ROCKVILLE, Md., Dec. 17, 2021 /PRNewswire/ -- RegeneRx Biopharmaceuticals, Inc. (OTCQB: RGRX) ("RegeneRx"), a clinical-stage drug development company focused on tissue protection, repair and regeneration, today announced that the U.S. FDA has accepted its request for a pre-BLA meeting pursuant to RGN-259, its novel product candidate for dry eye syndrome. The meeting is scheduled for February 28, 2022. A BLA (Biologics License Application) is FDA's standard "full approval" mechanism for biological products, including therapeutics and vaccines.
The purpose of the pre-BLA meeting is to discuss with FDA the format, content, and acceptability of the anticipated BLA application. The Sponsor (ReGenTree LLC) will provide the briefing document to the agency prior to the meeting that will include a review of clinical studies, non-clinical studies, CMC (manufacturing) requirements, and previous meeting minutes between RegeneRx, ReGenTree and FDA.
"I am pleased the FDA has accepted the pre-BLA meeting and look forward to our continued work with the agency on RGN-259 for dry eye syndrome. RGN-259 has shown significant efficacies in over 1,600 patients in several phase 3 clinical trials in this complicated multi-factorial disease. Importantly, it is safe and well-tolerated. We intend to keep investors updated as appropriate," stated J.J. Finkelstein, RegeneRx president and chief executive officer.
ReGenTree, LLC is a U.S. joint venture owned by HLB Therapeutics (formerly GtreeBNT) and RegeneRx Biopharmaceuticals, Inc. ReGenTree previously licensed RGN-259 from RegeneRx and is the entity (Sponsor) responsible for clinical and regulatory development of the product candidate.
RGN-259 is a sterile, preservative-free eye drop that in controlled clinical trials has been shown to quickly reduce certain signs and symptoms of dry eye syndrome and having no significant side effects that are commonly associated with other products approved for dry eye.
About RegeneRx Biopharmaceuticals, Inc.
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/neuro and dermal indications, four active strategic licensing agreements in the U.S., China, and Pan Asia (Korea, Japan, and Australia, among others), and the EU, and has patents and patent applications covering its products in many countries throughout the world.
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. Forward-looking statements in this press release include but are not limited to statements from us or within research published by third parties. There can be no assurance that positive results from any research or clinical trial by the Company, its collaborators, or independent parties in the U.S. or any other country will result in subsequent clinical confirmation or future value. There can be no assurance that the data currently intended to be submitted to the FDA is adequate for approval of a BLA for RGN-259. There can also be no assurance that any of the Company's drug candidates will result in any approved products in the U.S. or any other country. Please view 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, 2020, 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.