GenVec Receives Clearance From FDA for EUS Administration of TNFerade(TM).PACT Study to Include EUS Endoscopic ultrasonography (EUS) A medical procedure in which sound waves are sent to the stomach wall by an ultrasound probe attached to the end of an endoscope. Centers GAITHERSBURG, Md. -- GenVec, Inc. (Nasdaq: GNVC) today announced that it has reached agreement with the U.S. Food and Drug Administration to proceed with endoscopic ultrasound Endoscopic ultrasound (EUS) A medical procedure in which sound waves are sent to the stomach wall by an ultrasound probe attached to the end of an endoscope. administration (EUS) of TNFerade[TM] as an additional option to percutaneous injection (PTA PTA or parent-teacher association: see parent education. ) for patients participating in its pivotal clinical trial for locally advanced pancreatic cancer (PACT). "We are pleased to have received clearance from FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. 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." About TNFerade[TM] TNFerade is an adenovector, or DNA DNA: see nucleic acid. DNA or deoxyribonucleic acid One of two types of nucleic acid (the other is RNA); a complex organic compound found in all living cells and many viruses. It is the chemical substance of genes. carrier, which contains the gene for tumor necrosis factor-alpha Tumor necrosis factor (TNF, cachexin or cachectin and formally known as tumor necrosis factor-alpha) is a cytokine involved in systemic inflammation and is a member of a group of cytokines that all stimulate the acute phase reaction. (TNFa), an immune system protein with potent and well-documented anti-cancer effects, for direct injection into tumors. After administration, TNFerade stimulates the production of TNFa in the tumor. GenVec is developing TNFerade for use in combination with radiation and/or chemotherapy for the treatment of various cancers. About PACT GenVec's PACT trial is a multi-center, randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. , 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. About GenVec 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 HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. , malaria, seasonal and pandemic pandemic /pan·dem·ic/ (pan-dem´ik) 1. a widespread epidemic of a disease. 2. widely epidemic. pan·dem·ic adj. Epidemic over a wide geographic area. n. flu, and foot and mouth disease a contagious disease See also: Foot . 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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and . 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. |
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