Indevus Pharmaceuticals, Inc. Declared termination of the enrolment in Protocol MDP 301, clinical court of the Phase III on ABOUT 2000, Company possible vaginal microbicide for prevention HIV and other sexual sent infection. Test is subsidized by Medical Research Advice United Kingdom (MRC) and is organized by Program of the Development Microbicides (MDP), international partnership of the researchers installed to develop microbicides for prevention of the transmission HIV. This test enrolled 9,395 womans in clinic in South Africa, Tanzania, Uganda, and Zambii. It Is Expected that Results thereof test will be available by the end of 2009.
This - a second big test, testing safety and efficiency 0.5% dose ABOUT 2000 and most big trial of any microbicide to date. In July 2007, the enrolment 3,100 womans were terminated in Protocol HPTN 035 subsidized by National Institute to Allergies and Infectious Diseases (NIAID), a part National Institute Health (NIH). It Is Expected that Results from test HPTN 035 will be available early 2009.
” Termination of the enrolment in this test selects the significant stage for Indevus, our shareholders and for womans, who can win from product, which provides the operated feminine choice for HIV and prevention STD,” said Glenn L. The Cooper, M.D., chairman and the main controlling Indevus. “We have now terminated the enrolment in two central tests including over 12,000 participations of the womans. If test are a success, we expect that to be able in file, marketed applications with regulatory authorities, including New Application Medicine with USA. Food and Administration Medicine, in 2010.”
MDP 301 - much-national, mixed, double-blind, operated by test Phase III designed to study safety and efficiency ABOUT 2000 in prevention of the infections HIV in woman. Test will also value the effects in other sexual sent infection including shingles, chlamydia and gonorrhoera. All participants get the condoms and risk-reduction counsel. Test was opened in October 2005, and - currently underway in clinical centre in South Africa, Tanzania, Uganda and Zambii. The Termination of the test is expected in summer 2009.
HPTN 035 - much-national, mixed, operated test designed to study safety and efficiency ABOUT 2000 and the other possible vaginal microbicide in prevention of the infections HIV in woman. This test will also value the effects in other sexual sent infection including shingles, chlamydia and gonorrhoera. 0.5% Dose ABOUT 2000 is not tested in contrast with and no processing. All participants get the condoms and risk-reduction counsel. Test includes seven clinical centres in South Africa, Malawi, Zimbabwe, Zambii, and United Staff. Test was opened in February 2005, and 3,100 sound womans were enrolled before scheduled that ended in July 2007. The Termination of the test HPTN 035 is expected later this year. The Results from test is expected early 2009.
About Indevus
The Pharmaceuticalses Indevus, Inc - a pharmaceutical company to professions concerned with by aquisition, development and commercialization of the products to address the condition in urologies and endocrinology. The Approved products to Companies include SANCTURA(R) and SANCTURA XR(TM) for overactive bubble, VANTAS(R) for leading cancer of the prostate, SUPPRELIN(R) LA for central developed puberty, and DELATESTRYL(R) to address the male hypogonadism. The Conveyor of the development Indevus contains the multiple compositions within the main therapeutic areas of the Companies to several partnered or partnerable program in addition. The most leading compositions in development include, VALSTAR(TM) for cancer bubble, NEBIDO(R) for male hypogonadism, ABOUT 2000 for prevention of the infections HIV and other sexual- sent pathogen, and implantation octreotide for acromegaly.
About MDP
The Program of the Development Microbicides (MDP) is partnership Afro-European to develop vaginal microbicides for prevention of the transmission HIV. MDP is CO-ORDINATED together by Imperial College, London, and Clinical Device of the Test the Medical Research Advice VELIKOBR.. The Institutions of the Partner in Africa - an University, increasing the frequency of Hospital, Lusaka, Zambiyu; The Medical Research Study of the Advice Uganda Virus Institute, Entebbe; African Medical and Research Fund and National Institute for Medical Study, Mwanza, Tanzania; The Africa of the Centre for Health and Populations of the Studies, KwaZulu Referring to birth, South Africa; THE SOUTH AFRICAN Medical Study of the Advice, Durban; and Reproductive Health and Research Group HIV, Division Obstetrics and Gynaecology, University Witwatersrand, Johannesburg, South Africa. In Mozambique, there is two new places MDP in rural Research Centre of the Health Manhica and in Hospital Mavalane in town capital Maputo. The European partners include London School Hygiene and Tropical Medicine, St. The Hospital George, London, and Universities York, Southampton and Barcelona. The Clinical places are located in South Africa, Tanzania, Uganda, Zambiya and Mozambique.
MDP has BUILT eager multicultural and multiprotocol research network ready to undertake future functioning of comparable importance and difficulties. The Years of the functioning collegially created cohesiveness, efficiency and mutual trust amongst scientist, clinical personnel, managers data, and the other professional and supports of the personnel, including this Afro-European and fluent-African clinical experienced network, as well as sound relationship with surrounding society. MDP ALSO reached the significant improvements in laboratory possibility African and other research infrastructure, as well as modernization and reinforcement of the professional possibility on their own research places African.
ABOUT 2000 (the mothball sulfonate polymer), thematic vaginal microbicide under development to prevent the sexual transmission HIV and other sexual sent diseases.
Send to Look Statement
With the exclusion of descriptions history fact contained above, this press release contains forward to look statement, which include the risk and uncertainty, which could cause the actual results to Companies and financial condition to differ vastly from that expected forward to look statement. This risk and uncertainty are stated in sawdust of the Companies under the action of Securities from 1933 and Exchange Action of the Securities from 1934 under “Factor of the Risk” and elsewhere and includes, but not limited: dependency in success SANCTURA, SANCTURA XR, NEBIDO, VANTAS and SUPPRELIN LA; need for additional funds and corporative partner, including for development of our products; efficiency of our sellouts is forced; the competition and effect in pricing, expense, independent relationship and arrivals; the dependency on the third party for deliveries, for histrelin particularly, producing, marketing, and clinical test; the risk linked the manufacturer of some our products; the risk linked the contractual agreements, for production particularly and advancement co- SANCTURA and SANCTURA XR and production NEBIDO, VANTAS, SUPPRELIN LA and VALSTAR; the confidence in knowledge-based characteristic and have limited patents and personal rights; the dependency in market exclusivity, changes to policy of the indemnity and/or factors for SANCTURA, SANCTURA XR, VANTAS, SUPPRELIN LA, DELATESTRYL and any future products; acceptance by society healthcare our approved candidate of the products and product; the uncertainty refers to clinical test, plenipotentiary approval and commercialization of our products, particularly SANCTURA XR, NEBIDO, and VALSTAR; liability of the product and insurance uncertainty; the risk refers to bound suit Redux; the history of the operating losses and waiting the future losses; the uncertainty refers to element of control on financial statements; the estimation of our COMMON STOCKS; the risk referred the debts to indemnifying; the risk referred to raised use as lever; the total worldwide economic terms and bound uncertainty; and the other risk. Indevus does Not R the obligation publicly to correct any forward to look the wordings, as a result of new information independently, future event or otherwise.
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