Preliminary results of a phase 2 clinical trial using Remedy Pharmaceuticals’ new drug, RP-1127, presented at the 2012 International Stroke Conference, have shown positive results in the treatment of patients with severe stroke, prompt to develop significant brain swelling.
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 shows 12.5% incidence of major swelling in the group treated with RP-1127 vs. 88% in the historical group. No significant haemorrhages were found in any of the patients, versus 30% in the historical group, and the proportion of patients without severe disability/death at 30 days was 87.5% versus one-third in the historical group.
Follow-up with magnetic resonance imaging has shown 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,” said Kevin Sheth, 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,” said W Taylor Kimberly, Massachusetts General Hospital—institution involved in the trial. “They show a complete lack of swelling that normally takes place. Although this is an open label study, it is 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,” said 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.”
Detailed information on the GAMES Pilot study is available at: http://clinicaltrials.gov/ct2/show/NCT01268683
Remedy’s lead drug candidate, RP-1127, is a high affinity, well tolerated inhibitor of NCCa-ATP channels, which are key upstream mediators of the development of brain swelling (edema) and haemorrhage following ischaemic and traumatic injury.