Navigation Links
Medivation Completes Enrollment in Confirmatory, Pivotal Phase 3 'CONNECTION' Trial of Dimebon in Patients With Alzheimer's Disease
Date:6/11/2009

SAN FRANCISCO, June 11 /PRNewswire-FirstCall/ -- Medivation, Inc. (Nasdaq: MDVN) today announced the completion of patient enrollment in the CONNECTION study, a six-month, confirmatory, pivotal Phase 3 trial of the investigational drug dimebon in patients with mild-to-moderate Alzheimer's disease.

The international, double-blind, placebo-controlled, pivotal Phase 3 study enrolled 598 patients, exceeding the enrollment target of 525 patients. More than 40 percent of the patients enrolled were in the United States. The six-month study is evaluating the effect of dimebon on the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) and the Clinician's Interview-Based Impression of Change plus caregiver interview (CIBIC-plus) -- the two endpoints have historically been accepted by the U.S. Food and Drug Administration (FDA) to support registration of currently approved drugs for mild-to-moderate Alzheimer's disease.

"Completion of patient enrollment in this second pivotal trial moves us closer to our goal of submitting a marketing application to the FDA and bringing dimebon to market for the many Alzheimer's patients suffering from this devastating disease," said Lynn Seely, M.D., chief medical officer of Medivation. "We are gratified by the strong interest in this trial as indicated by our exceeding the enrollment goal. Together with our partner Pfizer, we are executing a comprehensive clinical plan to support an NDA filing, currently targeted for 2011, with a broad and differentiated label for dimebon in Alzheimer's disease. We are also conducting a Phase 3 safety study, which will provide us and Pfizer the opportunity to seek marketing approval earlier if results of the CONNECTION study confirm our previously completed first pivotal study, which was published in the Lancet last year."


'/>"/>

SOURCE Medivation, Inc.
Copyright©2009 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2 3 4

Related biology technology :

1. Medivation Announces Pricing of Public Offering
2. Medivation Announces First Quarter 2009 Financial Results Teleconference and Webcast on May 11, 2009
3. Medivation Announces Upcoming Scientific Presentations at Medical Conferences
4. Medivation Reports Fourth Quarter and Year-End 2008 Financial Results and Provides Corporate Update
5. Medivation Announces New Positive Efficacy Data From Phase 1-2 Trial of MDV3100 in Castration-Resistant Prostate Cancer Patients
6. Medivation Presents New Data on Dimebons Novel Mechanism of Action
7. Medivation Announces Participation in RBC Capital Markets 2008 Healthcare Conference
8. Medivation Reports Third Quarter 2008 Financial Results and Provides Corporate Update
9. Medivation Announces Third Quarter 2008 Teleconference and Webcast on November 10, 2008
10. Medivation Announces Expiration of Hart-Scott-Rodino Waiting Period for Collaboration With Pfizer
11. Medivation Announces Presentation of 24-Week Clinical Data of MDV3100 in Castration-Resistant Prostate Cancer Patients
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/23/2013)... 23, 2013 Pressure BioSciences, Inc. (OTCQB: PBIO) ... will host a teleconference to discuss its First Quarter ... The teleconference information is provided below: Date: ... Time (EDT) Dial-in: (800) 875-3456 (U.S.); (800) ... Passcode: VS22823 For those unable to participate ...
(Date:5/23/2013)... 2013 During the conduct of ... adhere to principles of good clinical practice (GCP) ... Dr. Jeremy Lim, Fellow, Clinical Development at Novartis ... ,     Understand the International Conference on Harmonization (ICH) ... regulations for the conduction of clinical trials , ...
(Date:5/23/2013)... SynCardia Systems, Inc. ( http://www.syncardia.com ), manufacturer of ... CE (Europe) approved Total Artificial Heart, announced today that ... than 380,000 visitors annually, is featuring the SynCardia ... portable driver as part of its $3 million Bodyworks ... kind. , “BodyWorks combines the latest technology with ...
(Date:5/23/2013)... 2013 Bed bugs already cost Alton Housing ... still ongoing, a report from kmov.com suggested that the said ... bug treatment. Meanwhile, to be of help, My Cleaning Products ... bed bug exterminator service. , The report, which ... so far spent $35,000 for bed bug elimination, ...
Breaking Biology Technology:Pressure BioSciences, Inc. to Discuss First Quarter 2013 Financial Results and Provide Business Update 2Adhering to Good Clinical Practice, New Webinar Hosted by Xtalks 2SynCardia Total Artificial Heart Featured in $3 Million Exhibition at Glasgow Science Centre 2SynCardia Total Artificial Heart Featured in $3 Million Exhibition at Glasgow Science Centre 3Bed Bug Exterminator Service Could Cost AHA $250K, My Cleaning Products Gives Tips How to Save Apartments from Costly Bed Bug Treatment 2
... Jan. 26 WellCentive, LLC,today announced that WellCentive ... Information Exchange) as its patient registry and disease,management ... use of WellCentive Registry, more than 1,000 my1HIE ... will be better able to,provide preventive care services ...
... Jan. 26 Sirion Therapeutics, Inc., a privately held ... Application (NDA) for ganciclovir ophthalmic gel, 0.15%, has been ... Administration (FDA). Sirion Therapeutics is seeking approval for ganciclovir ... caused by the herpes simplex virus. The FDA has ...
... YORK, Jan. 26 Netsmart Technologies, Inc., a ... health and human services organizations, today announced it ... the New York State Association of Alcoholism and ... company,s comprehensive education, online learning and learning management ...
Cached Biology Technology:my1HIE(sm) Implements WellCentive Registry 2my1HIE(sm) Implements WellCentive Registry 3Sirion Therapeutics New Drug Application for Ganciclovir is Accepted for Review by the FDA for the Treatment of Ocular Herpes 2Sirion Therapeutics New Drug Application for Ganciclovir is Accepted for Review by the FDA for the Treatment of Ocular Herpes 3Netsmart University Announces Partner Referral Agreement With New York Association of Alcohol and Substance Abuse Providers 2Netsmart University Announces Partner Referral Agreement With New York Association of Alcohol and Substance Abuse Providers 3
(Date:5/23/2013)... the new mechanism by which estrogen suppresses lipid synthesis ... potential new approach toward treating certain liver diseases. ... believe they are changing long-held views in the field. ... the journal Science Signaling . , "The dogma ... been that only receptors located in the nucleus respond ...
(Date:5/23/2013)... have succeeded in treating cerebral palsy with autologous cord ... a 2.5 year old boy had been in a ... Just two months after treatment with the cord blood ... following months, the child learned to speak simple sentences ... a Korean study, dispel the long-held doubts about the ...
(Date:5/22/2013)... CITY, May 22, 2013 U.S. Forest Service scientists ... that, with funding from the TKF Foundation, will examine ... communities and individuals recover from tragedy. , The TKF ... of six projects selected for grant funding. In addition ... sacred spaces in recovery and resiliency, the 3-year, $585,000 ...
Breaking Biology News(10 mins):UCI study reveals new mechanism for estrogen suppression of liver lipid synthesis 2First successful treatment of pediatric cerebral palsy with autologous cord blood 2'Landscapes of Resilience' to study how people use nature as a source of recovery 2
... 19 2011) Bone marrow-derived stem cells (BMDCs) have been ... to different cell populations in a variety of organs under ... aimed at repairing damaged brain tissue or helping to restore ... to the cerebellum at the back of the brain. In ...
... and neglected disease drug discovery, MMV and SCYNEXIS, Inc. have ... compounds with antimalarial activity and will provide it to researchers ... Box have confirmed activity against the blood-stage of P. ... and were selected by experienced medicinal chemists from an ...
... (IRSF) announced today that it is awarding over $1.5M to ... diverse topics from basic science and disease pathology to developing ... the world,s largest private source of funding for biomedical and ... spending of over $26M since 1998. It is the ...
Cached Biology News:Bone marrow-derived cells differentiate in the brain through mechanisms of plasticity 2MMV and SCYNEXIS offer 400 active compounds for neglected disease drug research at no cost 2IRSF awards over $1.5 million for basic and translational research for Rett syndrome 2IRSF awards over $1.5 million for basic and translational research for Rett syndrome 3
For testing the AQUA technique on your MS instruments....
Our original highly-purified, robust Taq Polymerase which delivers consistently high yields and minimal background...
A formulation of our Biolase DNA Polymerase which contains a Red Loading Dye...
... Neogens enzyme-linked immunosorbent assay (ELISA) ... as screening devices for the detection of ... The kits are intended for forensic use ... samples be confirmed by a quantitative method ...
Biology Products: