Pfizer And Medivation Initiate Phase 3 Trial Of Dimebon Added To Donepezil In Patients With Alzheimer's Disease

Main Category: Alzheimer's / Dementia
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 16 Apr 2009 - 3:00 PDT

email to a friend   printer friendly   opinions  

Pfizer (NYSE: PFE) and Medivation, Inc. (Nasdaq: MDVN) announced the initiation of a 12-month, Phase 3 clinical trial of the investigational drug Dimebon. The study, known as CONCERT, is designed to evaluate the safety and efficacy of Dimebon when added to ongoing treatment with donepezil HCI tablets, the leading Alzheimer's disease (AD) medication worldwide, in patients with mild-to-moderate AD.

The CONCERT study is part of a broad, Phase 3 clinical development program for Dimebon. The study builds on data from a small-scale safety and tolerability trial of Dimebon added to donepezil, which found the combination to be well tolerated. CONCERT is designed to complement previous and ongoing studies by further evaluating the efficacy of Dimebon. The Phase 3 program also includes the confirmatory 6-month CONNECTION study, which is designed to evaluate the safety and efficacy of Dimebon monotherapy in patients with mild-to-moderate AD and builds on results of the first pivotal trial of Dimebon in AD.

"Due to the complexity of Alzheimer's disease, the condition often requires combination treatment to help relieve symptoms and slow disease progression," said Bengt Winblad, professor of geriatrics, Karolinska Institute. "The CONCERT trial will explore the potential additive effects of Dimebon to ongoing donepezil therapy, two drugs thought to have different mechanisms of action. We believe this trial may serve to demonstrate the potential of Dimebon in AD."

Dimebon is an investigational compound currently in Phase 3 development for the treatment of Alzheimer's disease (AD) and in clinical development for Huntington's disease (HD). In preclinical models of AD and HD explored thus far, Dimebon has been shown to inhibit brain cell death, potentially by stabilizing and improving mitochondrial function in a way that prevents neuron death and dysfunction. The Dimebon mechanism is thought to be distinct from currently available AD medications.

Design of the CONCERT Study

The international, randomized, double-blind, placebo-controlled study will enroll approximately 1,050 patients with mild-to-moderate AD at approximately 100 sites in the United States, Australia, New Zealand and Western Europe. Patients on a stable dose of donepezil will be randomized to one of three treatment groups: Dimebon 20 mg three times per day, Dimebon 5 mg three times per day or placebo. Patients must be on treatment with donepezil for at least six months and at a stable dose of 10 mg daily for at least four months prior to enrollment in the study.

The primary endpoints are the Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog) and the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) - a measure of self-care and daily function.

About Alzheimer's Disease

Alzheimer's disease is a progressive degenerative brain disorder that gradually destroys a person's memory and ability to learn, reason, make judgments, communicate and carry out daily activities. As the disease progresses, patients may experience changes in personality and behavior, such as anxiety, suspiciousness or agitation, as well as delusions or hallucinations.

About the Pfizer/Medivation Dimebon Collaboration

Medivation and Pfizer have a global collaboration to develop and commercialize Dimebon for the treatment of Alzheimer's and Huntington's diseases. Under the terms of the agreement, the companies are working in partnership to bring Dimebon to market in the United States (U.S.). In addition, following FDA approval, Medivation will co-promote Dimebon to specialty physicians in the U.S. Pfizer has responsibility for development, regulatory and commercialization outside of the U.S.

Forward Looking Statements

PFIZER DISCLOSURE NOTICE: The information contained in this release is as of April 15. Pfizer assumes no obligation to update any forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about certain potential indications for Dimebon, including their potential benefits, that involves substantial risks and uncertainties. Such risks and uncertainties include, among other things, the uncertainties inherent in research and development; decisions by regulatory authorities regarding whether and when to approve any new drug applications that may be filed for such indications as well as their decisions regarding labeling and other matters that could affect the availability or commercial potential of any such indications; and competitive developments.

A further list and description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2008 and in its reports on Form 10-Q and Form 8-K.

MEDIVATION DISCOSURE NOTICE: This press release contains forward-looking statements, including statements regarding the timing of: initiation of clinical studies, filing of an NDA for Dimebon, the presentation of data with respect to Dimebon and the receipt of milestone payments as well as the extent of future expected financial results, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements involve risks and uncertainties that could cause Medivation's actual results to differ significantly from those projected, including, without limitation, risks related to progress, timing and results of Medivation's clinical trials, difficulties or delays in obtaining regulatory approval, enrollment of patients in Medivation's clinical trials, partnering of Medivation's product candidates, manufacturing of Medivation's product candidates, competition with Medivation's product candidates should they receive marketing approval, the adequacy of Medivation's financial resources, unanticipated expenditures or liabilities, intellectual property matters, and other risks detailed in Medivation's filings with the Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2008 filed March 16, 2009, with the SEC. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this release. Medivation disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release.

Source: Pfizer Inc

• Additional
• References
• Citations