Genzyme Corp. 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.
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.
“We are pleased to establish this relationship with Sunway, one of the most innovative young biotechnology companies in China,” said Genzyme Executive Vice President Duke Collier. “Our work with Sunway represents one of many ways that we hope to participate in the dynamic Chinese biotechnology industry and to contribute to its growth.”
Hu Fang, M.D., Sunway’s chief executive officer, added: “We are eager to begin working with Genzyme, one of the established leaders in the field of gene therapy. This collaboration allows us to expand our focus beyond oncology to include cardiovascular disease, another area of serious unmet medical need where innovative therapies are urgently needed.”