GAITHERSBURG, MD – November 19, 2008 – GenVec, Inc. (Nasdaq: GNVC) announced today top-line results of an interim analysis from its ongoing Phase III Pancreatic Cancer Clinical Trial with TNFerade™ (PACT) in patients with locally advanced pancreatic cancer. This interim analysis of overall survival, conducted after the 92nd death (one-third of total expected events), was designed to determine whether the study should continue and took place in the time frame originally estimated.
Interim data demonstrated an approximately 25% lower risk of death in the TNFerade plus standard of care (SOC) arm relative to the SOC alone (Hazard Ratio= 0.753; 95% Confidence Interval [0.494-1.15]). An independent Data Safety Monitoring Board reviewed the interim analysis data and recommended the trial continue as planned.
Kaplan-Meier analysis of data, based on this interim analysis, demonstrated that overall survival at 12 months was 39.9% in the TNFerade plus SOC arm versus 22.5% in the SOC arm. Overall survival at 18 months was 30.5% in the TNFerade plus SOC arm versus 11.3% in the SOC arm. At 24 months, overall survival was 10.6% in the TNFerade plus SOC arm versus 11.3% in the SOC arm. Median survival was 9.9 months in both arms of the trial.
“Successfully passing this milestone in the PACT trial represents an important step forward in the clinical development of TNFerade,” stated Mark Thornton, M.D., Ph.D., Senior Vice President of Product Development at GenVec. Thornton continued, “We believe these data are encouraging and justify moving forward with the trial. The continuation of the trial will allow the data to mature and provide for future analyses. We currently estimate we will reach the required number of events needed to conduct the next analysis of data in the PACT study in late 2009.”
The next interim analysis will be conducted after 184 deaths have occurred (two-thirds of total expected events) in the PACT trial. “At our current rate of enrollment we also anticipate having enrolled over 300 out of 330 total patients planned for the trial by the end of next year,” added Thornton.
About PACT
GenVec’s PACT trial is a multi-center, randomized, active, and controlled study of 330 patients designed to evaluate the safety and efficacy of TNFerade plus standard of care versus standard of care alone in patients with locally advanced pancreatic cancer.
About Hazard Ratios
The hazard ratio is an estimate of the treatment effect in the treated versus the control group in a trial. The hazard ratio reported means that, at the time of the interim analysis, a TNFerade patient had 0.75 times the chance of dying compared to someone in the standard of care group. The reciprocal of this hazard ratio, 1.33, means that a standard of care patient had 1.33 times the chance of dying compared to someone in the TNFerade group.
About TNFerade™
TNFerade, which has not yet been approved for use, is an adenovector, or DNA carrier, which contains the gene for tumor necrosis factor-alpha (TNF?), 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? in the tumor. TNFerade has been granted Fast Track product designation by the U.S. Food and Drug Administration (FDA) for its proposed use in the treatment of locally advanced pancreatic cancer. GenVec is developing TNFerade for use in combination with radiation and/or chemotherapy for the treatment of various cancers.
About Pancreatic Cancer
Pancreatic cancer, a disease in which malignant (cancer) cells are found in the tissues of the pancreas, is the fourth leading cause of cancer-related death in the United States. An estimated 37,680 Americans will be diagnosed with pancreatic cancer during 2008, and an estimated 34,290 Americans are expected to die from this disease in 2008. Currently, there are limited treatment options available for those with locally advanced pancreatic cancer.
About GenVec
GenVec, Inc. is a biopharmaceutical company developing novel therapeutic drugs and vaccines. GenVec’s lead product, TNFerade, is currently in a pivotal clinical study (PACT) in locally advanced pancreatic cancer. Additional clinical trials are in progress in rectal cancer, head and neck cancer, and melanoma. GenVec also uses its proprietary adenovector technology to develop vaccines for infectious diseases including HIV, malaria, foot-and-mouth disease, respiratory syncytial virus (RSV), and influenza. These product candidates are under development and have not been approved for use. Additional information about GenVec is available at www.genvec.com and in the company’s various filings with the Securities and Exchange Commission.
