China Reports Approval of World’s First Gene Therapy
11/22/2004 Dale Chenoweth In recent years, knowledgeable biomedical researchers have sometimes wondered aloud whether the first approved gene therapy would come from a U.S. company, or instead from one in Europe or maybe even Britain. The answer, apparently, is none of the above. China Steps Out Ahead In March of this year the Chinese company Shenzhen SiBiono GeneTech Company, Ltd. began marketing in China a cancer gene therapy called Gendicine. The therapy was approved in October 2003 by China’s State Food and Drug Administration (SFDA) for use against squamous cell carcinoma of the head and neck (SCCHN), a category of solid tumors originating in such sites as the pharynx, larynx, oral cavity, and nose. In a self-interview published online last May, the company’s founder and chair, Zhouhui Peng, MD, said several Phase II and III trials among 135 patients with advanced SCCHN showed 64 percent had a complete response (CR) to the adenovirus-p53 drug used in combination with radiotherapy, and 29 percent had a partial response (PR). That’s significantly better than the response to chemotherapy and radiotherapy regimens that are now standard treatment in the U.S. and elsewhere. Additional trials involving another 240 patients also were positive, said SiBiono, but their data was not released. In all the trials, the drug was given by direct injection into accessible tumors. The easy accessibility of head and neck tumors for direct injection and their high incidence in China made SCCHN a good target disease, the company said. Over 1.6 million people worldwide [...]