic level.

Gene therapy also holds the potential to provide "patient-friendly" treatment regimens for a variety of diseases. Today, many patients with hemophilia and diabetes must have repeated injections in order to manage their disease because proteins exist in the blood stream for a limited period of time before they are degraded or eliminated. Since DNA is more stable and functions inside the cell, the delivery of genes may result in longer-term expression of the necessary proteins. SLIDESHOW Heart Disease: Causes of a Heart Attack See Slideshow

Because of its accuracy, gene therapy has the potential to eliminate cancer cells without damaging normal, healthy tissue. Furthermore, cancer gene therapies may provide alternatives when a disease does not respond to other older treatments.

The potential of gene therapy is great but, compared to its promise, the results to date are still quite limited. However, the benefits of gene therapy are believed to be on the near horizon. Gene therapy is one of the hottest areas of medical research today. (And gene therapy companies have been among the hottest in the stock market.)

The remarkable advances in genetics, including the human genome project, have opened new doors for the exploration of gene therapy. New technologies are needed to speed the progress of gene therapy. As these new technologies such as the "bionic chip" arrive, we believe that, without a doubt, gene therapy will play an increasingly important and prominent part in medicine in the decades to come.

CONTINUE SCROLLING FOR RELATED SLIDESHOW

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Gene Therapy - The Future Is Here! - MedicineNet

Evotec has allied with Takeda to expand into gene therapy research. The move sees Evotec establish a 20-person team in Austria, the focal point of Takedas gene therapy operation, and sign up to work on programs for its Japanese partner.

Takeda acquired a gene therapy center in Orth an der Donau, Austria, through its acquisition of Shire, which picked up the site two years earlier in its takeover of Baxalta. Throughout the series of changes in ownership, which began when Baxter spun out Baxalta in 2014, a team at the site has worked on gene therapies.

Now, Evotec is set to start playing a role in those efforts. The German drug discovery shop has set up a gene therapy unit, Evotec GT, staffed by a team of more than 20 scientists in Orth an der Donau who have worked together for many years.

Virtual Clinical Trials Online

This virtual event will bring together industry experts to discuss the increasing pace of pharmaceutical innovation, the need to maintain data quality and integrity as new technologies are implemented and understand regulatory challenges to ensure compliance.

Evotec disclosed news of the move into gene therapies alongside details of a multiyear partnership with Takeda. The deal, which features an undisclosed upfront fee and other payments over time, tasks Evotec with applying its new gene therapy capabilities and broader drug discovery platform to Takedas cancer, rare disease, neuroscience and gastroenterology programs.

Neither Evotec nor Takeda referred directly to a transfer of employees in the statement to disclose the deal. However, Evotec did reveal that Friedrich Scheiflinger is leading its gene therapy unit. Until recently, Scheiflinger headed up drug discovery for Takeda in Austria, with a particular focus on gene therapies. In light of Evotecs comments about its new gene therapy team having worked together for years, it is likely that other gene therapy researchers made the move from Takeda with Scheiflinger.

The agreement gives Evotec a beachhead in the fast-growing gene therapy sector. In explaining(PDF) the rationale for moving into the space, Evotec expressed a desire to be "modality agnostic" and develop wholly and co-owned candidates.

Here is the original post:
Evotec allies with Takeda to move into gene therapy R&D - FierceBiotech

HAMBURG, GERMANY / ACCESSWIRE / April 6, 2020 / Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) today announced that the Company has established a dedicated site for research and development of gene therapy-based projects: Evotec Gene Therapy (Evotec GT) which will start operations with a strong team of gene therapy experts at an R&D site in Orth/Donau, Austria.

Evotec GT is an integral part of Evotecs integrated drug discovery platform and complements the Companys existing expertise. This strategic addition marks an important step towards Evotecs long-term vision of becoming a fully modality-agnostic drug discovery and development partnership company.

The team in Austria have worked together for many years and applied their research within gene therapy to different gene therapy-related technologies as well as various indications. The scientists have deep expertise in vectorology and virology as well as disease insights, in particular in hemophilia, hematology, metabolic and muscle diseases. Evotec GTs fully operational site will enable the Company to perform dedicated services in the field of gene therapy along the value chain of its customers from Pharma and biotech as well as foundations and academia.

Dr Werner Lanthaler, Chief Executive Officer of Evotec, commented: We are delighted to initiate our new gene therapy platform and step into this field, which perfectly fits into our business strategy going forward. In recent years, precision medicines based on cell and gene therapies have emerged and are predicted to grow significantly. Gene therapy is a promising approach in the development of genetic medicines for patients, especially for inherited and rare diseases. Finding the best candidate agnostic of modality for any given disease biology will ultimately bring forward the best medicine for patients.

Dr Friedrich Scheiflinger, EVP Head of Gene Therapy at Evotec, said: We are proud to join the growing Evotec team to add the highly promising modality of gene therapy to drug discovery projects. Our team has performed research in the field across different technologies and therapeutic areas for many years and we look forward to leveraging our expertise as part of the truly impressive, modality-agnostic Evotec platform.

About Gene Therapy

Gene therapy is a technique that modifies a persons genes to treat or prevent disease by introduction, removal or editing of genetic material, specifically DNA or RNA, within the cells of a patient. Gene therapies aim to replace a disease-causing gene with a healthy copy, inactivate a disease-causing gene, introduce a new or modified gene or interfere on an expression-regulatory level to support treatment of a disease. Through this modification of gene expression, gene therapies can increase levels of disease-fighting proteins or reduce levels of disease-causing proteins within the cell. Since direct insertion of genes into cells is still very inefficient, gene delivery is facilitated by vehicles which are most often of viral origin. The structure of these viral vectors has been modified to accommodate for the therapeutic gene and to render the vector non-infectious. Depending on the indication and the affected tissue, the technique can be either applied ex-vivo or in-vivo, i.e. with or without removing the cells from the patients body for the therapeutic procedure.

According to various analyst reports, the gene therapy market was valued at approx. $ 500 m in 2018 and the market is expected to reach > $ 5 bn by 2025 with an impressive CAGR of ~34% over the forecast period. Furthermore, rapid and significant progress in the molecular and cellular biology arena, driven by technological advancements in genomics and gene-editing tools, has contributed to an increasing number of approved gene therapies as well as an expanding pipeline. According to the Alliance for Regenerative Medicine (ARM), by the end of the second quarter of 2019, there were more than 700 clinical trials ongoing globally.[1]

ABOUT EVOTEC SE Evotec is a drug discovery alliance and development partnership company focused on rapidly progressing innovative product approaches with leading pharmaceutical and biotechnology companies, academics, patient advocacy groups and venture capitalists. We operate worldwide and our more than 3,000 employees provide the highest quality stand-alone and integrated drug discovery and development solutions. We cover all activities from target-to-clinic to meet the industrys need for innovation and efficiency in drug discovery and development (EVT Execute). The Company has established a unique position by assembling top-class scientific experts and integrating state-of-the-art technologies as well as substantial experience and expertise in key therapeutic areas including neuronal diseases, diabetes and complications of diabetes, pain and inflammation, oncology, infectious diseases, respiratory diseases, fibrosis, rare diseases and womens health. On this basis, Evotec has built a broad and deep pipeline of approx. 100 co-owned product opportunities at clinical, pre-clinical and discovery stages (EVT Innovate). Evotec has established multiple long-term alliances with partners including Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, CHDI, Novartis, Novo Nordisk, Pfizer, Sanofi, Takeda, UCB and others. For additional information please go to http://www.evotec.com and follow us on Twitter @Evotec.

FORWARD LOOKING STATEMENTS Information set forth in this press release contains forward-looking statements, which involve a number of risks and uncertainties. The forward-looking statements contained herein represent the judgement of Evotec as of the date of this press release. Such forward-looking statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any such statements to reflect any change in our expectations or any change in events, conditions or circumstances on which any such statement is based.

Contact Evotec SE:

Gabriele Hansen, SVP Corporate Communications, Marketing & Investor Relations, Phone: +49.(0)40.56081-255,

[1] Sources: https://www.grandviewresearch.com/industry-analysis/gene-therapy-market; https://www.marketwatch.com/press-release/at-339-cagr-gene-therapy-market-size-to-surpass-usd-518-billion-by-2025-2019-09-16; https://www.prnewswire.com/news-releases/gene-therapy-market-to-garner-6-21-bn-globally-by-2026-at-34-8-cagr-says-allied-market-research-300975194.html

SOURCE: Evotec AG via EQS Newswire

View source version on accesswire.com:

https://www.accesswire.com/583999/Evotec-Expands-into-Gene-Therapy

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Evotec Expands into Gene Therapy - Associated Press