Cytokinetics, Inc. : Cytokinetics Announces Opening of COSMIC-HF, a Phase II Clinical Trial of Oral Formulations of Omecamtiv

 Cytokinetics, Inc. : Cytokinetics Announces Opening of COSMIC-HF, a Phase II
  Clinical Trial of Oral Formulations of Omecamtiv Mecarbil in Patients with
                                Heart Failure

South San  Francisco,  CA,  February 12,  2013  -  Cytokinetics,  Incorporated 
(Nasdaq: CYTK)  announced  today the  opening  to  enrollment of  a  Phase  II 
clinical trial of oral formulations of omecamtiv mecarbil. This trial,  known 
as  COSMIC-HF  (Chronic   Oral  Study   of  Myosin   Activation  to   Increase 
Contractility in Heart Failure), is  sponsored by Amgen in collaboration  with 
Cytokinetics and is designed  to evaluate the safety  and efficacy of a  novel 
cardiac muscle myosin activator, omecamtiv  mecarbil, in patients with  heart 
failure and left ventricular systolic dysfunction.

"We are pleased that  this international Phase II  clinical trial designed  to 
evaluate several  oral  formulations of  omecamtiv  mecarbil is  now  open  to 
enrollment," stated  Andrew  A. Wolff,  MD,  FACC, Cytokinetics'  Senior  Vice 
President of Clinical Research and Development and Chief Medical Officer. "The
objective  of   this  trial   is  to   identify  and   characterize  an   oral 
modified-release formulation of omecamtiv mecarbil that may progress into  the 
Phase III clinical program. The data from COSMIC-HF, in combination with  the 
data from  the ongoing  ATOMIC-AHF clinical  trial evaluating  an  intravenous 
formulation of  omecamtiv  mecarbil,  will  contribute  to  the  design  of  a 
potential registration program for this drug candidate."

Amgen holds an  exclusive, worldwide  license (excluding  Japan) to  omecamtiv 
mecarbil  and  related  compounds,   subject  to  specified  development   and 
commercialization participation rights of Cytokinetics.

COSMIC-HF: Phase II Clinical Trial of Omecamtiv Mecarbil:

OSMIC-HF is a double-blind, randomized, placebo-controlled, multicenter,  dose 
escalation study  designed to  select and  evaluate an  oral  modified-release 
formulation of  omecamtiv mecarbil  in patients  with heart  failure and  left 
ventricular  systolic  dysfunction.   During  the   dose  escalation   phase, 
approximately 40 patients  will be  randomized 1:1:1:1  to placebo  or one  of 
three different  oral  formulations  of  omecamtiv mecarbil  in  each  of  two 
ascending dose  pharmacokinetic (PK)  cohorts to  enable selection  of one  of 
these oral formulations  for the planned  expansion phase of  the trial.  The 
dose of omecamtiv mecarbil will  be 25 mg twice daily  in the first PK  cohort 
and 50 mg twice daily in the second PK cohort. Following the dose  escalation 
phase of the trial, there is a  planned expansion phase of the trial in  which 
approximately 300  patients  will be  randomized  1:1:1 to  receive  one  oral 
formulation of omecamtiv mecarbil selected from the three studied in the prior
ascending dose PK cohorts at one of two dose levels or placebo. The two  dose 
levels of omecamtiv  mecarbil to be  studied in the  expansion cohort will  be 
based on the data from the ascending dose PK cohorts. The primary  objectives 
of this study are to select  an oral modified-release formulation and dose  of 
omecamtiv mecarbil  for chronic  twice  daily dosing  in patients  with  heart 
failure and  left ventricular  systolic dysfunction  and to  characterize  its 
safety, tolerability, and pharmacokinetics after  12 weeks of treatment.  The 
secondary objectives  are to  assess  the changes  from baseline  in  systolic 
ejection time,  stroke volume,  left ventricular  end-systolic diameter,  left 
ventricular  end-diastolic  diameter,  heart  rate  and  N-terminal  pro-brain 
natriuretic peptide  (a  biomarker  associated  with  the  severity  of  heart 
failure) after 12 weeks of treatment. 

ATOMIC-AHF: Phase IIb Clinical Trial of Intravenous Omecamtiv Mecarbil

ATOMIC-AHF is an  ongoing Phase  IIb clinical  trial designed  to evaluate  an 
intravenous formulation of  omecamtiv mecarbil in  approximately 600  patients 
enrolled in 3  sequential, ascending-dose  cohorts. In  each cohort,  patients 
will be randomized 1:1 to omecamtiv mecarbil or placebo. The primary objective
of this trial is to evaluate the  effect of 48 hours of intravenous  omecamtiv 
mecarbil compared to placebo on dyspnea (shortness of breath) in patients with
left ventricular systolic  dysfunction hospitalized for  acute heart  failure. 
The secondary objectives are to assess  the safety and tolerability of 3  dose 
levels of intravenous omecamtiv mecarbil compared with placebo and to evaluate
the effects of 48  hours of treatment with  intravenous omecamtiv mecarbil  on 
additional measures  of  dyspnea,  patients'  global  assessments,  change  in 
N-terminal pro brain-type natriuretic peptide and short-term clinical outcomes
in these  patients. In  addition,  the trial  is evaluating  the  relationship 
between omecamtiv  mecarbil  plasma  concentrations and  these  parameters  in 
patients with acute heart failure.

Development Status of Omecamtiv Mecarbil

In 2012, Cytokinetics and Amgen reviewed data from a prior Phase I randomized,
open-label, 4-period cross-over clinical trial designed to assess the  safety, 
tolerability and pharmacokinetics of  multiple oral formulations of  omecamtiv 
mecarbil in healthy volunteers. The formulations to be evaluated in COSMIC-HF
were selected from among those oral formulations. 

Prior to  the conduct  of the  ATOMIC-AHF  Phase IIb  and COSMIC-HF  Phase  II 
clinical trials,  omecamtiv mecarbil  was  the subject  of a  clinical  trials 
program conducted by Cytokinetics comprised of five Phase I trials in  healthy 
volunteers and two  Phase IIa  trials in  patients with  heart failure.  Those 
trials were designed to evaluate the safety, tolerability, pharmacodynamic and
pharmacokinetic  profiles  of  both  intravenous  and  oral  formulations   of 
omecamtiv mecarbil for the  potential treatment of  heart failure. Data  from 
each of these trials were reported previously.

About Cytokinetics

Cytokinetics is  a clinical-stage  biopharmaceutical  company focused  on  the 
discovery and development of novel  small molecule therapeutics that  modulate 
muscle function for the  potential treatment of  serious diseases and  medical 
conditions.  Cytokinetics'  lead  drug  candidate  from  its  cardiac   muscle 
contractility program, omecamtiv mecarbil, is in Phase II clinical development
for the potential treatment  of heart failure. Amgen  Inc. holds an  exclusive 
license worldwide  (excluding Japan)  to develop  and commercialize  omecamtiv 
mecarbil and related compounds, subject to Cytokinetics' specified development
and commercialization  participation  rights.  Cytokinetics  is  independently 
developing tirasemtiv, a skeletal muscle  activator, as a potential  treatment 
for  diseases  and  conditions  associated  with  aging,  muscle  wasting   or 
neuromuscular dysfunction. Tirasemtiv is currently  the subject of a Phase  II 
clinical trials program and has been granted orphan drug designation and  fast 
track status by  the U.S. Food  and Drug Administration  and orphan  medicinal 
product designation  by  the  European  Medicines  Agency  for  the  potential 
treatment  of  amyotrophic  lateral  sclerosis,  a  debilitating  disease   of 
neuromuscular  impairment  in   which  treatment   with  tirasemtiv   produced 
potentially clinically relevant  pharmacodynamic effects in  Phase II  trials. 
All of these drug  candidates have arisen  from Cytokinetics' muscle  biology 
focused research activities  and are  directed towards  the cytoskeleton.  The 
cytoskeleton is a complex biological  infrastructure that plays a  fundamental 
role within every human cell. Additional information about Cytokinetics can be
obtained at www.cytokinetics.com.

This press release  contains forward-looking  statements for  purposes of  the 
Private Securities Litigation  Reform Act  of 1995  (the "Act").  Cytokinetics 
disclaims any intent or obligation to update these forward-looking statements,
and claims  the  protection  of  the Act's  Safe  Harbor  for  forward-looking 
statements. Examples  of such  statements  include, but  are not  limited  to, 
statements relating  to Cytokinetics'  and  Amgen's research  and  development 
activities, including the  progress, conduct, design  and results of  clinical 
trials, the  significance  and utility  of  clinical trial  results,  and  the 
properties and  potential benefits  of  omecamtiv mecarbil  and  Cytokinetics' 
other drug candidates and potential drug candidates. Such statements are based
on management's current expectations, but actual results may differ materially
due to  various  risks  and  uncertainties, including,  but  not  limited  to, 
potential difficulties  or  delays  in the  development,  testing,  regulatory 
approvals  for   trial   commencement,   progression  or   product   sale   or 
manufacturing, or production of Cytokinetics' drug candidates that could  slow 
or prevent  clinical development  or product  approval, including  risks  that 
current and past results of clinical trials or preclinical studies may not  be 
indicative of  future  clinical  trials results,  patient  enrollment  for  or 
conduct of clinical  trials may  be difficult or  delayed, Cytokinetics'  drug 
candidates may have adverse side  effects or inadequate therapeutic  efficacy, 
the U.S. Food and Drug Administration or foreign regulatory agencies may delay
or limit Cytokinetics' or  its partners' ability  to conduct clinical  trials, 
and Cytokinetics may be  unable to obtain or  maintain patent or trade  secret 
protection for its  intellectual property; Amgen's  decisions with respect  to 
the design,  initiation,  conduct,  timing  and  continuation  of  development 
activities  for  omecamtiv  mecarbil;  Cytokinetics  may  incur  unanticipated 
research and development  and other costs  or be unable  to obtain  additional 
financing necessary  to  conduct development  of  its products  on  acceptable 
terms,  if  at  all;  Cytokinetics  may   be  unable  to  enter  into   future 
collaboration agreements for  its drug candidates  and programs on  acceptable 
terms, if at all; standards of  care may change, rendering Cytokinetics'  drug 
candidates obsolete;  competitive products  or  alternative therapies  may  be 
developed by  others  for  the treatment  of  indications  Cytokinetics'  drug 
candidates  and  potential   drug  candidates  may   target;  and  risks   and 
uncertainties relating  to  the  timing  and  receipt  of  payments  from  its 
partners, including milestones and royalties on future potential product sales
under Cytokinetics' collaboration agreements  with such partners. For  further 
information regarding these and other risks related to Cytokinetics' business,
investors  should  consult  Cytokinetics'  filings  with  the  Securities  and 
Exchange Commission.



Contact:
Joanna (Jodi) L. Goldstein
Manager, Corporate Communications & Marketing
(650) 624-3000

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