>>Long-Term Results from TNFerade(TM) Pancreatic Cancer Study and Updated Survival Results from TNFerade(TM) Esophageal Cancer Study Both Reported at Digestive Disease Week
Tuesday May 23, 4:08 pm ET
GAITHERSBURG, Md.--(BUSINESS WIRE)--May 23, 2006--GenVec, Inc. (Nasdaq:GNVC - News) 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.<<
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Cheers, Tuck |
