9,395 Women Enrolled in Trial Sponsored by Medical Research Council LEXINGTON, Mass., Aug. 22
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.
Contact:
Michael W. Rogers Robin L. DeCarlo
EVP and Chief Financial Officer Director, Corporate Communications
(781) 861-8444 (781) 402-3405
SOURCE Indevus Pharmaceuticals, Inc.
