ROCKVILLE, Md., May 2, 2018 /PRNewswire/ -- ReGenTree, LLC (the "Company"), a joint venture between GtreeBNT and RegeneRx Biopharmaceuticals (OTCQB: RGRX), announced today that the Company presented results of a comparison study of RGN-259 and marketed products for dry eye syndrome in a dry eye mouse model at ARVO (The Association for Research in Vision and Ophthalmology) meeting in Honolulu, Hawaii. The study was conducted by Jaewook Yang, M.D. at the T2B Infrastructure Center for Ocular Disease, InJe University Busan Paik Hospital in Korea. Gabriel Sosne, M.D. at Wayne State University School of Medicine and Hynda Kleinman, Ph.D. at The George Washington University School of Medicine were among the authors of the study.
The study found that RGN-259 treatment promoted recovery of mucins and goblet cells, improved corneal integrity, increased tears, and reduced inflammation in a dry eye mouse model. Such improvements with RGN-259 treatment were comparable to or better than that seen with approved prescription treatments such as cyclosporine A (Restasis®), lifitegrast (Xiidra®), and diquafosol (Diquas®), which are marketed in the USA or Japan. For detailed information about the results, please refer to abstract number 3807-C0034 at 2018 ARVO.
ReGenTree's Phase 3 clinical program includes two completed studies in dry eye syndrome that demonstrated positive clinical results for signs and symptoms of dry eye within the RGN-259 group compared to placebo and an ongoing study in patients with chronic neurotrophic keratopathy, an orphan indication. RGN-259 has also demonstrated a strong safety profile with fewer side effects compared to approved products currently on the market.
About RegeneRx Biopharmaceuticals, Inc. (www.regenerx.com)
RegeneRx is focused on the development of novel therapeutic peptides, including Thymosin beta 4 (Tβ4) and its constituent fragments, 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 the U.S., China, and Pan Asia (Korea, Japan, and Australia, among others), and has patents and patent applications covering its products in many countries throughout the world.
RegeneRx, through its U.S joint venture, ReGenTree LLC, recently completed patient enrollment and treatment in its second Phase 3 clinical trial in approximately 600 patients with dry eye syndrome, reported positive clinical results with no safety issues. ReGenTree is also conducting a 46-patient Phase 3 clinical trial in patients with neurotrophic keratopathy (NK) targeted for completion in 2018. Additionally, RGN-259 is being developed in patients with dry eye syndrome in Asia through RegeneRx's two Asian partnerships. RGN-259 has been designated an orphan drug in the U.S. for the treatment of NK.
RGN-352, the Company's Tβ4-based injectable formulation, is a Phase 2-ready drug candidate designed to be administered systemically to prevent and repair cardiac damage resulting from heart attacks and central nervous system tissue disorders such as peripheral neuropathy, multiple sclerosis and traumatic brain injuries such as stroke.
RGN-137, also designated an orphan drug in the U.S., is the Company's Tβ4-based dermal gel formulation that is being developed for epidermolysis bullosa, a rare skin condition. The Company's licensee, GtreeBNT, is sponsoring a phase 3 clinical trial in the U.S. and is expected to initiate the study in 2018.
For additional information about RegeneRx please visit www.regenerx.com.
About ReGenTree, LLC
ReGenTree is a U.S. joint venture company owned by GtreeBNT Co., Ltd, and RegeneRx Biopharmaceuticals, Inc. specifically to develop RGN-259 in the U.S.A. and Canada for ophthalmic indications. ReGenTree licensed the rights to RGN-259 from RegeneRx in 2015. Thus far, ReGenTree has completed two Phase 3 studies in the U.S. for dry eye which are ARISE-1 (Phase 2/3) and ARISE-2 (Phase 3). In addition to dry eye, the company is currently conducting a Phase 3 study for neurotrophic keratopathy (NK), an orphan indication in ophthalmology. For additional information about ReGenTree, please visit www.regentreellc.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 any current or future animal studies or clinical trials will result in future value or approved products. There can also be no assurance that the Company will apply for an NDA in the future or that if the Company applies for an NDA, that it will be accepted by the FDA and/or that the product candidate will be approved for marketing in the U.S. 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, 2017, 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.