January 2012 - The ALS Association Greater Sacramento

ResearchPage 6Open Enrollment Announced for Cytokenetics CK-2017357 ALS Drug TrialCytokinetics, Incorporated, manufacturer of the FDA-designated orphan drug CK-2017357, recently announced that ithas opened enrollment in a third Phase II clinical trial for people with ALS. The primary objective of this phase of theclinical trial is to evaluate the safety and tolerability of CK-2017357. A secondary goal of the trial is to evaluate theALSFRS-R, other measures of pulmonary function, muscle strength and fatigue, relationships between dose, plasmaconcentrations 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, andpharmacological effects of multiple ascending doses of CK- 2017357. At this time, an estimated 24 patients with ALSwho are also receiving the drug riluzole are scheduled to be enrolled at approximately 10 study centers in the UnitedStates. 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, andparticipants 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 Symposiumon ALS/MND in Sydney, Australia. Results showed those in the trial tolerated the daily dosages of CK-2017357 withminimal side effects. Some recipients experienced mild dizziness during the initial phase of the treatment, but the dizzinessappeared to cease as dosing continued during the two-week treatment period.New Issue of Research ALS Today AvailableThe Fall 2011 issue of Research ALS Today is now available. Published twice a year, Spring and Fall, the magazineprovides articles and information about current ALS research and activities of The ALS Association. Manyof the articles are written by investigators, who are making progress in the search to answer important questionsabout amyotrophic lateral sclerosis. Research ALS Today is edited by ALS Association Chief ScientistLucie Bruijn, Ph.D., a former ALS research investigator who remains focused on the cutting edge of ALS research.This issue highlights resources and journal news and features the following topics:TREAT ALS Research PortfolioRNA ProcessingCall for Research AbstractsSafenowitz Post-Doctoral FellowshipsStrike Out ALS Wristbands are NOW IN STOCK!!After many requests the office now has “Strike Out ALS” wristbands in bothadult and children’s sizes. If you would like to order your “Strike Out ALS”wristbands for $1 each plus shipping costs please call Alycia at (916) 979-9265.For more information on ALS research please visit our website at www.alssac.org