GenVec, Inc. reported today that the U.S. Food and Drug Administration (FDA) has approved GenVec’s TNFerade™ for Fast Track development in the treatment of locally advanced pancreatic cancer. TNFerade™ is designed to stimulate the production of immune system proteins with anti-cancer properties that are injected into tumors. GenVec is developing TNFerade™ for use in combination with other tools such as radiation and chemotherapy for the treatment of various cancers.
TNFerade™ qualifies for Fast Track status because GenVec provided the FDA with evidence that TNFerade™ may have potential to improve the survival rate of patients suffering from pancreatic cancer. The FDA grants Fast Track designation to drugs that are designed to treat life-threatening conditions and that have a proven potential to address an unmet medical need.
Fast Track designation only applies to situations where a developmental stage drug is used to treat one specific medical condition and not just to the drug by itself. Fast Track designation shortens the regulatory review process and provides for a faster licensing process if certain conditions are met.
Fast Track designation for TNFearde™ is an important milestone for GenVec and the possible treatment of pancreatic cancer, according to Mark Thornton, M.D., Ph.D., Senior Vice President for Product Development at GenVec. Thornton stated, “This Fast Track designation is an important step in the increasing focus on the clinical potential of TNFerade™ as a treatment for locally advanced pancreatic cancer.” He also noted that “[a]s further data emerge regarding TNFerade™, we look forward to working closely with the FDA to potentially expedite the review process for TNFerade™.”
GenVec, Inc. of Gaithersburg, Maryland is a developmental stage biopharmaceutical company focusing on unique therapeutic drugs and vaccines. GenVec’s most promising product is TNFerade™, which is currently in a pivotal clinical study regarding pancreatic cancer. TNFerade ™ is also being used and evaluated in trials for other types of cancers and tumors. GenVec uses its proprietary technology to develop vaccines for infectious diseases including foot-and-mouth disease, malaria, HIV, respiratory syncytial virus (RSV), HSV-2, and influenza.
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