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Rockville, MD, United States

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Patent
RegeneRx | Date: 2017-01-24

An ophthalmic composition for administration to an eye containing 0.001-1000 micrograms per ml by weight of thymosin beta 4 (T4), or an N-terminal variant, a C-Terminal variant, a conservative variant or an isoform thereof, and one or more of a tonicity agent, a buffering agent, a pH adjusting agent, and a solvent, a method of treating an eye of a human for dry eye syndrome by administering an effective amount of the ophthalmic composition to the eye of the human to treat the dry eye syndrome, and a method of treating a cornea of an eye of a human for corneal epithelial thinning by administering an effective amount of the ophthalmic composition to the cornea to treat corneal epithelial thinning.


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, or muscle weakness.  It is estimated that 20 million people in the United States have some form of peripheral neuropathy with an increased incidence 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, not including any possible extensions by the USPTO. "This patent continues to expand the scope of potential use of RGN-352, our systemic formulation of Tβ4, in patients with neural injury and disease. The neurovascular remodeling, repair and regeneration properties of Tβ4 found by Dr. Chopp and his team in their animal models elaborate the considerable potential for the use of Tβ4 in major disorders such as diabetic-induced peripheral neuropathy and other conditions or diseases that are associated with nerve damage," stated J.J. Finkelstein, RegeneRx's president and chief executive officer. 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, began enrollment in its second Phase 3 clinical trial in approximately ~500 patients with dry eye syndrome, which is expected to be completed in 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. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/regenerx-collaborators-receive-notice-of-allowance-of-us-patent-for-the-treatment-of-peripheral-neuropathy-300472912.html


Patent
RegeneRx | Date: 2015-04-07

Peptide fragments having amino acid sequences corresponding to portions of a thymosin beta 4, a thymosin beta 10 and/or a thymosin beta 15 amino acid sequence are provided, as well as methods of treatment utilizing same.


A method of treatment for treating, preventing, inhibiting or reducing tissue deterioration, injury or damage due to congestive heart failure disease, or for restoring tissue adversely affected by said disease, in a subject, includes administering to a subject an effective amount of a composition including a peptide agent including amino acid sequence LKKTET [SEQ ID NO: 1] or LKKTNT [SEQ ID NO: 2], a conservative variant thereof, or a peptide agent that stimulates production of an LKKTET [SEQ ID NO: 1] or LKKTNT [SEQ ID NO: 2] peptide, or a conservative variant thereof, in the tissue.


Patent
RegeneRx | Date: 2014-12-10

Peptide fragments having amino acid sequences corresponding to portions of a thymosin beta 4, a thymosin beta 10 and/or a thymosin beta 15 amino acid sequence are provided, as well as methods of treatment utilizing same.


Patent
RegeneRx | Date: 2016-01-19

A single unit dosage eye drop formulation including 0.1% to 0.6% by weight Thymosin 4 (T4) and an ophthalmically acceptable carrier.


Patent
RegeneRx | Date: 2013-02-04

Peptide fragments having amino acid sequences corresponding to portions of a thymosin beta 4, a thymosin beta 10 and/or a thymosin beta 15 amino acid sequence are provided, as well as methods of treatment utilizing same.


A composition including a peptide agent including amino acid sequence LKKTET [SEQ ID NO: 1] or LKKTNT [SEQ ID NO: 2], a conservative variant thereof, or a stimulating agent that stimulates production of an LKKTET [SEQ ID NO: 1] or LKKTNT [SEQ ID NO: 2] peptide, or a conservative variant thereof, the composition including at least one amino acid stabilizing agent or lyophilization bulking agent, the composition being in lyophilized form, or in a form capable of being lyophilized.


The present invention provides embodiments which involve methods of providing a predetermined concentration of thymosin beta 4 (TB4) at a predetermined time, t, in a body portion of a live human patient. The methods can include determining a thymosin beta 4 treatment dosage (D) using Formula I: C=(A)D.t^(B), wherein C is the predetermined concentration at time t, in ng/mL, D is the dosage of thymosin beta 4 administered in mg, t is the time elapsed after administration of dosage D in hours, A is about 30 to about 38, and B is about 0.5 to about 1; and administering the dosage (D) of thymosin beta 4 to the patient. Formula I may be, for example, C=(35.6)D.t^(0.754)(Formula II).


ROCKVILLE, Md., Feb. 27, 2017 /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 its licensee for RGN-137, GtreeBNT Co., Ltd.,...

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