ROCKVILLE -
NK is being developed by ReGenTree, a
In July, HLB announced that it signed a contract with a global CRO to simultaneously conduct SEER-2 as the second phase 3 clinical trial in the
The clinical study design of SEER-2 and SEER-3 is based on the results of the first phase 3 clinical trial (SEER-1), where the number of subjects was relatively small, but good results were obtained. In the SEER-2 and SEER-3 studies, approximately 70 patients will be recruited in each study to evaluate efficacy, in particular complete healing after 4 weeks treatment.
In the
For the SEER-3 clinical trial, which will be conducted simultaneously in the
NK is a degenerative disease that reduces the sensitivity of the cornea and in severe cases worsens to corneal perforation, and is a rare disease that occurs in about five per 10,000 people in the
The RGN-259 previously received an orphan drug designation for the treatment of NK from FDA, and a distinguished difference from many rare diseases is that the market is very significant. Due to the prevalence of NK patients who must be treated despite the high cost of drugs, the market is expected to be USD
The company [ReGenTree] plans to drastically shorten the development period of RGN-259 by conducting the two phase 3 clinical trials (SEER-2, SEER-3) in the
About RGN-259
RGN-259 is a sterile, preservative-free, eye drop developed to reduce damage and improve healing for various ophthalmic indications including dry eye syndrome and neurotrophic keratopathy. To date, over 1700 subjects have received RGN-259 indicating various degrees of efficacy in both DED and NK. RGN-259 has shown to be quick-acting, well-tolerated and does not have the documented side effects of other approved pharmaceutical products for these indications. Thymosin beta 4, the active pharmaceutical ingredient of RGN-259, that has demonstrated various mechanisms of action, including promotion of cell migration, cytoprotection, wound healing, and anti-inflammatory properties.
Forward-Looking Statements
Any statements in this press release that are not historical facts are forward-looking statements made under the provisions of the Private Securities Litigation Reform Act of 1995. Any forward-looking statements involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Forward-looking statements in this press release include but are not limited to statements from us, our partners, or within research published by third parties. There can be no assurance that positive results from any research or clinical trial by the Company, its collaborators, or independent parties in the
Contact:
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Email: las@regenerx.com
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