RegeneRx Completes Enrollment and Dosing of Phase IA Safety Trial for Potential Heart Drug
News Jul 04, 2008
RegeneRx Biopharmaceuticals, Inc. has announced that it has completed enrollment and dosing of 40 healthy subjects for its Phase IA 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 includes four groups of ten subjects each to assess the safety of escalating doses of RGN-352 injected into the blood stream. To date, there have been no significant drug-related adverse events. A final analysis and report will be completed after 28 days of follow-up of the last subject.
RegeneRx expects to initiate the second part of Phase I with a Phase IB trial in the 3rd quarter 2008 after submitting a IA report to the FDA. The IB trial design is similar to IA; however, the 40 subjects will be dosed once daily for 14 days, rather than given only a single dose, and will undergo a 28-day and a 6-month follow-up.
“We have reached an important milestone with the completion of enrollment and dosing of the Phase IA trial. RGN-352 appears to be safe in single doses at low, medium, and high concentrations. This is an exciting and positive step as we prepare for the IB phase of the trial. This trial is intended to provide the safety data for Phase II clinical trials that are being planned to evaluate RGN-352 for the treatment of patients immediately after an AMI and also to support other potential uses of RGN-352 in medical indications where short-term systemic administration of the drug candidate may be warranted,” stated J.J. Finkelstein, RegeneRx’s president and chief executive officer.