Healthcare Industry News: bivalirudin
News Release - October 4, 2006
The Medicines Company Commences Phase III Clinical Trial of CangrelorPARSIPPANY, N.J.--(HSMN NewsFeed)--The Medicines Company (NASDAQ: MDCO ) today announced that the first patient has been treated in a Phase III clinical trial called CHAMPION PLATFORM to evaluate the safety and efficacy of cangrelor, a fast-acting, reversible intravenous (IV) antiplatelet agent for preventing platelet activation and aggregation during the clotting process.
CHAMPION PLATFORM is a randomized, double-blind, placebo-controlled, parallel group study with a planned enrollment estimated at 4,400 patients. The primary objective of this study is to demonstrate that the efficacy of cangrelor plus usual care is superior to placebo plus usual care in patients requiring percutaneous coronary intervention (PCI). PCI, often referred to as coronary angioplasty, is a procedure conducted to clear blockages in arteries around the heart. Usual patient care during PCI includes a mix of IV and oral therapies that target the inhibition of blood clotting factors such as thrombin or platelets. The trials' co-primary investigators are Deepak Bhatt, MD of The Cleveland Clinic Foundation and Robert Harrington, MD of the Duke Clinical Research Institute.
The first patient was enrolled at the Dakota Clinic / Innovis Health, in Fargo, ND. The site's principal investigator is Dr. Edmund Fiksinski.
"With the commencement of CHAMPION PLATFORM, The Medicines Company has accomplished a key goal of initiating both cangrelor Phase III clinical trials in 2006," said John Kelley, President and Chief Operating Officer of The Medicines Company. "We believe our acute care franchise is taking shape nicely: Angiomax (bivalirudin) is growing in commercial strength, and our two IV acute care pipeline candidates, clevidipine and cangrelor moving forward as planned."
The cangrelor Phase III program is comprised of two multinational trials to evaluate cangrelor's effectiveness and safety in preventing ischemic events in patients who require PCI. The Company announced in April the start of patient enrollment of the CHAMPION PCI trial, which has a planned enrollment estimated at 9,000 patients. The Medicines Company expects patient enrollment in both Phase III trials to be completed in 2008.
If the trials are successfully completed and cangrelor receives regulatory clearance, the Company believes cangrelor will be the first IV platelet inhibitor to market that binds directly to the P2Y12 receptor, a clinically validated target to treat or prevent arterial thrombosis in patients undergoing PCI.
About The Medicines Company: The Medicines Company meets the demands of the world's most advanced medical practitioners by developing products that improve acute hospital care. The Company markets Angiomax® (bivalirudin) in the U.S. and other countries for use in patients undergoing coronary angioplasty, a procedure to clear restricted blood flow in arteries around the heart. The Medicines Company creates value using its range of clinical and commercial skills to develop products acquired from leading life science innovators. The Company's website is http://www.themedicinescompany.com.
Statements contained in this press release about The Medicines Company and cangrelor that are not purely historical, and all other statements that are not purely historical, may be deemed to be forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, the words "believes," "anticipates" and "expects" and similar expressions are intended to identify forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties that may cause the Company's actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by these forward-looking statements. Important factors that may cause or contribute to such differences include whether the Company's products will advance in the clinical trials process, whether clinical trial results will warrant submission of applications for regulatory approval, whether the Company will be able to obtain regulatory approvals, whether physicians will accept clinical trial results, and such other factors as are set forth in the risk factors detailed from time to time in the Company's periodic reports and registration statements filed with the Securities and Exchange Commission including, without limitation, the risk factors detailed in the Company's Annual Report on Form 10-Q filed on August 8, 2006, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
Source: The Medicines Company
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