Review of the First Commercially Approved Gene Therapy Product Presented in Human Gene Therapy
9/9/2005 New Rochelle, NY press release Business Wire (home.businesswire.com) China set a new milestone in the history of gene therapy with its approval of Gendicine, a recombinant adenovirus encoding human p53 tumor suppressor gene, for the treatment of head and neck squamous cell carcinoma, and Gendicine is now the core of the country's active clinical gene therapy program, according to a report in the September 2005 issue (Volume 16, Number 9) of Human Gene Therapy, a peer-reviewed journal published by Mary Ann Liebert, Inc. The paper is available free online at www.liebertpub.com/hum. Zhaohui Peng, Ph.D., M.D., Chairman and CEO of SiBiono GeneTech, the company that produces Gendicine, and author of the report describes the activities leading up to the successful commercial launch of Gendicine, the educational campaign aimed at helping the general public understand gene therapy, the establishment of a production facility, and the technology and quality control measures employed to ensure the production of a safe and effective gene therapy product. In the paper, entitled, "Current Status of Gendicine in China: Recombinant Human Ad-p53 Agent for Treatment of Cancers," Peng emphasizes the importance of the Chinese government's supportive policy toward research and development efforts in human gene therapy. The review offers valuable new insights into the development of Gendicine as it provides a summary of clinical data supporting the recombinant adenoviral product, most of which has been published only in the Chinese literature and has not been easily accessible to researchers worldwide. "I was delighted that Dr. Peng was [...]