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RegeneRx Files for Orphan Drug Designation For Thymosin Beta 4 RegeneRx Files for Orphan Drug Designation For Thymosin Beta 4 Drug to Be Tested for Epidermolysis Bullosa December 5, 2002 — Bethesda, Md RegeneRx Biopharmaceuticals, Inc. (OTCBB:RGRX) announced that it has filed an application with the Food and Drug Administration Office of Orphan Products Development (OOPD) requesting that its drug, Thymosin Beta 4 (Tß4), be designated an Orphan Drug for the treatment of Epidermolysis Bullosa (EB). A product may receive orphan designation if it is being tested for the treatment of a rare disease or condition affecting less than 200,000 persons in the U.S. This designation provides numerous incentives including tax credits for clinical research, seven years of marketing exclusivity upon approval of a New Drug Application, and the possibility of government research grants for clinical studies. According to J.J. Finkelstein, RegeneRx's President & CEO, "We very much look forward to evaluating the efficacy of Tß4 for EB. Data generated to date, at the NIH and elsewhere, provide a strong rationale for testing Tß4 as a treatment for this condition. In particular, the fact that Tß4 is found in significant concentrations in human wound and blister fluids and induces production of laminin-5, which is responsible for the adhesion of certain cellular components of the skin (and is mutated or deficient in most forms of EB), is very encouraging." EB is a group of inherited conditions in which there is fragility of the skin and mucous membranes. Any friction, rubbing, trauma to skin and/or mucous membranes causes blisters and skin to slough off. The disorder occurs in every racial and ethnic group throughout the world and affects both sexes equally. While many people get blisters on their hands and feet from time to time, people with EB get blisters much more easily and in much greater numbers. In severe EB, blisters seem to form without any apparent friction at all; they can even form inside the mouth, esophagus, stomach, intestines, and respiratory and genitourinary tracts. Tß4 is a naturally occurring peptide and the major actin-sequestering molecule in mammalian cells. As such, it plays a vital role in the regeneration, remodeling, and healing of injured or damaged tissues. Tß4 is found in highest concentration in blood platelets, the first molecules to reach the site of a wound. It has also been shown to influence T-cell differentiation, decrease toxicity induced by endotoxin and chemotherapy, and down-regulate a number of key inflammatory cytokines and chemokines. It has a significantly different mechanism of action than other potential wound healing agents, including growth factors, and may be delivered topically, virtually eliminating toxicity while allowing easy accessibility for frequent treatment. Tß4 has been shown to significantly accelerate wound healing in normal, diabetic, steroid-suppressed, and aged animals. Numerous recent papers have been published in major scientific journals describing the results of research on Tß4 conducted at the NIH and other institutions. Abstracts of these publications may be found at the company's web site. RegeneRx Biopharmaceuticals, Inc., Bethesda, MD, (www.RegeneRx.com) holds an exclusive worldwide license for Tß4 from NIH for wound healing and is developing it for the potential treatment of a variety of human diseases. The Company holds several patents related to the technology and has numerous patent applications pending. In November 2002, RegeneRx filed an IND to begin human clinical testing of its product. The information in this press release may include certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements concern the Company's current expectations regarding future events, including the regulatory approval process and the ongoing and prospective development and commercialization of Tß4 and possible future benefits to the Company, its shareholders, and patients. Due to the nature of clinical trials, product development and the regulatory approval process, the forward-looking statements contained in this press release are subject to risks and uncertainties, including those reflected in the Company's filings with the Securities and Exchange Commission, particularly its most recent Annual Report on Form 10-KSB. The Company assumes no obligation to update or revise any forward-looking statements made herein or any other forward-looking statements made by the Company. |
