Indevus HIV gel misses Phase III endpoint

Indevus announced Phase III results from an NIH-funded trial of PRO 2000, the company's vaginal microbicide for HIV prevention. Though women using the microbicide experienced a 30 percent lower risk of contracting HIV than the control group, the results were not statistically significant. However, it was the first study that demonstrated such a gel could possibly provide women with protection against the disease.

"We are extremely excited with the results of this trial," said Indevus CEO Glenn Cooper. "Though not conclusive, these results provide encouragement that PRO 2000 may offer a female-controlled method that can be used to protect against the sexual transmission of HIV.

The company is still waiting for results from another trial which enrolled nearly 10,000 women in Africa, Tanzania, Uganda and Zambia, where HIV infection rates are extremely high. The results from that study--funded by the United Kingdom's Medical Research Council--should be available by the end of 2009. Should PRO 2000 be found safe and effective, Indevus said it will pursue worldwide marketing approvals, and plans to work with government agencies and other organizations to help ensure access to the the drug in areas where patients can't afford it.

- here's Indevus' release [1]
- read the Forbes analysis [2]

Related Articles:
Endo plunks down $637M for Indevus [3]
Indevus inks licensing pact, lands FDA deal
Indevus gets approvable letter [4] (2007)