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Update on Dose-Escalation Trial of TNFerade in Pancreatic Cancer Shows Dose-Dependent Improvements in Tumor Shrinkage and Resectability and Patient Survival

Posted on: Monday, 16 May 2005, 09:00 CDT

GenVec, Inc. (Nasdaq:GNVC) reported encouraging findings from the dose-escalation portion of the company's Phase II trial of TNFerade(TM) in patients with locally advanced pancreatic cancer showing dose-dependent improvements in tumor shrinkage and resectability and in patient survival, as well as a decrease in the levels of tumor marker CA 19-9 in patients who received TNFerade. The data were presented at the annual meeting of the American Society of Clinical Oncology in Orlando, Florida by Neil Senzer, M.D., scientific director of the Mary Crowley Medical Research Center, in a poster entitled "Completion of Dose Escalation Component of Phase II Study of TNFerade Combined with Chemoradiation in the Treatment of Locally Advanced Pancreatic Cancer (LAPC)" that is available on GenVec's website, www.genvec.com, in the "Webcasts and Data" section. The Maximum Tolerated Dose (MTD) established during the dose-escalation portion of the Phase II trial, 4 x 10e11 pu, was generally well tolerated when administered in combination with standard chemotherapy and radiation.

"We believe that a very important aspect of this study was the high rate of surgical resection seen in patients treated with TNFerade at the MTD," said Paul H. Fischer, Ph.D., GenVec's president and CEO. "In our study, 5 out of 11 (45%) of treated patients went on to have surgical resections after treatment with TNFerade, in contrast to the less than 5% seen in most studies. For patients this can be very important, since successful surgical resection is often linked to prolonged survival. Therefore, it is especially meaningful that in the first cohort of seven patients treated at the MTD, three have survived more than 21 months."

TNFerade is a DNA carrier (adenovector) that contains the gene for tumor necrosis factor-alpha (TNF-alpha), a protein with potent and well-documented anti-cancer effects. After direct injection into tumors, TNFerade stimulates the production of TNF(alpha) in the tumor. TNFerade is now being tested in the 74-patient, randomized, controlled portion of this Phase II study in patients with locally advanced pancreatic cancer. Following randomization, the treatment group receives standard chemotherapy and radiation for a period of five weeks, with a weekly intratumoral injection of TNFerade at the MTD added to their treatment regimen. After five weeks, the patients are placed on standard Gemcitabine maintenance. The control group receives standard chemotherapy and radiation without the addition of TNFerade, followed by Gemcitabine maintenance.

GenVec is a biopharmaceutical company developing treatments for cancer, heart disease, vision loss, and vaccines for infectious diseases. TNFerade has not been approved for use by the U.S. Food and Drug Administration. Additional information on GenVec is available at www.genvec.com and in GenVec'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 studies and programs, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act. 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 statements herein include risks relating to the early stage of TNFerade(TM) development; GenVec's ability to secure and maintain relationships with collaborators; uncertainties with, and unexpected results and related analyses relating to clinical trials of GenVec's product candidates; the growth of revenues attributable to GenVec's vaccine program; the timing and content of future U.S. Food and Drug Administration regulatory actions with respect to GenVec, its product candidates, or its collaborators; dependence on the efforts of third parties; dependence on intellectual property; risks that GenVec may lack the financial resources and access to capital to fund its operations; and risks relating to the commercialization, if any, of GenVec's product candidates (such as marketing, regulatory, patent, product liability, supply, competition and other risks). Further information on the factors and risks that could affect GenVec's business, financial conditions and results of operations is 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.

Source: Business Wire

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