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Sigma-Tau to Conduct Phase II Clinical Trial in Europe with Tß4 for Venous Stasis Ulcers Sigma-Tau to Conduct Phase II Clinical Trial in Europe with Tß4 for Venous Stasis Ulcers Pharmaceutical Firm Accelerates Phase II Commitment June 23, 2004 — Bethesda, Md RegeneRx Biopharmaceuticals, Inc. (OTCBB:RGRX) (www.regenerx.com) announced today that its strategic partner, Sigma-Tau Group (Sigma-Tau), is planning to conduct a Phase II clinical trial in Europe in the 4th quarter of 2004 to test Thymosin beta 4 (Tß4) for the treatment of patients with venous stasis ulcers. The trial will be in addition to RegeneRx's planned Phase II trials in the U.S for the treatment of chronic pressure ulcers, epidermolysis bullosa, and other chronic dermal indications. In January 2004, RegeneRx exclusively licensed certain rights to Tß4 to a wholly owned subsidiary within Sigma-Tau Group for the treatment of internal and external wound healing in Europe and other contiguous and geographically relevant countries. "We are very pleased Sigma-Tau will be initiating Phase II trials with Tß4, as this significantly enhances our drug development efforts," explained J.J. Finkelstein, RegeneRx's President & CEO. "That they have decided to begin clinical trials earlier than originally contemplated shows their confidence in, as well as their commitment to, the technology and our partnership. Since the clinical trial in Europe will be conducted under RegeneRx's U.S. IND, data from the trial can be used to support our drug development efforts for venous stasis ulcers and other chronic dermal wounds in the U.S., as well as in Europe. As for its impact on initiation of our initial Phase II studies in the U.S., we expect to file an amendment to our IND in July," stated Mr. Finkelstein. "The planned studies fit well with Sigma-Tau's long standing know-how in vascular disease. Tß4 represents a very interesting compound, offering us the opportunity to investigate an important medical need, such as venous ulcers, and parallels Sigma-Tau's extensive clinical activities with carnitines in peripheral arterial disease," added Paolo Carminati, Director of R&D at Sigma-Tau. A venous stasis ulcer is an ulceration that develops on the ankle or lower leg in patients with chronic vascular disease. Venous blood flow in the lower extremities of these patients is impaired, leading to edema (swelling) and mild redness and scaling of the skin that gradually progress to ulceration. This condition affects approximately 500,000 patients in the U.S., a similar number in Europe, and about half that number in the remaining industrialized markets. Tß4 is a naturally occurring 43-amino acid peptide present in virtually all human cells. Tß4 represents a new class of wound healing drug and is different from other wound repair factors, such as growth factors, in that it promotes endothelial cell differentiation and keratinocyte cell migration, down-regulates a number of inflammatory cytokines and chemokines, and has a relatively low molecular weight, allowing it to diffuse relatively long distances through tissues. Key mechanisms of action are Tß4's ability to regulate the cell-building protein, actin, a vital component of the cytoskeleton as well as induce the production of laminin-5 and promote tissue re-epithelialization. It has been the subject of a significant amount of research at the NIH and a number of other academic institutions, and has been reported to be effective in the repair of dermal and corneal wounds in numerous animal models under a variety of experimental conditions. 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 numerous world-wide patent applications pending. Recently, RegeneRx received Orphan Drug designation for Tß4 for the treatment of epidermolysis bullosa. Phase I clinical trials were successfully completed with Tß4 for the treatment of dermal wounds and Phase II trials are expected to begin shortly. Sigma-Tau is a leading research-based Italian pharmaceutical Group with annual revenues in excess of $700 million and over 2300 employees worldwide. Therapeutic areas in which the company's research and development are focused include oncology, neurology, cardiovascular, gastroenterology, metabolism and immunology. Sigma-Tau has operating subsidiaries throughout Europe and the U.S. and maintains a presence in all of the world's major pharmaceutical markets. Sigma-Tau's press releases and corporate information are available at www.sigma-tau.it and www.sigma-tau.com. 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 ongoing and prospective development of Tß4 and possible future benefits to the Company, its shareholders, and patients. Due to the nature of product development and the regulatory approval process, the forward-looking statements 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. |
