Cell Genesys and GPC Biotech Report Positive Preclinical Results For Cardiovascular Gene Therapy for Restenosis
Significant Inhibition of Arterial Occlusion Following Gene Therapy In Pig Models
FOSTER CITY, Calif., MARTINSRIED, Germany and MUNICH, Aug. 6 /PRNewswire/ -- Cell Genesys, Inc. (Nasdaq: CEGE - news) today announced in collaboration with GPC Biotech AG (FSE: GPC) that in preclinical studies of cardiovascular gene therapy in porcine models, a novel cell cycle inhibitor fusion gene, p27/p16, has demonstrated potent inhibition of coronary artery occlusion resulting from restenosis, a complication associated with angioplasty treatment for coronary artery disease. Specifically, these studies showed a significant reduction of angioplasty-induced coronary intimal artery thickening in blood vessels -- in some cases more than 60 percent -- after treatment with p27/p16 gene therapy. These data were published in an August issue of the journal Circulation Research, the official journal of the American Heart Association, by James G. McArthur, Ph.D. and colleagues at Cell Genesys and GPC Biotech.
This preclinical study for preventing coronary restenosis is part of the companies' research collaboration to evaluate GPC Biotech's proprietary p27/p16 fusion genes which are created from the two cell cycle inhibitory genes p27 and p16. These in vivo studies, which used an infusion catheter mediated by an adenoviral gene delivery system, were initiated after encouraging results from preclinical studies of bypass graft and single and double balloon angioplasty induced restenosis in rabbits using p27/p16. These data were reported in November 1999 at the American Heart Association Meeting and were published in the journal, Molecular Therapy, the official journal of the American Society of Gene Therapy. In pigs, the model commonly used prior to initiating human trials, the p27/p16 gene therapy demonstrated significant inhibition of the proliferation of smooth muscle cells, which are responsible for the narrowing of the blood vessels, when compared with the untreated animals. Additionally, no toxicities were observed.
``We are encouraged by the data demonstrated in this preclinical study of p27/p16 for cardiovascular gene therapy, particularly in this therapeutically relevant model,'' stated Joseph J. Vallner, Ph.D., executive vice president and chief operating officer at Cell Genesys. ``Cell Genesys is very optimistic about the future of this technology and the important complement it could provide to existing stent therapies. With our primary focus on commercializing products for cancer, however, we plan to outlicense or partner our cardiovascular program with a company dedicated to developing therapeutics for cardiovascular disorders.''
``This study further demonstrates the commercial value of GPC Biotech's family of tumor suppressor and cell cycle control genes, including the p27/p16 fusion gene which was engineered by GPC Biotech scientists,'' stated Muzammil Mansuri, Ph.D., executive vice president and chief operating officer for GPC Biotech's Waltham/Boston, Massachusetts site. ``Cell Genesys' expertise in the field of gene therapy is a key element in fully realizing the exciting potential of p27/p16 gene therapy, which is being explored for both cardiovascular disease and cancer.''
In 1998, Cell Genesys exclusively licensed a group of natural cell cycle inhibitor genes essential to the growth and regulation of human cells, from Mitotix Inc., which was later acquired by GPC Biotech AG (Munich, Germany). The licensed genes include p16, p27 and additional novel p27/p16 fusion molecules. GPC Biotech holds issued patents on these genes for the development of both cardiovascular and cancer gene therapy products. These genes play a key role in the regulation of cellular growth and have the potential in gene therapy for the treatment of cardiovascular disorders, such as restenosis, and other diseases including cancer. GPC Biotech and Cell Genesys have an ongoing research collaboration for the optimization and testing of the p16, p27 and p27/p16 fusion molecules. In several preclinical models, the p27/p16 fusion gene, delivered by an adenoviral gene delivery system, has demonstrated greater anti-proliferative activity than either of the parental genes, p16 or p27.
Cell Genesys is focused on the development and commercialization of cancer vaccines and gene therapies to treat major, life-threatening diseases. The company is conducting clinical trials of GVAX® cancer vaccines in prostate cancer, lung cancer, pancreatic cancer and myeloma and expects to initiate new studies in acute leukemia during 2001. Preclinical stage programs include gene therapies for cancer, hemophilia and cardiovascular disorders. Cell Genesys' majority-owned subsidiary, Ceregene, is focused on gene therapies for central nervous system disorders. Cell Genesys also continues to hold a 10.5 percent equity interest in its former subsidiary, Abgenix, an antibody product company. Additionally, on August 2, 2001, Cell Genesys announced that it entered into a definitive agreement, expected to close in 30 days, for the acquisition of Calydon, Inc., a private biotechnology company focused on developing therapeutic products for cancer. For additional information, please visit the company's web site at www.cellgenesys.com.
GPC Biotech AG is a genomics- and proteomics-driven drug discovery company focused on applying a number of proprietary genomic, proteomic and drug discovery technologies to accelerate the identification and validation of novel drug targets for development of mechanism-based drugs in oncology, infectious diseases and immunology. GPC Biotech has leading cell cycle expertise and a broad intellectual property position with 59 patents issued, that are wholly owned, co-owned or exclusively/co-exclusively licensed, and over 180 patents pending. Drug discovery alliance partners include: Aventis Pharma, Bayer AG, DuPont Pharmaceuticals, Boehringer Ingelheim GmbH, the Altana AG subsidiary Byk Gulden, Cell Genesys, Inc., Evotec OAI AG, MorphoSys AG and Karo Bio USA. GPC Biotech AG is headquartered in Martinsried/Munich (Germany) with two wholly owned U.S. subsidiaries in Waltham/Boston, MA and in Princeton, NJ. For further information, please visit the corporate website at: gpc-biotech.com .... |
