SAN FRANCISCO, June 9 /PRNewswire-FirstCall/ -- Medivation, Inc. today announced it has initiated dosing of patients in its second pivotal Phase 3 trial of the investigational drug Dimebon(TM) in patients with mild-to-moderate Alzheimer's disease (AD). The international, double-blind, placebo-controlled safety and efficacy study of oral Dimebon is known as the CONNECTION study.
"We saw very encouraging results in our first pivotal trial, in which Dimebon demonstrated statistically significant improvements over placebo on all five efficacy endpoints at both six months and at one year. We look forward to confirming the efficacy and safety of Dimebon in the CONNECTION study," said Lynn Seely, M.D., Chief Medical Officer of Medivation. "The initiation of this study brings us a major step closer to our goal of obtaining regulatory approval for Dimebon. We are working to bring this investigational drug to market as quickly as possible to address the unmet medical need in Alzheimer's disease and bring hope to patients and caregivers."
The U.S. Food and Drug Administration (FDA) has informed Medivation that the CONNECTION study together with the previously completed pivotal trial can be used to support the approval of Dimebon to treat mild-to-moderate Alzheimer's disease, as long as a significant proportion of the sites in the CONNECTION study are located in the United States. Medivation expects to complete the CONNECTION study and apply for U.S. and European marketing approval in 2010.
Design of CONNECTION Study
The CONNECTION study will enroll approximately 525 patients with mild-to-moderate Alzheimer's disease at approximately 100 sites in the United States, Europe and South America. Patients 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 may not be taking any other Alzheimer's disease drugs during the trial. After completing six months of treatment, all patients -- including those randomized to placebo -- will be offered the opportunity to receive Dimebon in an extension trial until marketing authorization.
The primary endpoints of the trial are the Alzheimer's Disease Assessment Scale -- cognitive subscale (ADAS-cog) and the Clinician's Interview-Based Impression of Change plus caregiver interview (CIBIC-plus). These are the two endpoints that have been accepted by the FDA to support registration of all approved drugs for Alzheimer's disease.
"Currently available therapies for Alzheimer's disease have modest effects, for the most part," said Pierre Tariot, M.D., Director, Memory Disorders Center, Banner Alzheimer's Institute. "There is an urgent need for new treatments for a disease with such devastating effects on the quality of life of patients and their caregivers. Dimebon represents an innovative form of therapy that may have the potential to ameliorate symptoms and possibly improve the course of Alzheimer's disease. It is crucial that it be fully assessed as rapidly as possible."
For more information on the CONNECTION study, please visit http://www.connectionstudy.com or call 1-877-888-MDVN (1-877-888-6386).
Results of First Pivotal Phase 3 Trial
Medivation previously announced results from its first pivotal trial of Dimebon in 183 patients with mild-to-moderate Alzheimer's disease, which showed that Dimebon improved the clinical course of Alzheimer's disease by demonstrating statistically significant improvements over placebo in each of the five primary aspects of the disease -- memory, thinking, activities of daily living, behavior and overall clinical function. Significant gains over placebo were evident after as little as 12 weeks of treatment, and were maintained after both six months and a full year of treatment. Importantly, overall benefit compared to placebo continued to increase over time, and was larger at one year than at six months. Dimebon was well-tolerated throughout the entire one-year treatment period. The majority of adverse events were mild. Dry mouth (18.0 percent Dimebon, 1.1 percent placebo) and depressed mood were the most common events. Patients treated with Dimebon experienced significantly fewer serious adverse events than those treated with placebo at one year.
About Dimebon
Dimebon is an orally-available small molecule that has been shown to inhibit brain cell death in preclinical models relevant to Alzheimer's disease and Huntington's disease, making it a potential treatment for these and other neurodegenerative diseases. Preclinical data generated to date suggest that Dimebon operates through a novel mitochondrial mechanism of action.
Medivation is also evaluating Dimebon in an ongoing Phase 2 clinical trial in Huntington's disease.
About Medivation
Medivation, Inc. is a biopharmaceutical company focused on the rapid development of novel small molecule drugs to treat serious diseases of the central nervous system and cancers for which there are limited treatment options. Medivation aims to revolutionize the treatment of these diseases and offer hope to critically ill patients and their caregivers. The Company's current clinical development program includes a pivotal and confirmatory Phase 3 trial of Dimebon(TM) in Alzheimer's disease, a Phase 2 clinical trial of Dimebon in patients with Huntington's disease, and a Phase 1-2 clinical trial of MDV3100 in patients with castration-resistant (also known as hormone-refractory) prostate cancer. For more information, please visit us at http://www.medivation.com.
This press release contains forward-looking statements, including statements regarding anticipated clinical and regulatory milestones, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements involve risks and uncertainties that could cause actual results to differ significantly from those projected. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this release. None of the Company's product candidates has been approved for sale, significant additional animal and human testing is required in order to seek marketing approval for any of its product candidates, and Medivation cannot assure you that marketing approval can be obtained for any of its product candidates. Furthermore, as is typically the case at this stage of the regulatory review process, the FDA has not yet performed an in-depth review of Medivation's preclinical and clinical data, so its views remain subject to change. Medivation's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-KSB for the year ended December 31, 2007, and its Quarterly Report on Form 10-Q for the quarter ended March 31, 2008, include information about additional factors that could affect the Company's financial and operating results.
CONTACT: Patrick Machado, Chief Financial Officer of Medivation, Inc.,
+1-415-829-4101; or Amanda Mason of WeissComm Partners, +1-212-301-7221,
for Medivation, Inc.
Web site: http://www.medivation.com/
http://www.connectionstudy.com/
