Indevus Pharmaceuticals Announces Completion of Enrollment in Phase III Trial of PRO 2000
9,395 Women Enrolled in Trial Sponsored by Medical Research Council
LEXINGTON, Mass., Aug. 22 /PRNewswire-FirstCall/ -- Indevus Pharmaceuticals, Inc. (NASDAQ:IDEV) announced today the completion of enrollment in Protocol MDP 301, a Phase III clinical trial of PRO 2000, the Company's candidate vaginal microbicide for the prevention of HIV and other sexually transmitted infections. The trial is sponsored by the United Kingdom's Medical Research Council (MRC) and conducted by the Microbicides Development Programme (MDP), an international partnership of researchers established to develop microbicides for the prevention of HIV transmission. This trial enrolled 9,395 women at clinics in South Africa, Tanzania, Uganda, and Zambia. Results from this trial are expected to be available by the end of 2009.
This is the second large trial testing the safety and effectiveness of the 0.5% dose of PRO 2000 and the largest trial of any microbicide to date. In July 2007, enrollment of 3,100 women was completed in Protocol HPTN 035 sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). Results from the HPTN 035 trial are expected to be available by early 2009.
"The completion of enrollment in this trial marks a significant milestone for Indevus, our shareholders and for women who may benefit from a product that provides a female-controlled option for HIV and STD prevention," said Glenn L. Cooper, M.D., chairman and chief executive officer of Indevus. "We have now completed enrollment in two pivotal trials with over 12,000 women participating. If the trials are successful, we expect to be in a position to file marketing applications with regulatory authorities, including a New Drug Application with the U.S. Food and Drug Administration, in 2010."
MDP 301 is a multi-national, randomized, double-blind, placebo-controlled Phase III trial designed to examine the safety and effectiveness of PRO 2000 in preventing HIV infection in women. The trial will also assess effects on other sexually transmitted infections including herpes, chlamydia and gonorrhea. All participants receive condoms and risk-reduction counseling. The trial opened in October 2005, and is currently underway at clinical centers in South Africa, Tanzania, Uganda and Zambia. Completion of the trial is expected in the summer of 2009.
HPTN 035 is a multi-national, randomized, placebo-controlled trial designed to examine the safety and effectiveness of PRO 2000 and another candidate vaginal microbicide in preventing HIV infection in women. This trial will also assess effects on other sexually transmitted infections including herpes, chlamydia and gonorrhea. The 0.5% dose of PRO 2000 is being tested in comparison with a placebo and no treatment. All participants receive condoms and risk-reduction counseling. The trial involves seven clinical centers in South Africa, Malawi, Zimbabwe, Zambia, and the United States. The trial opened in February 2005, and 3,100 healthy women were enrolled before planned recruitment ended in July 2007. Completion of the HPTN 035 trial is expected later this year. Results from the trial are expected by early 2009.
About Indevus
Indevus Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in the acquisition, development and commercialization of products to treat conditions in urology and endocrinology. The Company's approved products include SANCTURA(R) and SANCTURA XR(TM) for overactive bladder, VANTAS(R) for advanced prostate cancer, SUPPRELIN(R) LA for central precocious puberty, and DELATESTRYL(R) to treat male hypogonadism. The Indevus development pipeline contains multiple compounds within the Company's core therapeutic areas in addition to several partnered or partnerable programs. The most advanced compounds in development include, VALSTAR(TM) for bladder cancer, NEBIDO(R) for male hypogonadism, PRO 2000 for the prevention of infection by HIV and other sexually-transmitted pathogens, and the octreotide implant for acromegaly.
About MDP
The Microbicides Development Programme (MDP) is an Afro-European partnership to develop vaginal microbicides for the prevention of HIV transmission. MDP is coordinated jointly by Imperial College, London, and the Clinical Trials Unit of the UK Medical Research Council. Partner institutions in Africa are University Teaching Hospital, Lusaka, Zambia; Medical Research Council Uganda Virus Research Institute, Entebbe; African Medical and Research Foundation and National Institute for Medical Research, Mwanza, Tanzania; the Africa Centre for Health and Population Studies, KwaZulu Natal, South Africa; South African Medical Research Council, Durban; and the Reproductive Health and HIV Research Unit, Department of Obstetrics and Gynaecology, University of Witwatersrand, Johannesburg, South Africa. In Mozambique, there are two new MDP sites at the rural Manhica Health Research Centre and at Mavalane Hospital in the urban capital of Maputo. European partners include the London School of Hygiene and Tropical Medicine, St. George's Hospital, London, and the Universities of York, Southampton and Barcelona. Clinical sites are located in South Africa, Tanzania, Uganda, Zambia and Mozambique.
MDP has built a vigorous multicultural and multidisciplinary research network ready to undertake future work of comparable importance and complexity. Years of working collegially have built cohesiveness, efficiency and mutual trust among the scientists, clinical staff, data managers, and other professionals and support staff comprising this Afro-European and pan-African clinical trial network, as well as sound relationships with surrounding communities. MDP has also achieved significant improvements in African laboratory capacity and other research infrastructure, as well as upgrading and reinforcement of professional capacity at its African research sites.
About PRO 2000
PRO 2000 (naphthalene sulfonate polymer) is a topical vaginal microbicide under development to prevent the sexual transmission of HIV and other sexually transmitted diseases.
Forward Looking Statements
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, SANCTURA XR, NEBIDO, VANTAS and SUPPRELIN LA; need for additional funds and corporate partners, including for the development of our products; effectiveness of our sales force; competition and its effect on pricing, spending, third-party relationships and revenues; dependence on third parties for supplies, particularly for histrelin, manufacturing, marketing, and clinical trials; risks associated with being a manufacturer of some of our products; risks associated with contractual agreements, particularly for the manufacture and co-promotion of SANCTURA and SANCTURA XR and the manufacture of NEBIDO, VANTAS, SUPPRELIN LA and VALSTAR; reliance on intellectual property and having limited patents and proprietary rights; dependence on market exclusivity, changes in reimbursement policies and/or rates for SANCTURA, SANCTURA XR, VANTAS, SUPPRELIN LA, DELATESTRYL and any future products; acceptance by the healthcare community of our approved products and product candidates; uncertainties relating to clinical trials, regulatory approval and commercialization of our products, particularly SANCTURA XR, NEBIDO, and VALSTAR; product liability and insurance uncertainties; risks relating to the Redux-related litigation; history of operating losses and expectation of future losses; uncertainties relating to controls over financial reporting; valuation of our Common Stock; risks related to repayment of debts; risks related to increased leverage; general worldwide economic conditions and related uncertainties; and other risks. Indevus undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.