Genstar GNT(formerly UroGen)-- an interesting speculation Message Board

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Biotech / Medical : Genstar GNT(formerly UroGen)-- an interesting speculation

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To: Paul Lee who started this subject	6/6/2002 7:41:42 AM
From: Paul Lee	of 100

update of the Company's hemophilia A clinical trial program today at the American Society of Gene Therapy meeting in Boston, MA. GenStar reported data on the first patient treated with MAX-AD Factor VIII in its Phase I clinical trial for severe hemophilia A. This disease is a hereditary bleeding disorder characterized by a deficiency in the Factor VIII blood clotting protein. Factor VIII levels of less than 1% are characteristic of severe disease while higher levels are associated with a more moderate condition. Preliminary data show that an expression level of Factor VIII at approximately the 1% level has been sustained for seven months following treatment. Side effects in the first patient included a transient inflammatory response with hematological and liver laboratory abnormalities that returned to normal values within nineteen days. Accrual to the study continues and additional eligible candidates have been identified. A Phase I clinical trial will also be initiated in Europe in the second half of 2002. Pre-clinical data was also presented demonstrating that anti-inflammatory agents like TNF-alpha blockers and liposome encapsulation of the vector can address the side effects associated with the administration of MAX-AD Factor VIII. "We continue to be encouraged with the sustained expression of Factor VIII in our first patient," stated Robert E. Sobol, M.D., Chief Executive Officer of GenStar. "We are also making significant progress in pre-clinical studies designed to enhance the efficacy of MAX-AD Factor VIII. We believe that TNF-alpha blockers and liposomal encapsulation of the vector offer great potential for future adoption in clinical trials, permitting the administration of higher doses resulting in higher Factor VIII levels in the absence of side effects." GenStar's MAX-AD Factor VIII gene therapy product for hemophilia A is a gene delivery system derived from the adenovirus. In contrast to earlier gene delivery approaches, GenStar's delivery system has been engineered to remove all the viral genes providing a large DNA-delivery capacity for therapeutic genes that are responsible for the production of Factor VIII. GenStar Therapeutics (www.genstar-rx.com) is a biopharmaceutical company developing innovative gene therapy products for the treatment of serious medical disorders. The Company's research and development efforts, utilizing advanced gene delivery technologies, are focused on hemophilia, cancer and vaccines. The Company has research agreements with Baxter Healthcare and Centocor, a Johnson & Johnson company. GenStar's hemophilia, prostate cancer and HIV/AIDS product development programs are supported, in part, by grants from the National Cancer Institute and the National Institute of Health.

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