ROCKVILLE, Md./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 a clinical trial update provided by GtreeBNT, RegeneRx's partner for development of RGN-259 and RGN-137 in the U.S.:
DRY EYE SYNDROME
"Regarding progress on ARISE-3, the manufacturing of the investigational product for ARISE-3 has been completed and the protocol for the study has been finalized and is now ready for the study. Also, since funding for the ARISE-3 clinical study is progressing smoothly towards the final stage, we will do our best to inform you of ARISE-3 study initiation as soon as possible. We also hope that our potential discussions with multinational pharmaceutical companies for a deal will accelerate the process by launching the ARISE-3 clinical trial."
ARISE-3 is the designation for the phase 3 clinical trial for RGN-259, RegeneRx's sterile, preservative-free, eyedrop to treat dry eye syndrome and other corneal wound disorders.
"The production of investigational product for an Open Study has been completed. We also have a signed a contract with the clinical sites where recruitment of EB patients will start soon. In terms of the regulatory aspect, the FDA already approved our Open Study Protocol. We are currently preparing for the final clinical trial with the goal of FPFV (first patient first visit) to occur in November 2018. In June of this year, the U.S. FDA has announced new guidelines solely for EB, and our company is currently revising our study design for Phase 3 in accordance with the new FDA guidelines. The company is preparing to enter the clinical trial phase 3 in 2019. Our Open Study which is starting now is expected to make a decisive contribution to setting up a strategic clinical phase 3 study incorporating the new U.S. FDA guidelines."
The EB clinical trial is to test RGN-137, RegeneRx's dermal gel for wound healing in epidermolysis bullosa patients. EB is an orphan disease in the U.S. and EU.
According to Gtree, "In summary the company is committed to providing important news for each pipeline under development, noting that the current progress is not far from the development progress plan, and moving toward a well-planned goal."
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 although no start date has been set as of this date. 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 Europe and is expected to initiate an open study in November 2018.
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.