February 2013 First patient dosed in Phase I/IIa study evaluating RPh201 effect on behavior and brain activity in chronic vegetative patients21/02/13
After receiving approval from the Israeli Ministry of Health, a collaborative Phase I/IIa study in Chronic Vegetative State (CVS) patients has been initiated by Regenera Pharma and Hadassah Medical Organization (HMO).
The study investigators’ are Prof. Tamir Ben-Hur, M.D., Head of the Department of Neurology at Hadassah and Dr. Netta Levin, M.D., a senior Neurologist at Hadassah.
This pilot double-blind, placebo-controlled Phase I/IIa study in CVS patients with disorders of consciousness, will evaluate the effect of RPh201 on the behavior and brain activity patterns. The first patient was admitted to the study and has started the treatment.
The patients will receive twice-weekly subcutaneous doses of RPh201, or Placebo, for three months. Ten subjects are expected to be enrolled and will be monitored for a follow-up period of an additional three months. During the study, patients will be assessed using relevant clinical and functional MRI measurements.
Evaluation of brain activity, before and after treatment will supply essential complementary information to the bedside assessment, and will allow early identification of recovery.
For more information about the study, please visit ClinicalTrials.gov.
Initiation of this trial represents another important milestone in the clinical development of RPh201. Regenera is expecting to reinforce its encouraging pre-clinical efficacy results as well as the safety profile that was clearly demonstrated for this drug.