Cytokinetics Announces First Patient Enrolled in VIGOR-ALS, an Open-Label Extension Clinical Trial of Tirasemtiv
Eligible Patients Have Completed Participation in Phase 3 Clinical Trial VITALITY-ALS
Style Magazine Newswire | 10/18/2016, 9:45 a.m.
SOUTH SAN FRANCISCO, Calif., Oct. 18, 2016 (GLOBE NEWSWIRE) -- Cytokinetics, Inc. (Nasdaq:CYTK) today announced the first patient has been enrolled in VIGOR-ALS (Ventilatory Investigations in Global Open-Label Research in ALS), an open-label extension clinical trial designed to assess the long-term safety and tolerability of tirasemtiv, in patients with ALS who have completed their participation in VITALITY-ALS, the Phase 3 clinical trial designed to assess the effects of tirasemtiv versus placebo on slow vital capacity (SVC) and other measures of respiratory and skeletal muscle function.
“People living with ALS desperately need new therapies and VIGOR-ALS reflects our commitment to the patients that participated in VITALITY-ALS and who contributed enormously to the development of a potential new medicine for patients with ALS,” said Fady I. Malik, MD, PhD, Cytokinetics’ Executive Vice President, Research & Development. “This trial will provide supplemental data on the effects of long-term use of tirasemtiv.”
VIGOR-ALS is an open-label extension trial of tirasemtiv in patients with ALS who completed participation in VITALITY-ALS. The primary endpoint of the trial is the incidence of adverse events in the patient population. Secondary endpoints include the time to events such as death or the first use of assisted ventilation or respiratory insufficiency (defined as tracheostomy or the use of non-invasive ventilation for ≥22 hours per day for ≥10 consecutive days); decline from baseline in percent predicted slow vital capacity (SVC), ALS functional rating scale-revised (ALSFRS-R); and the slope of change from baseline in percent predicted SVC and ALSFRS-R. Following enrollment, patients will begin dosing of tirasemtiv 125 mg twice daily (250 mg/day) for a period of 4 weeks and will titrate to their maximum tolerated dose (based on tolerability), to no higher than 250 mg twice daily (500 mg/day). Additional information on the trial can be found at clinicaltrials.gov.
Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease that afflicts approximately 30,000 people in the United States and a comparable number of patients in Europe. Approximately 6,000 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 percent 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 currently the subject of VITALITY-ALS, a Phase 3 clinical trial, designed to confirm and extend findings on measures of respiratory function and muscle strength from prior studies.