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Pancreas Cancer News and Archives | |
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For educational purposes only; not to be relied upon. Please read Pancreatica Disclaimer | |
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GenVec Presents Preliminary
Dose Escalation Data from Study Combining TNFerade(TM) with Chemotherapy
and Radiation in Patients With Locally Advanced Pancreatic Cancer GenVec, Inc., a biopharmaceutical company, announced preliminary data from the dose escalation portion of a Phase II study using TNFerade(TM) in combination with chemotherapy and radiation in patients with locally advanced, inoperable pancreatic cancer. The results, presented Sunday, June 1st in a poster presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois, indicated that TNFerade, when used in combination with standard chemotherapy and radiation, was well tolerated at the two dose levels evaluated to date. Local control or stabilization of the treated tumors was also seen in 11 of the 17 evaluable patients (65%) as reported by an independent radiology laboratory (4 partial responses, 2 minor responses, 5 stable disease). Following treatment, two patients with previously inoperable tumors were able to have their cancers removed surgically with no evidence of cancer in the surrounding tissue. One of these patients showed a pathological complete response (no evidence of viable tumor cells). Dr. Kenneth J. Chang, associate professor of medicine, head of Gastrointestinal Oncology and director of the H.H. Chao Comprehensive Digestive Disease Center at the University of California, Irvine, commented on the outcome of the study, "I am pleased with the promising results of this study. This is a novel therapy with the potential to be a significant clinical breakthrough in the treatment of patients with pancreatic cancer." The key goals of this dose-escalating phase are to select the dose and route of administration of TNFerade for the randomized portion of the Phase II study. Three doses of TNFerade (4 x 10(9) pu, 4 x 10(10) pu and 4 x 10(11) pu) and two routes of administration, endoscopy and percutaneous injection, are being evaluated. The combination of repeated intratumoral injections of TNFerade, infusional 5-FU and radiation was well tolerated. The maximum tolerated dose has not been reached. One transient dose limiting toxicity, grade 3 hypotension, was seen at the second dose level (4 x 10(10) pu). TNFerade(TM) uses GenVec's proprietary adenovector technology to produce the anti-tumor protein, tumor necrosis factor-alpha (TNF-alpha), at the site of the tumor. GenVec is a publicly held biopharmaceutical company focused on the development and commercialization of products 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 TNFerade(TM) for cancer, BIOBYPASS® for heart disease, and AdPEDF for macular degeneration. The Company is also collaborating with the U.S. Government for the development of therapeutic vaccine candidates for HIV, malaria and dengue viruses, and SARS. 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.
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