Results From Two Completed Studies Support Further Clinical Development
SOUTH SAN FRANCISCO, CA -- (Marketwire) -- 06/01/09 -- Cytokinetics, Incorporated (NASDAQ: CYTK) announced today that data from two Phase IIa clinical trials
evaluating CK-1827452 were presented in the Late Breaking Trials Session
and in two poster presentations at the 2009 Heart Failure Congress of the
European Society of Cardiology, held May 30-June 2, 2009 in Nice, France.
The company believes these results support further clinical development of
CK-1827452. Amgen Inc. has exercised its option and has obtained an
exclusive, world-wide (except Japan) license to CK-1827452, subject to
specified development and commercialization participation rights retained
by Cytokinetics.
"I am pleased to have the opportunity to present these data from the first
Phase IIa clinical trial of this novel mechanism compound in a Late
Breaking Session at the 2009 Heart Failure Congress of the European Society
of Cardiology. This rigorously conducted trial of CK-1827452 has generated
interesting results consistent with the novel mechanism of action of this
drug and support its further development as a possible treatment for
patients with heart failure," stated Dr. John McMurray MD, FACC, FRCP,
FESC, Professor of Medical Cardiology at the University of Glasgow in
Glasgow, Scotland, United Kingdom.
"Data from these key Phase IIa clinical trials evaluating CK-1827452
support our therapeutic hypothesis for this potentially important new drug
candidate in this complex disease population," stated Andrew A. Wolff, MD,
FACC, Cytokinetics' Senior Vice President of Clinical Research and
Development and Chief Medical Officer. "We believe these two clinical
trials, together with others we have conducted with CK-1827452, have
established a solid basis for further clinical development."
Late Breaking Trials Session
A Late Breaking Trials presentation titled "The Selective Cardiac Myosin
Activator, CK-1827452, Increases Systolic Function in Heart Failure" was
presented on Monday, June 1, by John McMurray, MD, FACC, FRCP, FESC,
Professor of Medical Cardiology at the University of Glasgow in Glasgow,
Scotland, United Kingdom. The clinical trial was multi-center,
double-blind, randomized, and placebo-controlled. Its primary objective
was to evaluate the safety and tolerability of CK-1827452 administered as
an intravenous infusion to stable heart failure patients. Its secondary
objectives were to establish a relationship between plasma concentration
and pharmacodynamic effect of CK-1827452 and to determine the
pharmacokinetics of CK-1827452 in this population. Overall, a total of 151
treatment periods were initiated in 45 patients.
The authors concluded that CK-1827452 significantly increases systolic
ejection time, stroke volume, and ejection fraction calculated by a hybrid
method employing Doppler-derived stroke volume in a concentration dependent
manner. Statistically significant increases were demonstrated in systolic
ejection time at plasma concentrations greater than 100 ng/mL, in stroke
volume at plasma concentrations greater than 200 ng/mL, and in hybrid
ejection fraction at plasma concentrations greater than 300 ng/mL. At
plasma concentrations greater than 400 ng/mL, increases in stroke volume
appeared to plateau in association with a concentration-dependent decline
in heart rate. In addition, the data demonstrated statistically
significant correlations between increasing CK-1827452 plasma concentration
and decreases in left ventricular end-systolic volume and left ventricular
end-diastolic volume. For the patients that were tolerant of all study
drug infusions, no consistent pattern of adverse events with either dose or
duration of infusion emerged.
This presentation included the first public disclosure of analyses showing
that patients with reduced stroke volumes ( < 50 mL) at baseline had
pharmacodynamic responses to CK-1827452 that were generally greater than
those in patients with greater stroke volumes at baseline, demonstrating
robust pharmacodynamic activity in this more severely affected
sub-population of patients from the study. The authors concluded that
these findings support further study and translation of this novel
mechanism into patients with 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 displayed on Sunday, May 31, 2009 and was
presented by Jonathan H. Goldman, MD, FACC, Chief Medical Officer, ICON
Medical Imaging, Warrington, PA. This poster included the first public
disclosure of analyses comparing the effect of CK-1827452 on ejection
fraction calculated from two ventricular volumes assessed by the biplane
Method of Discs and two 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.