GAITHERSBURG, Maryland and PALO ALTO, California (June 20, 2001) GenVec, Inc. (Nasdaq:GNVC), and the Biosynergy business unit of Varian Medical Systems, Inc. (NYSE:VAR), announced today they have extended a collaborative agreement combining advances in new gene therapy products with targeted radiation therapy for the treatment of cancer. A Phase Ib clinical trial of the combined treatment modalities was initiated in February of this year after promising preclinical results were achieved.
"GenVec is pleased to continue our relationship with Varian BioSynergy," said Henrik Rasmussen, M.D., Ph.D., GenVec's Vice President, Clinical Research & Regulatory Affairs. "The joint expertise of GenVec and Varian Biosynergy will positively influence the continued clinical investigation of one of GenVec's lead product candidates, TNFerade™, in combination with radiation therapy, for the treatment of cancer."
"Our collaboration provides an excellent opportunity for leaders in their respective industries to provide each other with access to state-of-the-art technology and expertise to improve the treatment of cancer," said Robert Sutherland, Ph.D., President of Varian Biosynergy. "The Biosynergy business unit was established to fulfill Varian Medical Systems' commitment to capitalize on combining radiation with the latest advances in molecular medicine, such as the work being done by GenVec in advancing the clinical development of TNFerade™ and converting genomics discoveries into new product opportunities."
"Varian and GenVec designed the collaboration to enhance the potential of both companies to develop new and improved commercial applications of their proprietary technologies,"said Tom Smart, GenVec's Senior Vice President, Corporate Development. "Under the agreement, which began in 1998, Varian will have primary responsibility for the development of equipment and software for delivery of targeted radiation therapy, while GenVec will have primary responsibility for developing gene therapy products. Our collective goal is to create better treatment options for cancer patients."
GenVec has commenced a Phase Ib clinical trial with its TNFerade™ gene therapy product with targeted radiation therapy in patients who have failed standard treatment. In this trial, TNFerade™ is injected directly into the tumor and combined with radiation therapy. TNFerade™ incorporates a proprietary adenovector carrying the gene coding for tumor necrosis factor alpha (TNFa), a therapeutic protein with a well-documented ability to destroy cancer cells and cut off the blood supply needed to support tumor growth. GenVec designed TNFerade™ to be triggered by targeted radiation for maximum gene expression at the tumor site in order to enhance the local therapeutic effect of TNFa. This proprietary technology maximizes the production of TNFa in the presence of radiation with minimal involvement in surrounding healthy tissue.
GenVec believes that TNFerade™ is the first gene therapy product using radiation-regulated gene expression to enter the clinic.
The trial, which will involve approximately 30 patients with a variety of cancers, follows successful preclinical tests with human tumor models, which showed "significantly higher tumor control rates" for cancers of the larynx, prostate, brain, and esophagus. "In all preclinical cases with the combined therapy, we saw either synergy or at least additive effects," said Dr. Rasmussen.
The trial is being conducted at several cancer centers across the country and is expected to be complete by the end of this year with results targeted for publication in Spring 2002.
Cancer is the second leading cause of death in the U.S., with over 1 million new cases diagnosed each year, and is responsible for more than 500,000 deaths in the U.S. annually. It is estimated that approximately 60 percent of all cancer patients will receive radiation at some stage in their disease.
GenVec is a publicly-held biotechnology company focused on the development and commercialization of novel gene-based therapies that produce medically beneficial proteins at the site of disease. The company combines its patented gene transfer technologies with proprietary therapeutic genes to create product candidates, such as BIOBYPASS® angiogen and GENSTENT™ biologic, that address medical needs in the area of cardiovascular disease, TNFerade™ biologic for oncology and the PEDF program for ophthalmology. Additional information on GenVec is available at its web site located at www.genvec.com and in the company's filings with the Securities and Exchange Commission.
Varian Medical Systems, Inc. , (NYSE:VAR) of Palo Alto, California, is the world's leading manufacturer of integrated cancer therapy systems as well as X-ray tubes and flat-panel sensors for imaging in medical, scientific, and industrial applications. Varian Medical Systems employs approximately 2,400 people and reported sales of $690 million in its most recent fiscal year ended September 29, 2000. The company's BioSynergy business unit is based in Mountainview, California.
Statements herein relating to future financial or business performance, conditions or strategies and other financial and business matters, including expectations regarding future revenues and operating expenses, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act. Forward-looking statements are typically identified by words or phrases such as "believe," "expect," "anticipate," "intend," "estimate," "assume," "plan," "outlook," "prospect," and variations of such words and similar expressions, or future or conditional verbs such as "will," "would," "should," "could," "may," or similar expressions. GenVec and Varian caution that these forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. The following factors, among others, could cause actual results to differ materially from forward-looking statements or historical experience: risks relating to the early stage of product candidates under development, risks relating to GenVec's ability to identify and enter into agreements with potential collaborative partners, uncertainties relating to clinical trials, dependence on third parties, future capital needs, and risks relating to the commercialization, if any, of GenVec's proposed product candidates (such as marketing, regulatory, patent, product liability, supply, competition and other risks); product demand and market acceptance risks; new product development and commercialization; the impact of managed care initiatives in the U.S. on capital expenditures and resulting pressures on medical equipment purchases. GenVec's and Varian's filings with the Security and Exchange Commission identify additional factors that can affect forward-looking statements. These forward-looking statements speak only as of the date of this press release, and GenVec assumes no duty to update forward-looking statements. |
