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Pfizer And Medivation Initiate Phase 3 Trial Of DimebonIn Patients With Huntington Disease
U.S. Orphan Drug Designation Granted for Dimebon for Treatment of HuntingtonDisease 30 Jul 2009 , New York, San Francisco : Pfizer Inc (NYSE: PFE) andMedivation, Inc. (NASDAQ: MDVN) today announced the initiation of a Phase 3trial of the investigational drug dimebon (latrepirdine)* in patients withHuntington disease.
The international safety and efficacy trial, known asHORIZON, is designed to evaluate the potential benefits of dimebon oncognition (thinking and memory) in patients with Huntington disease. Thecompanies also announced that the U.S. Food and Drug Administration (FDA)has granted orphan drug designation to dimebon for the treatment ofHuntington disease. "Based on the promising results of our Phase 2 trial of dimebon inHuntington disease, we are pleased to advance dimebon into late-stageclinical development," said Lynn Seely, M.D., chief medical officer forMedivation. "Huntington disease is a fatal genetic disease for which nomedications are currently approved by the FDA to treat the cognitiveimpairment associated with the condition."
Orphan status is granted by the FDA to promote the development of productsthat demonstrate promise for the treatment of rare diseases affecting fewerthan 200,000 Americans annually, such as Huntington disease, which affects30,000 individuals in the United States, with another 150,000 at risk.Orphan drug designation entitles Pfizer and Medivation to a seven-yearperiod of marketing exclusivity in the United States for dimebon if it isapproved by the FDA for the treatment of Huntington disease. It also enablesthe companies to apply for research funding, tax credits for certainresearch expenses, and a waiver from the FDA's application user fee.
*Latrepirdine is the proposed generic (nonproprietary) name for dimebon. Design of the HORIZON StudyThe double-blind, placebo-controlled Phase 3 trial will enroll approximately 350 patients with Huntington disease at approximately 50 sites in NorthAmerica, Europe and Australia. Patients will be randomized to receive eitherdimebon (latrepirdine) 20 mg three times daily or placebo for six months. The primary endpoints of the trial are the Mini Mental State Examination(MMSE), which measures cognition, and the Clinician's Interview-BasedImpression of Change, plus caregiver input (CIBIC-plus), which measuresglobal function. The trial will include only patients who have cognitiveimpairment, as subjectively assessed by an investigator and objectively byMMSE score. Secondary endpoints include the Neuropsychiatric Inventory (NPI), whichmeasures behavior; the Alzheimer's Disease Cooperative Study - Activities ofDaily Living (ADCS-ADL), which measures self-care and daily function; andthe Unified Huntington Disease Rating Scale (UHDRS'99) Total Motor Score,which measures motor impairment; and safety. The trial is being conducted in collaboration with the Huntington StudyGroup (HSG) and the European Huntington's Disease Network (EHDN). The HSG isa non-profit group of experienced clinical trial investigators from medicalcenters in the United States and abroad dedicated to clinical research ofHuntington disease. The EHDN is a non-profit network of professionals providing an infrastructure for large scale Huntington disease clinicaltrials throughout Europe. For more information about the HORIZON study, please
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