A more than three-fold reduction in mortality in patients ≤70 years old; adjudicated neurological mortality reduced more than three-fold, and death from edema reduced 10-fold.
Results Provide Additional Basis for Planned U.S. Phase 3 Trial in Large Hemispheric Stroke
NEW YORK, Feb. 22, 2016 (GLOBE NEWSWIRE) -- Remedy Pharmaceuticals, a privately-held, phase 3-ready pharmaceutical company focused on bringing life saving hospital-based treatment to people affected by central nervous system (CNS) related edema, today announced additional efficacy data from its Phase 2 trial of CIRARA™ for preventing edema (brain swelling) in patients with large hemispheric stroke. The results were presented by the study’s two principal investigators, Kevin N. Sheth, MD of Yale University and W. Taylor Kimberly, MD of Massachusetts General Hospital, in two oral presentations during the International Stroke Conference (ISC) 2016, held February 17-19, 2016 at the Los Angeles Convention Center in Los Angeles, California.
CIRARA is the Company’s lead product candidate for the treatment of CNS-related edema. The GAMES-RP study was a prospective double-blind, randomized, placebo-controlled Phase 2 trial comparing CIRARA to placebo. Top line results had previously been presented at the Neurocritical Care Society annual general meeting in October 2015 and announced by Remedy in a press release.
The additional analyses presented at ISC included adjudicated mortality, 6-month functional outcome data, and a post hoc analysis in patients 70 years or younger.
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Remedy Pharmaceuticals Announces Additional Results From Phase 2 CNS-Related Edema Study of CIRARA™ Presented at International Stroke Conference
Via: Yahoo! Finance