Cytokinetics, Inc. : Cytokinetics Announces Initiation of First-Time-in-Humans, Phase I Clinical Trial of CK-2127107

          Cytokinetics, Inc. : Cytokinetics Announces Initiation of
          First-Time-in-Humans, Phase I Clinical Trial of CK-2127107

Second Drug Candidate from Cytokinetics' Fast Skeletal Muscle Activator
Begins Clinical Trial in Expanded Development Program

South San Francisco, CA, April  1, 2013 - Cytokinetics, Incorporated  (Nasdaq: 
CYTK) announced  today  the  initiation of  a  first-time-in-humans,  Phase  I 
clinical trial  of CK-2127107  in healthy  male volunteers.  Cytokinetics  is 
developing CK-2127107, a novel small  molecule activator of the fast  skeletal 
muscle troponin complex,  for the  potential improvement  of skeletal  muscle 
function in  diseases and  medical  conditions associated  with  neuromuscular 
dysfunction, muscular weakness,  and/or muscle fatigue.  Like tirasemtiv,  the 
lead drug  candidate from  the company's  skeletal muscle  activator  program, 
CK-2127107 slows  the rate  of calcium  release from  the regulatory  troponin 
complex of  fast skeletal  muscle fibers,  which sensitizes  the sarcomere  to 

CK-2127107 was discovered in connection  with Cytokinetics' optimization of  a 
different chemical  series  than  that which  produced  tirasemtiv,  which  is 
currently being evaluated in BENEFIT-ALS (Blinded Evaluation of  Neuromuscular 
Effects and Functional Improvement with Tirasemtiv in ALS). BENEFIT-ALS is an
international,  double-blind,   randomized,  placebo-controlled,   Phase   IIb 
clinical trial designed  to evaluate  the safety,  tolerability and  potential 
efficacy of tirasemtiv in patients  with amyotrophic lateral sclerosis  (ALS). 
Advancing CK-2127107 to Phase I evaluation in healthy subjects is  consistent 
with Cytokinetics'  corporate strategy  to  characterize a  potential  back-up 
compound to tirasemtiv in humans and to enable the evaluation of fast skeletal
muscle  troponin  activation  in  a   potentially  broader  set  of   clinical 

The Phase  I  clinical trial  of  CK-2127107 is  a  double-blind,  randomized, 
placebo-controlled study  designed to  assess  the safety,  tolerability,  and 
pharmacokinetics of single ascending oral doses of CK-2127107 administered  to 
healthy adult males in a three period, escalating dose, crossover design. The
primary objective of this study is to determine the safety and tolerability of
single doses of  CK-2127107 administered  orally to  healthy male  volunteers. 
The secondary objective is to evaluate the pharmacokinetic profile of  single 
doses of CK-2127107.

"This  first-time-in-humans  clinical  trial  of  CK-2127107  builds  on   our 
expertise in the biology of skeletal muscle function," stated Fady Malik,  MD, 
PhD, Cytokinetics'  Senior Vice  President,  Research and  Early  Development. 
"Advancing CK-2127107 provides  us an  opportunity to develop  a pipeline  of 
drug candidates focused on skeletal muscle weakness resulting from an array of
diseases associated with muscle wasting or primary neuromuscular dysfunction."

"The initiation of  this Phase I  clinical trial is  further demonstration  of 
Cytokinetics' commitment to build  a portfolio of  drug candidates with  novel 
mechanisms that leverage our expertise in the biology of the cytoskeleton  and 
our pioneering  pharmacology  associated with  muscle  contractility,"  stated 
Robert I. Blum,  Cytokinetics' President  and CEO. "CK-2127107  is the  sixth 
novel chemical  entity  that has  arisen  from our  research  and  development 
activities to proceed to human clinical testing."

Background on Fast Skeletal Muscle Activators

Skeletal muscle contractility is driven by the sarcomere, the fundamental unit
of skeletal muscle contraction. It is a highly ordered cytoskeletal structure
composed of several key proteins. The  first, skeletal muscle myosin, is  the 
cytoskeletal motor protein that converts chemical energy into mechanical force
through its interaction  with a second  protein, actin. A  set of  regulatory 
proteins, which includes tropomyosin and  several types of troponin, make  the 
actin-myosin interaction dependent on changes in intracellular calcium levels.
Cytokinetics'  skeletal  muscle  contractility  program  is  focused  to   the 
discovery and development of small molecule skeletal sarcomere activators  and 
leverages Cytokinetics'  expertise  gained  from  its  ongoing  discovery  and 
development of  cardiac sarcomere  activators,  including the  cardiac  myosin 
activator omecamtiv  mecarbil, now  in  Phase IIb  clinical development  as  a 
potential treatment  for  heart  failure. In  non-clinical  models,  skeletal 
sarcomere activators have demonstrated pharmacological activity that may  lead 
to new therapeutic options for diseases associated with aging, muscle wasting,
and neuromuscular  dysfunction.  The  clinical  effects  of  muscle  wasting, 
fatigue and loss of mobility can range  from decreased quality of life to,  in 
some  instances,  life-threatening   complications.  By  directly   improving 
skeletal muscle function, a small molecule activator of the skeletal sarcomere
may potentially enhance physical performance  and quality of life in  patients 
with conditions marked  by muscle weakness,  including neuromuscular  diseases 
such as  ALS,  myasthenia gravis,  cachexia,  sarcopenia and  general  frailty 
associated with aging.

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 and CK-2127107, both fast skeletal muscle activators, as
potential treatments  for  diseases  and medical  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

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 conduct, design and results of clinical trials, the significance
and utility  of  clinical trial  results,  and the  properties  and  potential 
benefits of Cytokinetics' skeletal muscle activators, including tirasemtiv and
CK-2127107,  and  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, 
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; 
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; 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.


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


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Source: Cytokinetics, Inc. via Thomson Reuters ONE
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