Cytokinetics to Present Clinical Trial Data Relating to Tirasemtiv in Patients with Amyotrophic Lateral Sclerosis
Pharmacokinetics and Drug Interactions Analyses to be Presented at the 23rd International Symposium on ALS/MND
South San Francisco, CA, November 29, 2012 - Cytokinetics, Incorporated (Nasdaq: CYTK) announced today that a platform presentation relating to tirasemtiv is scheduled to be presented at the 23rd International Symposium on ALS/MND to be held December 5-7, 2012 at the Sheraton Chicago Hotel and Towers Hotel in Chicago, IL. The presentation will include pharmacokinetics and drug-drug interaction analyses from previously-reported clinical trials of tirasemtiv in patients with amyotrophic lateral sclerosis.
Tirasemtiv is the lead drug candidate that has emerged from the company's skeletal muscle contractility program. Tirasemtiv selectively activates the fast skeletal muscle troponin complex by increasing its sensitivity to calcium, which increases skeletal muscle force in response to neuronal input and delays the onset and reduces the degree of muscle fatigue. Tirasemtiv is currently being evaluated in BENEFIT-ALS, an international, double-blind, randomized, placebo-controlled, Phase IIb clinical trial designed to evaluate the safety, tolerability and potential efficacy of this novel drug candidate in patients with amyotrophic lateral sclerosis.
Platform Presentation at the 23rd International Symposium on ALS/MND
Date: Thursday, December 6, 2012
Abstract Number: C45
Presentation Time: 11:00 AM - 11:15 AM (Central Standard Time)
Session: 7B - Clinical Trials and Trial Design
Title: Pharmacokinetics and Interactive Effects of the Fast Skeletal Muscle Activator CK-2017357 and Riluzole
Presenter: Jeffrey M. Shefner, M.D., Ph.D., Professor and Chair, Department of Neurology at the Upstate Medical University, State University of New York
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, a skeletal muscle activator, as a potential treatment for diseases and 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 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 planned presentations, and the properties and potential benefits of Cytokinetics' drug candidates and potential 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, potential difficulties or delays in the development, testing, regulatory approval and production of Cytokinetics' drug candidates and 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 and that Cytokinetics' drug candidates and potential drug candidates may have unexpected adverse side effects or inadequate therapeutic efficacy. For further information regarding these and other risks related to Cytokinetics' business, investors should consult Cytokinetics' filings with the Securities and Exchange Commission.
Jodi L. Goldstein
Manager, Corporate Communications & Marketing