RegeneRx Partner Receives Canadian Patent For Treatment of Peripheral Neuropathy

ROCKVILLE, Md., Feb. 13, 2020 /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 Canadian Patent Office has issued a new patent to the Henry Ford Health System (HFHS) for treating patients with peripheral neuropathy using Thymosin beta 4 (Tβ4). Tβ4 is the active pharmaceutical ingredient in RegeneRx’s proprietary drug candidate, RGN-352, a first-in-class injectable formulation designed for systemic administration. Its use for the treatment of peripheral neuropathy or diabetic-induced vascular dysfunction has previously been patented in several other countries including in the U.S., EU, Asia and Israel.

RegeneRx in-licensed the intellectual property relating to the use of Tβ4 from the Henry Ford Hospital System in Detroit, MI based on work performed by Dr. Michael Chopp and his colleagues. The patent will expire in December of 2032.

An estimated 20 million people in the United States have some form of peripheral neuropathy, a condition that develops as a result of damage to the peripheral nervous system — the vast communications network that transmits information between the central nervous system (the brain and spinal cord) and every other part of the body. (Neuropathy means nerve disease or damage.) Symptoms can range from numbness or tingling, to pricking sensations (paresthesia), or muscle weakness. Areas of the body may become abnormally sensitive leading to an exaggeratedly intense or distorted experience of touch. Severe symptoms may include burning pain (especially at night), muscle wasting, paralysis, or organ or gland dysfunction. Diabetes mellitus is a common cause of peripheral neuropathy.

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, four active strategic licensing agreements in the U.S., China, 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. RGN-352, the Company’s injectable formulation of Tβ4, has successfully completed phase 1 clinical trials and is phase 2-ready. RGN-259, the Company’s preservative-free ophthalmic eye drop, is currently in phase 3 clinical trials for dry eye syndrome and neurotrophic keratopathy, both of which will have data read-outs this year. The Company’s dermal gel, RGN-137, is in phase 2 clinical trials for epidermolysis bullosa, a rare hereditary disease where the patients suffer from severe fragility of the skin and internal organs.

For additional information about RegeneRx please visit www.regenerx.com.

Forward-Looking Statements

Any statements in this shareholder letter 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 release include, but are not limited to, patents, know-how, statements regarding our strategic and research partnerships, clinical trials, regulatory applications and approvals, and the use of our drug candidates to treat various conditions. All forward-looking statements are expectations and estimates based upon information obtained and calculated by the Company at this time and are subject to change. Moreover, there is no guarantee any issued patents will provide exclusivity or will not be challenged in a particular jurisdiction, or that any clinical trial will be successful or confirm previous clinical results. 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, 2018, 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 shareholder letter 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.