GenStar Therapeutics Initiates Phase I Gene Therapy Clinical Trial for Hemophilia A; Gene Delivery System Utilized for the First Time In Patients
BUSINESS WIRE - June 18, 2001 09:06
SAN DIEGO, Jun 18, 2001 (BW HealthWire) -- GenStar Therapeutics (AMEX:GNT) announced today that it has initiated a Phase I gene therapy clinical trial for the treatment of hemophilia A. This investigational trial marks the first time that a patient has received GenStar's viral gene delivery system, MAXIMUM-AD. Hemophilia A is a hereditary bleeding disorder characterized by a deficiency in the blood clotting protein Factor VIII. Clinical development of the investigational treatment was supported by studies in animal models demonstrating sustained therapeutic levels of Factor VIII.
The Phase I clinical trial is a multi-center U.S. study intended to assess the safety of this therapeutic approach. It will also measure the expression of Factor VIII following administration of the therapy.
There are an estimated 300,000 persons with hemophilia worldwide. People with hemophilia A infuse themselves with therapeutic clotting Factor VIII. However, these injections do not provide sustained levels of Factor VIII to prevent bleeding episodes characteristic of this disorder.
"There is a clear need to develop alternative approaches for treating hemophilia," stated Robert E. Sobol, M.D., chief executive officer of GenStar.
GenStar, in collaboration with Baxter Healthcare Corporation, has developed this gene delivery platform from the common cold adenovirus. In this system, all viral genes have been removed permitting the maximum capacity for delivery of therapeutic genes to treat a variety of disorders.
GenStar Therapeutics 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, vaccines, and cancer. The company's prostate cancer product development program is supported, in part, by a grant from the National Cancer Institute. |
