Research Conducted Under Material Transfer Agreement Provides Potential Large Therapeutic Market Target for RGN-352 in the U.S. and EU
ROCKVILLE, Md., Aug. 14, 2017 /PRNewswire/ -- RegeneRx Biopharmaceuticals, Inc. (RGRX) ("the Company" or "RegeneRx"), a clinical-stage drug development company focused on tissue protection, repair and regeneration, today announced that the European Patent Office (EPO) has issued an Intent to Grant notice related to Thymosin beta 4 (Tβ4) for use in the treatment of peripheral neuropathy. Tβ4 is the active pharmaceutical ingredient in RegeneRx's proprietary drug candidate, RGN-352, a first-in-class product candidate designed for systemic administration to treat damaged tissue.
Peripheral neuropathy is a condition that develops as a result of damage to the peripheral nervous system, the communications network that transmits information between the brain and spinal cord to other parts of the body. Symptoms can range from numbness or tingling, to pricking sensations, muscle weakness and/or pain. It is estimated that 20 million people in the United States have some form of peripheral neuropathy, with a large number of patients in the EU, and is especially prevalent in patients with diabetes.
The patent will be issued to Dr. Michael Chopp and his colleagues at the Henry Ford Hospital System (HFHS) in Detroit, Michigan, and is the subject of a license agreement between RegeneRx and HFHS. Dr. Chopp and his team have published several scientific articles demonstrating that Tβ4 can ameliorate the effects of diabetic peripheral neuropathy in animal models of the disease. RegeneRx is responsible for all patent fees and commercialization of potential products. The patent will expire in December 2032.
"This patent continues to expand the scope of potential use of RGN-352, our systemic formulation of Tβ4, in patients with neural injury and peripheral nervous system disorders. The neurovascular remodeling, repair and regeneration properties of Tβ4 found by Dr. Chopp and his team in animal models expands the potential for the use of Tβ4 in major disorders such as peripheral neuropathy and other conditions or diseases that are associated with nerve damage. The granting of this patent, in addition to the U.S. patent application recently allowed on corresponding subject matter, will provide RegeneRx with a strong proprietary position with respect to the potential use of RGN-352 for the treatment of peripheral neuropathy, a large and underserved market," 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 September 2016, RegeneRx, through its U.S joint venture, ReGenTree LLC, completed patient enrollment and treatment in its second Phase 3 clinical trial in approximately ~600 patients with dry eye syndrome. Top line data is expected to be reported by the fourth quarter of 2017. 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.
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 any government patent authority in any country, or licenses held by the Company, or patent applications filed by the Company, including this most recent Notice of Allowance in the United States, 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, 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.