Pharmacy News Article

4 November 2009 - US-based pharmaceutical company Pfizer Inc (NYSE: PFE) and Medivation Inc (NASDAQ: MDVN), a biopharmaceutical company, said yesterday they have initiated two Phase III studies of the investigational drug dimebon (latrepirdine) in patients with moderate-to-severe Alzheimer's disease (AD).

Latrepirdine is the proposed generic (nonproprietary) name for dimebon. The two companies have a global collaboration to develop and commercialise dimebon for the treatment of Alzheimer's disease and Huntington disease.

Pierre Tariot, director of the Memory Disorders Center at the Banner Alzheimer's Institute and study investigator, said that the studies are intended to evaluate the potential added benefits of dimebon in combination with current standards of Alzheimer's care.

The first study, titled CONTACT, 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 second study, CONSTELLATION, 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.

In preclinical studies, dimebon has been shown to protect brain cells from damage and enhance brain cell survival, potentially by stabilising and improving mitochondrial function. The dimebon mechanism is distinct from currently available AD medications.

These studies are part of a Phase III clinical development programme, 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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