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GenVec halts enrolment of phase II trial for heart drug

Gaithersburg, MarylandSaturday, May 13, 2006, 08:00 Hrs  [IST]

GenVec, which plans to focus resources on the clinical development of TNFerade, its lead product candidate for the treatment of cancer, has decided, in agreement with its collaborator Cordis Corporation, to curtail enrolment of patients in the phase II trial of Biobypass for the treatment of severe coronary artery disease. Patients currently enrolled in the phase II study will complete follow up under the study protocol. The decision to curtail enrolment of patients in the Biobypass study will not result in any charges to GenVec's operating results. The company informed while announcing its financial results for the first quarter ended March 31, 2006. GenVec reported a net loss of $4.1 million ($0.06 per share) compared to a net loss of $3.5 million ($0.06 per share) in the comparable quarter of 2005. The increase in the net loss was primarily due to higher internal costs associated with the late stage clinical development of TNFerade. GenVec ended the first quarter of 2006 with $27.0 million in cash and investments. GenVec expanded its phase II pancreatic study of TNFerade into a targeted 330 patient phase II/III pivotal trial and launched a phase II study of TNFerade in patients with stage III and IV metastatic melanoma. Based on these developments and the data from previously completed TNFerade clinical studies, GenVec is re-aligning its portfolio of clinical stage trials to focus additional resources on TNFerade with a view to optimizing the development timeline for the TNFerade indications currently under clinical investigation. Operating expenses for the first quarter of 2006 increased 27 percent, to $10.3 million from $8.1 million in the first quarter of 2005, primarily due to higher internal development costs for TNFerade. Also contributing to the increase in operating costs was the one-time production of clinical grade HIV vaccine supplies for a phase II proof-of-concept trial ("POCET trial"). The POCET trial will be conducted and funded by the NIH and is expected to commence in the first half of 2007.

 
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