Genvec Receives Clearance From FDA For Eus Administration Of TNFerade
- Category: DNA RNA and Cells
- Published on Friday, 12 January 2007 02:00
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GAITHERSBURG, MD, USA | Jan 11, 2007 | GenVec, Inc. (Nasdaq: GNVC) today announced that it has reached agreement with the U.S. Food and Drug Administration to proceed with endoscopic ultrasound administration (EUS) of TNFerade™ as an additional option to percutaneous injection (PTA) for patients participating in its pivotal clinical trial for locally advanced pancreatic cancer (PACT).
“We are pleased to have received clearance from FDA for EUS administration of TNFerade,” stated Mark Thornton, M.D., Ph.D, GenVec’s senior vice-president of product development. “The addition of EUS may positively impact the recruitment of new centers and patients, and we look forward to enrolling the first EUS patient in this clinical trial.”
TNFerade is an adenovector, or DNA carrier, which contains the gene for tumor necrosis factor-alpha (TNFα), an immune system protein with potent and well-documented anti-cancer effects, for direct injection into tumors. After administration, TNFerade stimulates the production of TNFα in the tumor. GenVec is developing TNFerade for use in combination with radiation and/or chemotherapy for the treatment of various cancers.
GenVec’s PACT trial is a multi-center, randomized, active and controlled study targeted to enroll 330 patients, designed to evaluate the safety and efficacy of TNFerade plus standard of care (SOC) versus standard of care alone in patients with locally advanced pancreatic cancer.
GenVec, Inc. is a biopharmaceutical company developing novel gene-based therapeutic drugs and vaccines. Each of the Company’s therapeutic product candidates uses a common patent-protected technology platform to deliver genes that produce medically beneficial proteins directly at the site of disease. GenVec also uses its proprietary adenovector technology to develop vaccines for infectious diseases including HIV, malaria, seasonal and pandemic flu, and foot and mouth disease. Additional information about GenVec and its portfolio of product candidates is available at www.genvec.com and in the Company’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 programs and studies, 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 results discussed in the forward-looking statements or historical experience include risks relating to the early stage of GenVec’s product candidates under development; uncertainties with, and unexpected results and related analyses relating to clinical trials of GenVec’s product candidates including the length of time required to enroll suitable patient subjects and our ability to secure clinical trial sites; the timing and content of future U.S. Food and Drug Administration regulatory actions with respect to GenVec, its product candidates, or collaborators; risks relating to the commercialization, if any, of GenVec’s proposed product candidates (such as marketing, regulatory, patent, product liability, supply, competition and other risks); dependence on the efforts of third parties; dependence on intellectual property; the amount of revenues attributable to Genvec’s vaccine program; and risks that we may lack the financial resources and access to capital to fund our operations during the lengthy periods required to develop product candidates. Further information on the factors and risks that could affect GenVec’s business, financial conditions and results of operations, are contained in GenVec’s filings with the U.S. Securities and Exchange Commission (SEC), which are available at 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.
SOURCE: GenVec, Inc.