Cytokinetics, Inc. : Cytokinetics Announces Update to Heart Failure Program

 Cytokinetics, Inc. : Cytokinetics Announces Update to Heart Failure Program

ATOMIC-AHF Has Completed Patient Enrollment;

Dosing of Patients in COSMIC-HF Has Initiated

South San Francisco, CA, March 18, 2013 - Cytokinetics, Incorporated  (Nasdaq: 
CYTK) announced today that ATOMIC-AHF has completed patient enrollment in  its 
third and final cohort. ATOMIC-AHF  (Acute Treatment with Omecamtiv  Mecarbil 
to Increase Contractility  in Acute  Heart Failure)  is a  Phase IIb  clinical 
trial designed  to  evaluate  the  safety, tolerability  and  efficacy  of  an 
intravenous formulation of omecamtiv mecarbil compared to placebo in  patients 
with left ventricular  systolic dysfunction  who are  hospitalized with  acute 
heart failure. Cytokinetics expects results from ATOMIC-AHF will be  announced 
in mid-year 2013.

Cytokinetics also announced that dosing of patients has initiated in COSMIC-HF
(Chronic Oral Study of  Myosin Activation to  Increase Contractility in  Heart 
Failure). COSMIC-HF is  a Phase II  clinical trial designed  to evaluate  the 
pharmacokinetics, safety and efficacy of oral modified release formulations of
omecamtiv mecarbil, in patients  with chronic, stable  heart failure and  left 
ventricular systolic dysfunction. 

Amgen holds an  exclusive, worldwide  license (excluding  Japan) to  omecamtiv 
mecarbil and related compounds, subject to Cytokinetics' specified development
and commercialization  participation  rights.  ATOMIC-AHF  and  COSMIC-HF  are 
conducted by Amgen in collaboration with Cytokinetics.

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 plasma concentrations  of omecamtiv mecarbil  and these parameters  in 
patients with acute heart failure.

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

COSMIC-HF is a double-blind, randomized, placebo-controlled, multicenter, dose
escalation study designed to assess the pharmacokinetics (PK) and tolerability
of three oral modified-release formulations of omecamtiv mecarbil in  patients 
with heart failure and  left ventricular systolic  dysfunction, and to  select 
one of  them  for  further  evaluation. 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  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.  If necessary, a  third PK cohort  will 
evaluate 75 mg twice daily. 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  (or doses)  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.

Development Status of Omecamtiv Mecarbil

In 2012, dosing initiated in a Phase I open-label, single-dose clinical  trial 
designed  to  evaluate  the  safety,  tolerability  and  pharmacokinetics   of 
omecamtiv mecarbil in  patients with various  degrees of renal  insufficiency, 
including patients requiring chronic hemodialysis. This trial is conducted by
Amgen in collaboration with  Cytokinetics.  Also,  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  under evaluation  in  COSMIC-HF  were 
selected from among those oral formulations.

Prior to the conduct of the ongoing trials including ATOMIC-AHF and COSMIC-HF,
omecamtiv mecarbil was the subject of  a clinical trials program conducted  by 
Cytokinetics and 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. 

Additional information  about trials  of omecamtiv  mecarbil can  be found  at 
www.clinicaltrials.gov.

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 L. Goldstein
Manager, Corporate Communications & Marketing
(650) 624-3000

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