NIH Initiates International Microbicide Trial Including Pro 2000
11 February 2005, 10:42am ET
LEXINGTON, Mass.--(BUSINESS WIRE)--Feb. 11, 2005--Indevus Pharmaceuticals, Inc. (NASDAQ:IDEV) today announced the initiation of a large, international clinical trial sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), designed to examine the safety and effectiveness of two candidate topical microbicides, including the Company's PRO 2000, in preventing HIV infection in women.
Enrollment in this pivotal safety and effectiveness trial has begun at sites in Durban, South Africa and in Philadelphia at the University of Pennsylvania and is expected to expand to eight sites in five African countries, including Malawi, South Africa, Tanzania, Zambia and Zimbabwe. Approximately 3,220 women will be enrolled in the trial, which is expected to last approximately 30 months and include interim analyses of safety and efficacy data conducted by an independent data safety monitoring board.
"We are pleased that the NIH has chosen to include PRO 2000 in this significant international microbicide trial," said Glenn L. Cooper, M.D., chairman, president and chief executive officer of Indevus. "Data from this clinical trial, the first to measure the protective efficacy of PRO 2000 and the first of this magnitude to be conducted by NIAID, will build upon the database compiled from a number of earlier clinical studies with PRO 2000, completed under the sponsorship of government agencies and research organizations in the U.S., Europe, Africa and India, that showed a promising safety and acceptability profile for the drug.
"Nearly half of all people living with HIV worldwide are women, and the majority of new adult HIV infections are acquired from heterosexual intercourse," said Dr. Cooper. "Because vaginal microbicides increase the opportunities for sexually active women to play a more active role in the prevention of the heterosexual transmission of HIV and other sexually transmitted diseases (STDs), we see microbicide development as an important HIV prevention strategy. If effective, microbicides would be a valuable female-controlled means of slowing the pace of the HIV/AIDS epidemic."
Each woman in the NIAID-sponsored trial will be placed at random into one of four equally sized groups. One group will use PRO 2000 before each act of sexual intercourse, one will use a second microbicide, one will use a placebo gel, and one will not use any gel. All participants will receive condoms and extensive prevention counseling at each clinic visit. Researchers will evaluate the effectiveness of the candidate microbicides in preventing HIV and other sexually transmitted infections, including gonorrhea, herpes and chlamydia.
PRO 2000 is a topical vaginal microbicide under development by Indevus to prevent the sexual transmission of HIV and certain other sexually transmitted disease-causing viruses and bacteria. In addition to the NIAID trial described above, PRO 2000 has been selected by the Microbicides Development Programme (MDP) as the sole agent to be tested in a Phase III clinical trial due to start in 2005 and include at least 12,000 women in a number of African countries. Funded by a grant from the U.K. Department for International Development of approximately GBP 16 million, or approximately $28.6 million, the MDP is a partnership established to develop vaginal microbicides for the prevention of HIV transmission, administered by the Medical Research Council Clinical Trials Unit and Imperial College in London.
NIAID is a component of the National Institutes of Health, an agency of the U.S. Department of Health and Human Services. NIAID supports basic and applied research to prevent, diagnose and treat infectious diseases such as HIV/AIDS and other sexually transmitted infections, influenza, tuberculosis, malaria and illness from potential agents of bioterrorism. NIAID also supports research on transplantation and immune-related illnesses, including autoimmune disorders, asthma and allergies.
Indevus Pharmaceuticals is a biopharmaceutical company engaged in the acquisition, development and commercialization of products targeting certain medical specialty areas, including urology and infectious diseases. The Company currently markets SANCTURA for overactive bladder and has multiple compounds in clinical development, including pagoclone for stuttering, aminocandin for systemic fungal infections, PRO 2000 for the prevention of infection by HIV and other sexually transmitted pathogens, and IP 751 for pain and inflammatory disorders such as interstitial cystitis.
Except for the descriptions of historical facts contained herein, this press release contains forward-looking statements that involve risks and uncertainties that could cause the Company's actual results and financial condition to differ materially from those anticipated by the forward-looking statements. These risks and uncertainties are set forth in the Company's filings under the Securities Act of 1933 and the Securities Exchange Act of 1934 under "Risk Factors" and elsewhere, and include, but are not limited to: dependence on the success of SANCTURA(TM) and SANCTURA XR(TM); the early stage of products under development; uncertainties relating to clinical trials, regulatory approval and commercialization of our products, particularly SANCTURA and SANCTURA XR; risks associated with contractual agreements, particularly for the manufacture and co-promotion of SANCTURA and SANCTURA XR; dependence on third parties for manufacturing and marketing; competition; need for additional funds and corporate partners, including for the development of our products; failure to acquire and develop additional product candidates; history of operating losses and expectation of future losses; product liability and insurance uncertainties; risks relating to the Redux-related litigation; limited patent and proprietary rights; dependence on market exclusivity; valuation of our Common Stock; risks related to repayment of debts; risks related to increased leverage; and other risks.
CONTACT: Indevus Pharmaceuticals
Michael W. Rogers, 781-861-8444
Exec. VP and Chief Financial Officer
or
William B. Boni, 781-861-8444
VP, Corp. Communications
SOURCE: Indevus Pharmaceuticals
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