Open Enrollment Announced for Cytokenetics CK-2017357 ALS Drug Trial

Cytokinetics, Incorporated, manufacturer of the FDA-designated orphan drug CK-2017357, recently announced that it has opened enrollment in a third Phase II clinical trial for people with ALS.  The primary objective of this phase of the clinical trial is to evaluate the safety and tolerability of CK-2017357.  A secondary goal of the trial is to evaluate the ALSFRS-R, other measures of pulmonary function, muscle strength and fatigue, relationships between dose, plasma concentrations and functional effects, and physician and patient global assessments in the participants.

This clinical trial is a double-blind, placebo-controlled, ascending dose study to evaluate the safety, tolerability, and pharmacological effects of multiple ascending doses of CK- 2017357.  At this time, an estimated 24 patients with ALS who are also receiving the drug riluzole are scheduled to be enrolled at approximately 10 study centers in the United States.  The trial’s participants will be randomized to one of two dosing groups and receive twice daily doses of CK-2017357 or a placebo.  Clinical assessments will occur at pre-determined times during the course of the treatment, and participants will also take part in follow-up evaluations one week after receiving their final dosage.

For information about enrollment, go to www.clinicaltrials.gov. Click on "Search for Clinical Trials" and enter "CK-2017357 and ALS."  After clicking on the title of the clinical trial and scrolling down to the "Contacts and Locations" section, you will see the names of the sites participating in the trial.  If one is convenient for you and is indicated as "Recruiting," you may contact that site directly or email jmasonek@cytokinetics.com for additional information.

In addition, Jeremy M. Shefner, M.D., Ph.D. made a presentation on CK-2017357 at the 22nd International Symposium on ALS/MND in Sydney, Australia.  Results showed those in the trial tolerated the daily dosages of CK-2017357 with minimal side effects.  Some recipients experienced mild dizziness during the initial phase of the treatment, but the dizziness appeared to cease as dosing continued during the two-week treatment period.