Cytokinetics Highlights Progress and Expansion of Development Programs at Today's Research and Development Day
"As we will elaborate today, Cytokinetics has leveraged our expertise focused to cytoskeletal biology and the pharmacology of muscle function to construct a preclinical and clinical pipeline of novel compounds directed to activating or inhibiting muscle contractility," stated Robert I. Blum, President and Chief Executive Officer of Cytokinetics. "We believe that our productive research and development activities have yielded a pipeline of multiple compounds that are specifically engineered to potentially address key liabilities of existing drugs. In particular, we believe each of our clinical programs focused to cardiac and skeletal muscle may have the potential to define new paradigms for the treatment of severe diseases that are increasingly amongst the major contributors to the mortality, morbidities and excessive costs associated with aging demographics."
Mr. Blum will be accompanied by Sharon Barbari, EVP Finance and Chief Financial Officer, David Morgans, Ph.D., EVP Preclinical Research and Development, Andrew Wolff, M.D., FACC, SVP Clinical Research and Development and Chief Medical Officer and Fady Malik, M.D., Ph.D., FACC, Vice President Biology and Therapeutics to discuss the status of the clinical and nonclinical programs. In addition, the Cytokinetics team will be joined by thought leaders who have been invited to provide additional commentary as follows: Barry Greenberg, M.D., Professor of Medicine at the University of California San Diego and Director of the Advanced Heart Failure Treatment Program at the University of California Medical Center in San Diego; Jeffrey Rothstein, M.D., Ph.D., Professor of Neurology and Neuroscience at Johns Hopkins University; and Roger A. Fielding, Ph.D. Director and Senior Scientist of the Nutrition, Exercise Physiology, and Sarcopenia Laboratory at the Jean Mayer USDA Human Nutrition Research Center on Aging at the Tufts University School of Medicine.
Research & Development Day Highlights:
Senior management is scheduled to highlight recent progress made with key programs:
Ongoing Research: Presentation of key objectives and results related to company's Research platform and new directions.
Omecamtiv mecarbil (formerly CK-1827452): Review of Phase IIa clinical trials data that the company believes support the advancement of this novel cardiac muscle myosin activator into additional clinical trials for the potential treatment of heart failure.
CK-2017357: Presentation of nonclinical data supporting the advancement of this skeletal muscle activator into the ongoing first-time-in-humans Phase I clinical trial, together with a presentation of plans for additional clinical trials of CK-2017357 in 2009 and 2010.
Smooth Muscle Program: Presentation of the company's extension of its expertise in muscle contractility to its research and development program focused to smooth muscle myosin inhibition and discussion of therapeutic applications that may arise from this program.
Financial Overview: Summary of expenditures tied to research and development programs and guidance for 2009.
Interested parties may access the live audio webcast of this presentation and accompanying slides by visiting the Investor Relations section of the Cytokinetics website at www.cytokinetics.com. The live audio of the forum will also be accessible by dialing either (866) 999-2985 (United States and Canada) or (706) 679-3078 (International) and typing in the passcode 28892340. The webcast replay of the presentation will be archived on the Presentations page within the Investor Relations section of Cytokinetics' website following the event. The replay will also be available via telephone from September 18, 2009 at 12:00 p.m. Eastern Time until September 30, 2009 by dialing (800) 642-1687 (United States and Canada) or (706) 645-9291 (International) and typing in the passcode 28892340.
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' cardiac muscle contractility program is focused on cardiac muscle myosin, a motor protein essential to cardiac muscle contraction. Cytokinetics' lead compound from this program, omecamtiv mecarbil (formerly CK-1827452), a novel small molecule cardiac muscle myosin activator, is in Phase II clinical trials for the potential treatment of heart failure. In May 2009, Amgen Inc. exercised an option to obtain an exclusive worldwide (excluding Japan) license to this program, which includes rights to develop and commercialize omecamtiv mecarbil and related compounds. Under this agreement, Amgen has assumed responsibility for development and commercialization of omecamtiv mecarbil and related compounds, at its expense, subject to specified development and commercialization participation rights of Cytokinetics. In June 2009, Cytokinetics initiated a Phase I clinical trial of CK-2017357, a fast skeletal muscle troponin activator, in healthy volunteers in the United States. CK-2017357 is being developed as a potential treatment for diseases and medical conditions associated with aging, muscle wasting, and neuromuscular dysfunction. In January 2009, Cytokinetics announced the selection of a potential drug candidate directed towards smooth muscle contractility. Cytokinetics' smooth muscle myosin inhibitors have arisen from research focused towards potential treatments for diseases and conditions, such as systemic hypertension, pulmonary arterial hypertension or bronchoconstriction.
Cytokinetics' cancer development programs are focused on mitotic kinesins, a family of motor proteins essential to cell division. Cytokinetics is developing two drug candidates from this program, ispinesib and SB-743921, each an inhibitor of kinesin spindle protein. In addition, Cytokinetics and GlaxoSmithKline are collaborating on research and development activities focused on GSK-923295, an inhibitor of centromere-associated protein E (CENP-E).
All of these drug candidates and potential drug candidates have arisen from Cytokinetics' 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' research and development programs, including planned clinical trials for omecamtiv mecarbil and CK-2017357, and the properties and potential benefits of Cytokinetics' drug candidates and potential drug candidates, and the potential of such drug candidates to establish new paradigms of treatment. 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 omecamtiv mecarbil or Cytokinetics' other drug candidates or potential 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, omecamtiv mecarbil or Cytokinetics' other drug candidates or potential 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, conduct, timing and continuation of development activities for omecamtiv mecarbil; GSK's decisions with respect to the design, conduct, timing and continuation of development activities for GSK-923295; Cytokinetics may incur unanticipated research and development and other costs or be unable to obtain additional financing necessary to conduct development of its products; standards of care may change rendering omecamtiv mecarbil or Cytokinetics' other drug candidates or potential drug candidates obsolete; others may introduce products or alternative therapies for the treatment of indications omecamtiv mecarbil or Cytokinetics' other drug candidates or potential drug candidates may target; and risks and uncertainties relating to the timing and receipt of payments from its partners, including reimbursements, 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: Christopher S. Keenan Director, Investor & Media Relations (650) 624-3000
SOURCE: Cytokinetics, Inc.