The Medicines Company Announces Positive Results in a Phase 3 Trial of Cangrelor in the Treatment of Patients Undergoing PCI
CHAMPION PHOENIX Trial Meets Protocol-Specified Predefined Efficacy Endpoint; Intravenous Bolus and Infusion of Cangrelor Provided Statistically Significant Improvement in Ischemic Events at 48 Hours in Patients Undergoing PCI
Jan 08, 2013 (Marketwire via COMTEX) --The Medicines Company (NASDAQ: MDCO) today announced results for its pivotal Phase 3 clinical trial of cangrelor, which is in development to prevent platelet activation and aggregation that leads to thrombosis in the acute care setting, including in patients undergoing percutaneous coronary intervention (PCI).
Following the recommendation of the trial's Data Safety Monitoring Board (DSMB) in July 2012 to continue the protocol as planned, the CHAMPION PHOENIX trial completed enrollment in October 2012. After successful data lock, the data analysis revealed that the protocol defined primary composite efficacy endpoint of death, myocardial infarction, ischemia driven revascularization and stent thrombosis at 48 hours was met. Cangrelor demonstrated statistically significant improvement as compared to clopidogrel. Safety outcomes were similar to those observed in prior trials. The trial results are planned to be presented at a major upcoming scientific meeting.
Commenting on the trial and its conduct, Dr. Robert A. Harrington, MD, Professor of Medicine and Chairman of Medicine at Stanford University and Co-Principal Investigator said: "The PHOENIX trial was designed with careful consideration of the prior studies to determine whether cangrelor is associated with improved ischemic outcomes compared with the usual treatment of oral clopidogrel. We are grateful to the many investigators around the world who enabled rapid enrollment and the collection of high quality data. We are pleased that the trial delivered such clear results."
"We are looking forward to presenting detailed results to the medical community as soon as the data are fully analyzed," said Dr. Deepak L. Bhatt, MD, MPH, Chief of Cardiology at VA Boston Healthcare System, Senior Physician at Brigham and Women's Hospital, Professor of Medicine at Harvard Medical School and Co-Principal Investigator of the CHAMPION Trials.
Clive Meanwell MD, PhD, Chairman and Chief Executive Officer of The Medicines Company added that the Company expects to submit data both from the CHAMPION PHOENIX trial and from the BRIDGE trial in the USA and EU for regulatory review in 2013. "We believe that fast acting and rapidly reversible cangrelor may have an important role to play both in patients undergoing PCI and in patients who need to discontinue oral P2Y12 inhibitors prior to surgery," he said.
Cangrelor is an investigational agent not approved for commercial use in any market. Cangrelor, an intravenous small molecule antiplatelet agent, is in development to prevent platelet activation and aggregation that leads to thrombosis in the acute care setting including in patients undergoing percutaneous coronary intervention (PCI). The CHAMPION PHOENIX trial was a double-blind parallel group randomized study, which compares cangrelor to a clopidogrel loading dose administered as soon as possible after it is determined that the patient will undergo PCI. In 2011, the Company reported results of the BRIDGE trial, a prospective, randomized, double-blind, placebo-controlled multicenter trial which evaluated cangrelor or placebo in 210 patients with an acute coronary syndrome (ACS) or treated with a coronary stent and receiving a thienopryidine awaiting coronary artery bypass graft (CABG) surgery.
About The Medicines Company
The Medicines Company (NASDAQ: MDCO) provides medical solutions to improve health outcomes for patients in acute and intensive care hospitals worldwide. These solutions comprise medicines and knowledge that directly impact the survival and well being of critically ill patients.
Statements contained in this press release about the Company 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 on a timely basis or at all, whether results of clinical trials will be indicative of results in later clinical trials, whether clinical trial results will warrant submission of applications for regulatory approval, whether the Company will be able to obtain regulatory approvals, whether physicians, patients and other key decision-makers 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 Quarterly Report on Form 10-Q filed on November 9, 2012, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
The Medicines Company
Posted: January 2013