By Meg Tirrell - 2012-05-18T13:44:15Z Osiris Therapeutics Inc. (OSIR) surged the most in two years after the company said it won the worlds first approval for a stem-cell drug, gaining clearance in Canada to sell Prochymal for a disease that can attack patients who received bone-marrow transplants. Osiris rose 8.8 percent to $5.72 at 9:40 a.m. New York time, after earlier reaching $6 for the biggest intraday increase since June 2010. The shares had fallen 28 percent in the 12 months before today. Prochymal was approved for the treatment of acute graft versus host disease in children for whom steroids havent worked, the Columbia, Maryland-based company said yesterday in a statement. Steroids have a 30 percent to 50 percent success rate, and severe GvHD can be fatal in 80 percent of cases, according to the company. The therapy uses mesenchymal stem cells derived from bone marrow that can take on different forms to combat the immune reaction that causes patients to literally peel out of their skin and shed their intestinal lining, Osiris Chief Executive Officer Randal Mills said in a telephone interview. The disease has no equal. The company hasnt sought approval for this indication in the U.S., where … Continue reading →

Osiris Therapeutics Inc says Canadian health regulators have approved its treatment for acute graft-versus host disease in children, making it the first stem cell drug to be approved for a systemic disease anywhere in the world. Osiris shares rose 14 percent to $6.00 in extended trading after the news was announced. Graft versus host disease (GvHD) is a potentially deadly complication from a bone marrow transplant, when newly implanted cells attack the patient's body. Symptoms range from abdominal pain and skin rash to hair loss, hepatitis, lung and digestive tract disorders, jaundice and vomiting. The disease kills up to 80 percent of children affected, Osiris said. To date there have been no approved treatments for the disease. Canadian authorities approved the therapy, Prochymal, for use in children who have failed to respond to steroids. Prochymal was approved with the condition that Osiris carry out further testing after it reaches the market. C. Randal Mills, the company's chief executive, said in an interview that could take three to four years. Some investment analysts have been skeptical about Prochymal's future. In 2009, two late-stage clinical trials failed to show the drug was more effective overall than a placebo in treating the disease, … Continue reading →

COLUMBIA, Md.--(BUSINESS WIRE)-- Osiris Therapeutics Inc. (NASDAQ:OSIR - News) announced today it has received market authorization from Health Canada to market its stem cell therapy Prochymal (remestemcel-L), for the treatment of acute graft-vs-host disease (GvHD) in children. The historic decision marks the worlds first regulatory approval of a manufactured stem cell product and the first therapy approved for GvHD a devastating complication of bone marrow transplantation that kills up to 80 percent of children affected, many within just weeks of diagnosis. "I am very proud of the leadership role Canada has taken in advancing stem cell therapy and particularly gratified that this historic decision benefits children who would otherwise have little hope," said Andrew Daly, M.D., Clinical Associate Professor, Department of Medicine and Oncology at the University of Calgary, Canada and Principal Investigator in the phase 3 clinical program for Prochymal. "As a result of Health Canada's comprehensive review, physicians now have an off-the-shelf stem cell therapy in their arsenal to fight GvHD. Much like the introduction of antibiotics in the late 1920's, with stem cells we have now officially taken the first step into this new paradigm of medicine." Prochymal was authorized under Health Canada's Notice of Compliance with … Continue reading →

More Topics: Choose a Sector Accounting Firms Advertising/Media/Communications Capital CEO/Board General Business Health/Biotech Internet/Technology Investment Firms Law Firms Mergers & Acquisitions Money Managers People Private Companies Public Companies Venture Capital Posted May 17, 2012 Awards to advance regenerative medicine address diverse, debilitating diseases and conditions COLUMBIA, Md. - The Maryland Stem Cell Research Commissionhas completed its review of the 179 applications received in response to its three FY 2012 Requests for Applications (RFAs). The board of directors of the Maryland Technology Development Corporation (TEDCO) approved the Commission's recommendation to fund 40 new proposals with the Maryland Stem Cell Research Fund's (MSCRF) $12.4 million FY 2012 budget. "We are pleased to announce our grant awards for FY 2012," said Margaret Conn Himelfarb, MPH, chair of the Commission. "These projects address a diverse array of debilitating and costly diseases and conditions, some of which are traditionally underfunded. Maryland's investment in cutting-edge stem cell research continues to advance the field and strengthens our State's national leadership position in the life sciences. We are grateful to Governor Martin O'Malley and the Maryland General Assembly for recognizing the tremendous economic and humanitarian benefits of this pioneering research." This funding cycle, the Commission gave priority to … Continue reading →

IRVINE, Calif.--(BUSINESS WIRE)-- California Stem Cell, Inc. (CSC) announced today that well-known stem cell & regenerative medicine industry veteran Gregory A. Bonfiglio, J.D. has joined its Board of Directors. Gregory Bonfiglio has over 25 years of experience working with technology companies, and was an early investor in the stem cell industry. He is Managing Partner of Proteus Venture Partners, an investment & advisory firm he founded in early 2006 to provide venture funding and strategic advisory services in the stem cell & regenerative medicine space. Mr. Bonfiglio is on the Boards of VistaGen Therapeutics and StemCyte, Inc.; he is the Chairman of the Board of the Centre for Commercialization of Regenerative Medicine (RM Translation Center in Toronto, Canada). In addition, Mr. Bonfiglio sits on the Advisory Board and Finance Committee of the International Society for Stem Cell Research (ISSCR); he is on the Commercialization Committee of the International Society for Cellular Therapy (ISCT). Mr. Bonfiglio brings to CSC an extensive background in strategic consulting, having held partnership positions with various legal and venture firms, and having successfully led a team that took pioneering stem cell company Advanced Cell Technology public in early 2005. Were thrilled to welcome to our board … Continue reading →

Public release date: 15-May-2012 [ | E-mail | Share ] Contact: Elisa Williams willieli@ohsu.edu 503-494-4530 Oregon Health & Science University PORTLAND, Ore. Multiple myeloma patients are better equipped to halt progression of this blood cancer if treated with lenalidomide, or Revlimid, following a stem cell transplant, according to a study co-authored by a physician with the Oregon Health & Science University Knight Cancer Institute. The study, published in the New England Journal of Medicine, found a 63 percent reduction in the risk of progressive myeloma or death for the stem cell transplant patients that were treated with lenalidomide maintenance therapy. "These results add to the evidence that the combination of standard therapies such as stem cell transplantation with the emerging biologic therapies, like lenalidomide, have extended the lives of multiple myeloma patients," said Richard Maziarz, M.D., of the OHSU Knight Cancer Institute who was one of the study's co-authors. Maziarz serves as medical director of the Adult Stem Cell Transplantation Program & Center for Hematologic Malignancies at the OHSU Knight Cancer Institute. "We know that for at least three years following a transplant that maintenance therapy with this drug vastly improves the chances that the cancer won't come back and … Continue reading →