Pancreatic Cancer Drug Preliminary Data Released

GAITHERSBURG, Md. -- GenVec, Inc., a biopharmaceutical company, announced preliminary data from the dose escalation portion of a Phase II study using TNFerade 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 percent) 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).

Kenneth J. Chang, MD, 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 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 for cancer, BIOBYPASSfor heart disease, and AdPEDF for macular degeneration. The Company is also collaborating with the US government for the development of therapeutic vaccine candidates for HIV, malaria and dengue viruses and SARS.

For more information, visit: www.genvec.com