Firm aims to start Phase II trials with RGN-352, a formulation of thymosine beta 4, later this year.

RegeneRx Biopharmaceuticals received a $3 million grant from the NIH’s National Heart, Lung and Blood Institute to fund clinical development of RGN-352 as a treatment for patients who have suffered an acute myocardial infarction. The firm says that it plans to start a Phase II trial with the compound this year.

RGN-352 is an injectable formulation of the naturally occurring peptide, thymosine beta 4 (Tβ4). Tβ4 is a major actin regulating peptide that has been shown to play a key role in the protection, regeneration, and remodeling of injured or damaged tissue, RegeneRx explains. The peptide is found in high concentrations in blood platelets, wound fluid, and other tissues in the body.

The firm’s Tβ4-based therapeutic pipeline includes three candidates: RGN-137, RGN-259, and RGN-352. In addition to its development for the treatment of cardiac tissue damage after heart attack, RGN-352 is being developed for the management of multiple sclerosis.

RGN-137 is a topical gel formulation of the Tβ4 peptide in development to help speed dermal healing. Phase II trials in pressure ulcers and venous stasis ulcers were completed in 2009. A Phase II study evaluating RGN-137 in the treatment of epidemolysis bullosa is ongoing.

RGN-259 is a Tβ4-based sterile eye drop in development for corneal healing. RegeneRx says it plans to support a physician-sponsored corneal trial this year in patients with dry eye associated with graft vs. host disease (GvHD).

A previous Phase II trial in diabetic patients undergoing corneal epithelial debridement during vitrectomy surgery was closed in 2009 due to very slow enrollment and new clinical data generated under a Compassionate Use IND. The Compassionate Use trial, published in the May issue of the Archives of Ophthalmology, evaluated RGN-259 in the treatment of nonhealing corneal ulcers in four patients with chronic neurotrophic keratitis. The results showed that all four patients demonstrated either complete healing of their eye ulcers or significant improvement after 28 days of treatment and continued to improve after treatment ended.

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