Company Leadership Joins The ALS Association to Raise Awareness, Education and Funding for People With ALS and Their Caregivers
SOUTH SAN FRANCISCO, Calif., May 02, 2016 (GLOBE NEWSWIRE) -- Cytokinetics, Inc. (Nasdaq:CYTK) today announced that it will ring the Closing Bell at Nasdaq this afternoon in recognition of ALS Awareness Month and the company’s commitment to education, awareness, research and development activities focused to amyotrophic lateral sclerosis (ALS). Cytokinetics’ senior leadership team will be joined in this symbolic act by the leadership of the National, Golden West and New York Chapters of The ALS Association as well as people living with ALS and their loved ones.
“These are promising and hopeful times for both our company and the ALS community and we are honored to ring in ALS Awareness Month in recognition of the great strides we are taking to urgently advance the development of an investigational medicine for the potential treatment of ALS,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “We look forward to joining the ALS community on Capitol Hill next week to meet with government officials and advocate for increased education, awareness and funding on behalf of ALS patients and caregivers.”
Cytokinetics is evaluating tirasemtiv, a potential treatment for people living with ALS, in VITALITY-ALS, an international Phase 3 clinical trial designed to assess the effects of tirasemtiv versus placebo on slow vital capacity and other measures of skeletal muscle strength in patients with ALS. The trial is expected to enroll patients in more than 75 centers in 11 countries and is anticipated to complete enrollment in the second quarter of 2016.
In addition to clinical development, Cytokinetics is actively participating in initiatives led by The ALS Association involving leading clinicians, researchers, industry representatives and people living with ALS, to inform guidance to help accelerate the execution of ALS clinical trials through innovative design approaches, and to pave the way for faster approvals of new medicines for people living with ALS.
Cytokinetics entered into a research collaboration with Origent Data Sciences, Inc., a market leader in patient-level predictive modeling for neurological conditions including ALS, to refine and prospectively validate an Origent computer model to predict the course of ALS disease progression leveraging data from Cytokinetics’ clinical trials of tirasemtiv. Funded by Origent’s receipt of a grant from The ALS Association, this joint research program will enable the first prospective validation of the predictive model in a clinical trial setting. In addition, The ALS Association has awarded Cytokinetics a grant to support the collection of clinical data and plasma samples to advance the discovery of biomarkers in ALS. The collaboration between Cytokinetics, The ALS Association, and the Barrow Neurological Institute will enable plasma samples collected from patients enrolled in VITALITY-ALS to be added to The Northeastern ALS Consortium (NEALS) Repository, a resource for the academic community to identify biomarkers that may help to assess disease progression and underlying disease mechanisms in ALS.
Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease that afflicts approximately 25,000 people in the United States and a comparable number of patients in Europe. Approximately 5,600 new cases of ALS are diagnosed each year in the United States. The average life expectancy of an ALS patient is approximately three to five years after diagnosis and only 10% of patients survive for more than 10 years. Death is usually due to respiratory failure because of diminished strength in the skeletal muscles responsible for breathing. Few treatment options exist for these patients, resulting in a high unmet need for new therapies to address functional deficits and disease progression.
Tirasemtiv, a novel skeletal muscle activator, selectively activates the fast skeletal muscle troponin complex by increasing its sensitivity to calcium and, in preclinical studies and early clinical trials, demonstrated increases in skeletal muscle force in response to neuronal input and delays in the onset and reductions in the degree of muscle fatigue. Tirasemtiv has been studied in clinical trials that have enrolled over 1000 people internationally. Tirasemtiv is the subject of a Phase 3 clinical trial program designed to confirm and extend findings on measures of respiratory function and muscle strength from prior studies.
Cytokinetics is a late-stage biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators 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 increase muscle function and contractility. Cytokinetics’ lead drug candidate is tirasemtiv, a fast skeletal muscle activator, for the potential treatment of ALS. Tirasemtiv 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 ALS. Cytokinetics retains the right to develop and commercialize tirasemtiv. Cytokinetics is collaborating with Amgen Inc. to develop omecamtiv mecarbil, a novel cardiac muscle activator, for the potential treatment of heart failure. Cytokinetics is collaborating with Astellas Pharma Inc. to develop CK-2127107, a fast skeletal muscle activator, for the potential treatment of spinal muscular atrophy and chronic obstructive pulmonary disease. Amgen holds an exclusive license worldwide to develop and commercialize omecamtiv mecarbil and Astellas holds an exclusive license worldwide to develop and commercialize CK-2127107. Both licenses are subject to Cytokinetics’ specified development and commercialization participation rights. For additional information about Cytokinetics, visit 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’ and its partners’ research and development activities, including the initiation, conduct, design, enrollment, progress, continuation, completion and results of clinical trials, the significance and utility of preclinical study and clinical trial results; the expected availability of clinical trial results; and the properties and potential benefits of Cytokinetics' 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 further clinical development of tirasemtiv in ALS patients which will require significant additional funding, and Cytokinetics may be unable to obtain such additional funding on acceptable terms, if at all; the FDA and/or other regulatory authorities may not accept effects on slow vital capacity as a clinical endpoint to support registration of tirasemtiv for the treatment of ALS; 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; and patient enrollment for or conduct of clinical trials may be difficult or delayed. For further information regarding these and other risks related to Cytokinetics' business, investors should consult 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.
Vice President, Corporate Communications, Investor Relations