Regenerx Biopharmaceuticals Inc has filed an Investigational New Drug Applications (IND) with the US FDA requesting permission to begin a phase 2 clinical trial to evaluate the safety and wound healing efficacy of a Thymosin beta 4 (TB4) eye drop formulation in patients recovering from ophthalmic surgery. The company may initiate the study 30 days after filing the IND if it does not otherwise hear from the agency.
The phase 2 ophthalmic trials will enrol diabetic patients undergoing vitrectomy surgery who have a small flap removed from their corneas during surgery. Diabetic patients often have difficulty healing properly. RegeneRx's focus will be to determine whether a TB4-based eye drop is as effective in treating corneal wounds in humans as it has been shown to be in various animal models by Dr Gabriel Sosne and his colleagues at the Kresge Eye Institute in Detroit, as well as others. Dr Sosne's work has shown that TB4 can reduce inflammation, prevent apoptosis (natural cell death), improve cellular adhesion (connection between various cell layers), and promote re-epithelialization (re-growth of the outer layer of the cornea), all of which are vital to the complex wound healing process. Dr Sosne is a member of the company's medical and scientific advisory board.
"We have been diligently working toward this goal over the past year and look forward to the initiation of the first human clinical trials with TB4 in ophthalmic patients. Formulating a sterile ophthalmic eye drop required extensive process research, conducted on a very tight time line. I would like to thank all our collaborators and RegeneRx staff for working so hard to ensure we met our filing target for this IND application," said David Crockford, RegeneRx's vice president for clinical and regulatory affairs.
RegeneRx is focused on the discovery and development of novel molecules to accelerate tissue and organ repair. Currently, RegeneRx is developing TB4, a 43 amino acid peptide, in part, under an exclusive world-wide license from the National Institutes of Health. Preliminary research suggests that TB4 may prove efficacious for multiple indications; therefore, RegeneRx is developing TB4 as the cornerstone of its therapeutic platform.