ROCKVILLE, Md., April 1, 2015 /PRNewswire/ -- RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) (“the Company” or “RegeneRx”) today announced that a new medical paper has been published describing the positive effects of Thymosin beta 4 (TB4) in patients with severe dry eye. The results met key efficacy objectives of the study and the physicians stated that statistically significant differences in both signs and symptoms of severe dry eye were seen at various time points throughout the study. Of particular note at day 56, the RGN-259-treated group had 35.1% reduction of ocular discomfort compared with vehicle control (P=0.0141), and 59.1% reduction of total corneal fluorescein staining compared with vehicle control (P = 0.0108). Other improvements seen in the RGN-259-treated patients included tear film breakup time and increased tear volume production.
The physician-initiated, phase 2, randomized, placebo controlled study was completed in 2012 and published in the current issue of Cornea, 2015 May;34(5):491-496 and conducted by Drs. Gabriel Sosne and Stephen Dunn at the Kresge Eye Institute, Wayne State University and Michigan Cornea Consultants in Detroit, Michigan, and Chaesik Kim, the biostatistician for the study, who is also affiliated with the Kresge Eye Institute and Wayne State University. Dr. Sosne serves on RegeneRx’s scientific advisory board and RegeneRx contributed RGN-259 and placebo for the study and provided limited financial support.
About RegeneRx Biopharmaceuticals, Inc. (www.regenerx.com)
RegeneRx is focused on the development of a novel therapeutic peptide, Thymosin beta 4, for tissue and organ protection, repair and regeneration. RegeneRx currently has three drug candidates in clinical development for ophthalmic, cardiac and dermal indications, three active strategic licensing agreements in China, Pan Asia (Korea, Japan, and Australia, among others) and the U.S., and has an extensive worldwide patent portfolio covering its products. RGN-259, the Company’s Tß4-based ophthalmic drug candidate, has been designated an orphan drug for the treatment of neurotrophic keratopathy (NK). RegeneRx was recently allowed by the FDA to move into Phase III clinical trials with RGN-259 for the treatment of patients with NK. The drug candidate is also being studied in patients with dry eye syndrome in the U.S. and Asia. RegeneRx, through its U.S. joint venture, ReGenTree LLC, will be developing RGN-259 in the United States. RGN-352, the Company’s Tß4-based injectable, is a Phase 2-ready drug candidate designed to be administered systemically to prevent and restore tissue damage associated with acute events such as heart attacks, strokes, and other similar traumatic injuries. For additional information about RegeneRx please visit www.regenerx.com.
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. There can be no assurance that positive results from any clinical trials by the Company, or its collaborators, in the U.S. or any other country will result in subsequent clinical confirmation or future value. There can also be no assurance that any of the Company’s drug candidates will result in any approved products in the U.S. or any other country. Please view these and other risks described in the Company’s filings with the Securities and Exchange Commission (“SEC”), including those identified in the “Risk Factors” section of the annual report on Form 10-K for the year ended December 31, 2014, and subsequent quarterly reports filed on Form 10-Q, as well as other filings it makes with the SEC. Any forward-looking statements in this press release represent the Company’s views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. The Company specifically disclaims any obligation to update this information, as a result of future events or otherwise, except as required by applicable law.
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/regenerxs-rgn-259-meets-key-efficacy-objectives-in-phase-2-clinical-trial-in-patients-with-severe-dry-eye-reported-in-current-issue-of-cornea-300059263.html
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