RegeneRx Biopharmaceuticals, Inc announced the publication of the first human data from a case study of patients evaluated with its ophthalmic product candidate RGN-259. The data have been published in the May 2010 issue of Archives of Ophthalmology, an American Medical Association peer-reviewed journal. In the study, four patients with chronic neurotrophic keratitis, a degenerative corneal disease induced by a nerve impairment, were treated with RGN-259 under a compassionate use IND. The most common causes of this disease include the herpes zoster virus.
To be eligible for treatment in the study, patients must have had a corneal lesion that had remained unhealed for a minimum of six weeks. In one case, a patient had a non-healing wound for nearly 14 months. The patients were treated for 28 days with RGN-259 and evaluated 28 days after treatment. Three of the patients experienced complete healing of their wounds, with substantial healing in the fourth patient. There were no drug-related adverse events and all patients reported reduced ocular irritation.
The study was conducted by Dr Stephen Dunn and his colleagues in the Department of Ophthalmology, Children's Hospital of Michigan, Wayne State University, and the William Beaumont Hospital in Detroit, Michigan. Dr Dunn is not affiliated with the company; Dr Gabriel Sosne, a co-author of the study, is a member of RegeneRx's scientific advisory board.
Dr Dunn and his colleagues are planning a phase-2 study with RGN-259 in patients with dry eye associated with graft vs. host disease later this year that will be supported, in part, by RegeneRx.
RegeneRx is focused on the development of a novel therapeutic peptide, Thymosin beta 4, or TB4, for tissue and organ protection, repair and regeneration.