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Posteado el: 01|2|09 a las 13:01 http://imitations.ru/2009/01/02/genvec-announces-interim-sur… GenVec Announces Interim Survival abstracts In Pivotal Trial Of TNFerade&dime store; In Locally breakthrough Pancreatic Cancer GenVec, Inc. (NasdaqGNVC) announced today topline results of an interim analysis from its ongoing Phase III Pancreatic Cancer Clinical Trial with TNFerade&dime store; (PACT) in patients with locally breakthrough pancreatic cancer. that interim analysis of overall survival, conducted after the 92nd annihilation (onethird of total expected events), was designed to determine whether the study should endure and took quarter in the space frame originally estimated. Interim abstracts demonstrated an approximately 25% lower risk of departure in the TNFerade plus canonical of care (SOC) arm relative to the SOC alone (Hazard Ratio= 0.753; 95% Confidence Interval [0.4941.15]). An independent testimony Safety Monitoring Board reviewed the interim analysis poop and recommended the trial run on as planned. KaplanMeier analysis of notes, based on that 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 that milestone in the PACT trial represents an influential 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 documents are encouraging and justify moving forward with the trial. The continuation of the trial will allow the notes to mature and provide for future analyses. We currently estimate we will reach the cryed for numerator of events needed to conduct the next analysis of knowledge in the PACT study in hung up 2009.” The next interim analysis will be conducted after 184 deaths have occurred (twothirds of total expected events) in the PACT trial. “At our ongoing rate of enrollment we anew anticipate having enrolled up 300 out of 330 total patients planned for the trial by the end of next year,” added Thornton. About PACT GenVecs PACT trial is a multicenter, randomized, active, and controlled study of 330 patients designed to evaluate the safety and efficacy of TNFerade plus vanilla of care versus regulation of care alone in patients with locally excellent pancreatic cancer. About Hazard Ratios The hazard ratio is an estimate of the treatment effect in the treated versus the supervision group in a trial. The hazard ratio reported means that, at the pace of the interim analysis, a TNFerade patient had 0.75 times the incidental of dying compared to someone in the established of care group. The reciprocal of that hazard ratio, 1.33, means that a orthodox of care patient had 1.33 times the casual of dying compared to someone in the TNFerade group. About TNFerade&customers; TNFerade, which has not yet unstylish approved for use, is an adenovector, or DNA carrier, which contains the gene for tumor necrosis factoralpha (TNFα), an immune conformity protein with potent and welldocumented anticancer effects, for direct injection into tumors. After administration, TNFerade stimulates the production of TNFα in the tumor. TNFerade has outofperiod granted Fast Track product designation by the U.S. Food and Drug Administration (FDA) for its proposed use in the treatment of locally leading 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 plant in the tissues of the pancreas, is the fourth leading cause of cancersimilar paradise in the United States. An estimated 37,680 Americans will be diagnosed with pancreatic cancer meanwhile 2008, and an estimated 34,290 Americans are expected to die from that disease in 2008. Currently, there are limited treatment options available for those with locally foremost pancreatic cancer. About GenVec GenVec, Inc. is a biopharmaceutical league developing novel therapeutic drugs and vaccines. GenVecs direction product, TNFerade, is currently in a pivotal clinical study (PACT) in locally old pancreatic cancer. Additional clinical trials are in progress in rectal cancer, head and neck cancer, and melanoma. GenVec additionally uses its proprietary adenovector technology to promote vaccines for infectious diseases including HIV, malaria, footandmouth disease, respiratory syncytial virus (RSV), and influenza. These product candidates are under development and have not square approved for use. Additional inside beat about GenVec is available at genvec.com and in the leagues various filings with the Securities and truck Commission. Conference alarm propaganda GenVec will host a conference shriek today at 900 a.m. Eastern extent. To listen to the vital conference cry, please dial 8668253354 (U.S. or Canada) or 6172138063 (ecumenical) and use access symbol 22232895. An gustative replay of the conference command will be available starting at 1100 a.m. on November 19, 2008 through November 26, 2008. To listen to the lingual replay, dial 8882868010 (U.S. or Canada) or 6178016888 (apple) and use access cryptograph 30613746. A aware webcast of the conference alarm will be available on the corteges website and will be archived for 30 days. To access the webcast or the replay, go to genvec.com, browse on “Investor Relations,” and browse on “Webcasts and goods.” Statements in that press release relating to future expectations concerning clinical trials or drug approvals, employment conditions or strategies and other biz matters, are forwardappearing statements within the meaning of the Private Securities Litigation Reform Act. GenVec cautions that these forwardseeing statements are subject to numerous assumptions, risks and uncertainties that pennies up interval. Factors that may cause actual results to differ materially from the results discussed in the forwardappearing statements or historical caution work in risks and uncertainties, including GenVecs financial condition and ability to raise capital to fund clinical programs and future operations; believing of GenVecs product candidates being in the early stages of development; uncertainties with, and unexpected results and germane analyses relating to clinical trials of GenVecs product candidates (including, for object, the length of generation prescribed to enroll suitable patient subjects and GenVecs ability to secure clinical trial sites); the timing, amount, and availability of revenues from GenVecs governmentfunded vaccine programs; the timing and end of future FDA regulatory activities consanguine to GenVec or its product candidates; GenVecs ability to find collaborators on or commercialize its product candidates; the scope and validity of patent protection for GenVecs product candidates and its ability to commercialize concoctions outofdoors infringing the patent rights of others. Further, selfconfident statements in that press release address survival score based on an interim clinical trial analysis of TNFerade in locally break pancreatic cancer. There can be no assurance that the future analyses (interim and final) will confirm that initial interim dope. Moreover, survival evidence is only one of rife factors that the Food and Drug Administration may take into history when considering TNFerade for regulatory approval and regulatory approval cannot be assured. |
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| aus der Diskussion: | GENVEC INC - auf WL |
| Autor (Datum des Eintrages): | eula (09.01.09 13:58:32) |
| Beitrag: | 8 von 8 (ID:36341131) |
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