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Osiris Begins Phase II Clinical Trial With Adult Stem Cell Therapy for the Treatment of Heart Attack

The Austin American Statesman, April 1, 2009

Deep in the heart of Texas, the Heart Hospital of Austin is one of approximately 40 hospitals throughout the United States and Canada that have been chosen to participate in an FDA-approved clinical trial for the use of adult stem cells in the treatment of heart attack patients.

Specifically, the double-blind, placebo controlled Phase II clinical trial will evaluate the efficacy of an allogeneic adult stem cell product developed by the biotech company Osiris Therapeutics. Known as Prochymal, this proprietary adult stem cell therapy has already demonstrated exceptionally strong safety results in the Phase I clinical trial, during which time Prochymal was found to be even safer than a placebo. The current Phase II clinical trial will evaluate the ability of Prochymal to regenerate damaged heart tissue following a heart attack. The first patient to be enrolled in the clinical trial, a 58-year-old male, was already treated on Monday, within days of his heart attack. Approximately 20 patients will be enrolled in the study over the next 6 to 8 months, all of whom will receive the Prochymal treatment within 7 days of having suffered a heart attack. Prochymal is administered intravenously, and the entire therapy takes less than an hour to complete. Of the 40 hospitals that are participating in the clinical trial, only the Heart Hospital of Austin and one other hospital, in Kansas, have already begun treating patients.

According to 74-year-old Miles Simmons, who is also enrolled in the study in Austin and is scheduled to receive the Prochymal therapy, "I have a lot of grandchildren and I love them and I would like to spend more time with them. I think it's wonderful. If you have technology, then use it." As Dr. Roger Gammon, a cardiologist with the Heart Hospital of Austin and the director of the clinical trial, explains, "It would change everything for people with heart attacks. Research in this area has just exploded, and a lot of funding is going to have to come from the government to really push it forward. What's kind of unique and new is it's given intravenously. The cells are drawn to the heart and they implant there. If it works, it will be fantastic."

Prochymal is composed strictly of adult stem cells, not embryonic stem cells. More specifically, Prochymal is composed of mesenchymal stem cells that are derived from the bone marrow of healthy adult donors. As such, not only is Prochymal entirely removed from the ethical controversies surrounding embryonic stem cells, but Prochymal is also free of the numerous medical risks posed by embryonic stem cells, not the least of which is the strong natural tendency of embryonic stem cells to form teratomas (tumors), which all pluripotent stem cells must, by definition, be able to form. By sharp contrast, since adult stem cells are not pluripotent, they are incapable of forming teratomas and do not pose such risks. Even though Prochymal is composed of non-autologous, allogeneic (in which the donor and the recipient are not the same person) adult stem cells, there is no risk of immune rejection since mesenchymal stem cells have been proven in multiple studies to be "immune privileged", "universal donor" cells.

Nevertheless, embryonic stem cells remain a contentious issue, and on Friday of this week the Texas State Senate is scheduled to debate the topic of funding for embryonic stem cell research. According to Republican Senator Tommy Williams, "I think people agree that there's the potential for moral hazard here, and so I think it's important to give our state agencies and research institutions guidance." The Texas state budget was passed on Wednesday, but no state funds will be used for embryonic stem cell research until the Legislature sets a policy.

Meanwhile, adult stem cell products such as Prochymal eliminate any need for debate. In a similar type of clinical trial, a hospital in Houston is also using adult stem cells for the repair of neurological tissue in stroke patients.

As Dr. Gammon adds, "We are excited to be the first to treat a patient in this groundbreaking study and to lead the way in this important research. Austin Heart and the Heart Hospital of Austin were selected because of their proven history of excellence in cardiovascular research and strong performance in the earlier Phase I trial. There's a lot of enthusiasm in the cardiovascular community about the potential of stem cell therapies for treating heart disease. Earlier studies have established confidence in the safety of the therapy, but more research is needed to study its effectiveness."

Osiris Therapeutics is the leading stem cell therapeutic company in the world, involved in the research and development of therapeutic products that are based exclusively upon adult stem cells, not embryonic stem cells. Osiris was founded in 1992 and went public in 2006. Its products focus on the treatment of inflammatory, orthopedic and cardiovascular conditions. The company's proprietary adult stem cell product Prochymal is the only stem cell therapeutic product currently designated by the FDA as both an Orphan Drug and as a Fast Track product. In addition to the current Phase II clinical trial for the regeneration of cardiac tissue following myocardial infarction, Prochymal is also in Phase II clinical trials for the regeneration of pancreatic beta islet cells in patients with Type I diabetes and for the repair and regeneration of damaged lung tissue in patients with chronic obstructive pulmonary disease. Prochymal is also currently being evaluated in three separate Phase III clinical trials, two of which are for graft vs. host disease (GvHD) and the third of which is for Crohn's disease, both of which are potentially fatal conditions. Additionallly, the company's adult stem cell product Chondrogen has also been approved to begin Phase II and III clinical trials for osteoarthritis of the knee. Osiris currently has 47 U.S. patents, each with one or more foreign counterparts. In 2008 Osiris formed a strategic alliance with Genzyme worth approximately $1.3 billion, and that same year the U.S. Department of Defense awarded Osiris a contract to develop Prochymal as a treatment for acute radiation syndrome.

The Heart Hospital of Austin has been ranked the number one leading hospital in Texas for overall cardiac services for 6 years in a row, since 2004, during which time it has also ranked among the top 5% of hospitals in the nation for overall cardiac services, and in 2009 it was also chosen as number one among hospitals in Texas for cardiac surgery.



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