SAN FRANCISCO and CHICAGO, April 17 Medivation,Inc. (Nasdaq: MDVN) today announced that Alzheimer's patients treated with theinvestigational drug Dimebon(TM) showed improvement in the key aspects ofcognitive function over a one-year period compared with placebo. Theimprovement occurred in not only memory and language, but also in more complexfunctions such as awareness of time and place, and praxis -- the process ofgetting an idea and initiating and completing a new motor task. Theseclinical results were generated during a pivotal trial of Dimebon in patientswith mild-to-moderate Alzheimer's disease (AD).
The data were presented today during an oral presentation at the 60thAnnual Meeting of the American Academy of Neurology (AAN) by Steven H. Ferris,Ph.D., the Gerald J. and Dorothy R. Friedman Professor of Psychiatry at NewYork University and director of the NYU Alzheimer's Disease Center.
"The finding that Dimebon improved memory, orientation, language andpraxis in Alzheimer's disease patients suggests that it provides a broadrather than a selective cognitive benefit," said Dr. Ferris. "This is animportant finding given that deficits in memory and thinking are one of thehallmarks of Alzheimer's disease and cause patients and caregivers significantdistress."
Dimebon Significantly Improved Cognitive Function at One Year
The data presented at the AAN Annual Meeting included results of ananalysis of the 11 subdomains of the Alzheimer's Disease AssessmentScale-cognitive subscale (ADAS-cog), a standardized measure of cognition inpatients with AD and one of two endpoints the U.S. Food and DrugAdministration (FDA) has used to approve all currently marketed drugs formild-to-moderate AD. In the study, ADAS-cog was assessed at the beginning ofthe study and at weeks 12, 26, 39 and 52.
Results showed that Dimebon-treated patients were significantly improvedcompared with placebo on 9 of the 11 ADAS-cog subdomains after one year oftreatment. Benefits were observed in memory (word recall, p=0.04; wordrecognition, p=0.03; remembering instructions, p=0.10); orientation (p= 0.01);constructional praxis (the ability to copy simple drawings or patterns,p=0.005) and ideational praxis (the ability to perform a familiar but complexsequence of actions, p=0.006); and language (following commands, p<0.0001;naming objects, p<0.0001; word finding, p=0.005; comprehension, p=0.15;overall language, p=0.0002).
"We have recently presented a number of different findings from our firstpivotal trial of Dimebon at scientific conferences, demonstrating that thisinvestigational drug has a beneficial impact on the key aspects of Alzheimer'sdisease -- from behavioral symptoms to thinking and memory problems toimpairments in daily function," said Lynn Seely, M.D., chief medical officerof Medivation. "Medivation is committed to rapidly developing Dimebon as atreatment for mild-to-moderate Alzheimer's disease to make it available to themillions of people who suffer from this increasingly prevalent disease, forwhich new treatment options are desperately needed."
Dimebon Showed Statistically Significant Benefit Versus Placebo on All KeyEfficacy Endpoints
Medivation previously announced efficacy and safety results from thepivotal, 12-month, double-blind, placebo-controlled trial of Dimebon in 183patients with mild-to-moderate AD. Dimebon improved the clinical course ofAlzheimer's disease patients by causing statistically significant improvementsover 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 oftreatment, and were maintained after both six months and a full year oftreatment. In addition, after six months of treatment, Dimebon patients weresignificantly better on all fi