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Genzyme Corporation (Cambridge, MA) and Sunway Biotech Company Limited (Shanghai, China) will collaborate to manufacture, develop, and commercialize the experimental gene therapy Ad2/HIF-1a in China.
Genzyme Corporation (Cambridge, MA) and Sunway Biotech Company Limited (Shanghai, China) 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 at 40 US and European medical centers.
Under the terms of the collaboration, 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 the Phase 1 and Phase 2 studies in China, focusing on patients with critical limb ischemia, a severe form of peripheral arterial disease that often leads to limb amputation. Genzyme previously completed a Phase 1 study of Ad2/HIF-1a involving patients with critical limb ischemia.
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 and Sunway will equally fund a Phase 3 development program, and the companies will jointly commercialize a therapy in China if the development program is successful.