STATEMENT: Indevus pharmaceuticals announces PRO 2000 found to show promise in large HIV prevention study

By PR Newswire (Indevus) 9 February 2009: Indevus Pharmaceuticals, Inc. (Nasdaq: IDEV) announced today that a National Institutes of Health (NIH)-sponsored clinical study found that participating women who received PRO 2000, the Company's candidate vaginal microbicide for HIV prevention, had an approximately 30% lower risk of acquiring HIV infection than women who received a placebo or no vaginal product.

http://news.prnewswire.com/DisplayReleaseContent.aspx?ACCT=104&STORY=/www/story/02-09-2009/0004968465&EDATE=

All women participating in the study were offered free condoms and safer-sex counseling. This is the first trial to suggest any microbicide may prevent male-to-female sexual transmission of HIV although the beneficial effect did not reach statistical significance. The results will be presented today at the 16th Conference on Retroviruses and Opportunistic Infections in Montreal.

"We are extremely excited with the results of this trial," stated Glenn L. Cooper, M.D., chairman and chief executive officer of Indevus. "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.

"In addition to the HPTN 035 trial, we are awaiting results from the MRC-sponsored trial which will provide data on nearly 10,000 women," continued Dr. Cooper. "These results should be available by the end of 2009."

The HIV Prevention Trials Network (HPTN) 035 trial was a multi-national, randomized, placebo-controlled trial to assess the safety and effectiveness of PRO 2000 and another investigational vaginal microbicide (BufferGel(R), ReProtect, Inc.) in preventing HIV infection in women. The trial was sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), a component of the NIH, and conducted by the NIH-funded Microbicide Trials Network (MTN) at seven clinical centers in Malawi, Zimbabwe, South Africa, Zambia, and the United States.

The trial was initiated in February 2005 and enrolled approximately 3,100 eligible, HIV-uninfected women, all of whom provided written informed consent. Enrolled participants were randomly assigned to one of four arms: PRO 2000 gel (0.5% strength), BufferGel, a placebo gel, or no gel. Women enrolled in the three gel arms were asked to apply the assigned study product vaginally up to one hour before each act of sexual intercourse. The gel arms were double-blinded so that neither the participant nor the study staff knew the identity of the assigned study product. Women in all four arms received a standard-of-care HIV prevention package, which included free male condoms, risk-reduction counseling, and treatment of sexually transmitted infections. Participants were followed for 12-30 months (20 months on average), depending on when they entered the study.

A total of 194 new HIV infections occurred among study participants over the course of the trial. Of these, 36 occurred in the PRO 2000 arm, 54 in the BufferGel arm, 51 in the placebo arm, and 53 in the no-gel arm. Based on these data, PRO 2000 was 30 percent effective (approximately 33 percent effectiveness would have been considered statistically significant). The adverse event profile was similar in all four arms, indicating that 0.5% PRO 2000 is safe for vaginal use. A full analysis of the trial data is underway.

Microbicides Media and Communications Initiative

STATEMENT: Indevus pharmaceuticals announces PRO 2000 found to show promise in large HIV prevention study

Personal tools


	Just In Times Live Blog: Promising results in blocking HIV during first days of infection: M2010 2010-06-18 Times Live Blog: New drugs in the pipeline for anti-HIV microbicides: results presented at M2010 2010-06-18 Times Live Blog: Where was the polio vaccine discovered? 2010-06-18 More news… News Archives June 2010 May 2010 April 2010 March 2010 February 2010 December 2009 More... Member Log in User Email Password Cookies are not enabled. You must enable cookies before you can log in. Search Site	STATEMENT: Indevus pharmaceuticals announces PRO 2000 found to show promise in large HIV prevention study By PR Newswire (Indevus) 9 February 2009: Indevus Pharmaceuticals, Inc. (Nasdaq: IDEV) announced today that a National Institutes of Health (NIH)-sponsored clinical study found that participating women who received PRO 2000, the Company's candidate vaginal microbicide for HIV prevention, had an approximately 30% lower risk of acquiring HIV infection than women who received a placebo or no vaginal product. http://news.prnewswire.com/DisplayReleaseContent.aspx?ACCT=104&STORY=/www/story/02-09-2009/0004968465&EDATE= All women participating in the study were offered free condoms and safer-sex counseling. This is the first trial to suggest any microbicide may prevent male-to-female sexual transmission of HIV although the beneficial effect did not reach statistical significance. The results will be presented today at the 16th Conference on Retroviruses and Opportunistic Infections in Montreal. "We are extremely excited with the results of this trial," stated Glenn L. Cooper, M.D., chairman and chief executive officer of Indevus. "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. "In addition to the HPTN 035 trial, we are awaiting results from the MRC-sponsored trial which will provide data on nearly 10,000 women," continued Dr. Cooper. "These results should be available by the end of 2009." The HIV Prevention Trials Network (HPTN) 035 trial was a multi-national, randomized, placebo-controlled trial to assess the safety and effectiveness of PRO 2000 and another investigational vaginal microbicide (BufferGel(R), ReProtect, Inc.) in preventing HIV infection in women. The trial was sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), a component of the NIH, and conducted by the NIH-funded Microbicide Trials Network (MTN) at seven clinical centers in Malawi, Zimbabwe, South Africa, Zambia, and the United States. The trial was initiated in February 2005 and enrolled approximately 3,100 eligible, HIV-uninfected women, all of whom provided written informed consent. Enrolled participants were randomly assigned to one of four arms: PRO 2000 gel (0.5% strength), BufferGel, a placebo gel, or no gel. Women enrolled in the three gel arms were asked to apply the assigned study product vaginally up to one hour before each act of sexual intercourse. The gel arms were double-blinded so that neither the participant nor the study staff knew the identity of the assigned study product. Women in all four arms received a standard-of-care HIV prevention package, which included free male condoms, risk-reduction counseling, and treatment of sexually transmitted infections. Participants were followed for 12-30 months (20 months on average), depending on when they entered the study. A total of 194 new HIV infections occurred among study participants over the course of the trial. Of these, 36 occurred in the PRO 2000 arm, 54 in the BufferGel arm, 51 in the placebo arm, and 53 in the no-gel arm. Based on these data, PRO 2000 was 30 percent effective (approximately 33 percent effectiveness would have been considered statistically significant). The adverse event profile was similar in all four arms, indicating that 0.5% PRO 2000 is safe for vaginal use. A full analysis of the trial data is underway.