Primary Results from GALACTIC-HF to be Presented in Late Breaking Clinical Trial Session
Cytokinetics to Host Investor/Media Event and Webcast Related to GALACTIC-HF Results on November 13, 2020 at 1:00 PM ET
SOUTH SAN FRANCISCO, Calif., Nov. 06, 2020 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced six presentations at the American Heart Association (AHA) Scientific Sessions 2020, taking place online from November 13, 2020 – November 17, 2020, including the presentation of primary results from GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure), the Phase 3 event driven cardiovascular outcomes clinical trial of omecamtiv mecarbil, in a Late Breaking Clinical Trial session, as well as five poster presentations.
Results from GALACTIC-HF, one of the largest heart failure trials ever conducted, will be presented at a live, virtual, embargoed AHA News Briefing on Thursday, November 12, 2020 from 1:30-2:30 PM CT.
Late Breaking Clinical Trial Session
Title: Omecamtiv Mecarbil in Chronic Heart Failure With Reduced Ejection Fraction: The Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure (GALACTIC-HF) Trial
Session: LBS.01 - Heart Failure and Atrial Fibrillation: Vitamins, Minerals, Nutrients, and More
Speaker: John Teerlink, M.D., Professor of Medicine, University of California San Francisco, Director of Heart Failure, San Francisco Veterans Affairs Medical Center and Executive Committee Chair, GALACTIC-HF
Date: November 13, 2020
Presentation Time: 10:35 – 10:45 AM CT
Cytokinetics Investor/Media Event
Cytokinetics will host an investor/media event related to the results of GALACTIC-HF on November 13, 2020 at 1:00 PM ET that will be simultaneously webcast and can be accessed at https://wsw.com/webcast/cc/cytk/1388034 or by visiting the Investors & Media section of Cytokinetics’ website at www.cytokinetics.com. An archived replay of the virtual event will be available via Cytokinetics’ website until November 13, 2021. Members of Cytokinetics’ senior management will be joined by the following physician experts:
- John Teerlink, M.D., Professor of Medicine, University of California San Francisco, Director of Heart Failure, San Francisco Veterans Affairs Medical Center and Executive Committee Chair, GALACTIC-HF
- G. Michael Felker, M.D., M.H.S, Professor of Medicine, Vice-Chief of Cardiology for Clinical Research, Duke University School of Medicine and Director of Cardiovascular Research, Duke Clinical Research Institute
- Scott Solomon, M.D., Edward D. Frohlich Distinguished Chair, Professor of Medicine, Harvard Medical School and Director of Noninvasive Cardiology, Brigham and Women's Hospital
- Nihar R. Desai, M.D., MPH, Associate Professor of Medicine, Associate Chief, Cardiovascular Medicine, Yale School of Medicine, Center for Outcomes Research and Evaluation
ePosters On Demand
The following posters will be available on demand from the start of the conference on November 13, 2020 at 9:00 AM CT until the end of the conference on November 17, 2020, 8:30 PM CT.
Title: The Cardiac Myosin Inhibitor, CK-3772271, Attenuates Cardiac Fibrosis and Diastolic Dysfunction in the Dahl/Salt Sensitive Rat Model of Heart Failure With Preserved Ejection Fraction
Session: MP.APS.05 - Heart Failure I
Presenter: Darren Hwee, Ph.D., Associate Director, Pharmacology, Cytokinetics
Poster Number: P1762
Title: Pharmacodynamic Effects of a Single Dose of CK-3773274 in Cats With Hypertrophic Cardiomyopathy
Session: CE.APS.01 - Protein Dysfunction in Heart Failure
Presenter: Joshua Stern, D.V.M., Ph.D., Associate Professor & Chief of Service: Cardiology, School of Veterinary Medicine, University of California, Davis
Poster Number: P756
Title: Demographic and Clinical Characteristics of Patients With Obstructive Hypertrophic Cardiomyopathy in a Large, Nationwide Us Cohort
Session: HF.APS.29 - Different Aspects of Hypertrophic Cardiomyopathy
Presenter: Michael Butzner, MPH, CCRP, HEOR Consultant, Cytokinetics
Poster Number: P1735
Title: Thirty Day Episode of Care Spending Following Heart Failure Hospitalization Among Medicare Beneficiaries With Heart Failure
Session: HF.APS.17 - Heart Failure Quality of Care and Process Improvement
Presenter: Nihar R. Desai, M.D., MPH, Yale University School of Medicine
Poster Number: P975
Title: Characteristics and Outcomes of Patients With Heart Failure With Reduced Ejection Fraction and a Worsening Heart Failure Event
Session: HF.APS.11 - Acute and Advanced Heart Failure
Presenter: Anthony P. Carnicelli, M.D., Duke Clinical Research Institute – DCRI
Poster Number: P427
Cytokinetics is a late-stage biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which muscle performance is compromised and/or declining. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact muscle function and contractility. Cytokinetics is collaborating with Amgen Inc. (Amgen) to develop omecamtiv mecarbil, a novel cardiac muscle activator. Omecamtiv mecarbil is the subject of an international clinical trials program in patients with heart failure including GALACTIC-HF, of which topline results were recently reported, and METEORIC-HF, which is ongoing. Amgen holds an exclusive worldwide license to develop and commercialize omecamtiv mecarbil with a sublicense held by Servier for commercialization in Europe and certain other countries. Cytokinetics is developing reldesemtiv, a fast skeletal muscle troponin activator (FSTA) for the potential treatment of ALS and other neuromuscular indications following conduct of FORTITUDE-ALS and other Phase 2 clinical trials. The company is considering potential advancement of reldesemtiv to Phase 3 pending ongoing regulatory interactions. Cytokinetics is collaborating with Astellas Pharma Inc. (Astellas) to research, develop and commercialize other novel mechanism skeletal sarcomere activators (not including FSTAs). Licenses held by Amgen and Astellas are subject to specified co-development and co-commercialization rights of Cytokinetics. Cytokinetics is also developing CK-274, a novel cardiac myosin inhibitor that company scientists discovered independent of its collaborations, for the potential treatment of hypertrophic cardiomyopathies. Cytokinetics has granted Ji Xing Pharmaceuticals Limited an exclusive license to develop and commercialize CK-274 in China and Taiwan, in accordance with Cytokinetics’ planned global registration programs. Cytokinetics is conducting REDWOOD-HCM, a Phase 2 clinical trial of CK-274 in patients with obstructive HCM. Cytokinetics continues its over 20-year history of pioneering innovation in muscle biology and related pharmacology focused to diseases of muscle dysfunction and conditions of muscle weakness.
For additional information about Cytokinetics, visit www.cytokinetics.com and follow us on Twitter, LinkedIn, Facebook and YouTube.
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 the GALACTIC-HF clinical trial, including the results thereof; statements relating to the METEORIC-HF clinical trial; the potential benefits of omecamtiv mecarbil, including its ability to represent a novel therapeutic strategy to increase cardiac muscle function and restore cardiac performance; the timing and likelihood of regulatory approval for omecamtiv mecarbil, Cytokinetics' and its partners' research and development activities; the design, timing, results, significance and utility of preclinical and clinical results; and the properties and potential benefits of 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, 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; Cytokinetics' drug candidates may have adverse side effects or inadequate therapeutic efficacy; the FDA or foreign regulatory agencies may delay or limit Cytokinetics' or its partners' ability to conduct clinical trials; Cytokinetics may be unable to obtain or maintain patent or trade secret protection for its intellectual property; the nature of Amgen's decisions with respect to the design, initiation, conduct, timing and continuation of development activities for omecamtiv mecarbil; 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.
Senior Vice President, Corporate Communications, Investor Relations
Source: Cytokinetics, Incorporated