The Medicines Company has successfully completed the EVOLUTION-On phase III clinical trial of Angiomax (bivalirudin), the second of two safety trials of the Angiomax phase III cardiac surgery programme. EVOLUTION-On evaluated the use of Angiomax as an anticoagulant during cardiac surgeries conducted with the use of a cardiac pulmonary bypass machine (on-pump).
The primary objective of EVOLUTION-On was to demonstrate that Angiomax is a safe alternative anticoagulant to heparin with protamine reversal in on-pump cardiac surgery. The primary endpoint results, a comparison of rates of acute procedural success, met the pre-specified objectives. Patients treated with Angiomax demonstrated a 95.0 per cent success rate, compared to a 91.8 per cent success rate in patients treated with heparin and protamine reversal. Acute procedural success was defined at seven days post-surgery as absence of death, Q-wave MI (heart attack), repeat operation or catheterization for coronary revascularization, or stroke, according to the company release.
Mark Sumeray, VP of Product Development at The Medicines Company, stated, "With completion of EVOLUTION-On, The Medicines Company has finished the safety portion of the phase III clinical trial programme of Angiomax in cardiac surgery. If the phase III efficacy studies known as CHOOSE meet their endpoints, we expect to file for US regulatory clearance to use Angiomax in cardiac surgery patients with a condition known as HIT/TS." "If approved for use in patients with HIT/TS for a surgery indication, Angiomax would be the first new anticoagulant introduced to the operating suite since the first cardiac surgeries were conducted in the 1950's," he asserts.
Clive Meanwell, chairman and CEO of The Medicines Company, noted, "We had ambitious clinical trial plans for 2004 at The Medicines Company, with ten phase III clinical trials operating concurrently in three programme areas -Angiomax in the treatment of acute coronary syndromes, Angiomax in cardiac surgery, and Clevelox (clevidipine) in cardiac surgery. With completion of the second phase III safety trial of Angiomax in cardiac surgery added to the recently announced completion of the two phase III efficacy trials of Clevelox, we close out the year having reached important timeline goals to keep us on track for expected future growth."
The Medicines Company is sponsoring the phase III clinical study programme investigating Angiomax as an anticoagulant in both on-pump and off-pump cardiac surgery to address a medical need among patients with or at risk for heparin-induced thrombocytopenia and thrombosis syndrome (HIT/TS). HIT/TS occurs when a patient exposed to heparin forms heparin antibodies. If heparin is administered again to a patient while heparin antibodies are present, that patient is at a significantly higher risk of developing HIT/TS. HIT/TS results in reduced platelet counts (HIT) and may progress to widespread, life-threatening blood clots (HIT/TS). There is currently no approved alternative to heparin for patients undergoing cardiac surgery where heparin is contraindicated, such as patients with HIT/TS.
Both the EVOLUTION-On and EVOLUTION-Off trials were open-label, multi-centre, randomized studies. The Medicines Company expects full data results from the EVOLUTION programme to be published and/or presented under scientific peer review.
Angiomax (bivalirudin) is currently approved in the US and the European Union, as well as other countries.