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news.Regenerx Biopharmaceuticals has announced that based on encouraging Compassionate Use data showing RGN-259's potential healing effects in patients with non-healing corneal ulcers, the company will close its current double blind, placebo controlled, Phase II clinical trial targeting a small subset of diabetic patients undergoing vitrectomy surgery in order to focus on a patient population with broader market potential.
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The small proof-of-concept diabetic vitrectomy (DV) trial has been enrolling slowly due to newer surgical procedures that have resulted in a decreasing number of vitrectomy procedures in the US where partial removal of the corneal surface is required.
The trial has completed patient treatment with the lowest dose of RGN-259. These patients will be evaluated as part of the trial closure, which is expected to take approximately 60 days to complete. There have been no reported drug related adverse events. The company estimates it will save approximately $1.8 million in future costs associated with the DV trial.
The company has also reported that Steven Dunn, the principal investigator holding the Compassionate Use IND, has sought permission from the Institutional Review Board to expand enrollment to 10 patients, allow a longer treatment period if necessary, and include patients with punctate keratitis (numerous small corneal wounds commonly affecting comfort and vision). The patients will be evaluated for both corneal healing and improved visual acuity.
David Crockford, vice president of clinical and regulatory affairs at Regenerx, said: Now that we have seen the clinical activity of RGN-259 in neurotrophic keratopathy patients receiving treatment for their corneal ulcers, we believe it makes sense to close the diabetic vitrectomy trial and seek to focus on a larger commercial opportunity.
Supporting data from both studies may allow RegeneRx to accelerate the clinical development of RGN-259 by conducting a Phase II/III trial and, if warranted, requesting fast track status for marketing approval by the FDA.