Cytokinetics, Inc.: Cytokinetics Announces Additional Data from BENEFIT-ALS to be Presented at the 13th International Congress

Cytokinetics, Inc.: Cytokinetics Announces Additional Data from BENEFIT-ALS to   be Presented at the 13th International Congress on Neuromuscular Diseases  South San Francisco,  CA, July  3, 2014-  Cytokinetics, Incorporated  (Nasdaq:  CYTK)   announced    today    that   additional    data    from    BENEFIT-ALS  (BlindedEvaluation    ofNeuromuscularEffects     andFunctionalImprovement  withTirasemtiv in  ALS)  will  be  presented  during  a  poster  presentation  scheduled at the 13^th International Congress on Neuromuscular Diseases to  be  held July 5-10, 2014 at the Acropolis Convention Centre in Nice, France.  The  poster will include the first public presentation of the effects of tirasemtiv across patient subgroups on pre-specified secondary endpoints.  Poster Presentation  at the  13^th  International Congress  on  Neuromuscular  Diseases  Title: Novel Data from BENEFIT-ALS: Blinded Evaluation of Neuromuscular Effects and Functional Improvement with Tirasemtiv in Patients with Amyotrophic Lateral Sclerosis Presenter: Andrew Wolff, MD, FACC Date: Thursday, July 10, 2014 Presentation Time: 11:30 AM - 12:30 pm Central European Summer Time Poster Number: PS4-411 Abstract Number: 428  About Tirasemtiv and BENEFIT-ALS  Tirasemtiv, a novel skeletal muscle activator, is the lead drug candidate from Cytokinetics' skeletal  muscle  contractility  program.Tirasemtivselectively  activates  the  fast  skeletal  muscle  troponin  complex  by  increasing  its  sensitivity to calcium and, in preclinical studies, demonstrated increases  in  skeletal muscle force in  response to neuronal input  and delays in the  onset  and reductions in the degree of  muscle fatigue. BENEFIT-ALS was a Phase  IIb,  multinational, double-blind,  randomized,  placebo-controlled  clinical  trial  designed to  evaluate  the  safety, tolerability  and  potential  efficacy  of  tirasemtiv in patients with amyotrophic lateral sclerosis (ALS).  BENEFIT-ALS  did not achieve its primary efficacy  endpoint, the mean change from  baseline  in the ALS Functional  Rating Scale in its  revised form (ALSFRS-R);  however,  treatment  with  tirasemtiv  resulted  in  a  statistically  significant   and  potentially clinically  meaningful  reduction in  the  decline of  Slow  Vital  Capacity (SVC), a measure of the strength of the skeletal muscles  responsible  for breathing that  has been  shown to be  an important  predictor of  disease  progression  and  survival  in  prior  trials  in  patients  with  ALS.   The  statistically significant difference between  treatment groups in change  from  baseline in SVC  persisted through at  least 4  weeks after the  last dose  of  study drug. The analyses of other pre-specified secondary efficacy  endpoints  produced mixed results. Cytokinetics expects to continue to analyze the  data  from BENEFIT-ALS to inform the potential further development of tirasemtiv  in  patients living with ALS.  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 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 (ALS). 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  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' research  and  development  activities,  including  the  potential  significance  and  utility  of  the  results   from  preclinical  studies  and  clinical  trials  of  tirasemtiv;  planned  further  analyses of the results  from BENEFIT-ALS and the  potential outcomes of  such  analyses; potential further development of tirasemtiv; planned  presentations;  and the properties and potential benefits of skeletal muscle activators and of tirasemtiv and Cytokinetics' other 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,  the  results of  BENEFIT-ALS  may  not  support  further  clinical  development  of  tirasemtiv; further clinical  development of  tirasemtiv in  ALS patients,  if  supported  by  the  BENEFIT-ALS  data,  will  require  significant  additional  funding, and Cytokinetics 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;  Amgen's and  Astellas'  decisions  with respect  to  the  design,  initiation,  conduct, timing  and  continuation  of development  activities  for  omecamtiv  mecarbil and CK-2127107,  respectively; 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' filings  with  the Securities and Exchange Commission.  Contact: Joanna L. Goldstein Manager, Investor Relations & Corporate Communications (650) 624-3000  ------------------------------------------------------------------------------  This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients. The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein. Source: Cytokinetics, Inc. via Globenewswire HUG#1812290  
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