CEGE.....can you say short squeeze? Hehehehe!
Cell Genesys and GPC Biotech Report Successful Preclinical Studies for Novel Cancer Gene Therapy
Unique Growth Inhibitory Fusion Gene Can Target Multiple Tumor Types
FOSTER CITY, Calif. and MUNICH, Germany, Aug. 23 /PRNewswire/ -- Cell Genesys, Inc. (Nasdaq: CEGE - news) announced today, in collaboration with GPC Biotech AG (Frankfurt: GPC) that a novel gene therapy employing a unique, proprietary fusion gene, referred to as p27/p16, was capable of killing multiple cancer cell types in preclinical studies. Of particular significance was that tumor cell death was induced in twelve of fourteen human tumor cell types regardless of whether the cells contained a normal or mutated p53 gene-a naturally occurring tumor suppressor gene which typically protects against cancer but is mutated in more than 50 percent of all human cancers. Additionally, the tumor cell killing with p27/p16 gene therapy was selective and did not affect surrounding normal tissue. These data were published in the August issue of the journal, Molecular Therapy, by James G. McArthur, Ph.D., and colleagues at Cell Genesys and GPC Biotech.
In the reported work, a number of preclinical studies were conducted to evaluate gene therapy with p27/p16, a unique fusion gene comprised of two cell cycle inhibitory genes, p27 and p16, which control tumor growth by blocking tumor cell division and inducing tumor cell death. In a series of studies in human tumor models in mice, the p27/p16 gene was delivered to the tumor using an adenoviral gene delivery system. Gene therapy with the p27/p16 fusion gene blocked tumor progression in approximately 50 percent of the treated animals, a result that was highly statistically significant in these experiments (p= .002). The fusion gene demonstrated five to 50-fold greater tumoricidal activity than either of the individual p16 and p27 genes. In addition, p27/p16 gene therapy demonstrated microscopic evidence of an antiangiogenic effect against the tumor with inhibition of tumor blood vessel formation.
``We are encouraged by the preclinical studies performed to date with p27/p16 gene therapy particularly with respect to the breadth of antitumor activity and selectivity for tumor as opposed to normal cells,'' stated Joseph J. Vallner, Ph.D., executive vice president and chief operating officer at Cell Genesys. ``The success of this program together with our expanding research efforts in cancer gene therapy involving antiangiogenesis demonstrates Cell Genesys' growing pipeline of potential cancer products and is an important complement to our program in human clinical trials of GVAX® cancer vaccines.''
``This project exemplifies the substantial value of GPC Biotech's extensive estate of issued patents in the field of tumor suppressor genes and growth control, including p27/p16 which is derived from the tumor suppressor genes p16 and p27 and was originally engineered by scientists at Mitotix Inc., now GPC Biotech Inc. In the hands of Cell Genesys with its world class expertise in gene therapy, the p27/p16 fusion gene has exciting potential in the treatment of both cancer and cardiovascular disease,'' stated Muzammil Mansuri, Ph.D., executive vice president and chief operating officer for GPC Biotech's Cambridge, MA site.
In 1998, Cell Genesys exclusively licensed a family of cell cycle inhibitor genes from Mitotix, Inc., which was recently acquired by GPC Biotech AG (Munich, Germany). The licensed genes include p16, p27 and novel p27/p16 fusion genes. The collaboration was initially focused on the development of cardiovascular gene therapy products and was expanded to include cancer gene therapy products in 1999. The p16 and p27 cell cycle inhibitor genes, also referred to as cyclin dependent kinase inhibitors (CDKi), play a key role in the regulation of cellular division. Moreover, the p16 gene, a known tumor suppressor gene, has been shown to be missing or mutated in many important cancers. Gene therapy employing p16, p27 and/or the p27/p16 fusion gene could therefore potentially be used to treat a variety of cancers. In addition, such gene therapy may have applicability to the treatment of other diseases characterized by abnormal cell growth such as restenosis, a condition resulting from the excessive growth of blood vessel smooth muscle cells which can arise after angioplasty for coronary artery disease and other cardiovascular disorders. GPC Biotech and Cell Genesys have an ongoing research collaboration for the optimization and testing of the p16, p27 and p27/p16 fusion genes.
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 two multicenter Phase II human clinical trials for its GVAX® cancer vaccine in prostate cancer, a multicenter Phase I/II trial of GVAX® vaccine in lung cancer and expects to initiate additional GVAX® vaccine trials in pancreatic cancer, myeloma and leukemia during the coming year. Preclinical stage programs include gene therapy for hemophilia, cancer, cardiovascular disorders and Parkinson's disease. Cell Genesys' assets outside gene therapy include its approximately 12 percent ownership of Abgenix, Inc. and the company's licensing program in gene activation technology. For additional information, please visit the company's web site at www.cellgenesys.com.
GPC Biotech AG is a genomics-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. The proprietary technologies provide life-science companies with a unique ``one-stop-shop'' resource by fully integrating functional genomics, proteomics and bioinformatics into drug discovery. GPC Biotech has globally-leading cell cycle expertise and a broad intellectual property position with 40 issued patents and over 120 patents pending. Drug discovery alliance partners include: Aventis Pharma, Bayer AG, DuPont Pharmaceuticals, Boehringer Ingelheim, Byk Gulden, Cell Genesys, Maxim Pharmaceuticals, Evotec Biosystems, MorphoSys, Genetica, Gene Alliance, Karo Bio USA and Atugen. GPC Biotech AG is headquartered in Munich, Germany with US subsidiaries GPC Biotech Inc. in Cambridge, MA and GPC Biotech USA in Princeton, NJ. For further information, please visit the corporate web site at www.gpc-biotech.com.
Statements made herein, other than statements of historical fact, including statements about Cell Genesys' progress and results of cancer and other preclinical studies, clinical trials, marketability and success of potential products and nature and growth of product pipelines, corporate partnerships, licenses and intellectual property including that pertaining to gene delivery technology and the company's patent portfolio are forward-looking statements and are subject to a number of uncertainties that could cause actual results to differ materially from the statements made, including risks associated with the continuation of research collaborations with GPC Biotech AG and others, the success of research and development programs, results achieved in future preclinical studies and clinical trials, the regulatory approval process, competitive technologies and products, the scope and validity of patents, corporate partnerships and additional financings. For information about these and other risks which may affect Cell Genesys, please see the company's Annual Report on Form 10-K dated March 30, 2000 as well as Cell Genesys' reports on Form 10-Q and 8-K and other reports filed from time to time with the Securities and Exchange Commission.
This press release may contain certain views and forward-looking statements, which include terms such as ``believes'', ``assumes'', ``expects'', ``intends'' and similar language. Such views and forward-looking statements are based upon currently available information and are subject to known and unknown risks, uncertainties and other factors, as a result of which the actual future financial performance, development or performance of GPC Biotech or the business of GPC Biotech may substantially deviate from the anticipated events presented herein. Such factors include, but are not limited to, the following: competition from other companies, GPC Biotech's capital needs, financing costs, changes in operating costs, the ability to find and retain qualified staff, uncertainties relating to drug development and obtaining regulatory approvals, uncertainties related to the operations of GPC Biotech and other factors identified in GPC Biotech's Offering Circular dated May 30, 2000. GPC Biotech is not undertaking any obligation to release publicly any updates to any forward-looking statements to reflect events or circumstances after the date of this release or to reflect the occurrence of unanticipated events. |
