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Athersys, Inc. (Nasdaq:ATHX) announced today that it has been granted U.S. patent 8,147,824 that covers the use of non-embryonic, multipotent stem cells for the reduction in severity or prevention of Graft-versus-Host Disease (GvHD), a serious condition associated with hematopoietic stem cell transplants (HSCTs) used to treat leukemia and related conditions. Athersys recently completed a successful clinical study evaluating the adjunctive administration of MultiStem® for prevention of GvHD, an indication for which the company has already received orphan drug designation.
The issued patent covers the use of MultiStem, Athersys' proprietary cell product platform, for the suppression of GvHD when administered in conjunction with an HSCT. The patent covers the administration of non-embryonic, multipotent stem cells derived from bone marrow as well as other tissues sources and applies to single or repeat dosing over a broad dose range in the context of HSCT-based treatment.
Athersys recently announced positive results from its Phase I clinical trial of MultiStem administered to patients undergoing HSCTs. In the highest dose group, a substantial reduction from the expected GvHD incidence was observed. Additionally, there were apparent benefits in several other important clinical parameters over the observation period, including engraftment rates, mortality and incidence of infection, relative to what would typically be expected for the high risk patient population enrolled in the study. The clinical results support the further, accelerated development of MultiStem for the prevention and reduction of GvHD. The company will be interacting with theFDA to discuss plans for the next phase of clinical development, which is intended to include a blinded, controlled Phase II/III study of MultiStem for GvHD prophylaxis and HSCT support.
"GvHD prophylaxis and transplant support represent areas of substantial unmet clinical need and as such, represent an attractive market opportunity for Athersys," said William (B.J.) Lehmann, President and COO of Athersys. "The '824 patent provides the company with protection in this high value area through 2028 and lays the groundwork for additional protection in related areas of treating immune system dysfunction."
Athersys received orphan drug designation from the U.S. Food and Drug Administration for prevention of GvHD in September 2010. Orphan drug designation, which is intended to facilitate drug development for disease indications affecting fewer than 200,000 individuals, provides substantial potential benefits to the sponsor, including funding for certain clinical studies, study-design assistance, tax incentives and seven years of market exclusivity for the product upon regulatory approval.
Leukemia and certain related conditions are often treated with radiation and chemotherapy to eliminate cancerous or diseased cells, but this process also severely compromises the native blood forming and immune system in the patient, leaving them susceptible to infection and other complications. To address this, a patient will often receive an allogeneic HSCT, whereby following radiation and chemotherapy treatment a patient's blood stem cells are replaced with a transplant of hematopoietic stem cells obtained from the bone marrow or peripheral blood of a healthy donor. Donors may be related or unrelated to the patient, but are matched according to tissue type in order to minimize the potential for GvHD, where donor immune cells transplanted with the donor HSCT attack tissue and organs of the patient. Following the transplant, the patient will often remain hospitalized in specialized units until successful engraftment provides a sufficiently functional immune system.
According to the Center for International Blood and Marrow Transplant Research, each year there are approximately 25,000 allogeneic HSCT performed globally, although this number is projected to increase due to the anticipated growth in incidence of hematologic malignancies associated with an aging population. While this treatment approach can be an effective medical therapy for these types of cancer, it is often associated with substantial tissue damage and side effects. GvHD is a frequent complication associated with allogeneic HSCT, affecting approximately half or more of transplant recipients, and advanced GvHD can be severely debilitating or even fatal. Several factors affect a patient's likelihood of having GvHD and GvHD severity, including the treatment protocol used, the degree of tissue match between donor and recipient (with lower GvHD rates and severity associated with related donors and better tissue matches), and the condition of the patient among other factors.
MultiStem® cell therapy is a patented product that has shown the ability to promote tissue repair and healing in a variety of ways, such as through the production of multiple therapeutic factors produced in response to signals of inflammation and tissue damage. MultiStem has demonstrated therapeutic potential for the treatment of inflammatory and immune disorders, neurological conditions, and cardiovascular disease, as well as other areas, and represents a unique "off-the-shelf" stem cell product that can be manufactured in a scalable manner, may be stored for years in frozen form, and is administered without tissue matching or the need for immune suppression. The product is extensively characterized for safety, consistency and potency. Athersys has forged strategic partnerships with Pfizer Inc. to develop MultiStem for inflammatory bowel disease and with RTI Biologics, Inc. to develop cell therapy for use with a bone allograft product in the orthopedic market.
Athersys is a clinical stage biotechnology company engaged in the discovery and development of therapeutic product candidates designed to extend and enhance the quality of human life. The Company is developing its MultiStem® cell therapy product, a patented, adult-derived "off-the-shelf" stem cell product platform for disease indications in the cardiovascular, neurological, inflammatory and immune disease areas. The Company currently has several clinical stage programs involving MultiStem, including for treating inflammatory bowel disease, ischemic stroke, damage caused by myocardial infarction, and for the prevention of graft versus host disease. Athersys has also developed a diverse portfolio that includes other technologies and product development opportunities, and has forged strategic partnerships and collaborations with leading pharmaceutical and biotechnology companies, as well as world-renowned research institutions in the United States and Europe to further develop its platform and products.
Tags: clinical trials