Navigation Links
European Enrollment Begins in Pivotal Phase 3 Trial of Novel Combination Medicine Developed by Cogentus Pharmaceuticals
Date:6/16/2008

Worldwide COGENT-1 Study of CGT-2168 Expands to Europe; Focus on Reducing

Gastrointestinal Side Effects of Antiplatelet Therapy

MENLO PARK, Calif., June 16 /PRNewswire/ -- Cogentus Pharmaceuticals, Inc. today announced that the first patient has been enrolled in Europe in the company's pivotal Phase 3 study of its novel combination medicine CGT-2168. The patient entered the COGENT-1 study at the Zadebie cardiology clinic in Skierniewice, Poland.

(Logo: http://www.newscom.com/cgi-bin/prnh/20071112/COGENTUSLOGO)

The study, which began in North America in January, is evaluating the antiplatelet medicine CGT-2168, a combination of clopidogrel (currently marketed by Bristol-Myers Squibb Co. and Sanofi-Aventis as Plavix(R)) and a gastroprotectant (omeprazole) in a single pill. Developed by Cogentus, CGT-2168 is designed to provide cardiovascular benefits while reducing potentially serious gastrointestinal side effects commonly associated with dual antiplatelet therapy.

Antiplatelet therapy is an integral part of treating patients with acute coronary syndrome and has been shown to be effective in preventing major cardiovascular events. However, the combination of clopidogrel and aspirin is associated with gastrointestinal bleeding, which in some cases requires hospitalization and can even result in death.

"Millions of cardiac patients in Europe have benefited from antiplatelet therapy," said Gilles Montalescot, M.D., Ph.D., Professor of Cardiology at the Institut de Cardiologie, Pitie-Salpetriere Hospital in Paris. "It is important that our patients have access to innovative new treatment options that can enhance compliance with treatment and provide positive outcomes. We look forward to being part of the COGENT program."

Among the estimated 4,000 patients worldwide who will participate in the study, approximately half will receive clopidogrel and aspirin; the other half will receive CGT-2168 (clopidogrel plus omeprazole) and aspirin. Patients will be assessed regularly for any gastrointestinal side effects such as bleeding and ulcers as well as receive ongoing monitoring of their cardiovascular status.

"This is yet another important milestone for our company," said Cogentus Chairman and Chief Executive Officer Mark A. Goldsmith, M.D., Ph.D. "COGENT has been very well received by the medical community in North America, with strong enrollment. Now we will begin to gather important data from investigators in Europe and broaden the patient base of the study."

ABOUT COGENTUS

Cogentus Pharmaceuticals, Inc., of Menlo Park, CA, is a privately held specialty pharmaceutical company founded in 2006. Cogentus (http://www.cogentus.net) is committed to becoming a premier developer of innovative, fixed-dose combination prescription medicines serving unmet medical needs that drive significant commercial opportunities.

COGENT stands for Clopidogrel and the Optimization of Gastrointestinal Events Trial. In addition to North America and Europe, the COGENT program also will include patients in South America, where clinical sites are expected to come on line later this year.

Plavix(R) is a registered trademark of Sanofi-Aventis.


'/>"/>
SOURCE Cogentus Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine technology :

1. XTENT Announces European Regulatory Update
2. Targeted Genetics Announces Positive Phase 1/2 tgAAC94 Data Presented at Annual European Congress of Rheumatology
3. Peptimmune Presents Early Clinical Data at European Neurological Society and Federation of Clinical Immunology Societies Meetings
4. European Unions CHMP Issues Positive Opinion on Sugammadex
5. PLC Systems Announces Approval of First European Study to Evaluate RenalGuard(TM)
6. PRoFESS(R) Results Announced at XVII European Stroke Conference
7. Neurobiological Technologies, Inc. Presents Dosing Rationale for Viprinex(TM) (ancrod) at the European Stroke Conference
8. Final Results of Ideal Study Presented at Annual Meeting of the European Association for the Study of the Liver (EASL)
9. European Medicines Agency Adopts Positive Opinion for Ranolazine for Treatment of Chronic Angina
10. More Clinical Data Required to Support European Approval of CAP Indication for TYGACIL
11. Idenix Pharmaceuticals Presents Positive Preclinical Data on HCV Programs at The Annual Meeting of The European Association for the Study of the Liver (EASL)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... , June 23, 2016 ... "Pharmaceutical Excipients Market by Type (Organic Chemical (Sugar, ... Formulation (Oral, Topical, Coating, Parenteral) - Global Forecast to ... The global pharmaceutical excipients market ... at a CAGR of 6.1% in the forecast period ...
(Date:6/23/2016)... -- Research and Markets has announced the addition ... to their offering. The ... commercial environment for MedImmune to enter. The US ageing population ... to drive considerable growth for effective anti-influenza medications. The introduction ... considerably, but development is still in its infancy. ...
(Date:6/23/2016)... 23, 2016 Revolutionary technology includes ... Oticon , industry leaders in advanced audiology and hearing ... Oticon Opn ™, the world,s first internet connected hearing ... IoT devices.      (Photo: http://photos.prnewswire.com/prnh/20160622/382240 ... number of ,world firsts,: , TwinLink™ - ...
Breaking Medicine Technology:
(Date:6/26/2016)... (PRWEB) , ... June 26, 2016 , ... Pixel Film ... Pro X. , "Film editors can give their videos a whole new perspective by ... Austin - CEO of Pixel Film Studios. , ProSlice Levels contains over 30 ...
(Date:6/25/2016)... Washington, D.C. (PRWEB) , ... June 25, 2016 ... ... will discuss health policy issues and applications at AcademyHealth’s Annual Research Meeting June ... share their work on several important health care topics including advance care planning, ...
(Date:6/25/2016)... Lewisville, TX (PRWEB) , ... June 25, 2016 , ... ... in the United States, named Dr. Sesan Ogunleye, as the Medical Director of its ... be the facility Medical Director of our new Mesquite location,” said Dr. James M. ...
(Date:6/25/2016)... ... ... Conventional wisdom preaches the benefits of moderation, whether it’s a matter of ... too high can result in disappointment, perhaps even self-loathing. However, those who set the ... Research from PsychTests.com reveals that behind the tendency to set low expectations ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... Marcy was in a crisis. Her son ... lash out at his family verbally and physically. , “When something upset him, he couldn’t ... would use it. He would throw rocks at my other children and say he was ...
Breaking Medicine News(10 mins):