Healthcare Industry News: TNFerade
News Release - May 23, 2006
Long-Term Results from TNFerade(TM) Pancreatic Cancer Study and Updated Survival Results from TNFerade(TM) Esophageal Cancer Study Both Reported at Digestive Disease WeekGAITHERSBURG, Md.--(HSMN NewsFeed)--May 23, 2006--GenVec, Inc. (Nasdaq:GNVC ) announced today that Kenneth Chang, M.D., medical director of the Comprehensive Digestive Disease Center at the University of California at Irvine and a clinical investigator for several studies involving GenVec's investigational cancer drug TNFerade(TM), presented updated survival information from a clinical study demonstrating the potential utility of TNFerade in treating patients with esophageal cancer. In an oral presentation yesterday at the annual Digestive Disease Week conference in Los Angeles, Dr. Chang reviewed evidence of esophageal tumor response to TNFerade when delivered by intratumoral injection once per week for five weeks with concurrent chemoradiation (cisplatin, 5-FU, radiation).
The study compared the safety and efficacy of four different doses of TNFerade in 24 patients with locally advanced resectable esophageal cancer prior to surgery. Overall patient survival for all dose levels is currently 83 percent at 18 months and 64 percent at 24 months, which compares favorably to six comparable recent studies showing one-year survival rates of 52 percent and five comparable recent studies showing two-year survival of 33 percent. Patients who received lower doses of TNFerade had lower risk of toxicity, while pathologic complete responses were achieved in 36 percent of resected patients who received the three highest doses. Study investigators concluded that TNFerade(TM) may reduce the rate of disease progression and recurrence in patients with locally advanced resectable esophageal cancer.
At the conference today, GenVec also announced findings from the first clinical study of TNFerade(TM) in patients with locally advanced pancreatic cancer. James Farrell, M.D., Director of Pancreaticobiliary Endoscopy & Endoscopic Ultrasound at the Division of Digestive Disease, University of California, Los Angeles, reported in an oral presentation that TNFerade was generally well tolerated up to the maximum tolerated dose and that there were positive dose-dependent effects of TNFerade on disease progression, local tumor response and resectability, and overall survival.
The dose escalation Phase II study was designed to determine the safety, feasibility and antitumor activity of five weekly intratumoral injections of TNFerade(TM) delivered via endoscopic ultrasound (EUS) or CT-guided percutaneous approaches (PTA) in combination with chemoradiation in patients with locally advanced, unresectable pancreatic adenocarcinoma. Study investigators believe the findings from 50 patients treated to date were sufficiently encouraging to justify expansion of this trial into a randomized Phase II/III study (PACT study) which is now enrolling patients at clinical sites in the United States. GenVec is also conducting Phase II trials with TNFerade in patients with rectal cancer and metastatic melanoma.
About Digestive Disease Week
Digestive Disease Week (DDW) is the largest international gathering of physicians, researchers and academics in the field of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW takes place May 20-25, 2006 in Lost Angeles, at the Los Angeles Convention Center. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. For more information visit www.ddw.org.
TNFerade is an adenovector, or DNA carrier, which contains the gene for tumor necrosis factor-alpha (TNF(alpha)), an immune system protein with potent and well-documented anti-cancer effects, for direct injection into tumors. After administration, TNFerade stimulates the production of TNF(alpha) in the tumor. GenVec is developing TNFerade for use in combination with radiation and/or chemotherapy for the treatment of various cancers.
GenVec, Inc. is a biopharmaceutical company developing novel gene-based therapeutic drugs and vaccines. Additional information on GenVec and its portfolio of product candidates is available at www.genvec.com and in the company's various filings with the Securities and Exchange Commission. The presentations can be found on GenVec's website by selecting Webcasts & Data/Recent Data Presentations/TNFerade.
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. 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 relating to clinical trials; 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; and risks that we may lack the financial resources and access to capital to fund our operations. 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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