GenVec Announces First Patient Treated with TNFerade(TM) for Head and Neck Cancer at University of Chicago.Two Phase I/II Studies Underway GAITHERSBURG, Md. -- GenVec, Inc. (Nasdaq:GNVC) today announced that the first patient has been dosed in a Phase I/II trial with TNFerade[TM] for head and neck cancer at the University of Chicago Medical Center. GenVec is sponsoring two separate Phase I/II studies at the University of Chicago to explore the use of TNFerade as a second-line treatment for unresectable, recurrent tumors, and as a first-line treatment A first-line treatment or first-line therapy is a medical therapy recommended for the initial treatment of a disease, sign or symptom, usually on the basis of empirical evidence for its efficacy. for elderly or frail patients. The trials are being funded by the National Cancer Institute. The two separate trials, which will be led by principal investigators Everett Vokes, M.D., and Tanguy Seiwert, M.D., could enroll up to 70 patients with unresectable, recurrent tumors and up to 60 elderly or frail patients with new onset, locally advanced disease. The investigators will first determine best dose in each indication, and will assess safety and locoregional control of the cancer following TNFerade treatment as a component of standard of care. "The start of these trials marks another milestone in our clinical progress with TNFerade," stated Mark Thornton Mark Thornton is an American economist who adheres to the principles of the Austrian school. Thornton received his B.S. from St. Bonaventure University (1982), and his Ph.D. from Auburn University (1989). , M.D., M.P.H., Ph.D., GenVec's senior vice-president of product development. "We know that local control is crucial for effective treatment of head and neck cancers, and is a respected regulatory endpoint. Since TNFerade is administered directly at the tumor site, it is ideally suited for these specific indications. TNFerade also has a well-established safety profile, so we believe it is a potentially appropriate treatment for elderly or frail cancer patients who cannot tolerate the cytotoxic cy·to·tox·ic adj. Of, relating to, or producing a toxic effect on cells. cy  to·tox·ic effects of systemically administered cancer therapies. We look forward to continued progress in these clinical trials," added Dr. Thornton. About TNFerade[TM] TNFerade is an adenovector, or DNA DNA: see nucleic acid. DNA or deoxyribonucleic acid One of two types of nucleic acid (the other is RNA); a complex organic compound found in all living cells and many viruses. It is the chemical substance of genes. carrier, which contains the gene for tumor necrosis factor-alpha Tumor necrosis factor (TNF, cachexin or cachectin and formally known as tumor necrosis factor-alpha) is a cytokine involved in systemic inflammation and is a member of a group of cytokines that all stimulate the acute phase reaction. (TNF TNF abbr. tumor necrosis factor TNF, n an abbreviation for tumor necrosis f [eth]), an immune system immune system Cells, cell products, organs, and structures of the body involved in the detection and destruction of foreign invaders, such as bacteria, viruses, and cancer cells. Immunity is based on the system's ability to launch a defense against such invaders. protein with potent and well-documented anti-cancer effects, for direct injection into tumors. After administration, TNFerade stimulates the production of TNF[eth] in the tumor. GenVec is developing TNFerade for use in combination with radiation and/or chemotherapy for the treatment of various cancers. About GenVec GenVec, Inc. is a biopharmaceutical company developing novel gene-based therapeutic drugs and vaccines. Each of the Company's product candidates uses patent-protected technology to deliver genes that produce beneficial proteins. GenVec's lead product, TNFerade[TM] is currently in a pivotal Phase II/III study (PACT) in locally advanced pancreatic cancer pancreatic cancer Malignant tumour of the pancreas. Risk factors include smoking, a diet high in fat, exposure to certain industrial products, and diseases such as diabetes and chronic pancreatitis. Pancreatic cancer is more common in men. ; and Phase II studies are in progress in rectal cancer Rectal Cancer Definition The rectum is the portion of the large bowel that lies in the pelvis, terminating at the anus. Cancer of the rectum is the disease characterized by the development of malignant cells in the lining or epithelium of the rectum. and melanoma. GenVec also uses its proprietary adenovector technology to develop vaccines for infectious diseases including HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. , malaria, seasonal and pandemic pandemic /pan·dem·ic/ (pan-dem´ik) 1. a widespread epidemic of a disease. 2. widely epidemic. pan·dem·ic adj. Epidemic over a wide geographic area. n. flu, and foot and mouth disease a contagious disease See also: Foot . Additional information about GenVec is available 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 programs and studies, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and . GenVec cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties which change over time. Factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks relating to the early stage of GenVec's product candidates under development; uncertainties with, and unexpected results and related analyses relating to clinical trials of GenVec's product candidates including the length of time required to enroll suitable patient subjects and our ability to secure clinical trial sites; the timing and content of future U.S. Food and Drug Administration regulatory actions with respect to GenVec, its product candidates, or collaborators; 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); dependence on the efforts of third parties; dependence on intellectual property; the amount of revenues attributable to Genvec's vaccine program; and risks that we may lack the financial resources and access to capital to fund our operations during the lengthy periods required to develop product candidates. Further information on the factors and risks that could affect GenVec's business, financial conditions and results of operations, are contained in GenVec's filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. These forward-looking statements speak only as of the date of this press release, and GenVec assumes no duty to update forward-looking statements. |
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