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Press Release

RegeneRx Updates on RGN-259 Phase 3 Dry Eye Trial

RegeneRx
Posted on: 31 Jul 17

ROCKVILLE, Md., July 27, 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 that its U.S. joint venture, ReGenTree LLC, has completed treatment of the last patient enrolled in its Phase 3 "ARISE-2" clinical trial testing RGN-259 preservative-free eye drops for dry eye syndrome ("DES").

ARISE-2 is a double-masked, placebo-controlled clinical trial that enrolled approximately 600 patients in the U.S. and was initiated less than 12 months ago. The trial is designed to replicate the clinical results achieved in ARISE-1, a Phase 2b/3 clinical trial in patients with DES.  Patient data will be scrubbed and validated prior to data lock and subsequent statistical analysis.  ReGenTree will report the results as soon as practicable thereafter.

"We are pleased with the progress of this very important Phase 3 clinical trial and with the effort by all of the parties associated with the trial.  We look forward to the data readout, which we hope will launch us into the next stage of commercialization of RGN-259," stated J.J. Finkelstein, RegeneRx's president and chief executive officer.    

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 drug candidate, has been designated an orphan drug in the U.S. for the treatment of neurotrophic keratopathy (NK). In July 2017, RegeneRx, through its U.S joint venture, ReGenTree LLC, completed enrollment and treatment of the last patient in its second Phase 3 clinical trial in approximately 600 patients with dry eye syndrome. The Company is simultaneously conducting a 46-patient Phase 3 clinical trial in patients with NK targeted for completion in 2018.  RGN-259 is also being developed in patients with dry eye syndrome in Asia through RegeneRx's two Asian partnerships.  

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. The Company's licensee, GtreeBNT, is sponsoring a phase 3 clinical trial in the U.S. and is expected to initiate the study in the third quarter of 2017.

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 clinical trial results to be materially different from historical clinical results or from any future clinical results expressed or implied by such forward-looking statements. There can be no assurance that any notices or patents issued by any government patent authority in any country, or licenses held by the Company, or patent applications filed by the Company, will result in approved products or future value. 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, 2016, 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.

Editor's Details

Mike Wood
PharmiWeb.com
www.pharmiweb.com
editor@pharmiweb.com

Last updated on: 31/07/2017

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