trial restarts
GenStar Therapeutics Announces Regulatory Progress of the Company's Phase I Gene Therapy Clinical Trial for Hemophilia A
BUSINESS WIRE - September 25, 2001 08:32
SAN DIEGO, Sep 25, 2001 (BW HealthWire) -- GenStar Therapeutics (AMEX: GNT - news) today announced that the U.S. Food and Drug Administration (FDA) notified the Company that they may proceed with clinical testing of its hemophilia A treatment, MAX-AD FVIII. The trial had previously been stopped when a higher treatment dose showed adverse effects of transient blood coagulation and laboratory liver test abnormalities. Hemophilia A is a hereditary bleeding disorder characterized by a deficiency in the blood clotting protein Factor VIII.
Patient enrollment has resumed for the Company's Phase I clinical trial for MAXIMUM AD Factor VIII (MAX-AD(TM) FVIII). The Phase I clinical trial is a multi-center U.S. study intended to assess the safety of GenStar's MAX-AD FVIII, as well as measure the expression of Factor VIII following administration of the therapy.
"In consultation with the FDA, we have developed a modified dose-escalation protocol that will allow us to assess the impact of lower doses than in the original study design on the clinical findings and expression of Factor VIII," said Robert E. Sobol, M.D., chief executive officer of GenStar. "We are pleased to report this progress, and expect to complete the trial next year."
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's MAX-AD FVIII program is being developed in collaboration with Baxter Healthcare and its prostate cancer product development program is supported, in part, by a grant from the National Cancer Institute. |
