• 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 willing to share his company’s experience regarding the development of the first commercial gene therapy product,” says James M. Wilson, M.D., Ph.D., Editor-in-Chief, and Head of the Gene Therapy Program, Division of Medical Genetics, University of Pennsylvania School of Medicine, in Philadelphia. “This is an important milestone for the field. The broad-based use of this product for head and neck cancer in China will yield very useful information, which we look forward to hearing more about.”

Gendicine contains a genetically engineered form of the human p53 gene, which plays a key role in at least half of all human cancers. Delivery of a normal p53 gene, packaged in a non-pathogenic adenovirus that infects tumor cells, replaces the mutated form of p53 present in the tumor and exerts its anti-tumor effects through one or more possible mechanisms. It may, for example, induce tumor cell death, activate the immune system to attack the tumor, cut off blood supply to the tumor tissue, prevent the spread of tumor cells, or even make the cancerous cells more sensitive to conventional chemotherapy and radiation treatment.

Human Gene Therapy is an authoritative peer-reviewed journal published monthly in print and online that presents reports on the transfer and expression of genes in mammals, including humans. Related topics include improvements in vector development, delivery systems, and animal models, particularly in the areas of cancer, heart disease, viral disease, genetic disease, and neurological disease, as well as ethical, legal, and regulatory issues related to the gene transfer in humans. Tables of contents and a free sample issue may be viewed online at www.liebertpub.com.

Mary Ann Liebert, Inc., is a privately held, fully integrated media company known for establishing authoritative peer-reviewed journals in many promising areas of science and biomedical research, including Tissue Engineering, Stem Cells and Development, and Cloning and Stem Cells. Its biotechnology trade magazine, Genetic Engineering News (GEN), was the first in its field and is today the industry’s most widely read publication worldwide. A complete list of the firm’s 60 journals, books, and newsmagazines is available at www.liebertpub.com.