Promising preliminary safety and immune response results from the HVTN 064 trial of a Pharmexa HIV vaccine presented at HIV Vaccine Trials Network meeting

HORSHOLM, Denmark | November 9, 2007 | At the fall meeting of the HIV Vaccine Trials Network, Pharmexa today announced preliminary results from the HVTN 064 Phase I trial of Pharmexa's epitope based recombinant protein vaccine EP1043, which was tested alone and in combination with Pharmexa's epitope based DNA vaccine EP1090.

The HVTN 064 trial enrolled 84 healthy volunteers. The preliminary study analyses indicate the EP1043 protein vaccine is safe and well tolerated when administered alone or in combination with the EP1090 DNA vaccine. Although the data are still blinded, it appears that the protein also induces robust immune responses in the majority of vaccine recipients, with a response rate of approximately 80% in certain dose groups, after only two immunizations. There was no apparent synergistic effect with EP1090.

EP1043 is a recombinant protein composed of 18 conserved Helper T-cell epitopes from the Env, Gag, Pol, and Vpu proteins from HIV. Because the HIV sequences used to identify the epitopes are those commonly observed in infected individuals from all regions of the world, this vaccine is intended to provide worldwide coverage. EP-1043 was designed for use in combination with DNA or viral vectored vaccines for HIV. For the HVTN 064 trial the protein was formulated with Alhydrogel adjuvant.

Mark Newman, Ph.D., SVP, R&D Laboratories at Pharmexa says: "We consider these preliminary results with the EP1043 protein very encouraging. To our knowledge, this vaccine is unique in its design and the demonstration that it is immunogenic and can be administered safely is a significant step forward."

SOURCE: PHARMEXA

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