RegeneRx Update on Dry Eye and EB Clinical Trials

ROCKVILLE, Md., Jan. 4, 2019 /PRNewswire/ -- RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) ("the Company" or "RegeneRx"), a clinical-stage drug development company focused on tissue protection, repair and regeneration, is updating the status of the U.S. phase 3 dry eye clinical trial (ARISE-3) and the U.S. trial in patients with epidermolysis bullosa (EB) based on a letter to stockholders issued today by its partner, GtreeBNT.  GtreeBNT is the sponsor of the EB trial while a U.S. joint venture between GtreeBNT and RegeneRx, ReGenTree, LLC, is the sponsor of the dry eye trial. 

ARISE-3 DRY EYE TRIAL

GtreeBNT stated that it is planning to sign the contract for management of the clinical trial in February and that the trial will start thereafter.  The company went on to say that manufacturing of the investigational drug has been completed and confirmed that the FDA had previously agreed on the protocol.  The company also clarified that while the FDA requires multiple pivotal studies and reproducibility for NDA approval, due to the multi-factorial nature of dry eye syndrome and heterogeneity of the patient population, Gtree is not designing ARISE-3 to do more than the FDA requires for products currently on the market.  The company also stated that it intends to keep its stockholders informed on the progress with ARISE-3 after the contract is signed.

EPIDERMOLYSIS BULLOSA TRIAL

GtreeBNT stated that it has selected the clinical trial sites that specialize in EB and one of the sites has begun patient recruitment.  Since most of the clinical trial sites selected are university hospitals, the approval procedures from the institutional review boards (IRB) is required and will take several months to complete in some cases, most of which are expected to come in February.  Therefore, it is expected that several hospitals will begin enrolling and administering the investigational drug simultaneously and that GtreeBNT expects fairly rapid progress.

"We are pleased our partner, GtreeBNT, is now moving forward with these two important clinical trials after some delay and that they will be keeping us informed of the progress on a regular basis, which we will relay to our stockholders. We look forward to success with both of our product candidates over the next twelve months and hope that 2019-2020 will be the most productive period in the history of RegeneRx," stated J.J. Finkelstein, RegeneRx president and CEO. 

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, completed patient enrollment and treatment in its second Phase 3 clinical trial (ARISE-2) in approximately 600 patients with dry eye syndrome and reported positive clinical results with no safety issues.  Plans for a third Phase 3 trial (ARISE-3) have been finalized and the clinical trial contract is expected to be in February 2019 with patient enrollment thereafter.  ReGenTree is also conducting a 46-patient Phase 3 clinical trial in patients with neurotrophic keratopathy (NK).  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.  It may also have applications in patients with severe septic shock.

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 clinical trials in the U.S. and patient recruitment has begun.

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 animal studies or clinical trials or joint ventures will start on time, be completed within a projection time-frame, or result in future value or approved products. There can also be no assurance that the Company or its licensees will apply for an NDA in the future or that if the Company or a licensee 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. or any other country. There can be no assurance that RegeneRx will be able to finance operations through the completion of clinical development of its products by its partners.  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.

For further information: Lori Smith, 301.208.9191, las@regenerx.com

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