Resverlogix Officially Attains Phase 3 Status with a European Regulatory Authority
News Jun 23, 2015
Resverlogix Corp. has announced that following recent meetings with various European regulatory bodies, the first confirmation for our Phase 3 clinical plan has officially been received.
A further regulatory and protocol design update will be provided to the market post the approval of additional regulatory bodies and the launch of our planned Phase 3 clinical trial entitled BETonMACE.
"This represents a momentous step forward in the clinical development of RVX-208," stated Donald McCaffrey, president and chief executive officer of Resverlogix. "With this important regulatory confirmation now complete, we expect to launch the upcoming BETonMACE Phase 3 clinical trial this fall. The primary endpoint of the BETonMACE trial is designed to show a relative risk reduction (RRR) of Major Adverse Cardiac Events (MACE) in high-risk cardiovascular and diabetes mellitus (DM) patients, as we have seen in previous Phase 2 clinical trials with RVX-208," further stated Mr. McCaffrey.