Randomized Portion of the Phase II Clinical Study of TNFerade(TM) in Pancreatic Cancer,GenVec Receives FDA Clearance

Main Category: Pancreatic Cancer
Also Included In: Clinical Trials / Drug Trials
Article Date: 13 Feb 2005 - 9:00 PST

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GenVec, Inc announced that it has received a letter from the US Food and Drug Administration (FDA) today, which allows the company to proceed with the randomized, controlled portion of the Phase II clinical trial of TNFerade in patients with locally advanced pancreatic cancer. This clinical study is designed to assess the clinical benefit of using TNFerade in combination with standard of care treatment in patients with this disease. In October 2004, the FDA placed the TNFerade clinical program on hold due to blood clots seen in patients with esophageal cancer in a separate Phase II trial. In response, GenVec submitted data to the FDA and requested permission to move forward only with the pancreatic cancer study. Other indications that were affected (esophageal and rectal cancer) remain on clinical hold.

The 74-patient randomized, controlled portion of the Phase II study will assess the activity of TNFerade when administered concurrently with 5- flourouracil (5-FU) plus radiation followed by Gemcitabine, versus 5-FU plus radiation followed by Gemcitabine. Outcome measures will include progression- free survival at three months post-treatment, median survival, tumor resectability post-treatment, and objective tumor response.

Results of the dose-escalation portion of this study of TNFerade in patients with pancreatic cancer were presented at the American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium on January 28, 2005. The poster presentation can be viewed by accessing the following website address: genvec.com/art/download/Senzer0501_poster.pdf. The dose for the upcoming randomized trial, 4 x 10e11 pu, was shown to be generally well-tolerated. Eleven patients, in two groups, received the 4 x 10e11 pu dosage. The median survival attained by the first group (7 patients) receiving the 4 x 10e11 pu dose was reported at 16.5 months. Median survival for the second group (4 patients) receiving the 4 x 10e11 pu dose has not yet been reached. Sixty percent demonstrated tumor shrinkage greater than 25 percent (6 of 10 evaluable patients) and 20 percent demonstrated tumor shrinkage exceeding 50 percent (2 of 10 evaluable patients). Dose-related improvements in time to disease progression and rates of surgical resection post-treatment were also seen.

"We are very pleased to resume clinical testing of TNFerade in patients with pancreatic cancer and look forward to enrolling patients in this phase of the study as quickly as possible. In the meantime, we will work closely with the FDA to chart a course for the potential clinical development of other promising indications for TNFerade," said Paul D. Kessler, M.D., GenVec's executive director of clinical research.

TNFerade is an adenovector, a 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. After direct injection into tumors, TNFerade stimulates the production of TNF-alpha in the tumor. GenVec clinical investigators have been evaluating TNFerade in combination with radiation and chemotherapy for the treatment of various cancers.

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 http://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 revenues and operating expenses, 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 product candidates under 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 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 http://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.

GenVec, Inc.
http://www.genvec.com

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