Monday, February 9, 2009

Indevus HIV drug trial ends with poor results

By Marc Songini

Lexington-based Indevus Pharmaceuticals Inc. has wrapped up a clinical study for its Pro 2000 anti-HIV drug that indicated it lowered infection risk for women by 30 percent — just shy of a statistically significant 33 percent.

Indevus claimed this is the first trial to suggest a microbicide may prevent male-to-female sexual transmission of HIV. The Pro 2000 trial was multi-national, randomized and placebo-controlled. It was sponsored by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. The trial was run at seven clinical centers in Malawi, Zimbabwe, South Africa, Zambia and the United States in communities with a high rate of HIV infection.

Initiated in February 2005, it enrolled approximately 3,100 eligible, HIV-uninfected women; 194 new HIV infections occurred among study participants. Of these infections, 36 occurred in the group using Pro 2000. A second large trial for Pro 2000 is currently underway, being sponsored by the United Kingdom’s Medical Research Council.

Although inconclusive, the results of this trial are encouraging that Pro 2000 may offer a female-controlled method to protect against the sexual transmission of HIV, the company claimed. Glenn Cooper, the chairman and CEO of Indevus, stated he was “extremely excited” with the trial results. The U.S. Centers for Disease Control and Prevention estimates half of the 33 million people infected with HIV/AIDS worldwide are women, and most them are infected via heterosexual intercourse.

Indevus specializes in the acquisition, development and commercialization of drugs that treat urology and endocrinology related problems.