US-based specialty pharmaceutical company Tenax has completed patient enrolment in its Phase III LEVO-CTS trial of Levosimendan to be used during cardiac surgery.
Discovered and developed by Orion Pharma, levosimendan is an intravenously administered calcium sensitiser for patients with acute decompensated congestive heart failure (CHF).
At therapeutic dosages, levosimendan improves myocardial contractility without increasing oxygen requirements and causes coronary and systemic vasodilation.
The double-blind, randomised, placebo-controlled LEVO-CTS study will test the use of levosimendan administered before and during cardiac surgery to reduce the incidence of low cardiac output syndrome (LCOS) and associated morbidity and mortality.
The secondary endpoints of the trial will determine the potential pharmacoeconomic benefits and the incidence rate of LCOS resulted by the administration of levosimendan.
The study has enrolled a total of 880 patients.
Tenax Therapeutics CEO John Kelley said: “We are very pleased to reach this milestone after more than two years of hard work, and would like to thank all of the patients and investigators who have taken part in the trial.
“Consistent clinical execution and increased trial visibility has significantly accelerated the enrolment rate during these past 12 months, and we believe the expanded number of patients ensures that we have the best possible chance for success.
“We now look forward to sharing top-line results with you during the next few months, and we are prepared for a near-term NDA submission and commercial effort if the data reads out positively. We continue to believe that levosimendan has the potential to fill an important void in the current treatment paradigm for cardiac surgery.”