RegeneRx JV Announces Results of ARISE-2 Dry Eye Trial

ROCKVILLE, Md., Oct. 31, 2017 /PRNewswire/ -- RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) ("the Company" or "RegeneRx"), a clinical-stage drug development company focused on tissue protection, repair and regeneration, today announced the results of its phase 3 dry eye trial sponsored by its U.S. joint venture, ReGenTree, LLC.  The ARISE-2 trial investigated the safety and efficacy of RGN-259 compared to placebo for the treatment of the signs and symptoms of dry eye syndrome in 601 patients. 

The following two paragraphs are excerpted from the ReGenTree press announcement:

"The ARISE-2 study, which was conducted together with Ora, Inc., demonstrated a number of statistically significant improvements in both signs and symptoms of dry eye syndrome with 0.1% RGN-259 versus placebo, while showing excellent safety, comfort, and tolerability profiles. The ocular discomfort symptom showed a statistically significant reduction in the RGN-259-treated group at day 15 as compared to placebo (p=0.0149) in the change from baseline. For sign, RGN-259 also improved the dry eye patient's ability to withstand an exacerbated condition in a patient subgroup with both compromised corneal fluorescein staining and Schirmer's test at baseline. In this population, RGN-259 showed superiority over placebo in reducing corneal fluorescein staining in the change from baseline at days 15 and 29 (p=0.0207 and 0.0254, respectively). RGN-259 confirmed its global effects on dry eye syndrome and fast onset in multiple sign and symptom efficacies with no safety issues in the ARISE-1 and ARISE-2 studies as well as in the pooled data, although ARISE-2 was not successful in duplicating the results of ARISE-1 where the study population was limited and less diversified."

"Won S. Yang, President & CEO of ReGenTree, stated, 'We are very excited with the ARISE-2 results, which show RGN-259's important additional efficacies lacking in approved treatments, such as very fast onset and multiple global effects in both signs and symptoms of dry eye syndrome. I believe these two studies, ARISE-1 and ARISE-2 with efficacy of Tβ4 in both signs and symptoms, will continue building a strong foundation of its strengths when considered with the totality of the data set. ReGenTree plans to proceed with a development plan for the next step through a meeting with the FDA based on the results of ARISE-2 trial. We are optimistic that the results from ARISE-2 will accelerate discussions with potential investors interested in reaching a global deal for the development and marketing of RGN-259.'"

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.

RGN-259, the Company's Tβ4-based ophthalmic eye drops, is currently the subject of phase 3 clinical trials for patients suffering from dry eye syndrome as well and for patients having chronic neurotrophic keratopathy (NK), a non-healing corneal lesion designated an orphan indication in the U.S. 

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 damage associated 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 by the Company's licensee, GtreeBNT.

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 any current or future clinical trials will result in approved products or future value. 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.

For further information: For RegeneRx: Lori Smith, 301.208.9191, las@regenerx.com; Investor Contact: Stephanie Prince, PCG Advisory Group, 646.762.4518, Sprince@pcgadvisory.com

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