Preliminary results from Remedy Pharmaceuticals' RP-1127 Phase 2 trial on stroke

Each year, over 700,000 people in the United States suffer a stroke. For most, medical science can do very little. Some will die; a number will suffer debilitating aftereffects. Now, preliminary results of a Phase 2 clinical trial using Remedy Pharmaceuticals' new drug, RP-1127, presented at the 2012 International Stroke Conference in New Orleans on February 2, offer hope to many of these patients.

The study, GAMES-Pilot, is designed to test the drug RP-1127 in patients with severe stroke - those likely to develop significant brain swelling - which, based on historical data, if left untreated, would lead to death or severe disabilities.

Results of the GAMES-Pilot turn these dire statistics on their heads: incidence of major swelling was a remarkable 12.5% versus 88% in the historical group, no significant hemorrhages were found in any of the patients, versus 30% in the historical group, and most telling, the proportion of patients without severe disability/death at 30 days was an astounding 87.5% versus one-third in the historical group.

As further proof, follow up Magnetic Resonance Imaging (MRI) on the patients have been notable for qualitative findings: absence of midline shift and ventricle compression, striking preservation of sulci, and preservation of white matter - all very positive indicators for improved recovery.

"The data from the GAMES-Pilot study in critically ill stroke patients are compelling," notes Dr. Kevin Sheth of the University of Baltimore Hospital and the Principal Investigator of the study. "The neuroimaging and clinical findings give reason to have hope for a treatment that may save lives, prevent brain surgery, and result in improved outcomes."

"The images presented from the study are remarkable," says Dr. W. Taylor Kimberly from Massachusetts General Hospital, whose institution is involved in the trial. "They show a complete lack of swelling that normally takes place. Although this is an open label study, it's very unusual to see this level of improvement in patients with these severities of stroke."

"In recent years, medical science has made many breakthrough discoveries particularly in cancer and heart disease. Yet for stroke, the third leading killer in America, only thrombolysis has been approved as a treatment," says Dr. Eugene Means, Remedy's Medical Director, continuing, "Data reported from the GAMES-Pilot Study would suggest that we may be close to identifying a potentially effective therapy."

"No one before has shown utility of a drug in treating large strokes, and armed with these data, we will push forward aggressively on multiple fronts" exclaims Sven Jacobson, CEO of Remedy Pharmaceuticals, the sponsor of the GAMES-PILOT study.