The Medicines Company's MDCO-2010 Meets Clinical Trial Objectives in Patients Undergoing Open-Heart Surgery
PARSIPPANY, NJ--(Marketwire - October 15, 2011) - Clinical investigators today reported results of the first study in open heart surgery patients of MDCO-2010, an investigational antifibrinolytic agent designed to limit blood loss during surgery. MDCO-2010 is being developed by The Medicines Company (NASDAQ: MDCO).
The Phase IIa clinical trial met its two objectives: 1) demonstrate safety of a periprocedural infusion of escalating doses of MDCO-2010 and 2) investigate MDCO-2010 pharmacokinetic, pharmacodynamics and clinical effects. The trial demonstrated that MDCO-2010 has linear, predictable plasma pharmacokinetics with rapid clearance. In addition, MDCO-2010 was associated with significantly reduced 12-hour chest tube drainage and less transfusion requirements as compared to placebo.
Dr. Lars Englberger, M.D., of University Hospital Berne (Berne, Switzerland) presented the data at the ANESTHESIOLOGY 2011 conference in Chicago, IL. Dr. Englberger said, "Bleeding after cardiac surgery is a significant clinical problem that results in increasing morbidity and mortality. Cardiac anesthesiologists, surgeons and intensive care physicians are demanding new tools to address common bleeding problems. The results of this first-in-patient study of MDCO-2010 are clearly positive and set a basis for larger trials to further refine a dose and determine patients that will benefit most from this novel therapy."
Dimitrios Goundis, PhD, head of R&D at The Medicines Company added, "MDCO-2010 is an important part of our portfolio of acute and intensive care hospital compounds and marketed products. The results reported by Dr. Englberger and his colleagues are highly encouraging. We plan to move forward with MDCO-2010 in a randomized Phase IIb trial in 2012 on the strength of these data."
Summary methods and results
The Phase IIa trial was a randomized, double-blind, placebo-controlled study in 32 men and women undergoing elective, primary CABG surgery. MDCO-2010 or placebo was infused immediately after heparin bolus until sternal closure. Patients were randomized within cohorts in a 3:1 ratio to receive either one of five MDCO-2010 doses (24 patients in total) or saline as placebo (8 patients).
Cohort 1: loading 5 µg/kg, maintenance 12.5 µg/kg/h; 3 patients
Cohort 2: loading 11 µg/kg, maintenance 25 µg/kg/h; 3 patients
Cohort 3: loading 27 µg/kg, maintenance 62.5 µg/kg/h; 6 patients
Cohort 4: loading 47 µg/kg, maintenance 109 µg/kg/h; 6 patients
Cohort 5: loading 94 µg/kg, maintenance 219 µg/kg/h; 6 patients
Investigators measured blood loss by the amount of blood drained via chest tubes at 12 hours postoperatively. The median chest tube drainage in placebo patients was 900 mL (SD +/- 349). The median chest tube drainage in three of the MDCO-2010 cohorts was significantly lower. Blood loss and red cell transfusion data as presented by the investigators is below:
----------------------------------------------------------------------------
Placebo Cohort I Cohort 2 Cohort Cohort 4 Cohort 5
(N=8) (N=3) (N=3) 3(N=6) (N=6) (N=6)
----------------------------------------------------------------------------
12 hour postoperative
chest tube drainage, 900 450 595 350* 350* 360*
median ± SD [mL] ± 349 ± 172 ± 125 ± 39 ± 106 ± 220
----------------------------------------------------------------------------
Patients receiving
transfusions 4/8 0/3 0/3 1/6 1/6 2/6†
----------------------------------------------------------------------------
Average number of
transfusions per
patient 2.00 0 0 0.33 0.17 0.67†
----------------------------------------------------------------------------
*p < 0.025 vs. placebo
†1 patient in cohort 5 received additional heparin without protamine
reversal
----------------------------------------------------------------------------
About MDCO-2010
MDCO-2010 is a novel, synthetic, small molecule serine protease inhibitor with strong antifibrinolytic and moderate anticoagulant activity. The Medicines Company is developing MDCO-2010 as an intravenous antifibrinolytic drug for the reduction of blood loss during surgery. The safety and efficacy of MDCO-2010 has not been established or approved by the FDA or any regulatory agency for any use.
About CABG surgery
CABG surgery is a procedure in which surgeons bypass a blockage in the patient's artery by grafting a vein to the artery on both sides of the blockage to restore blood flow around the obstruction.
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 Medicines 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," "plans" 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 physicians, patients and other key decision-makers will accept clinical trial results, whether the Company's products will advance in the clinical trials process on a timely basis or at all, 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 August 2, 2011, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.