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RegeneRx Cleared to Initiate Phase II Clinical Trial with Tß4 for Chronic Pressure Ulcers RegeneRx Cleared to Initiate Phase II Clinical Trial with Tß4 for Chronic Pressure Ulcers November 2, 2004 — Bethesda, Md RegeneRx Biopharmaceuticals, Inc. (OTCBB:RGRX) (www.regenerx.com) announced it received no objections from FDA within the statutory thirty-day comment period and will initiate its first Phase II clinical trial to test its drug, Thymosin beta 4 (Tß4), for the treatment of chronic pressure ulcers. “We are continuing to proceed according to our clinical development plan,” said J.J. Finkelstein, RegeneRx President & Chief Executive Officer. “We are very pleased to have cleared this important milestone without any technical or regulatory issues. The next twelve to eighteen months should be quite exciting as we obtain clinical data from patients using Tß4,” he went on to say. The Phase II trial is a randomized, double-blind, placebo-controlled trial designed to test several dosages of Tß4 in patients with chronic pressure ulcers at a number of medical centers in the U.S. The drug will be topically administered to each patient over a period of several weeks. The study should be completed and analyzed within twelve months. The Phase II trial is the first in a portfolio of complementary clinical trials planned by RegeneRx, designed to evaluate Tß4’s effect on wound healing for specific types of dermal and ocular wounds. “We also have plans to study patients with epidermolysis bullosa (EB), a rare skin disorder for which Tß4 has been designated an Orphan Drug, as well as patients with diabetic lower extremity ulcers,” said Finkelstein. “Additionally, our partner in Europe, Sigma-Tau Group, is planning to conduct a Phase II study in Italy this year to evaluate Tß4 for the treatment for chronic venous stasis ulcers.” Chronic pressure ulcers (sometimes known as chronic pressure sores) result from a number of factors including immobility, age, disease, or the use of drugs such as steroids and chemo-therapeutic agents. It is estimated that over 3 million people have chronic pressure ulcers in the U.S. with 1.6 million new cases annually. Treatment costs in the most serious cases may exceed $40,000 per patient per episode and may require months or years to heal the ulcers, if ever. Tß4 is a naturally occurring 43-amino acid peptide present in virtually all human cells. It represents a new class of wound healing drug and exhibits a number of properties important to the wound healing cascade such as promoting endothelial cell differentiation and cell migration, down-regulating a number of inflammatory cytokines and chemokines, and inducing collagen deposition. A key mechanism of action is Tß4’s ability to regulate the cell-building protein, actin, a vital component of the cytoskeleton and essential for wound healing. It has also been shown that Tß4 directly influences the production of laminin-5, a protein necessary for proper adhesion of certain types of mammalian cells and another important component of the wound healing process. RegeneRx is a biopharmaceutical company developing Tß4 as a platform technology for the treatment of acute and chronic wounds and for the treatment of a variety of human diseases involving tissue and organ repair under an exclusive world-wide license from the NIH. The Company holds several patents related to the technology and has over forty world-wide patent applications pending. Recently, Tß4 was designated an “Orphan Drug” by the FDA for the treatment of patients with epidermolysis bullosa, thus potentially extending the period of market exclusivity and allowing the company to be eligible for FDA grants and tax credits, among other benefits. 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. |
