ROCKVILLE, Md., Dec. 16, 2016 /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 it has received notice of Intent to Grant a patent from the European Patent Office for treating neural injury using Thymosin beta 4 (Tβ4), the active pharmaceutical ingredient in the RegeneRx's proprietary drug candidate, RGN-352. The treatment claims include treating neural injury by remyelinating damaged neurons using Tβ4, which has been shown to promote migration of certain immature brain cells, called oligodendrocyte progenitor cells, to the site of injury and to enhance the maturation of these cells to become functional oligodendrocytes that then aid in the repair of the damaged brain. Researchers have demonstrated that not only can Tβ4 repair damaged brain tissue but that it also significantly restores motor and cognitive function in experimental animal models.
The research supporting this patent was conducted by Dr. Michael Chopp's research team at the Henry Ford Hospital System in Detroit, MI and has been published in numerous neurological scientific journals.
The patent expiry is March 26, 2030, not including any potential extensions.
"This patent expands the scope of potential administration of RGN-352, our systemic formulation of Tβ4, in patients with neural injury and disease. The reparative and regenerative results found by Dr. Chopp and his team in the injured neural tissue in their animal models builds considerably on the results seen at other tissue sites, including in the heart after a heart attack. Tβ4 appears to recruit immature cells to the site of injury and cause them to mature into cells of destiny, similar to the goal of stem cell therapy but without the difficulty of isolating and delivering stem cells," 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 March 2016, RegeneRx, through its U.S joint venture, ReGenTree LLC, completed a 317-patient Phase 2b/3 clinical trial in patients with dry eye syndrome (DES). The dry eye trial results were announced in May 2016 and ReGenTree has subsequently begun enrollment in a second Phase 3 DES trial in approximately ~500 patients. The Company is simultaneously conducting a 46-patient Phase 3 clinical trial in patients with NK. 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 multiple sclerosis and traumatic injuries such as stroke. 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 notices or patents issued by the U.S. Patent and Trademark Office or EU patent authorities, or licenses held by the Company, or patent applications filed by the Company, including this most recent Notice of Allowance in the EU, or any current or future clinical trials 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, 2015, 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.
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SOURCE RegeneRx Biopharmaceuticals, Inc.