Cell Genesys and EntreMed Report Positive Preclinical Studies Of Antiangiogenesis Gene Therapy
BOSTON, June 6 /PRNewswire-FirstCall/ -- Cell Genesys, Inc. (Nasdaq: CEGE - News) and EntreMed, Inc. (Nasdaq: ENMD - News) today reported encouraging preclinical data demonstrating that the systemic delivery of the Angiostatin gene, an angiogenesis inhibitor gene that blocks the growth of tumor blood vessels, significantly decreased tumor burden and increased survival in multiple types of cancer in preclinical animal studies. In these studies, EntreMed's Angiostatin gene was combined with Cell Genesys' adeno-associated viral (AAV) gene delivery system. A single injection of Angiostatin-AAV gene therapy resulted in at least 50 percent tumor reduction and prolongation of survival in a highly aggressive mouse tumor model of metastatic melanoma and reduction in tumor burden in various other tumor models including lung, pancreatic, breast and prostate. Stable levels of Angiostatin were measured in serum throughout the duration of the study (as long as 120 days following the gene therapy treatment), and the treatment was well tolerated with no evidence of toxicity. These data were presented by Karin Jooss, Ph.D., associate director of preclinical oncology at Cell Genesys, at the American Society of Gene Therapy Meeting (ASGT) in Boston, MA.
The Angiostatin-AAV gene therapy demonstrated the most significant evidence of antitumor activity of the various combinations of angiogenesis inhibitor genes and gene delivery vectors tested which also included studies with Cell Genesys' adenoviral vector and EntreMed's Endostatin gene. In a melanoma model, lung tumor metastases were reduced by more than 75 percent in animals treated with Angiostatin-AAV. Survival was prolonged to 120 days -- approximately four-fold longer than the control group's survival. Additionally, in a mouse model of spontaneous pancreatic cancer, Angiostatin- AAV decreased tumor burden by more than 30 percent. Inhibition of primary tumor progression was also observed in mouse models of breast cancer, lung cancer and prostate cancer. In all studies, the angiogenesis inhibitor gene therapy was delivered systemically by a single intravenous injection. Additional preclinical studies are under way including studies with Angiostatin-AAV and Endostatin-AAV in combination with chemotherapy.
"We are encouraged by the preclinical data we have observed to date with Angiostatin-AAV gene therapy particularly with respect to the broad range of tumor types inhibited," stated Peter K. Working, Ph.D., vice president, research and development at Cell Genesys. "Cell Genesys' preclinical programs in cancer gene therapy combined with the company's extensive clinical programs for multiple GVAX® cancer vaccines and oncolytic virus therapies further demonstrate the depth of the company's product pipeline in cancer."
Dr. Ed Gubish, EntreMed President and Chief Operating Officer, commented, "Today's data demonstrating up to a 50 percent tumor reduction in preclinical models further validates numerous other scientific reports that gene therapy effectively delivers angiogenesis inhibitors, particularly Angiostatin, systemically. We congratulate Cell Genesys for a developing such a high quality scientific program and conducting such sound research." Dr. Gubish continued, "Delivery of EntreMed's angiogenesis inhibitor genes via gene delivery systems complements our current clinical program where patients currently self-inject our angiogenesis proteins."
Angiostatin is a naturally occurring protein that has been shown to block tumor growth by preventing angiogenesis, the development of blood vessels that supply the tumor with blood. Direct administration of Angiostatin was shown to be safe and well tolerated in EntreMed's Phase I clinical trials in multiple types of cancer. Phase II trials are scheduled to begin later this summer.
Cell Genesys' proprietary AAV gene delivery system, which has previously been shown to deliver genes safely and efficiently in a wide range of studies, is being used to deliver the antiangiogenic genes and may provide added benefit over direct administration of the proteins. Gene delivery systems are the means by which therapeutic genes are introduced into target cells or tissues to induce a therapeutic effect and are a critical component of any successful gene therapy. AAV vectors are capable of delivering genes into the DNA of target cells, enabling potentially permanent gene expression.
In August 1999, Cell Genesys and EntreMed entered into a research collaboration to evaluate the use of EntreMed's Angiostatin and Endostatin in combination with Cell Genesys' AAV and adenoviral gene delivery systems in preclinical studies designed to assess whether the gene therapy can treat tumors by inhibiting their blood supply. Based on the results of the preclinical studies, a potential business collaboration will be considered.
Cell Genesys is focused on the development and commercialization of innovative therapeutic products for cancer based on gene therapy technologies. The company is pursuing three cancer product platforms -- GVAX® cancer vaccines, oncolytic virus therapies and in vivo cancer gene therapies. Clinical trials of GVAX® vaccines are under way in lung cancer, prostate cancer, pancreatic cancer, leukemia and myeloma. Clinical trials of oncolytic virus therapies include CG7060 and CG7870 in prostate cancer. Preclinical stage programs include oncolytic virus therapies and gene therapies for multiple types of cancer. Cell Genesys' majority-owned subsidiary, Ceregene, is focused on gene therapies for neurologic disorders. Cell Genesys also continues to hold approximately nine million shares of common stock in its former subsidiary, Abgenix, an antibody products company. Cell Genesys is headquartered in Foster City, CA and has manufacturing operations in San Diego, CA, Hayward, CA and Memphis, TN. For additional information, please visit the company's website at www.cellgenesys.com.
EntreMed, Inc., The Angiogenesis Company®, is a clinical-stage biopharmaceutical company developing angiogenesis therapeutics that inhibit abnormal blood vessel growth associated with a broad range of diseases such as cancer, blindness and atherosclerosis. The company's strategy is to accelerate development of its core technologies through collaborations and sponsored research programs with pharmaceutical and biotechnology companies, universities and government laboratories. EntreMed has three drug candidates in over 15 clinical trials, as well as a rich pipeline of new proteins, genes and small molecules under development and in preclinical studies. For further information, visit EntreMed's web site at www.entremed.com.
Statements made herein about Cell Genesys and its subsidiaries, other than statements of historical fact, including statements about the progress and reports of clinical trials and progress and reports of preclinical programs including those focusing on antiangiogenesis gene therapy, marketability and success of potential products and nature of product pipelines, licenses and intellectual property 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 success of research and development programs, the success and results of clinical trials, the regulatory approval process, competitive technologies and products, patents 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 April 1, 2002 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.
Statements herein about EntreMed that are not descriptions of historical facts are forward-looking and subject to risk and uncertainties. Actual results could differ materially from those currently anticipated due to a number of factors, including those set forth in the company's Securities and Exchange Commission filings under "Risk Factors," including risks relating to the early stage of products under development; uncertainties relating to clinical trials; dependence on third parties; future capital needs; and risks relating to the commercialization, if any, of the company's proposed products (such as marketing, safety, regulatory, patent, product liability, supply, competition and other risks).
CONTACT: Jennifer Cook Williams, Associate Director Corporate Communications of Cell Genesys, Inc., +1-650-425-4542; or Amy Finan, Director, Corporate Communications of EntreMed, Inc., +1-240-864-2640, or +1-240-413-3300
SOURCE: Cell Genesys, Inc. |
