Pharmexa cleared for U.S. phase 1b trial of HIV vaccine EP1090

By Lisa Kerner

Charlotte, N.C., Aug. 29 - Pharmexa said it is approved in the United States to begin a 24-week phase 1b trial of the vaccine EP1090 in 32 HIV-infected patients.

The randomized, double blind, placebo-controlled study will test two groups dosed with 1 mg or 4 mg of EP1090 administered with the Biojector 2000 needle-free injection device.

Safety and immunogenicity are the primary trial endpoints, with results expected in the third quarter of 2007.

EP1090 is an epitope-based DNA vaccine that activates cytotoxic T-lymphocytes (CTL or killer T cells) of the immune system to attack HIV-infected cells, according to a company news release.

Pharmexa said EP1090 has been successfully tested in both HIV-infected patients and in healthy volunteers, as well as in combination with the vaccine EP1043 in a large phase 1 trial.

The most advanced vaccines in the company's prophylactic pipeline are the EP1090 + EP1043 combination product, and the EP1233 DNA vaccine designed for use with the viral vector vaccine MVA-BN32 developed in collaboration with Bavarian Nordic.

Pharmexa is a pharmaceutical company based in Horsholm, Denmark. Its U.S. subsidiary, Pharmexa-Epimmune, has a number of HIV programs financed in whole or in part by the National Institutes of Health.

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