First Malaria Vaccine Trial Launched Under GenVec/U.S. Navy Collaboration.GAITHERSBURG, Md. -- GenVec, Inc. (Nasdaq:GNVC) announced today that they are collaborating with the Naval Medical Research Center (NMRC NMRC New Millennium Research Council NMRC Naval Medical Research Center NMRC National Microelectronics Research Centre (University College Cork, Ireland) NMRC National Monuments Record Centre (UK) ) in Silver Spring, MD, to conduct the first clinical study of an experimental malaria vaccine based on the company's gene delivery and cell culture manufacturing technologies for the production of recombinant adenovirus adenovirus Any of a group of spheroidal viruses, made up of DNA wrapped in a protein coat, that cause sore throat and fever in humans, hepatitis in dogs, and several diseases in fowl, mice, cattle, pigs, and monkeys. vaccine vectors. Under sponsorship from the United States Army United States Army Major branch of the U.S. military forces, charged with preserving peace and security and defending the nation. The first regular U.S. fighting force, the Continental Army, was organized by the Continental Congress on June 14, 1775, to supplement local Medical Materiel ma·te·ri·el or ma·té·ri·el n. The equipment, apparatus, and supplies of a military force or other organization. See Synonyms at equipment. Development Activity (USAMMDA USAMMDA United States Army Medical Materiel Development Activity ), and with financial support from the US Agency for International Development, the Congressionally Directed Peer Review Medical Program, and the Military Infectious Diseases Research Program, NMRC will initiate this FDA-approved study at their clinical trials center, located on the campus of the National Naval Medical Center The National Naval Medical Center in Bethesda, Maryland, also known as the Bethesda Naval Hospital, is considered the flagship of the United States Navy's system of medical centers. in Bethesda. GenVec has been collaborating with the NMRC for the past four years to develop adenovector-based malaria vaccine candidates. The vaccine now undergoing clinical testing consists of two adenovectors, each encoding a different antigen from the protozoal protozoal pertaining to or caused by protozoa. protozoal myeloencephalitis see equine protozoal myeloencephalitis. protozoal hepatitis caused usually by Toxoplasma, Neospora, Leishmania. parasite Plasmodium falciparum. The vaccine is designed to stimulate T-cell and antibody immune responses and attack both the liver and blood stages of this complex parasite. This approach of eliciting a broad-spectrum immune response and attacking multiple stages of the malaria parasite's life cycle has shown promise in preclinical studies. The first (safety) phase of the study will evaluate the safety and immunogenicity immunogenicity /im·mu·no·ge·nic·i·ty/ (-je-nis´it-e) the property enabling a substance to provoke an immune response, or the degree to which a substance possesses this property. of two vaccine doses in healthy volunteers. After safety evaluation and confirmation of the optimal dose, the second (challenge) phase of the study will evaluate the protective effects of the vaccine following exposure to malaria. The ability to safely challenge human volunteers provides a unique opportunity for assessing the efficacy of candidate vaccines prior to the initiation of field trials. Paul Fischer, Ph.D., president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of GenVec, stated: "This study represents an important step forward in our collaboration with the Naval Medical Research Center that, if successful, will help validate our approach to developing novel vaccines against malaria, which remains one of the world's most prevalent and serious infectious diseases. We look forward to seeing the initial results of this study later this year." 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 relating to clinical trials; 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; and risks that we may lack the financial resources and access to capital to fund our operations. 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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