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Regenerative Therapies: Helping Horses Self-Heal The Horse – TheHorse.com

The art (and existing science) of regenerative medicine in equine practice, and whats to come

Regenerative therapy is an umbrellaterm encompassing any method that encourages the body to self- heal. Because it is drawing onits own properties, healing tissue more closely resembles native tissue than weak, disorganized scar tissue typically seen post-injury.

The goal is to allow restoration of normal function and structure of the injured tissue to allow horses to perform at their previous level, whatever that might be, with a reduced risk of reinjury, says Kyla Ortved, DVM, PhD, Dipl. ACVS, ACVSMR, assistant professor of large animal surgery at the University of Pennsylvanias New Bolton Center, in Kennett Square.

She says the three main components of regenerative medicine that help tissues self-heal include:

A specific therapy may incorporate some or all three of these components, says Ortved.

Due to the regenerative therapy industrys popularity and continued growth, many articles weve published review recent laboratory studies about stem cell production and data on efficacy andsafety (you can find them at TheHorse.com/topics/regenerative-medicine). Here, well review the basics of three regenerative modalities commonly used in equine medicine and when veterinarians and horse owners might consider each.

With this approach the practitioner collects blood from a horse and processes it using a commercial system that concentrates the platelets. When he or she injects that concentrated platelet product back into the horse, granules within the platelets release an array of growth factors that aim to facilitate and modulate the healing process. Specifically, granule-derived growth factors encourage target tissue cells at the injury site to migrate and proliferate, improve extracellular matrix synthesis, and stimulate blood vessel development.

Recently, leukocyte-reduced PRP hasbecome many equine veterinarians PRP product of choice. These preparations contain fewer white blood cells (leukocytes) and, reportedly, inflammatory mediators than normal PRP products do. These mediators break tissues down, effectively counteracting the anabolic (tissue-building) effects of the platelets and their granules.

Veterinarians can easily prepare ACS by collecting a blood sample from the patient, then incubating it with special commercially available glass beads to stimulate interleukin-1 receptor antago- nist protein (IRAP) production. Theythen inject the resultant IRAP-rich serumsample back into the patient at the target location or injury site. This protein blocks the action of interleukin-1, a powerful and damaging pro-inflammatory mediator. Additionally, glass bead incubation stimulates the production of anti-inflammatory mediators and growth factors similar to those found in PRP.

Ortved says its important to remember that all biologics, including PRP and IRAP, contain various concentrations of growth factors and bioactive protein.

Remember, they are made from your horses blood and, therefore, containall of the components in blood, just in varying concentrations, she says.

Regenerative therapies that contain highconcentrations of IRAP include IRAP II, autologous protein solution (APS), and bone marrow aspirate concentrate (BMAC).

In certain tissues, such as adipose (fat) and bone marrow, we can find specific cells that have the ability to self-renew and grow more than 200 types of body cells. Veterinarians can isolate these cells, called stem cells or progenitor cells, and either:

Perhaps more important than theirability to differentiate into other celltypes, stem cells have powerful anti-inflammatoryproperties and play acentral role in coordinating healing in alltypes of tissues through cell-to-cell signaling,Ortved says.

Which of these three modality typeswill provide the most benefit to yourhorse depends on a variety of factors thatyou and your veterinarian will consider.

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Regenerative Therapies: Helping Horses Self-Heal The Horse - TheHorse.com

ViaCyte Announces $27 Million Financing to Advance Next Generation Cell Therapies for Diabetes – PRNewswire

SAN DIEGO, May 26, 2020 /PRNewswire/ --ViaCyte, Inc., a privately held regenerative medicine company, today announced the close of an approximately $27 million private financing, part of the Series D preferred stock financing entered into in late 2018. Investors included, Bain Capital Life Sciences, TPG Capital, RA Capital Management, Sanderling Ventures, and several individual supporters of the Company. Proceeds from the financing will be used to further advance the Company's multi-product candidate approach to develop medicines that have the potential to transform the way insulin-requiring diabetes is managed, potentially providing a functional cure for patients with type 1 diabetes.

Coinciding with the financing, the Company also appointed Ian F. Smithas Executive Chairperson. Mr. Smith was appointed to the Company's Board of Directors in July 2019 and succeeds Fred Middleton, who remains on the board.

Commenting on the financing, Paul Laikind, Ph.D., Chief Executive Officer and President of ViaCyte, said, "During these difficult times we are grateful for the continued support of our investors as well as our clinical trial participants, whose safety and health remains our focus and commitment. We are steadfast in our mission to deliver potentially life sustaining therapies for patients with insulin-requiring diabetes and to continue the significant progress we have made in the past year. ViaCyte is the first company to demonstrate production of C-peptide, a biomarker for insulin, in patients with type 1 diabetes receiving a stem cell-derived islet replacement. Moving forward, we are optimizing the effectiveness of both PEC-Direct and PEC-Encap, the latter of which incorporates novel device material technology created in collaboration with W.L. Gore & Associates. We are also making important progress on our PEC-QT program with our partner, CRISPR Therapeutics, and are now moving into pre-IND activities. This program is designed to eliminate the need for immuno-suppression and could have a transformative impact on a broader population of insulin-dependent patients."

Dr. Laikind continued, "In conjunction with the closure of the financing, we are also pleased to announce the appointment of Ian F. Smith as our Executive Chairperson, succeeding Fred Middleton. Since joining the board last July, Ian and I have worked closely to accelerate ViaCyte's growth and prepare for the future. We are extremely grateful to Fred for his many years of service as Chairperson of ViaCyte's Board of Directors. Throughout his time leading the Board, Fred provided expert guidance as ViaCyte has consistently broken new ground in the field of regenerative medicine and cell replacement therapies."

Mr. Middleton said, "I am proud to have chaired the Board as ViaCyte developed into a leading company in the regenerative medicine field.I am confident that Ian's unique expertise and executive leadership, specifically with innovative growth-oriented companies, and specifically in corporate strategy and operations, as well as capital markets will help ViaCyte progress its important work and firmly establish itself as a leader in the cell therapy sector."

About ViaCyte's Pipeline

The PEC-Direct product candidate, currently being evaluated in the clinic, delivers ViaCyte's PEC-01 cells (pancreatic islet progenitor cells) in a non-immunoprotective device and is being developed for type 1 diabetes patients who have hypoglycemia unawareness, extreme glycemic lability, and/or recurrent severe hypoglycemic episodes. The PEC-Encap (also known as VC-01) product candidate, also undergoing clinical evaluation, delivers the same pancreatic islet progenitor cells but in an immunoprotective device. PEC-Encap is being developed for all patients with type 1 diabetes. In collaboration with CRISPR Therapeutics, ViaCyte is developing immune-evasive stem cell lines from its proprietary CyT49 cell line. These immune-evasive stem cell lines, which are being used in the PEC-QT program, have the potential to further broaden the availability of cell therapy for all patients with insulin-requiring diabetes, type 1 and type 2. In addition, a pluripotent, immune evasive cell line has the potential to be used to produce any cell in the body, thus enabling many other potential indications.

About ViaCyte

ViaCyte is a privately held regenerative medicine company developing novel cell replacement therapies as potential long-term diabetes treatments to achieve glucose control targets and reduce the risk of hypoglycemia and diabetes-related complications. ViaCyte's product candidates are based on directed differentiation of pluripotent stem cells into PEC-01 pancreatic islet progenitor cells, which are then implanted in durable and retrievable cell delivery devices. Over a decade ago, ViaCyte scientists were the first to report on the production of pancreatic cells from a stem cell starting point and the first to demonstrate in an animal model of diabetes that, once implanted and matured, these cells secrete insulin and other pancreatic hormones in response to blood glucose levels and can be curative. More recently, ViaCyte demonstrated that when effectively engrafted, PEC-01 cells can mature into glucose-responsive insulin producing cells in patients with type 1 diabetes. To accelerate and expand its efforts, ViaCyte has established collaborative partnerships with leading companies including CRISPR Therapeutics and W.L. Gore & Associates. ViaCyte is headquartered in San Diego, California. The Company also has a robust intellectual property portfolio, which includes hundreds of issued patents and pending applications worldwide. ViaCyte is funded in part by the California Institute for Regenerative Medicine (CIRM) and JDRF. For more information on ViaCyte, please visit http://www.viacyte.comand connect with ViaCyte on Twitter, Facebook, and LinkedIn.

SOURCE ViaCyte, Inc.

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ViaCyte Announces $27 Million Financing to Advance Next Generation Cell Therapies for Diabetes - PRNewswire

High Rate of Responses Seen With Ide-cel in Heavily Pretreated Myeloma – Targeted Oncology

Treatment with idecabtagene vicleucel (ide-cel; bb2121) led to responses in 73% of heavily pretreated patients with relapsed or refractory multiple myeloma, and complete responses (CRs) in 33%, according to topline findings from the pivotal phase 2 KarMMA trial.

Data shared during the 2020 ASCO Virtual Scientific Program demonstrated a median duration of response (DOR) of 10.7 months, and amedian progression-free survival (PFS) of 8.8 months (95% CI, 5.6-11.6).

Ide-cel demonstrated frequent, deep, and durable responses in heavily pretreated, highly relapsed/refractory patients with myeloma, said Nikhil C. Munshi, MD, director of Basic and Correlative Science, Jerome Lipper Multiple Myeloma Center, Dana-Farber Cancer Institute, and professor of Medicine, Harvard Medical School. Overall, ide-cel provides an attractive option for the treatment of patients with triple-class exposed relapsed/refractory myeloma.

In March 2020, Bristol Myers Squibb andbluebird bio, Inc., the codevelopers of ide-cel, submitted a Biologics License Application (BLA) to the FDA for the use of the BCMA-targeting chimeric antigen receptor (CAR) T-cell therapy as a treatment for adult patients with multiple myeloma who have received at least 3 prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody.

However, earlier this month, the FDA issued aRefusal to File letter tothe companies regarding the BLA. In its initial review, the agency concluded that additional information was needed for the Chemistry, Manufacturing and Control module of the BLA. The FDA did not ask for any further clinical or nonclinical data according to the companies, which plan to resubmit the application by the end of July of this year.

The phase 2 KarMMA trial (NCT03361748) included 128 patients with relapsed/refractory multiple myeloma who received at least 3 prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody.

The median age was 61 months (range 33-78), 35% of patients had high-risk cytogenetics, 51% had high tumor burden, 39% had extramedullary disease, and 85% had 50% tumor BCMA expression. ECOG performance status was 0 (45%), 1 (53%), or 2 (2%). R-ISS disease stage was I (11%), 2 (70%), or III (16%). Patients had received a median of 6 (range, 3-16) prior antimyeloma regimens.

Ninety-four percent of patients had received 1 prior autologous stem cell transplant, and 34% had received more than 1. Eighty-eight percent of patients received bridging therapies during CAR T-cell manufacturing; however, only 4% of patients responded to the treatment. Regarding refractory status, 94% of patients were refractory to anti-CD38 antibodies and 84% were triple refractory.

Patients were treated at CAR+ T cell doses of 150 x 106 (n = 4), 300 x 106 (n = 70), or 450 x 106 (n = 54). The median follow-up was 18 months, 15.8 months, and 12.4 months, respectively. Across all patients, the median follow-up was 13.3 months. The primary end point was objective response rate (ORR), with secondary end points including CR, DOR, PFS, overall survival (OS), and quality of life.

Across all patients, the 73% ORR (95% CI, 65.8%-81.1%; P <.0001) included a 33% CR rate (95% CI, 24.7-40.9; P <.0001), a 20% very good partial response rate, and a 21% partial response rate. The overall CR rate comprised 26% of patients who achieved a CR/stringent CR (sCR) and were minimal residual disease (MRD)-negative, and 7% of patients who achieved a CR/sCR but who did not have MRD data. The median time to first response was 1 month (range, 0.5-8.8) and the median time to CR was 2.8 months (range, 1-11.8).

Durable responses were observed across all doses, said Munshi. At the dose of 450 x 106 CAR+ T cells, the ORR was 82% and the CR/sCR rate was 39%.

Clinically meaningful efficacy in terms of ORR was observed across subgroups, irrespective of age, risk categorization, tumor burden, BCMA expression level, extramedullary disease, triple-refractory status, penta-refractory status, and bridging therapy.

PFS increased as the target dose increased. At the 450 x 106 CAR+ T-cell dose, the median PFS was 12.1 months (95% CI, 8.8-12.3). The median PFS also increased by depth of response with a median of 20.2 months (95% CI, 12.3not evaluable) among patients who achieved a CR/sCR.

Munshi said the survival data are immature. At the time of the analysis, the median OS was 19.4 months (95% CI, 18.2not evaluable) and the 1-year OS rate was 78%.

Cytokine release syndrome (CRS) frequency increased with dose but was mostly low-grade, said Munshi. Overall, 84% of patients had 1 CRS event, with the majority (78%) being grade 1/2. There were 5 cases of grade 3 CRS, 1 case of grade 4, and 1 case of grade 5. The median time to onset of CRS was 1 day (range, 1-12), and the median duration of CRS was 5 days (range, 1-63). Fifty-two percent of patients received tocilizumab (Actemra) for CRS management, and 15% of patients received corticosteroids.

Neurotoxicity was mostly low grade and was similar across target doses, said Munshi. Overall, 18% of patients had 1 neurotoxicity event. There were 19 cases of grade 1/2 neurotoxicity and 4 cases of grade 3. There were no grade 4 or 5 incidents. The median time to onset of neurotoxicity was 2 days (range, 1-10), and the median duration was 3 days (range, 1-26). Two percent of patients received tocilizumab for neurotoxicity, and 8% of patients received corticosteroids.

The other significant adverse event, according to Munshi, was cytopenia91% of patients had any grade neutropenia (89% grade 3), and 63% (52% grade 3) had any grade thrombocytopenia. The median time to recovery of grade 3 neutropenia and thrombocytopenia was 2 months and 3 months, respectively, said Munshi.

There were 5 deaths within 8 weeks of ide-cel infusion2 following myeloma progression and 3 from AEs (CRS, aspergillus pneumonia, and GI hemorrhage). There was also 1 other AE-related death (CMV pneumonia) that occurred within 6 months, in the absence of myeloma progression.

Reference

Munshi NC, Anderson Jr LD, Jagannath S, et al. Idecabtagene vicleucel (ide-cel; bb2121), a BCMA-targeted CAR T-cell therapy, in patients with relapsed and refractory multiple myeloma (RRMM): Initial KarMMa results. Presented at: 2020 ASCO Virtual Scientific Program; May 29-31, 2020. Abstract 8503.

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High Rate of Responses Seen With Ide-cel in Heavily Pretreated Myeloma - Targeted Oncology

Study reveals factors influencing outcomes in kidney cancer treated with immunotherapy – Science Codex

BOSTON - By analyzing tumors from patients treated with immunotherapy for advanced kidney cancer in three clinical trials, Dana-Farber Cancer Institute scientists have identified several features of the tumors that influence their response to immune checkpoint inhibitor drugs.

The research was presented during the Clinical Science Symposium at the American Society of Clinical Oncology (ASCO) Annual Meeting and published simultaneously in Nature Medicine. The researchers say the study provides important clues about kidney cancer genetics and its interaction with the immune system that may prove to be vital in our ability to predict which patients are likely to benefit from immunotherapy drugs, which have been approved for first- and second-line treatment in the disease, but which don't work in all patients. The study showed that features that are typically linked to immunotherapy response or resistance in other types of cancer don't work the same way in advanced clear cell renal cell cancer (ccRCC).

"Kidney cancer breaks all those rules," said David Braun, MD, PhD, a Dana-Farber kidney cancer specialist and first author of the report. Co-senior authors are Toni Choueiri, MD, Catherine J. Wu, MD, Sachet A. Shukla, PhD, and Sabina Signoretti, MD all of Dana-Farber. Other authors are from the Broad Institute of MIT and Harvard, Bristol Myers Squibb, and Brigham and Women's Hospital.

Clear cell renal cell cancer is the most common form of kidney cancer. There are about 74,000 new cases of kidney cancer in the United States each year, and about 15,000 deaths. Checkpoint inhibitor immunotherapy drugs such as pembrolizumab (Keytruda) and nivolumab (Opdivo) used in advanced kidney cancer work by blocking PD-1, a protein on immune T cells that normally keep these cells from attacking other cells in the body. By blocking PD-1, these drugs boost the immune response against kidney cancer cells.

PD-1 checkpoint inhibitors have brought a powerful new weapon to bear on advanced kidney cancer, which generally doesn't respond to standard chemotherapy. In cancers such as melanoma and lung cancer, checkpoint inhibitors - drugs like pembrolizumab (Keytruda) and nivolumab (Opdivo) - tend to be more effective against tumors with a "high mutational burden," that is, their DNA is riddled with many mutations. Advanced clear cell renal cell cancer, by contrast, has a moderate number of mutations yet is relatively responsive to checkpoint inhibitors - and scientists don't know why that is. Another puzzling difference is that in melanoma and some other cancers, tumors that are infiltrated with large numbers of immune CD8 T cells, creating what's termed an inflamed or "hot" environment within the tumor, respond better to PD-1 blockade. But the reverse is true in advanced kidney cancer - high infiltration by CD8 T cells is associated with a worse outcome.

In this study, the scientists analyzed 592 tumors collected from patients with advanced kidney cancer who were enrolled in clinical trials of PD-1 blocking drugs. They used whole-exome and RNA sequencing and other methods to uncover the genomic changes and other factors that were associated with how the patients' tumors responded to the drugs - specifically, the patients' progression-free survival and overall survival.

The study was aimed at determining what features of advanced kidney cancer cells were associated with their response or resistance to PD-1 inhibitors. In analyzing the tumors from advanced ccRCC patients treated with PD-1 inhibitors, the investigators looked for biomarkers - genetic changes, mutations, copy number alterations, and so forth - in the genomes of the kidney cancer cells that might be correlated with patient outcomes - such as progression-free survival and overall survival.

Braun said that some of the most interesting findings were characteristics of the kidney tumors that - unlike with other types of cancer - did not influence responsiveness to PD-1 inhibitor drugs. For example, tumors containing a large number of neoantigens - proteins made by cancer-related DNA mutations that may make the tumors more responsive to immunotherapy, but this proved not to be true of the kidney tumors. Also, even though the kidney tumors were heavily infiltrated by CD8 immune T cells - which causes other kinds of cancer to provoke a strong immune attack against the tumors - this actually led to no difference in outcome for these kidney cancer patients. "To our surprise, the immunologically 'hot' tumors did not respond any better than the 'cold' tumors," said Braun.

Another factor that affects responsiveness in some types of cancer - the specific HLA molecules inherited by individuals that present antigens to the immune system - didn't affect the immune response to advanced kidney tumors. "That surprised us," said Dr. Wu, chief of Division of Stem Cell Transplantation and Cellular Therapies. "We reasonably hypothesized that the potential of the patient's immune system to present and react to a greater diversity of antigens may be associated with better outcomes, but clearly kidney cancer does not fit the standard mold," noted Wu.

"However, we did uncover some factors that may explain the unexpected observations," said Dr. Shukla who leads the computational group at the Dana-Farber Translational Immunogenomics Laboratory. The study uncovered that advanced kidney tumors heavily infiltrated with CD8 T cells did not respond well to immune checkpoint blockers even though they were immunologically "hot" tumors. The scientists, with their comprehensive analysis of changes in the kidney tumors' genomes, found that the tumors were depleted of mutated PBRM1 genes - which are correlated with improved survival with PD-1 blockade therapy - and also had an abundance of deletions of a chromosomal segment known as 9p21.3, which is associated with worse outcomes with PD-1 blockade. "We believe that these two factors may explain why CD8 T cell infiltration of the tumors did not make them responsive to checkpoint blocker therapy," explained Shukla, "while other types of cancer that exhibited CD8 T cell infiltration but did not have those chromosomal changes did respond."

"Our work highlights the importance of integrating genomic data with immunopathologic data generated through painstaking review by expert pathologists," said Dr. Signoretti, professor of pathology at Harvard Medical School. "Our findings reveal that interactions between immune T cell infiltration and alterations in the tumor DNA (such as inactivation of the PBRM1 gene and the abundance of 9p21.3 deletions) can be important influences on tumors' response to PD-1 blockade - perhaps not only in kidney cancer but in other types of tumors as well."

"The current study provides critical insights into immunogenomic mechanisms contributing to response and resistance to immunotherapy in clear cell renal cell cancer," said Dr. Choueiri, director of the Lank Center for Genitourinary Oncology and the Jerome and Nancy Kohlberg Professor of Medicine at Harvard Medical School. "The detailed clinical, genomic, transcriptomic, and immunopathology data produced by this study will serve as a valuable resource for the cancer immunology community. This work, therefore, will be important for ongoing research in precision medicine and immuno-oncology, helping to identify which patients are likely to respond to current therapies, and providing fundamental information to aid in development of rational combination therapies to overcome resistance in the future."

"One notable thing," said Choueiri, "is the collaboration between multiple disciplines and stakeholders: Immunology, pathology, genetics, computational and clinical expertise all converged on one tumor, while involving academic and industry stakeholders."

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Study reveals factors influencing outcomes in kidney cancer treated with immunotherapy - Science Codex

Global, The US and Europe Regenerative Medicines Market Outlook 2019-2027 Share, Consequence of COVID-19 on Market, Demand, Top Companies, Trend,…

The global regenerative medicine market is estimated to grow on the back of rising healthcare expenditure with increasing demand for efficient disease treating practices coupled with growing technological developments and discoveries. The world bank reported a rise in global current health expenditure (% GDP) from 9.453% in 2011 to 10.023% in 2016.

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Additionally, global regenerative medicines market is estimated to grow at a robust rate on the back of increasing adoption of stem cell technology to address the rising prevalence of chronic diseases. Moreover, emerging applications of gene therapy in regenerative medicines for tackling infectious diseases such as, malaria, HIV, tuberculosis and influenza or to target angiogenesis during cardiac surgery is leading to subsequent expansion in usage base of regenerative medicines around the globe.

Increasing incidences of chronic oncogenic diseases such as cancer with an estimated new cases of 18.1 million in 2018 as per International Agency for Research on Cancer (IARC), is anticipated to display rapid growth in application of regenerative medicines in the upcoming years. Additionally, increasing application of regenerative medicines to treat auto-immune hepatitis, is expected to back the rampant growth in the upcoming years. Moreover, government initiatives to eliminate chronic diseases is anticipated to aid the growth in upcoming years.

For instance, World Health Organization (WHO) launched an initiative to eliminate hepatitis completely by 2030. Furthermore, Regenerative medicines comprising blood stem cell implants can be used to restore healthy bone marrow in patients with leukemia. Besides, experiments in the gene therapy segment to explore benefits for various other medical applications, is expected to propel considerable growth in the regenerative medicines market in the upcoming years.

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Application of regenerative medicines in tissue-engineering cartilages, modifying chondrocytes, and other tissue engineering technologies for treating traumatic and degenerative joint diseases is estimated to drive the market growth in the upcoming years. Additionally, increasing use of regenerative medicines in hepatocyte transplants for chronic liver disease treatments and liver failure conditions is propelling an exponential growth in the global market.

Moreover, increasing use of poly-hemoglobin blood substitute produced through regenerative medicines to treat conditions of blood contamination or blood shortages is further propelling growth in the utilization of regenerative medicines in the hospitals, blood banks and research institutes.

Tissue engineering is a field majorly focused on development of tissue and organ substitutes by controlling biological, biophysical and/or Biomechanical parameters in the laboratory. Of late, tissue engineering has gained popularity on the back of its utilization to bioengineer implantable devices, reconstitutedecellularized organs, and manufacture organs using3D bio-printing.

Additionally, rising geriatric population across the globe holds immense opportunities for regenerative medicines in the upcoming years. According to World Bank, population aged 65 and above increased from 7.64% in 2010 to 8.926% of the overall population in 2018. Moreover, change in climatic conditions and increase in sedentary lifestyles has led to drastic demographic changes in developed and developing countries, resulting in growing number of disease cases associated with aging. This aspect is attributed to contribute considerably to the regenerative medicines market growth across the globe

Changing environmental conditions with increasing penetration of ultraviolet rays to the earths surface due to global warming consequently impacting the human health by causing oncologic and dermatology based diseases is attributed to create an upsurge in demand for regenerative medicines during the forthcoming years.

Additionally, increasing exposure of the present population to X-rays and gamma rays due to high nuclear energy involving practices is increasing incidences of cancer, subsequently propelling the regenerative medicines market across North America.

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A sharp reduction in the size of secondary care institutions across Europe in the past decade has resulted in the streamlining of healthcare delivery and stimulated more efficient and integrated model of care that is anticipated to lead to complete conquer of the hospital-centric pattern of care over the forthcoming years. These change in patterns of healthcare are attributed to influence the regenerative medicines market positively across Europe

Increasing prevalence of diabetes retinopathy with rising cases of diabetes mellitus across Asia has resulted in rise in adoption of regenerative medicines for cornea regeneration and other ophthalmic applications driving the market subsequently in the continent over the past. Besides, new application discoveries in the field of regenerative medicines through extensive research and development activities across the countries of India, Japan and China are anticipated to boost the market positively during the forecast period

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Global, The US and Europe Regenerative Medicines Market Outlook 2019-2027 Share, Consequence of COVID-19 on Market, Demand, Top Companies, Trend,...

Viracta Therapeutics to Host Key Opinion Leader Call on the Treatment of EBV-Associated Lymphoma – Yahoo Finance

Call Will Feature Ronald Levy, MD (Stanford University) and Pierluigi Porcu, MD (Thomas Jefferson University)

SAN DIEGO, May 28, 2020 /PRNewswire/ --Viracta Therapeutics, Inc. (the "Company"), a precision oncology company targeting virus-associated malignancies, today announced that it will host a key opinion leader (KOL) call discussing the treatment of Epstein-Barr virus (EBV)-associated lymphoma on Friday, June 5th at 12 P.M. Eastern Time.

The call will feature presentations by Key Opinion Leaders Ronald Levy, MD (Stanford University) and Pierluigi Porcu, MD (Thomas Jefferson University), who will discuss the current treatment landscape and unmet medical need in EBV-associated lymphoma. The call will be followed by a question and answer session with Drs. Levy and Porcu. Dial-in and webcast information for the call is shown below.

Dial-in and Webcast Information

Domestic:

1-877-705-6003

International:

1-201-493-6725

Conference ID:

13704262

Webcast:

Click Here For Webcast

On the call, Viracta's management team will also provide an update on the clinical development of the company's lead program, nanatinostat in combination with the antiviral valganciclovir as an oral combination therapy in a Phase 2 clinical trial for the treatment of EBV-associated lymphoma.

About the KOLs

Dr. Ronald Levy is a Professor of Medicine and former Chief of the Division of Oncology at Stanford University School of Medicine. Dr. Levy is widely known as a pioneer in the use of monoclonal antibodies for the treatment of cancer. His research efforts have focused on the treatment of lymphoma and he played a key role in developing Rituximab, a drug that has revolutionized lymphoma treatment world-wide. Among many other honors, Dr. Levy was a recipient of the King Faisal International Prize in Medicine.Dr. Levy's current research concentrates on the development of therapeutic vaccine approaches for the treatment of lymphoma and other cancers.

Dr. Pierluigi Porcu is a Professor of Medical Oncology and Director of the Division of Hematologic Malignancies and Hematopoietic Stem Cell Transplantation in the Department of Medical Oncology at Thomas Jefferson University, and a member of the Sidney Kimmel Cancer Center (SKCC).Dr. Porcu's Lab at the SKCC is focused on studying the role of the EBV in a subset of T-cell and NK-cell lymphomas, epigenetic mechanisms of T-cell and NK-cell transformation, new targets of therapy in EBV-associated T-cell and NK-cell lymphomas, and predictive biomarkers of response to epigenetic therapy in lymphoma. For the past 10 years, Dr. Porcu has been listed among the U.S. News & World Report's Top Cancer Doctors in America, Newsweek's Top Hematology Doctors, and since moving to Philadelphia he has been on Philadelphia Magazine's Top Doctors list.

About Nanatinostat

Nanatinostat (VRx-3996) is an orally available histone deacetylase (HDAC) inhibitor being developed by Viracta.Nanatinostat is selective for specific isoforms of Class 1 HDACs which is key to inducing latent viral genes in EBV-associated malignancies. The nanatinostat and valganciclovir combination is being investigated in EBV-associated lymphomas in an ongoing Phase 2 clinical trial [NCT03397706].

Viracta has received Fast Track designation from the FDA for the nanatinostat and valganciclovir combination in relapsed/refractory lymphomas, as well as Orphan Drug Designation for the treatment of post-transplant lymphoproliferative disorder, plasmablastic lymphoma, and angioimmunoblastic T-cell lymphoma.

About EBV-Associated Cancers

Approximately 95% of the world's adult population is infected with Epstein-Barr virus (EBV). Infections are commonly asymptomatic. Following infection, the virus remains latent in a small subset of lymphatic cells for the duration of the patient's life. Under certain circumstances, such cells may undergo malignant transformation and become lymphoma. In addition to lymphomas, EBV is associated with a variety of solid tumors, including nasopharyngeal carcinoma and gastric cancer.

About Viracta Therapeutics, Inc.

Viracta is a precision oncology company targeting virus-associated malignancies. The Company's proprietary investigational drug, nanatinostat, is currently being evaluated in combination with the antiviral agent valganciclovir as an oral combination therapy in a Phase 2 clinical trial for Epstein-Barr virus positive lymphomas. Viracta is pursuing application of this Kick and Kill platform approach in other EBV associated malignancies, such as nasopharyngeal carcinoma, gastric carcinoma and other viral related cancers.

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Viracta Therapeutics to Host Key Opinion Leader Call on the Treatment of EBV-Associated Lymphoma - Yahoo Finance

As Japan reopens, coronavirus testing slowed by bureaucracy and staff shortages – KDAL News

Wednesday, May 27, 2020 8:34 p.m. CDT by Thomson Reuters

By Ju-min Park and Kiyoshi Takenaka

TOKYO (Reuters) - At the beginning of April, a young Japanese sumo wrestler known as Shobushi came down with a fever. His coaches tried calling a local public health centre to get him a coronavirus test, but the phone lines were busy.

For four days, he was turned away by clinics in Tokyo overwhelmed during a surge of COVID-19 cases. He was finally admitted to hospital on April 8 when he began coughing up blood, but died of the disease on May 13, the Japan Sumo Association said.

Shobushi's death caused a public outcry over Japan's testing limitations and reliance on overstretched public health centres at a time when most experts say widespread virus checks are crucial to contain the pandemic.

With Japan lifting its state of emergency and reopening its economy this week, its pandemic response has been hailed as an unlikely success. In a global death toll of more than 300,000, Japan has confirmed around 800 deaths from 16,000 cases.

Yet at the same time, Japan ranks the second lowest in its testing among OECD countries.

As of May 20, Japan conducted 3.4 tests per 1,000 people, far below Italy's 52.5 and 39 in the United States, according to Oxford University data. South Korea has carried out tests on 15 people per 1,000 people.

In more than a dozen interviews with Reuters, public health officials, doctors and experts warned Japan's slow scaling up of tests could mask the scale of infections and make its population vulnerable to future outbreaks.

Critics say vested interests and bureaucracy inside Japan's health ministry caused bottlenecks at overworked public health centres, and officials waited too long to allow private labs to run tests.

"It is true that announced figures for infection and deaths are low, but those are based on the tests that were curbed," said Yasuharu Tokuda, the director of the Muribushi Okinawa Center for Teaching Hospitals. "It is clear that there are quite a few (cases) that have fallen through the cracks."

Even the government's top advisor, Shigeru Omi, told parliament "nobody knows" whether the true number of coronavirus cases "could be 10 times, 12 times or 20 times more than reported."

Omi's panel of experts has called on the government to speed up testing, including of people with mild symptoms.

The health ministry said it is ramping up the use of private labs to reduce the workload on public health centres.

"Our stance that tests should be conducted on people in need has been consistent from the beginning. We have had testing capacity increased continuously," Takuma Kato, a senior health ministry official, told Reuters.

"NOT ENOUGH" TESTS

Public health centres are at the forefront of Japan's response to the pandemic. While South Korea bolstered its public health system in the wake of past epidemics, Japan has halved the number of public health centres since the 1990s.

Struggling with overworked staff and flooded with calls, public health centres have asked the government to allow more private clinics to administer polymerase chain reaction (PCR) tests.

Japan says it can run up to 22,000 PCR tests a day, but less than a third - around 6,000 tests - are actually conducted on a daily basis. About 75% of tests have been processed through public health centres and government institutions, according to the health ministry.

In a previously unreported May 6 letter, the association of public health centre directors urged Katsunobu Kato, the minister of health, to overhaul Japan's testing policy.

"Currently, there are not enough PCR tests conducted for the coronavirus," they wrote in the letter seen by Reuters.

Some regional governments have begun running temporary testing stations with the help of local medical associations in April, bypassing public centres.

IDLE LABS, UNUSED MACHINES

While public health centres are overwhelmed, university labs are sitting idle.

Shinya Yamanaka, a Nobel Prize-winning stem cell biologist at Kyoto University, has offered his lab to boost testing capacity.

"If we can make good use of resources at places like university labs, PCR testing can exceed 100,000 (per day), far more than 20,000," Yamanaka said in an internet TV debate with Prime Minister Shinzo Abe on May 6.

The health ministry welcomed his proposal, but said further considerations were needed.

"We are grateful for their offer of help at this time of emergency. We want to work together, carefully matching our needs to their offer," Masami Sakoi, the assistant health minister, told Reuters.

Critics say testing was limited, in part, by health ministry technocrats who wanted to maintain a tight grip on information, rather than cooperate with private institutions.

Kenji Shibuya, who heads the Institute for Population Health at King's College London, said officials wanted to gather high-quality research data using public health centres.

The health ministry denies suggestions that ministry technocrats are intentionally curbing testing, and say their approach has proven successful so far.

Sakoi from the health ministry said it was important to carry out PCR tests that doctors deemed necessary, and pointed out Japan's public insurance system started covering the tests in March as part of the government's effort to make them more accessible.

"When we think about using the test results to form policy measures, the current method needs to be maintained for the time being though concerns that it lacks flexibility for boosting the number of tests is understandable," Sakoi said.

Still, the approach is alarming some experts.

"It's safer to assume that Japan has just been lucky than to believe it has taken the right steps," said Tokuda, the epidemiology expert.

(Reporting by Ju-min Park, Kiyoshi Takenaka, Antoni Slodkowski, Ami Miyazaki, Sakura Murakami; Editing by Mari Saito and Lincoln Feast.)

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As Japan reopens, coronavirus testing slowed by bureaucracy and staff shortages - KDAL News

COTA, Inc. Announces Participation in the 2020 American Society of Clinical Oncology (ASCO) Virtual Scientific Program and DIA 2020 Virtual Global…

BOSTON, May 29, 2020 /PRNewswire/ --COTA, Inc., a healthcare technology company that uses real-world data (RWD) to bring clarity to cancer care, is pleased to announce its involvement and participation in two industry leading conferences - the 2020 American Society of Clinical Oncology (ASCO) Virtual Scientific Program taking place May 29-31 and the DIA 2020 Virtual Global Annual Meeting to be held June 14-18. Collectively, the involvement at these two premier events further underscores the importance of RWD's role in clinical research and oncology care delivery.

"As real-world data continues to play an increasing role in clinical research with expanding regulatory applications, COTA is proud to be a leader in the space, and share our expertise and findings at two of the industry's most important meetings," said Mike Doyle, President and CEO of COTA. "Not only are we working to provide clinically relevant insights that might otherwise remain hidden, but we are doing so by collaborating with industry experts, including Friends Of Cancer Research. This work is more important than ever during these unprecedented times, and we look forward to sharing our findings with conference attendees."

ASCO 2020 Areas of Study and Abstracts

The company is proud to announce that five abstracts have been accepted at ASCO's 2020 annual meeting. The key areas of study include the following:

COTA has partnered with leading organizations, life science companies, hospitals, and cancer centers to produce these important findings. Links to the full abstracts and additional author information can be found below:

1. Incorporating molecular markers in standard prognostic models for DLBCL patients using real-world data.

2. Disparities in clinical characteristics and treatment of multiple myeloma in African American patients.

3. Trends in immunotherapy use in patients with advanced non-small cell lung cancer (aNSCLC) patients: Analysis of real-world data.

4.Overall survival (OS) in advanced non-small cell lung cancer (aNSCLC) patients treated with frontline chemotherapy or immunotherapy by comorbidity: A real-world data (RWD) collaboration.

5. Assessing real-world clinical response in patients with multiple myeloma (MM): A survey of the literature.

Industry Thought Leaders to Share Expertise at DIA 2020

In addition to its involvement in ASCO20, the Company will also be participating in DIA 2020, leading panel discussions with industry experts and thought leaders.

"As the value of real-world data becomes more accepted and its use more widely adopted, we are looking forward to speaking with industry leaders with invaluable insights on the topic," saidCK Wang, M.D., COTA's Chief Medical Officer. "With expertise spanning from a past Associate Director of the FDA, to an epidemiologist with over 20 years of healthcare research experience, as well as a pharmacoepidemiologist with 25 years of academic and industry experience, these will be fruitful discussions that can help push the industry forward as it expands its use of RWD."

About COTA, Inc.Founded by doctors, engineers and data scientists, COTA is committed to bringing a patient-first approach to cancer care through the use of real-world evidence. The Company organizes fragmented, often hidden data from the real world to provide clarity in cancer care. Combining clinical expertise in cancer with proprietary technology and advanced analytics, COTA helps inform decisions and action in oncology. COTA partners with providers, payers, and life science companies to ensure that everyone touched by cancer has a clear path to the right care. To learn more about COTA and how to make better decisions with the right data, visit cotahealthcare.com.

For more information, please contact:

Jaimee Ryan

Jessika Parry

COTA, Inc.

Next Step Communications

Jaimeeryan@cotahealthcare.com

COTA@nextstepcomms.com

617-733-5509

781-308-3317

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Scots mum, 28, who lost newborn baby tragically dies from lung inflammation weeks after cancer all clear – The Scottish Sun

A MUM who lost her newborn baby and battled cancer twice has tragically died.

Danielle Currie, 28, sadly passed away on May 11 - just weeks after being told she could leave Glasgow's Beatson Oncology Centre.

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The mum, from Drumchapel, had undergone a successful stem cell transplant in February following a second diagnosis of Hodgkins Lymphoma.

Danielle left the Beatson, where she had been treated after the op, on March 23 - but was rushed to the Queen Elizabeth University Hospital with a high temperature two weeks later.

She tragically passed away on May 11, with her loved ones revealing her death certificate states the cause of death as inflammation of the lungs and pneumonitis

A fundraising page has been set up in her name to raise money for her fiance, Derrick McNaught, 28.

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Danielle gave birth to twins Grahame and Sofia McNaught in December 2017, who arrived after just 24 weeks and weighed just one pound, six ounces and one pound, two ounces, respectively.

Heartbreakingly, Grahame died at only 11 days old - but miracle sister Sofia battled against a chronic lung condition to survive.

Home carer Danielle was diagnosed with Hodgkins Lymphona in October 2018, just weeks after her daughter had been allowed to leave hospital.

Cousin Leanne Dawson told the Daily Record: "Danielle and Derrick went through such a hard time after the twins were born. Then came the cancer diagnosis.

"Danielle never said 'why me?' She just got on with it and kept smiling."

"She lost her hair with chemotherapy and often took infections which is horrible, especially for someone of her age.

"She was a new mum and couldn't look after her baby. But she carried on and stayed positive."

Danielle went into remission in March 2019 but the cancer returned a few months later in July.

Leanne, 38, said: "Danielle never said 'why me?' She just got on with it and kept smiling.

"Planning her wedding to Derrick and getting better for Sofia was a good focus for her.

"If anything, she always worried about everyone else, which just summed her up."

After getting the all clear for a second time in March, Danielle headed home the shield with at-risk daughter Sofia.

But in April, she was admitted to hospital and sadly passed away in May.

Leanne, from West Lothian, said: "Her lungs were damaged and had to be drained of liquid, which doctors said could have been a result of the stem cell transplant. It was a horrible time."

Heartbroken Derrick, who cannot work due to his Epilepsy, is now caring for Sofia. But the tot was among the many loved ones who couldn't attend Danielle's funeral this week due to lockdown restrictions.

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A GoFundMe page set up to support Derrick and Sofia has well surpassed the original target of 2,000 and has raised more than 5,600.

Over 180 people have donated money to the family during this tragic time.

To donate to the page, click here.

We pay for your stories and videos! Do you have a story or video for The Scottish Sun? Email us at scoop@thesun.co.uk or call 0141 420 5300

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Scots mum, 28, who lost newborn baby tragically dies from lung inflammation weeks after cancer all clear - The Scottish Sun

"COVID-19: Treatment or vaccines? What seems more likely, and what could be more beneficial?" – Kalkine Media

According to WHO data, as on 29 May 2020 (at 7:02 PM CEST), there were more than 5.7 million confirmed cases, and over 357k deaths recorded worldwide. COVID-19 has taken lives, shut down economies, and has made people cocooned to their respective homes. However, for the healthcare sector, COVID-19 has presented one of the most significant financial opportunities. What the world currently needs is a potent medicine for treating the virus or an effective vaccine to prevent COVID-19 from affecting people. The struggle lies whether to create a treatment or develop a vaccine. Lets dig dipper on this situation.

COVID-19 and its current treatments

According to the World Health Organization (WHO), COVID-19 acts as a pneumonia-like illness as it creates shortness of breath affecting lungs. However, over time, it has been found that the virus affects the other organs as well, such as kidneys, liver, skin, and brain. At present, the treatments primarily consist of existing antivirals or drugs approved for other indications. Doctors are also using EUA drugs to treat people suffering from SARS-CoV-2 induced disease. A EUA or emergency use authorization from the US Food and Drug Administration (FDA) allows doctors to use the drug for medication without following proper FDA approval process.

Currently, the FDA has assigned emergency use authorization (EUA) to three drugs Chloroquine and Hydroxychloroquine indicated for Malaria, remdesivir indicated for Viral and a sedation drug to be used with FDA.

Sorrento Therapeutics (NASDAQ:SRNE) recently announced that it had developed an antibody drug that had shown positive results in early testing by blocking the COVID-19 strain. According to the company, the drug can be used for treatment as well as to prevent infection.

In Australia, many companies are developing COVID-19 treatments using various platforms

Mesoblast Limited (ASX:MSB) and Cynata (ASX:CYP) are using stem cell therapies and have launched clinical trials to see if the overactive inflammatory response of the body can be reduced.

Cancer biotech Noxopharm (ASX:NOX) has submitted a pre-IND (Investigational New Drug) for Veyonda clinical trial for treating inflammation caused by COVID-19. Antiviral condom lube maker Starpharma (ASX:SPL) claimed its active ingredient acted positively against COVID-19 infection in the lab. However, the efficacy and safety of the drugs still need to be ensured. And hence, there is a delay in proper approved treatments entering the markets.

According to industry experts, COVID-19 is expected to become a seasonal disease every year, making treatments an essential need, and thus, a viable opportunity for pharmaceutical and biotech companies to invest in developing the treatment.

ALSO READ:COVID-19 Treatment: Developments in Australia

While treatment is the need of the hour, vaccines will go a long way

A vaccine protects people to build immunity against an antibody or SARS-CoV-2 in case of COVID-19. A virus will have no effect on vaccinated people. According to WHO, as on 27 May 2020, there are 10 COVID-19 vaccine candidates under clinical assessment and 115 COVID-19 vaccine candidates in pre-clinical stage.

Currently, Moderna Inc (NASDAQ:MRNA) is testing its messenger RNA (mRNA) vaccine in a phase I clinical trial in Seattle, Washington. Moderna is expected to start a phase II study of its vaccine in May 2020 and a phase III clinical trial in July. FDA has agreed to fast-track review upon phase III clinical trial success of the vaccine.

Inovio Pharmaceuticals Inc (NASDAQ:INO) has also quickly developed a potential vaccine for SARS-CoV-2 with phase I clinical trial enrollment completed in late April. The company is expected to start a phase II/III clinical trial in the summer.

The University of Queensland in Australia has a research team which is developing a vaccine by growing viral proteins in cell cultures. The group began pre-clinical testing stages in early April. Pharmaceutical companies, Johnson & Johnson and Sanofi are also developing vaccines of their own.

However, according to the director of NIH, Dr Anthony Fauci, a vaccine meant for widespread use will take almost 12 to 18 months to enter the market.

Bottomline

Medicines and vaccines reside side by side. COVID-19 has presented the healthcare sector with an opportunity to serve the people worldwide and rake in big money by creating the right medicine for the treatment of the coronavirus disease, or by developing an effective vaccine to prevent it from affecting people. As per UNICEF Australia, vaccines do assist in building up public health and bring down death rates stemming from various diseases. However, vaccines are not 100% effective, and the vaccination rate per country also varies, creating an earnest need for prescribed medicines to beat the novel coronavirus.

Do Read: How Healthcare and Research Companies are coming up with Ground-Breaking Technologies to Deal with COVID-19

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"COVID-19: Treatment or vaccines? What seems more likely, and what could be more beneficial?" - Kalkine Media