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news.Regenerx Biopharmaceuticals, a developer of novel peptides to accelerate tissue and organ repair, has completed a Phase Ia clinical trial in which RGN-352 was tested in 40 healthy subjects.
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The double-blind, placebo-controlled trial included four groups of 10 subjects each to assess the safety of escalating doses of RGN-352 injected into the blood stream. After a 28-day follow-up of each subject and a review of all relevant data, RGN-352 was determined to be safe and well-tolerated at the four doses tested.
Based on these results, RegeneRx expects to shortly initiate a Phase Ib trial. The Phase Ib trial design is similar to Phase 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 post-treatment assessment with a six-month follow-up.
RGN-352 is an injectable formulation of Tâ4 being developed to reduce cardiac damage in patients after an acute myocardial infarction, as well as for other potential systemic uses.
David Crockford, vice president of clinical and regulatory affairs at Regenerx, said: “We believe that the Phase Ia and Ib trials will provide safety and pharmacokinetic data that will enable RegeneRx to design a Phase II trial to evaluate RGN-352 for the treatment of patients immediately after an acute myocardial infarction, as well as for other medical indications where systemic administration may be warranted.”