Genzyme and Sunway to Collaborate on Gene Therapy Program in China
Genzyme Corp. (NASDAQ: GENZ) and Sunway Biotech Co. Ltd. announced that they will collaborate to manufacture, develop, and commercialize the experimental gene therapy Ad2/HIF-1a in China. The product is Genzyme's most advanced gene therapy candidate and is currently in Phase 2 clinical testing in the United States and Europe.
Sunway is a privately-held, Shanghai-based biotechnology company founded in 1995. According to the company, it is one of only two companies in the world to have successfully developed and commercialized a gene therapy product. Sunway's H101, an adenovirus agent for the treatment of head and neck cancer, was approved in China in 2005. With strong technical, regulatory, manufacturing and clinical expertise, Sunway is working towards becoming a preferred partner to western biopharmaceutical firms looking to develop and commercialize products in China.
Ad2/HIF-1a is an engineered form of the HIF-1a gene designed to promote the growth of new blood vessels and improve circulation in the limbs of patients with peripheral arterial disease. Genzyme is currently conducting a Phase 2 clinical trial of Ad2/HIF-1a involving more than 300 patients at 40 U.S. and European medical centers. The trial is examining the safety and effectiveness of locally delivered Ad2/HIF-1a to benefit patients with intermittent claudication, a form of peripheral arterial disease that results in disabling pain or fatigue in the legs, brought on by exercise.
Under the collaboration with Sunway, Genzyme will transfer its process for manufacturing Ad2/HIF-1a to Sunway, who will produce the product at its Shanghai facility for clinical trials. Sunway will design, fund and conduct Phase 1 and Phase 2 studies in China, focusing on patients with critical limb ischemia, a more severe form of peripheral arterial disease that often leads to the need for limb amputation. Genzyme previously completed a Phase 1 study of Ad2/HIF-1a involving patients with critical limb ischemia.
A Phase 3 development program would be funded equally by Genzyme and Sunway, and the companies envision jointly commercializing a therapy in China if the development program is successful.
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Topic world Gene therapy
Genetic diseases once considered untreatable are now at the center of innovative therapeutic approaches. Research and development of gene therapies in biotech and pharma aim to directly correct or replace defective or missing genes to combat disease at the molecular level. This revolutionary approach promises not only to treat symptoms, but to eliminate the cause of the disease itself.
Topic world Gene therapy
Genetic diseases once considered untreatable are now at the center of innovative therapeutic approaches. Research and development of gene therapies in biotech and pharma aim to directly correct or replace defective or missing genes to combat disease at the molecular level. This revolutionary approach promises not only to treat symptoms, but to eliminate the cause of the disease itself.
