| Pfizer And Medivation Initiate Two Phase 3 Trials Of Dimebon In Patients With Moderate-To-Severe Alz |
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03/11/2009 17:34 (17 Day 12:40 minutes ago) | |||||
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The FINANCIAL -- Pfizer Inc (NYSE: PFE) and Medivation, Inc. (NASDAQ: MDVN) on November 3 announced the initiation of CONTACT and CONSTELLATION, two Phase 3 trials of the investigational drug dimebon (latrepirdine) in patients with moderate-to-severe Alzheimer’s disease (AD).
The CONTACT study will assess as primary endpoints the potential benefits of adding dimebon to ongoing treatment with donepezil HCI tablets, the leading AD medication worldwide, on neuropsychiatric symptoms and activities of daily living. The CONSTELLATION study will evaluate as primary endpoints the effects of adding dimebon to memantine HCI, another standard of care, on cognition, memory and activities of daily living.
“Alzheimer’s disease is a growing global epidemic with an unmet clinical need. Many patients with moderate-to-severe Alzheimer’s disease experience behavioral and neuropsychiatric symptoms, which are among the leading causes of placement in care facilities for these patients,” said Pierre N. Tariot, MD, director of the Memory Disorders Center at the Banner Alzheimer’s Institute and study investigator. “These studies are intended to evaluate the potential added benefits of dimebon in combination with current standards of Alzheimer’s care.”
In preclinical studies, dimebon has been shown to protect brain cells from damage and enhance brain cell survival, potentially by stabilizing and improving mitochondrial function. The dimebon mechanism is distinct from currently available AD medications.
“Pfizer and Medivation are committed to developing dimebon as a treatment that may meaningfully improve the lives of patients across the full spectrum of Alzheimer’s disease severity,” said Lynn Seely, M.D., chief medical officer for Medivation. “The initiation of the CONTACT and CONSTELLATION studies is an important milestone in the broad clinical development of dimebon.”
These studies are part of a comprehensive Phase 3 clinical development program, currently consisting of seven trials, to assess the safety and efficacy of dimebon across all stages of Alzheimer’s disease, as monotherapy and in combination with currently available Alzheimer’s treatments, and in Huntington disease.
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