GenVec and NIH Move HIV Vaccine Candidate Into Human Clinical Trials

GAITHERSBURG, Md. -- GenVec, Inc. announced today that the Vaccine Research Center (VRC) of the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) has initiated a Phase I clinical study to test an HIV vaccine candidate developed utilizing GenVecs proprietary gene delivery technology. The study will be sponsored, managed and funded by NIAID and will employ HIV vaccine candidates produced by GenVec under its subcontract with SAIC-Frederick, Inc. (SAIC), and developed in collaboration with NIAID under a cooperative research and development agreement (CRADA). This Phase I, dose escalating, double blind, placebo controlled study is designed to assess safety and immune response.

C. Richter King, PhD, GenVecs vice president of research, commented on the initiation of the trial, This is a major advancement in the field of HIV vaccine development. This unique vaccine candidate is being developed for worldwide use (targeting clades A, B, and C) and is designed to attack the virus on both antibody (B-cell) and cellular (T-cell) levels. We are excited about the initiation of this trial and the multi-protection approach this vaccine candidate may offer.

King continued, This vaccine candidate has the potential to treat HIV infections on a global level and should provide further validation of the safety and versatility of GenVecs technology platform. The Phase I study represents the first of a number of planned HIV vaccine trials to be conducted by the VRC using GenVecs adenovector and cell line technology. The fact that GenVecs packaging cell line is being used for a prophylactic vaccine is an important milestone for the field. HIV is a global health problem and GenVec is excited to be working with the team of experts at the NIAID, VRC and SAIC to develop vaccines that address this major health issue.

Human immunodeficiency virus (HIV) is the virus that causes acquired immunodeficiency syndrome (AIDS). In 2003, an estimated 40 million people worldwide were living with HIV or AIDS. HIV infects 600 people every hour, totaling over 14,400 new infections each day. Last year, new HIV infections totaled 5 million with an estimated 3 million deaths. The Centers for Disease Control and Prevention estimate that 950,000 U.S. residents are living with HIV infection and that approximately one quarter of those are unaware of their infection.

Source: GenVec, Inc.