GAMES-RP is a Phase 2 randomized, double blind, placebo controlled, multi-center study of RP-1127 in patients with a severe ischemic stroke who are likely to experience clinically significant brain swelling, culminating in further ischemic damage, enlargement of the infarct, brain herniation, and death.
GAMES-RP was launched after the successful completion of a pilot trial (GAMES-Pilot) involving patients with severe stroke.
Based on historical data, if untreated, approximately 80% of GAMES-Pilot patients would have been expected to die or survive bedridden and incontinent, requiring constant nursing care. The GAMES-Pilot trial turned those dire statistics on their head, with only a 20 percent incidence rate.
GAMES-RP is currently recruiting at 12 centers across the US – Stanford University Medical Center, University of Louisville Hospital, University of Maryland Medical Center, Oregon Health & Science University Hospital, Cleveland Clinic, Northwestern Memorial Hospital, Massachusetts General Hospital, UMASS Memorial Medical Center, Medical University of South Carolina, Ohio State University Wexner Medical Center, Yale-New Haven Hospital, and Maine Medical Center.
The company is in active discussions with several additional sites. The trial is expected to be completed at the end of this year or early next year.
"Preliminary data indicates RP-1127 may be a life saving therapy," notes Sven Jacobson, Chief Executive Officer of Remedy, adding, "We’re extremely pleased that Broadview shares our desire to move RP-1127 to market rapidly so that this fragile patient population can at last be helped."
"It is particularly encouraging that Broadview are experts in this field." adds David Geliebter, Chairman of Remedy and Managing Partner of Carrot Capital. "Their advisors include Eugene Braunwald, MD; Eric A. Rose, MD; T. Forcht (Teo) Dagi, MD, DMedSc, MPH, MTS; and other luminaries, which further validates the work we have done to date and the potential we all see in RP-1127."
A poster presentation on GAMES-RP will be presented at the 2014 International Stroke Conference in February.
Remedy Pharmaceuticals will be presenting at the Neurotech Investing & Partnering Conference 2014 in Boston in April, and its CEO, Sven Jacobson will be participating in the conference’s "Traumatic Injury: Stroke and TBI" panel.