RegeneRx Completes Enrollment and Dosing of Phase I Safety Trial for Potential Heart Drug
News Mar 03, 2009
RegeneRx Biopharmaceuticals, Inc. has announced that it has completed enrollment and dosing of 40 healthy volunteers for its Phase IB double-blind, placebo-controlled clinical trial testing RGN-352, an injectable formulation of Tß4 for potential use in treating acute myocardial infarction patients (AMI or heart attack).
The trial included four groups of ten subjects each to assess the safety and tolerability of escalating doses of RGN-352 injected daily into the blood stream over a 14-day period.
To date, RGN-352 appears safe and well-tolerated. There have been no serious drug-related adverse events. A final analysis and report will be submitted to the U.S. Food and Drug Administration in approximately 180 days.
Previously, RegeneRx completed its Phase IA trial in which a single dose of RGN-352, escalating over increasing concentrations, was deemed to be safe and well-tolerated.
“Completing enrollment and dosing of the final part of our Phase I trial is a very important milestone. Although we will submit a final report in six months, thus far RGN-352 appears to be safe and well-tolerated at all doses studied. Based on these data we are prepared to concentrate on our Phase II cardiovascular program and how best to implement a study whose objective is to prevent and repair damage to the heart after a heart attack. Other potential uses of RGN-352 in conditions where short-term systemic administration of the drug candidate may be warranted will also be evaluated,” stated David Crockford, RegeneRx’s vice president for clinical and regulatory affairs.