RegeneRx Biopharmaceuticals, a developer of a novel therapeutic peptide, Thymosin beta 4, or Tß4, for tissue and organ protection, repair and regeneration, has screened and recruited first patient in a double-blind, placebo-controlled Phase 2 clinical trial evaluating RGN-259 in patients with dry eye associated with graft vs. host disease.
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RegeneRx claims that RGN-259 is a sterile, preservative-free topical eye drop formulation of the novel therapeutic peptide Thymosin beta 4, or Tß4.
The Phase 2 trial is expected to recruit 20 patients over the next several months, with data reported later in 2011.
RegeneRx president and CEO J J Finkelstein said that the first patient is an important milestone in the use of RGN-259 for the treatment of dry eye.
"A successful Phase 2 dry eye trial, in addition to the positive dry eye animal study announced early last month, would be strong evidence of RGN-259’s capabilities for the treatment of dry eye and other ophthalmic conditions," Finkelstein said.
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