Cytokinetics, Inc. : Cytokinetics Provides Update on BENEFIT-ALS

       Cytokinetics, Inc. : Cytokinetics Provides Update on BENEFIT-ALS

South San Francisco, CA,  July 8, 2013  - Cytokinetics, Incorporated  (Nasdaq: 
CYTK) announced  today  an  update  on the  conduct  of  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).

BENEFIT-ALS is currently designed to enroll  up to 500 patients with ALS.  To 
date, over  450 patients  have been  enrolled  in this  study.   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 was  recently  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.

Since the error was detected,  the company has taken  steps to ensure that  no 
further incorrect study  drug assignments  have occurred  and the  programming 
error in the electronic data capture system controlling study drug  assignment 
has been corrected. In  addition, the company recently  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.

Cytokinetics is  in communication  with regulatory  authorities regarding  how 
best to respond  to the  error in  drug assignment  in order  to preserve  the 
intended scientific value  of BENEFIT-ALS.  The company  continues to  enroll 
patients in the study under the current protocol and may amend the protocol to
allow increased enrollment. Following further communications with  regulatory 
authorities, Cytokinetics expects to provide updated guidance relating to  the 
conduct of BENEFIT-ALS, which may include revisions to the timing of  publicly 
available results from  the study as  well as  to the projected  costs of  the 

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 Phase  II 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 Cytokinetics'  discussions with regulatory  authorities 
and the outcomes of  those discussions; potential  amendments to the  protocol 
for  BENEFIT-ALS,  including  potential  changes  in  enrollment  limits;  the 
provision of further guidance with respect to the timing of publicly available
results from BENEFIT-ALS  and the projected  costs of the  study; the  design, 
enrollment, conduct and  results of  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: if the BENEFIT-ALS protocol is amended to increase enrollment,
it will  result  in  increased time  to  enroll  and complete  the  trial  and 
increased costs to  conduct the  trial, and Cytokinetics  may not  be able  to 
enroll patients in the  trial above the current  500-patient limit until  such 
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 

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


This announcement is distributed by Thomson Reuters on behalf of Thomson
Reuters clients.

The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and other
applicable laws; and
(ii) they are solely responsible for the content, accuracy and originality of
information contained therein.

Source: Cytokinetics, Inc. via Thomson Reuters ONE
Press spacebar to pause and continue. Press esc to stop.