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Aastrom Biosciences to Present at World Stem Cells & Regenerative Medicine Congress

Posted: Published on May 18th, 2012

ANN ARBOR, Mich., May 17, 2012 (GLOBE NEWSWIRE) -- Aastrom Biosciences, Inc. (Nasdaq:ASTM - News), the leading developer of patient-specific expanded multicellular therapies for the treatment of severe chronic cardiovascular diseases, today announced that company president and CEO Tim Mayleben will be presenting at the World Stem Cells & Regenerative Medicine Congress at the Park Plaza hotel in London, UK. The presentation entitled "Phase 3 Development of a Cellular Therapy Product" will take place on Monday, May 21, 2012 at 4:40 pm (BST). The Aastrom presentation will cover the benefits of a special protocol assessment and offer insights on achieving manufacturing readiness. The presentation will also address the role of clinicians and patients in the Phase 3 development process. About Aastrom Biosciences Aastrom Biosciences is the leader in developing patient-specific, expanded multicellular therapies for use in the treatment of patients with severe, chronic cardiovascular diseases. The company's proprietary cell-processing technology enables the manufacture of ixmyelocel-T, a patient-specific multicellular therapy expanded from a patient's own bone marrow and delivered directly to damaged tissues. Aastrom has advanced ixmyelocel-T into late-stage clinical development, including a Phase 3 clinical program to study patients with critical limb ischemia and a planned Phase 2b clinical trial … Continue reading →

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Aastrom Biosciences to Present at World Stem Cells & Regenerative Medicine Congress

Posted: Published on May 18th, 2012

ANN ARBOR, Mich., May 17, 2012 (GLOBE NEWSWIRE) -- Aastrom Biosciences, Inc. (Nasdaq:ASTM - News), the leading developer of patient-specific expanded multicellular therapies for the treatment of severe chronic cardiovascular diseases, today announced that company president and CEO Tim Mayleben will be presenting at the World Stem Cells & Regenerative Medicine Congress at the Park Plaza hotel in London, UK. The presentation entitled "Phase 3 Development of a Cellular Therapy Product" will take place on Monday, May 21, 2012 at 4:40 pm (BST). The Aastrom presentation will cover the benefits of a special protocol assessment and offer insights on achieving manufacturing readiness. The presentation will also address the role of clinicians and patients in the Phase 3 development process. About Aastrom Biosciences Aastrom Biosciences is the leader in developing patient-specific, expanded multicellular therapies for use in the treatment of patients with severe, chronic cardiovascular diseases. The company's proprietary cell-processing technology enables the manufacture of ixmyelocel-T, a patient-specific multicellular therapy expanded from a patient's own bone marrow and delivered directly to damaged tissues. Aastrom has advanced ixmyelocel-T into late-stage clinical development, including a Phase 3 clinical program to study patients with critical limb ischemia and a planned Phase 2b clinical trial … Continue reading →

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Industry Consultant Gregory Bonfiglio Joins California Stem Cell Board of Directors

Posted: Published on May 18th, 2012

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 →

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Advanced Cell Technology to Present at World Stem Cells & Regenerative Medicine Congress in London

Posted: Published on May 18th, 2012

MARLBOROUGH, Mass.--(BUSINESS WIRE)-- Advanced Cell Technology, Inc. (ACT; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that chairman and CEO Gary Rabin will be presenting at the World Stem Cells and Regenerative Medicine Conference, May 21-23, in London. Mr. Rabins presentation, titled Successes and ongoing advancements of human clinical trials for the treatment of AMD & Stargardts Disease, will be given on Monday, May 21 at 5:05 p.m. BST (London time). Mr. Rabin will provide an update on ACTs three ongoing human clinical trials in the U.S. and E.U. for Dry Age-Related Macular Degeneration (Dry AMD) and Stargardts Macular Dystrophy (SMD). ACT recently announced Data and Safety Monitoring Board (DSMB) approval to move forward with enrollment and treatment of additional patients with SMD in its U.S. SMD trial, and to treat the final two patients to round out the initial dosing arm in its European trial. All three of the companys ongoing clinical trials use human embryonic stem cell (hESC)-derived retinal pigment epithelial (RPE) cells. About SMD, Dry AMD and Degenerative Diseases of the Retina Stargardts Macular Dystrophy (SMD) is one of the most common forms of macular degeneration in the world. SMD causes progressive vision … Continue reading →

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Advanced Cell Technology to Present at World Stem Cells & Regenerative Medicine Congress in London

Posted: Published on May 18th, 2012

MARLBOROUGH, Mass.--(BUSINESS WIRE)-- Advanced Cell Technology, Inc. (ACT; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that chairman and CEO Gary Rabin will be presenting at the World Stem Cells and Regenerative Medicine Conference, May 21-23, in London. Mr. Rabins presentation, titled Successes and ongoing advancements of human clinical trials for the treatment of AMD & Stargardts Disease, will be given on Monday, May 21 at 5:05 p.m. BST (London time). Mr. Rabin will provide an update on ACTs three ongoing human clinical trials in the U.S. and E.U. for Dry Age-Related Macular Degeneration (Dry AMD) and Stargardts Macular Dystrophy (SMD). ACT recently announced Data and Safety Monitoring Board (DSMB) approval to move forward with enrollment and treatment of additional patients with SMD in its U.S. SMD trial, and to treat the final two patients to round out the initial dosing arm in its European trial. All three of the companys ongoing clinical trials use human embryonic stem cell (hESC)-derived retinal pigment epithelial (RPE) cells. About SMD, Dry AMD and Degenerative Diseases of the Retina Stargardts Macular Dystrophy (SMD) is one of the most common forms of macular degeneration in the world. SMD causes progressive vision … Continue reading →

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World’s First Approved Stem Cell Drug; Osiris Receives Marketing Clearance from Health Canada for Prochymal

Posted: Published on May 18th, 2012

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 →

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World's First Approved Stem Cell Drug; Osiris Receives Marketing Clearance from Health Canada for Prochymal

Posted: Published on May 18th, 2012

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 →

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Canada approves stem cell therapy

Posted: Published on May 18th, 2012

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 →

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Osiris Wins Canadian Approval for First Stem-Cell Therapy

Posted: Published on May 18th, 2012

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 →

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Baron and Budd Warns Women About Side Effects of YAZ, Yasmin

Posted: Published on May 18th, 2012

DALLAS--(BUSINESS WIRE)-- The Federal Drug Administration (FDA) has recently decided to strengthen warning labels on the oral contraceptive YAZ and its sister drug Yasmin regarding increased risks of blood clots from using the medications. Baron and Budd, a national law firm dedicated to protecting the rights of consumers, is warning women about the new labels and the adverse health effects of YAZ, Yasmin, Beyaz and Ocella. YAZ, Yasmin, Beyaz and Ocella belong to a newer family of birth control pills that contain drospirenone (DRSP). Studies have found that women who use birth control pills that contain DRSP are at an increased risk of developing blood clots when compared to traditional birth control pills. The new FDA warnings follow the recommendations of an FDA advisory committee that evaluated the potential health risks of YAZ and other DRSP-containing birth control pills. After reviewing studies of the health risks, the committee recommended stronger warning labels for the DRSP family of drugs. Women need to be aware of things that could threaten their health, said Laura Baughman, attorney at Baron and Budd. Even though YAZ has been aggressively marketed to treat a variety of issues, that does not mean that it can deliver on … Continue reading →

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