Indevus Announces Initiation of Phase III Trial of PRO 2000; Medical Research Council Sponsored Trial to Enroll Approximately 10,000 Women
LEXINGTON, Mass.--(BUSINESS WIRE)--Oct. 25, 2005--Indevus Pharmaceuticals, Inc. (NASDAQ: IDEV) today announced the initiation of a large, international Phase III clinical trial of PRO 2000, the Company's topical, vaginal microbicide in development for the prevention of sexually transmitted infections, including HIV, herpes, chlamydia and gonorrhea. The trial is being sponsored by the Medical Research Council of the United Kingdom (MRC) and conducted by the UK Government-funded Microbicides Development Programme (MDP).
The trial has opened for enrollment at clinics in Johannesburg, South Africa and the Masaka district of Uganda, and is expected to expand to additional sites in South Africa, Tanzania and Zambia. Approximately 10,000 women will be enrolled in the trial, which is expected to last approximately three to four years and include interim analyses of safety and efficacy data conducted by an independent data safety monitoring committee.
"With the initiation of this study, two large safety and effectiveness trials of PRO 2000 with combined recruitment targets of approximately 13,200 participants are underway," said Glenn L. Cooper, M.D., chairman, president and chief executive officer of Indevus. "In February of this year, we announced the initiation of an NIH-sponsored trial being conducted at sites in the U.S. and a number of African countries. Together the two trials represent approximately $100 million in funding.
"We believe, upon successful completion of the trials, we would be in position to file marketing applications with regulatory authorities, including a New Drug Application with the U.S. Food and Drug Administration. In addition to the work being done on the two trials, we have begun discussions with potential public and private sector partners for the commercialization and distribution of PRO 2000," continued Dr. Cooper.
"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. "The highest infections rates are found in sub-Saharan Africa, which is the primary area where both PRO 2000 trials are being conducted. Globally, there is a significant need among sexually active women for a female-controlled option for HIV / STD prevention.
"We are pleased that the MRC has selected PRO 2000 as the only active agent in this significant international microbicide trial. The MRC trial is the result of a long-standing and productive public-private partnership," concluded Dr. Cooper.
Each woman enrolled in this double-blind, placebo-controlled trial will be assigned at random to receive one of two PRO 2000 strengths (0.5% or 2%) or a placebo. The women will be asked to apply the study product prior to sexual intercourse. In addition, all participants will receive condoms and risk-reduction counseling. Researchers will evaluate the effectiveness of PRO 2000 relative to placebo in preventing HIV and other sexually transmitted infections, including gonorrhea, herpes and chlamydia.
The development program for PRO 2000 includes a number of pre-clinical and early clinical studies conducted by government agencies and research organizations in the U.S., Europe, Africa and India. An NIH-supported study demonstrated that PRO 2000 can afford protection from the sexual transmission of HIV in an animal model. Results from a Phase I/II trial conducted by the NIH, in which no serious side effects were reported and investigators concluded that PRO 2000 was safe and well tolerated, were presented at the International Congress of Sexually Transmitted Infections in June 2001. Other Phase I trials showed a promising safety and acceptability profile for the drug in healthy, sexually abstinent women. In addition, Phase I trials designed to evaluate the safety of male exposure to PRO 2000 were conducted. There were no serious side effects reported and investigators concluded that PRO 2000 was safe and well tolerated.
In June 2003, a Phase II trial funded by the European Commission was initiated in Uganda to assess the safety of PRO 2000 in approximately 200 sexually active women. Findings from a study conducted at the Mount Sinai School of Medicine were presented earlier this year at the 12th Conference on Retroviruses and Opportunistic Infections. The findings demonstrated that PRO 2000 retained activity against HIV and HSV following intravaginal administration to HIV-infected women.
About the MRC
The MRC is a national tax-payer funded organization in the UK. The MRC supports medical research aimed at improving human health. The organization has funded work which has led to some of the most significant discoveries and achievements in medicine in the UK. The MRC Clinical Trials Unit was formed by the amalgamation of the MRC HIV Clinical Trials Centre and MRC Cancer Trials Office and supports trials in a wide range of specialties.
About the MDP
The MDP is a partnership to develop vaginal microbicides for the prevention of HIV transmission. It is funded by the UK Department for International Development (DFID) and the MRC, and administered by the MRC Clinical Trials Unit and Imperial College, London. It brings together academic institutions in the North and South, non-profit organizations and pharmaceutical companies.
About PRO 2000
PRO 2000 is a candidate topical microbicide for the prevention of sexually transmitted infections including infection by the Human Immunodeficiency Virus (HIV), the cause of Acquired Immunodeficiency Syndrome (AIDS). The Company believes the compound blocks the entry of sexually transmitted disease (STD) pathogens into human cells. In addition to its demonstrated activity against HIV infection in laboratory tests and animal models, PRO 2000 has been shown to be active against other STD pathogens such as herpes, chlamydia, and the bacterium that causes gonorrhea.
About HIV and STDs
An estimated 5 million people worldwide were newly infected with HIV in 2004, and an estimated 39 million adults and children are thought to be living with HIV infection. The virus's predominant route of transmission worldwide is through heterosexual contact, with women being more susceptible to infection than men. Nearly half of those infected with HIV are now women, and surveys indicate that hundreds of millions of women worldwide are concerned about contracting HIV / STDs. More than 400 million new cases of STDs occur worldwide each year, threatening the health and fertility of a growing number of people and increasing the risk of HIV infection. These statistics highlight the vast need for new, safe, effective, female-controlled options for HIV / STD prevention.
About Indevus
Indevus Pharmaceuticals is a biopharmaceutical company engaged in the acquisition, development and commercialization of products targeting certain medical specialty areas, including urology and gynecology. The Company currently markets SANCTURA(R) for overactive bladder and has multiple compounds in clinical development, including SANCTURA XR(TM), the once-daily formulation of SANCTURA, NEBIDO(R) for the treatment of male hypogonadism, PRO 2000 for the prevention of infection by HIV and other sexually transmitted pathogens, IP 751 for interstitial cystitis, pagoclone for stuttering, and aminocandin for systemic fungal infections.
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, Inc.
Michael W. Rogers, 781-861-8444
EVP and Chief Financial Officer
or
Brooke D. Wagner, 781-402-3410
VP, Corp. Communications
SOURCE: Indevus Pharmaceuticals, Inc.
