SOUTH SAN FRANCISCO, CA, Aug. 31, 2009 (Marketwire) --
SOUTH SAN FRANCISCO, CA -- (Marketwire) -- 08/31/09 -- Cytokinetics, Incorporated (NASDAQ: CYTK) announced today that data from two Phase IIa clinical trials evaluating omecamtiv mecarbil (formerly CK-1827452), one in stable heart failure patients and one in patients with ischemic cardiomyopathy and angina, were presented at the European Society of Cardiology Congress 2009 in Barcelona, Spain. The company believes these data provide support for the further clinical development of this novel drug candidate as a potential treatment for heart failure. Amgen Inc. exercised an option to obtain an exclusive, world-wide (excluding Japan) license to omecamtiv mecarbil, subject to specified development and commercialization participation rights of Cytokinetics.
"We believe the data from these Phase IIa clinical trials evaluating omecamtiv mecarbil in heart failure patients provide additional support for our therapeutic hypothesis for this drug candidate that warrants further evaluation as an important potential treatment option in this complex disease," stated Andrew A. Wolff, MD, FACC, Cytokinetics' Senior Vice President of Clinical Research and Development and Chief Medical Officer. "Now, together with our partner Amgen, we look forward to progressing into Phase IIb clinical trials and evaluating the impact of this novel mechanism on other clinical aspects of heart failure."
Poster Presentations
A poster titled, "Echocardiographic Detection of Increases in Ejection Fraction in Patients with Heart Failure Receiving the Selective Cardiac Myosin Activator, CK-1827452" was presented on Monday, August 31, 2009 by Andrew A. Wolff, MD, FACC, Senior Vice President of Clinical Research and Development and Chief Medical Officer, Cytokinetics, Inc., South San Francisco. This poster included three analyses of the effect of omecamtiv mecarbil on ejection fraction. In one analysis, ejection fraction was calculated from two ventricular volumes assessed by the traditional, image-based biplane Method of Discs; in two other analyses, ejection fraction was calculated by each of two different hybrid methods that use a measurement of stroke volume based on Doppler interrogation of the left ventricular outflow tract and a single assessment of ventricular volume by the Method of Discs. In all three analyses, ejection fraction increased with the plasma concentration of omecamtiv mecarbil; however, increases of greater magnitude were observed with the hybrid methods. Ejection fraction assessed by the hybrid methods correlated better with systolic ejection time than did ejection fraction assessed by the Method of Discs. Ejection fraction by the hybrid method based on left ventricular end-systolic volume was slightly better-correlated with systolic ejection time than the hybrid ejection fraction based on left ventricular end-diastolic volume.
A poster titled, "Phase II Safety Study Evaluating the Novel Cardiac Myosin Activator, CK-1827452, in Patients with Ischemic Cardiomyopathy and Angina" was presented on Monday, August 31, 2009 by Andrew A. Wolff, MD, FACC, Senior Vice President of Clinical Research and Development and Chief Medical Officer, Cytokinetics, Inc., South San Francisco. This poster presentation included data from a double-blind, randomized, placebo-controlled Phase IIa clinical trial evaluating the effect of omecamtiv mecarbil on symptom-limited exercise tolerance in heart failure patients with ischemic cardiomyopathy and angina, and included a detailed public disclosure of specific adverse events in the trial. Previously, at the 2009 Heart Failure Congress of the European Society of Cardiology, held in Nice, France, Barry H. Greenberg, MD, Chair of the Safety Review Committee for this clinical trial and Director, Advanced Heart Failure Treatment Program, University of California, San Diego Medical Center, presented a poster summarizing the data from this clinical trial. The primary safety endpoint of this clinical trial was stopping an exercise treadmill test, performed during double-blind therapy with omecamtiv mecarbil or placebo, due to angina at a stage earlier than the shorter of two baseline exercise treadmill tests. This endpoint occurred in one patient receiving placebo and in no patients receiving either the lower or higher of two dose levels of omecamtiv mecarbil.
