Cytokinetics Announces New Data Presented at the International Symposium on ALS/MND
Patient Baseline Characteristics from VITALITY-ALS Comparable to BENEFIT-ALS Physician Survey Shows Regional Variability in Use of Noninvasive Ventilation
Style Magazine Newswire | 12/8/2016, 3:46 p.m.
SOUTH SAN FRANCISCO, Calif., Dec. 09, 2016 (GLOBE NEWSWIRE) -- Cytokinetics, Inc. (Nasdaq:CYTK) today announced that new data was presented at the 27th International Symposium on ALS/MND in Dublin, Ireland, including patient baseline characteristics from VITALITY-ALS and results of an international physician survey on the use of noninvasive ventilation (NIV) in the treatment of ALS.
VITALITY-ALS, a multi-national, randomized, double-blind, placebo-controlled 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 in patients with ALS, completed enrollment in August 2016. The trial screened 866 patients, enrolled 744 and randomized 566 patients.
Baseline characteristics of patients enrolled in VITALITY-ALS are similar to those from BENEFIT-ALS and other recently conducted clinical trials in patients with ALS. Patients enrolled in VITALITY-ALS are on average 57.6 years of age, 65 percent male, 7.7 months from diagnosis, 20.6 months from their first symptom and had an average percent predicted SVC of 90.7 percent. Like other trials of tirasemtiv, the most common adverse events (AEs) observed to date are dizziness, fatigue and nausea. Approximately 24 percent of patients withdrew from VITALITY-ALS during the two week open-label phase, primarily due to AEs, similar to what was observed during the first two weeks of tirasemtiv treatment in BENEFIT-ALS, the Phase 2 clinical trial of tirasemtiv in patients with ALS.
“We’re pleased to provide the first look at the patient population from VITALITY-ALS and note the consistency with previously conducted large-scale ALS trials,” said Jeremy M. Shefner, M.D., Ph.D., Lead Investigator of VITALITY-ALS, Professor and Chair of Neurology at Barrow Neurological Institute, and Professor and Executive Chair of Neurology at the University of Arizona, Phoenix. “We look forward to sharing full results from VITALITY-ALS in late 2017 and remain hopeful that treatment with tirasemtiv may slow the decline of SVC and other measures of muscle strength including measures of respiratory function.”
Vital Capacity Key Driver to Initiating Noninvasive Ventilation
Results of an international physician survey on the use of NIV in the treatment of ALS presented by Terry Heiman-Patterson, M.D., Director of the Center for Neurodegenerative Disorders, and Professor of the Department of Neurology at the Lewis Katz School of Medicine at Temple University, revealed similarities in best practices for initiating NIV in North America and Europe, yet differences in the time to initiation. Among ALS specialists including physicians, nurse practitioners, and physician assistants, US specialists rank upright FVC, supine FVC, and symptoms of orthopnea and/or dyspnea as the three most important factors influencing NIV initiation, while EU specialists prioritize symptoms of orthopnea and/or dyspnea, sleep-related symptoms, and supine SVC.
Regional variations were observed in the timing of NIV initiation, in part influenced by varying insurance coverage and regulations. In the US, 70 percent of specialists indicated that insurance regulations and national health care coverage impact time to NIV initiation, compared to 47.5 percent of EU specialists. The FVC/SVC value at which specialists reported initiating NIV also differed regionally, with many US specialists citing an upright FVC/SVC <50 percent vital capacity, and EU specialists more often initiating NIV at a higher upright FVC/SVC of <70 percent or <80 percent.