ROCKVILLE, Md., May 22, 2015 /PRNewswire/ -- RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) ("the Company" or "RegeneRx") today announced a peer-reviewed publication of the results of the Company's 72-patient, placebo-controlled Phase II study evaluating RGN-259 (RegeneRx's preservative-free eye drops) for the treatment of dry eye patients using Ora Inc.'s controlled adverse environment (CAE®) model. The exploratory study was completed in late 2011, and the results, which were previously disseminated by the Company in a press release, identify the key efficacy targets for a larger, multi-center, Phase IIb/III U.S. clinical trial targeted for later this year. The trial will be sponsored by ReGenTree, LLC, a U.S. joint venture owned by RegeneRx and G-treeBNT.
In this just published study, a number of important outcome measures, including central, superior, and peripheral corneal staining demonstrated statistically significant improvements in the RGN-259-treated group compared to placebo (p=0.0075, p=0.0210 and p=0.0379, respectively). RGN-259 also reduced exacerbation of ocular discomfort after CAE® challenge (p=0.0224). The drug candidate was well-tolerated and there were no observed adverse side effects. As previously reported, the co-primary outcome measures, inferior corneal staining and patient ocular discomfort 24 hours after CAE® challenge, did not show statistically significant differences.
"We are quite excited to have identified significant improvements in both signs and symptoms of dry eye, which have since been confirmed in subsequent studies. Not only have we identified FDA-approvable sign and symptom endpoints that will be the target of U.S. dry eye trials later this year, we also saw the potential for RGN-259 as a preventative modality for patients prone to dry eye syndrome as evidenced by their improvements after challenge in a controlled adverse environment. Additionally, the statistically significant improvements in central corneal staining at 24 hours post-CAE® are consistent with the acceleration of healing seen in other patients treated with RGN-259. We look forward to the larger, more robust study that is expected to begin later this year," stated Dr. Gabriel Sosne, Associate Professor, Department of Ophthalmology and Anatomy/Cell Biology, Wayne State University School of Medicine Kresge Eye Institute, Detroit, Michigan, and one of the authors of the paper. Dr. Sosne is a member of RegeneRx's Scientific Advisory Board.
The clinical trial report, "Thymosin beta 4 ophthalmic solution for dry eye: a randomized, placebo-controlled, Phase II clinical trial conducted using the controlled adverse environment (CAE™) model," was authored by Gabriel Sosne and George Ousler and published in Clinical Ophthalmology, May 2015; Vol. 2015:9, 877-884.
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 TB4-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, is developing RGN-259 in the United States and expects to initiate a Phase IIb/III trial later this year. RGN-352, the Company's TB4-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.
About Ora Inc.
Ora Inc. is a global, full-service ophthalmic clinical research and product development firm. Over the past 30 years, it has helped clients earn 39 FDA approvals. Ora supports a wide array of organizations, from start-ups to global pharmaceutical and device companies, to efficiently and successfully bring their new products from concept to market. Ora's pre-clinical and clinical models, unique methodologies and regulatory strategies have been refined and proven across thousands of projects both in the U.S. and internationally. Ora brings together the world's most extensive and experienced network of ophthalmic experts and R&D professionals in order to maximize the value of new product initiatives. For additional information, please visit http://oraclinical.com.
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.
SOURCE RegeneRx Biopharmaceuticals, Inc.