ANAHEIM, Calif., July 24, 2013 /PRNewswire/ -- Questcor Pharmaceuticals, Inc. (NASDAQ: QCOR) announced today that patient screening will commence in connection with Questcor's Phase 2 Study to explore the safety and tolerability of H.P. Acthar® Gel (repository corticotropin injection) in patients with Amyotrophic Lateral Sclerosis (ALS). ALS -- often referred to as Lou Gehrig's disease -- is a progressive, degenerative disease affecting motor neurons. ALS is a serious debilitating disease that significantly alters one's quality of life. According to the ALS Association, the average life expectancy from the time of diagnosis for someone affected by this disorder is about two to five years.
The study will seek to enroll up to 40 patients in an 8-week randomized, open-label trial designed to explore the safety and tolerability of four dosing regimens of Acthar. Patients who successfully conclude the initial 8-week trial will then have the option to participate in a 28-week open-label extension with a 3-week taper and one week follow-up period. The study will also examine whether Acthar provides any functional improvement to ALS patients.
"Questcor has focused its expanding R&D efforts on devastating medical conditions for which patients are in need of new treatment options," said Dr. David Young, Questcor's Chief Scientific Officer. " We are continually understanding more about the mechanism of action of Acthar and how it might provide benefit to patients in need. Initial non-clinical research efforts provided us with data suggesting that Acthar may potentially provide therapeutic benefit to patients with ALS, leading us to conduct this important phase 2 study to further explore this possibility."
"In addition to this ALS trial, Questcor has on-going trials in idiopathic membranous nephropathy, systemic lupus erthymatosus, and diabetic nephropathy," continued Dr. Young. "These trials, combined with many mechanism of action studies and numerous Questcor-sponsored investigator initiated studies, are aimed at building the body of evidence surrounding the safety and efficacy of Acthar in both on-label and potential new indications."