Cytokinetics, Inc. : Cytokinetics Provides Additional Update and Revised Guidance For BENEFIT-ALS

   Cytokinetics, Inc. : Cytokinetics Provides Additional Update and Revised
                           Guidance For BENEFIT-ALS

Protocol Amended to Preserve the Intended Scientific Value of the Clinical

Patient Enrollment Expected to Conclude in 2013 and Results Expected in Early

South San Francisco,  CA, July 23,  2013 -Cytokinetics, Incorporated  (Nasdaq: 
CYTK) announced today an  amendment to the  protocol for BENEFIT-ALS  (Blinded 
Evaluation of Neuromuscular Effects and Functional Improvement with Tirasemtiv
in ALS). BENEFIT-ALS is a Phase IIb, multinational, double-blind,  randomized, 
placebo-controlled  clinical   trial   designed  to   evaluate   the   safety, 
tolerability and  potential efficacy  of tirasemtiv,  a fast  skeletal  muscle 
troponin activator, in patients with amyotrophic lateral sclerosis (ALS).  The 
primary analysis of BENEFIT-ALS will compare the mean change from baseline  in 
the ALS Functional Rating Scale in its revised form, or ALSFRS-R (a clinically
validated instrument designed  to measure disease  progression and changes  in 
functional status), in  patients receiving tirasemtiv  versus those  receiving 

Cytokinetics recently  announced  that  it  had  been  informed  by  its  data 
management vendor  that a  programming error  in the  electronic data  capture 
system  controlling  study  drug  assignment  caused  58  patients   initially 
randomized to and  treated with  tirasemtiv to  receive placebo  instead at  a 
certain study visit and for the remainder of the study. No patients randomized
to placebo were dispensed incorrect treatment. Cytokinetics and all  clinical 
trial site personnel remain blinded to  the specific patients affected by  the 
error. Following detection of the error, the company took steps to ensure that
no further  incorrect  study drug  assignments  occurred and  to  correct  the 
programming error in the electronic data capture system controlling study drug
assignment. In addition, the company convened an ad hoc meeting of the study's
Data Safety Monitoring Board (DSMB) to assess whether the error in  dispensing 
study drug had impacted the safety  of the 58 affected patients. After  review 
of the relevant safety  data from BENEFIT-ALS, the  DSMB reported no  concerns 
regarding patient safety.

Following interactions with regulatory  authorities, Cytokinetics amended  the 
protocol for BENEFIT-ALS to enable  increased enrollment to approximately  680 
patients and to update the statistical methods section, in both cases with the
objective to maintain the originally intended statistical power of the  trial. 
To date, over 500 patients have been enrolled in BENEFIT-ALS. Enrollment  is 
expected to  continue  as the  new  protocol amendment  becomes  effective  at 
participating investigative  centers. The  company  now expects  to  complete 
patient enrollment in BENEFIT-ALS during the second half of 2013, with results
to be available in early 2014.  These changes to BENEFIT-ALS are expected  to 
increase the direct clinical trial costs  by approximately $5 million in  2013 
and 2014. 

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 to develop and commercialize omecamtiv mecarbil and  related 
compounds,   subject    to    Cytokinetics'    specified    development    and 
commercialization  participation   rights.   Cytokinetics   is   independently 
developing tirasemtiv,  a  fast  skeletal muscle  activator,  as  a  potential 
treatment for diseases  and medical conditions  associated with  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  earlier   Phase  IIa  trials.  Cytokinetics   is 
collaborating with  Astellas Pharma  Inc. to  develop CK-2127107,  a  skeletal 
muscle activator structurally distinct from tirasemtiv, for  non-neuromuscular 
indications. 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

Forward-Looking Statements 

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  the  objectives   of  the  protocol  amendment   for 
BENEFIT-ALS to maintain the originally intended statistical power and preserve
the intended scientific value  of the trial;  the design, enrollment,  conduct 
and results  of  BENEFIT-ALS;  the  expected  timing  for  the  completion  of 
enrollment  and  availability  of  results  from  BENEFIT-ALS;  the   expected 
additional costs to conduct BENEFIT-ALS;  the effectiveness of steps taken  to 
prevent further  occurrences  of  incorrect study  drug  assignment;  and  the 
properties and  potential benefits  of  Cytokinetics' 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: Cytokinetics may not be able to enroll additional patients  in 
BENEFIT-ALS  until  the  protocol   amendment  is  implemented;   Cytokinetics 
anticipates that it  will be  required to  conduct at  least one  confirmatory 
Phase III clinical  trial of  tirasemtiv in  ALS patients  which will  require 
significant additional funding, and it may be unable to obtain such additional
funding on acceptable terms,  if at all; 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; 
Cytokinetics may incur unanticipated research and development and other  costs 
or be unable to obtain  additional financing necessary to conduct  development 
of its products; 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' most  recent  Quarterly  Report  on Form  10-Q  filed  with  the 
Securities and Exchange Commission.

Cytokinetics, Incorporated:                       
Joanna L. Goldstein   
Manager, Investor Relations & Corporate Communications
(650) 624-3000


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Source: Cytokinetics, Inc. via Thomson Reuters ONE
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