GAITHERSBURG, Maryland (May 14, 2001) - GenVec, Inc. (Nasdaq:GNVC), a leading gene therapy company, announced today that data from studies with TNFerade™, a product candidate intended for use in combination with radiation therapy to improve the treatment of cancer, were presented at The American Society of Clinical Oncology's 2001 Annual Meeting in San Francisco, California (May 12 - May 15). The preclinical studies demonstrated that TNFerade was well tolerated in animal experiments and appears to have a large therapeutic window.
TNFerade™ delivers the tumor necrosis factor alpha (TNF-alpha) gene to the tumor, where it directs the production of TNF-alpha. TNF-alpha is a therapeutic protein that has been found to both directly fight cancer and increase the effectiveness of radiation therapy. Historically, the broad clinical use of TNF-alpha has been limited due to the toxicity of this protein when it is administered systemically.
The results of GenVec's preclinical studies, which were presented, demonstrate that TNFerade™ is very well tolerated in a number of different animal models. Importantly, high levels of TNF-alpha were produced in the tumor but no detectable levels were found in the blood. The studies confirmed the synergistic effect between TNF-alpha and radiation. GenVec designed TNFerade™ so that maximum gene expression is caused by radiation therapy in order to enhance the local therapeutic effect of TNF-alpha. Radiation resulted in a 12-fold increase in levels of TNF-alpha in the tumor. This proprietary technology adds to the safety profile of TNFerade™ by maximizing production of TNF-alpha only in the presence of radiation.
"We are very encouraged by these data because they confirm our drug development strategy of delivering genes to produce medically beneficial proteins at the site of disease," said Dr. Henrik Rasmussen, GenVec's Vice President of Clinical Research and Regulatory Affairs. "In the case of TNFerade™, our gene therapy approach has allowed us to capitalize on the well known anticancer properties of TNF-alpha by causing the sustained production of TNF-alpha in the tumor with minimal risk of systemic toxicity by avoiding non-target tissues."
GenVec recently announced the start of Phase I clinical trials of TNFerade™ in patients who had failed standard treatment and were currently receiving radiation for local tumor control. The Phase I clinical study is being conducted at several U.S. clinical sites. TNFerade™ is GenVec's latest drug candidate to enter human clinical trials. BIOBYPASS® angiogen, is now in randomized Phase II human clinical studies for the treatment of coronary artery disease and peripheral vascular disease, and is being developed in collaboration with Pfizer, Inc.
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 various filings with the Securities and Exchange Commission.
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 cautions 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). GenVec's SEC reports 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. |
