ROCKVILLE, Md., Sept. 6, 2018 /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 the recommended INN (International Nonproprietary Name) for Thymosin Beta 4 is timbetasin, as published by the World Health Organization (WHO).
The term "INN" is an official name given to a new active pharmaceutical ingredient as prescribed by the WHO and is given for the classification of substances. Any drug substance that has the characteristics of "Thymosin beta 4" that will be developed as a pharmaceutical product in the future must use the name "timbetasin", a term requested by GtreeBNT. The common name, "timbetasin," was designated according to the guidelines for WHO INN naming and has a symbolic meaning that can be associated with Thymosin Beta 4.
An INN is basically given based on the structure of the compound and the mechanism of action. Registration of the INN by the WHO means that the compound has been certified and officially recognized as a global new drug substance.
This is a necessary step for the market approval and launch of a new pharmaceutical product, considered an essential step in new drug development for verification as a global product candidate, officially required by the FDA in NDA applications.
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. A third Phase 3 trial (ARISE-3) is planned for the 3rd or 4th quarter of 2018. 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 2018.
For additional information about RegeneRx please visit www.regenerx.com.
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 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. Receipt of a WHO INN does not ensure that a drug candidate will be approved in any regulated territory. 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.