Shanghai Sunway Biotech Co. Ltd. announced today that the Chinese State Food and Drug Administration (CFDA) has approved H101, an oncolytic adenovirus, to be used in combination with chemotherapy as a treatment for patients with late stage refractory Nasopharyngeal cancer, a type of head and neck cancer prevalent in China. This marks the first oncolytic viral therapy approved by any regulatory agency in the world.
H101 is a modified adenovirus, a type of common cold virus found in most people. The deletion of an E1B-55kd segment in the virus results in its ability to selectively replicate in and kill tumor cells, while leaving normal cells unaffected. The therapy has a very good safety profile -- for most patients the main side effect is fever. The CFDA approval is based on a multi-center, randomized parallel-group study comparing 5-fluorouracil and cisplatin-based chemotherapy with and without H101. The H101 study group demonstrated a 27% increase in the number of patients who had complete or partial tumor size reduction compared to the control group.
"We welcome the CFDA's approval of H101, and we are pleased that cancer patients in China can now benefit from this innovative treatment," said Fang Hu, M.D., Sunway's president and chief executive officer. "Moving forward, we will continue the clinical trials to test for H101's additional indications including non-small cell lung cancer. At the same time, we are preparing to take the therapy to the world market. Sunway is well-positioned to reach this goal because of its exclusive worldwide rights to oncolytic adenoviral therapy, the clinical success of H101 in China, and the initial trial results of Onyx-015 in the United States."
The concept of an oncolytic virus was first developed in a similar adenovirus called Onyx-015 by Dr. Frank McCormick, the founder of Onyx Pharmaceuticals. Sunway acquired from Onyx Pharmaceuticals the worldwide rights to Onyx-015 and six patents covering the use of oncolytic adenovirus for cancer therapy. "I am absolutely thrilled and delighted," said Dr. McCormick. "I am looking forward to further involvement in future clinical trials in the U.S. and Europe."
"Sunway is making every effort to continue to innovate, especially in regard to the ability of oncolytic virus to dissolve tumor and release tumor antigen. Our goal is to realize the promise of a personalized in vivo cancer vaccine," Dr. Hu said.Read full story »