SOUTH SAN FRANCISCO, Calif., Nov. 26, 2018 (GLOBE NEWSWIRE) — Cytokinetics, Inc. (Nasdaq: CYTK) today announced five poster presentations at the 29th International Symposium on ALS/MND in Glasgow, Scotland, UK. The posters will be presented on Friday, December 7, 2018 and Saturday, December 8, 2018 and will include baseline characteristics and demographics from FORTITUDE-ALS, the Phase 2 clinical trial of reldesemtiv in patients with ALS, results of an analysis of the correlation between slow vital capacity (SVC) measured in home and in the clinic for people with ALS in FORTITUDE-ALS, additional analyses from VITALITY-ALS, the Phase 3 clinical trial of tirasemtiv in patients with ALS, and new results from IMPACT-ALS, a patient and caregiver survey conducted by The ALS Association Golden West Chapter and funded in part by Cytokinetics.
Friday, December 7, 2018 (All times listed below are local time in Glasgow)
Poster Session A
Title: Update on FORTITUDE-ALS: A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate Efficacy, Safety and Tolerability of Reldesemtiv in Patients with Amyotrophic Lateral Sclerosis
Presentation Time: 5:45 – 8:00 PM
Poster Moderated: 6:00 – 6:50 PM
Poster Number: CLT-24
Theme: CLT9, Clinical trials and clinical design
Poster Presenter: Jeremy M. Shefner, M.D., Ph.D, Professor and Chair of Neurology at Barrow Neurological Institute, and Professor and Executive Chair of Neurology at University of Arizona, Phoenix
Title: Correlation of SVC Measured at Home and Clinic in ALS
Presentation Time: 5:45 – 8:00 PM
Poster Moderated: 6:00 – 6:50 PM
Poster Number: CLT-04
Theme: CLT9, Clinical trials and clinical design
Poster Presenter: Stacy Rudnicki, M.D., Director, Clinical Research and Development, Cytokinetics
Title: VITALITY-ALS: Changes from Baseline in Percent Predicted SVC and ALSFRS-R Among Patients with Time from ALS Diagnosis < 6.1 Months
Presentation Time: 5:45 – 8:00 PM
Poster Moderated: 6:00 – 6:50 PM
Poster Number: CLT-22
Theme: CLT9, Clinical trials and clinical design
Poster Presenter: Andrew Wolff, M.D., Senior Vice President, Chief Medical Officer, Cytokinetics
Title: Non-Invasive Ventilation use in Patients Enrolled in VITALITY-ALS
Presentation Time: 5:45 – 8:00 PM
Poster Moderated: 6:00 – 6:50 PM
Poster Number: CLT-05
Theme: CLT9, Clinical trials and clinical design
Poster Presenter: Stacy Rudnicki, M.D., Director, Clinical Research and Development, Cytokinetics
Saturday, December 8, 2018
Poster Session B
Title: Updated Results from a US-Focused Online Survey of Patient and Caregiver Perspectives and Disease Burden in ALS
Presentation Time: 5:45 – 8:00 PM
Poster Moderated: 6:00 – 6:50 PM
Poster Number: EPI-29
Theme: 5, Epidemiology and Informatics
Poster Presenter: Amy Laverdiere, Director, New Product Planning & Business Analysis, Cytokinetics
About Cytokinetics
Cytokinetics is a late-stage biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and best-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 GALACTIC-HF, an international Phase 3 clinical trial in patients with heart failure. 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 also collaborating with Amgen to develop AMG 594, a first-in-class cardiac troponin activator, discovered under the companies’ joint research program. Further development of AMG 594 is subject to the collaboration agreement between Amgen and Cytokinetics. Cytokinetics is collaborating with Astellas Pharma Inc. (“Astellas”) to develop reldesemtiv, a fast skeletal muscle troponin activator (FSTA). Reldesemtiv has been granted orphan drug designation by the FDA for the potential treatment of spinal muscular atrophy. Reldesemtiv was the subject of a positive Phase 2 clinical study in patients with spinal muscular atrophy which showed increases in measures of endurance and stamina consistent with the mechanism of action. Reldesemtiv is currently the subject of a Phase 2 clinical trial in patients with amyotrophic lateral sclerosis. Cytokinetics is also advancing CK-601, a next-generation FSTA into IND-enabling studies under the collaboration with Astellas. Astellas holds an exclusive worldwide license to develop and commercialize reldesemtiv. Licenses held by Amgen and Astellas are subject to specified co-development and co-commercialization rights of Cytokinetics. Cytokinetics recently filed an IND for CK-274, a novel cardiac myosin inhibitor that company scientists discovered independent of its collaborations. Cytokinetics continues its 20-year history of pioneering innovation in muscle biology and related pharmacology focused to diseases of muscle dysfunction and conditions of muscle weakness.
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Forward-Looking Statements
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’ and its partners’ research and development activities of Cytokinetics’ product 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 risks related to Cytokinetics’ business outlined in Cytokinetics’ filings with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and Cytokinetics’ actual results of operations, financial condition and liquidity, and the development of the industry in which it operates, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that Cytokinetics makes in this press release speak only as of the date of this press release. Cytokinetics assumes no obligation to update its forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
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Cytokinetics
Diane Weiser
Vice President, Corporate Communications, Investor Relations
(415) 290-7757