Genzyme and Sunway to collaborate on gene therapy programme
A collaboration between Genzyme and Sunway Biotech will see the manufacture and commercialisation of a gene designed to promote the growth of new blood vessels.The experimental gene therapy Ad2/HIF-1a in China is one of Genzyme\'s most advanced gene therapy candidates. It is currently in Phase 2 clinical testing in the US and in Europe.
A collaboration between Genzyme and Sunway Biotech will see the manufacture and commercialisation of a gene designed to promote the growth of new blood vessels.The experimental gene therapy Ad2/HIF-1a in China is one of Genzyme's most advanced gene therapy candidates. It is currently in Phase 2 clinical testing in the US and in Europe.
The experimental gene therapy Ad2/HIF-1a in China is one of Genzyme's most advanced gene therapy candidates. It is currently in Phase 2 clinical testing in the US and in 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, which has a gene therapy manufacturing facility in San Diego, California, is conducting a Phase 2 clinical trial of Ad2/HIF-1a involving more than 300 patients at 40 U.S. and European medical centres. 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.
Sunway, a Shanghai-based biotechnology company, is said to be one of only two companies in the world to have successfully developed and commercialised 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 commercialise products in China.
Under the collaboration with Sunway, Genzyme will transfer its process for manufacturing Ad2/HIF-1a to Sunway. Sunway will produce the product at its Shanghai facility for clinical trials as well as designing, funding and conducting Phase 1 and Phase 2 studies in China that focus 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 programme would be funded equally by Genzyme and Sunway, and the companies envision jointly commercialising 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, Sunway's chief executive officer, said: "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."
