While the study did not meet the two primary outcome measures selected prior to the beginning of the trial, statistically significant sign and symptom improvements attributable to RGN-259 were identified. We believe these sign and symptom improvements are clinically relevant endpoints that would be acceptable outcome measures for future pivotal trials, which we intend to confirm with FDA at a post-Phase 2 meeting.
Wednesday, January 18, 2012
Drug news: Mixed results from RegeneRx clinical trials
On Nov. 4th, RegeneRx Biopharma announced results of their 30-day clinical trial. The drug failed to meet either of the two primary outcome measures they were targeting; however, they did identify some sign & symptom improvements. A follow-up press report clarified their position on this and a report put out on Jan 5th indicates they will be shifting the focus of further research on the drug.