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

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To: Paul Lee who started this subject3/27/2002 10:31:56 AM
From: Paul Lee   of 100
 
GenStar Therapeutics Presents at NYSSA Biotechnology Conference
Update Provided on Research and Development Programs and Hemophilia Clinical Trial
SAN DIEGO--(BW HealthWire)--March 27, 2002--GenStar Therapeutics (AMEX: GNT - news) provided an update of the Company's R&D programs and its Hemophilia A clinical trial this week at the New York Society of Security Analysts (NYSSA) Biotechnology Conference.

GenStar reported updated data on the first patient treated 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. Data show that eight months following treatment with MAX AD Factor VIII, the patient has sustained an expression level of Factor VIII at approximately the 1% level. Accrual to the study continues and additional eligible candidates have been identified. A Phase I clinical trial will also be initiated in Europe by the second half of 2002.

Additionally, GenStar reported a successful pre-IND meeting with the FDA, positioning the Company to initiate Phase I clinical trials for the treatment of prostate cancer in late 2002. The Company also presented pre-clinical data on an HIV vaccine candidate demonstrating induction of HIV immunity in vivo.

``We are encouraged that our first patient continues to express Factor VIII, demonstrating the potential of GenStar's technology to sustain gene expression that will be required for successful therapy of chronic diseases,'' stated Robert E. Sobol, M.D., Chief Executive Officer. ``We look forward to initiating our Hemophilia A trial in Europe and completing enrollment in the United States. We are also pleased that our prostate cancer and HIV vaccine programs are moving forward as planned.''

GenStar Therapeutics is a biotechnology company currently developing gene therapy products for the treatment of hemophilia A, prostate cancer and HIV/AIDS. The Company's lead product for the treatment of hemophilia is being developed in collaboration with Baxter International and its hemophilia, prostate cancer and HIV/AIDS product development programs are supported in part by grants from the National Cancer Institute and the National Institutes of Health.

Hemophilia A is a potentially life threatening hereditary disease that affects over 50,000 people in the United States and Europe. The disease results from a defect in the Factor VIII gene, which produces the Factor VIII protein essential for blood clotting. Current therapies for Hemophilia A are based upon intermittent injections of the Factor VIII protein that do not provide the sustained levels of Factor VIII needed to prevent bleeding episodes characteristic of the disorder. GenStar's product carries the entire human Factor VIII gene sequence and uses a molecular switch with a genetic sequence designed for increasing Factor VIII expression in the liver, one of its normal biological sites of production. GenStar's clinical study is open for accrual and will be evaluating additional patients. Transient liver and hematologic laboratory abnormalities observed in the first patient have returned to normal values and the trial has resumed at a lower dose with a dose escalation design. MAX AD, the Company's core technology is a gutted adenoviral vector that can be applied broadly across gene-based applications. For more information, please visit the Company's website at genstar-rx.com.
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