Regenerx Biopharmaceuticals, Inc. (AMEX:RGN) announced the outcome of its Phase II clinical trial evaluating the safety and wound-healing efficacy of RGN-137 for the treatment of patients with chronic pressure ulcers. RGN-137 is a topical gel formulation of thymosin beta 4 peptide (Tβ4). The drug candidate was found to be safe and well-tolerated at all three dose levels, with no drug-related serious adverse events, which was the primary objective of the study. Regarding the secondary objective of the study, there were no statistically significant differences observed for complete wound healing or the rate of wound healing between the placebo group and any of the three RGN-137 dose levels. The mid-dose level of RGN-137 was observed to offer more rapid initiation of wound healing when compared to placebo, although this improvement was not statistically significant.

Fifteen U.S. clinical sites enrolled seventy-two patients in a Phase II pressure ulcer clinical trial to evaluate the safety, tolerability, and wound healing effectiveness of three different Tβ4 concentrations (0.01%, 0.02%, and 0.1%) vs. placebo, applied topically, once daily for up to 84 consecutive days. Trial subjects were 19 to 85 years of age and had at least one stable Stage III or IV pressure ulcer with a surface area between 5 and 70 cm². Stage III and IV pressure ulcers are full thickness wounds that penetrate through the skin and muscle, sometimes completely to the bone.

"While we are pleased that we met the primary objective of this pressure ulcer trial indicating no safety issues with RGN-137 in pressure ulcer patients, we had hoped to see an increased incidence of complete wound closure over the 84-day treatment course comparing our drug candidate to placebo. We will continue to analyze the data and will make a decision on future development of RGN-137 for pressure ulcers after we review data from the pending Phase II venous stasis trial," stated J.J. Finkelstein, RegeneRx's president and chief executive officer. In addition to the pressure ulcer and venous stasis trials, RegeneRx is also presently evaluating RGN-137 in a Phase II clinical trial in patients with epidermolysis bullosa (EB).

"We continue to believe that RGN-137 can be effective in dermal wound healing. It is important to note that all skin ulcers are not the same. Venous stasis ulcers differ from pressure ulcers as they result from venous insufficiency rather than from constant pressure or shearing factors. Likewise, patients with the more serious types of EB (dystrophic and junctional) have wounds that result from genetic factors, leading to a deficiency in collagen VII and an adhesive protein called laminin-5. Tβ4 has been shown to accelerate collagen deposition and promote laminin-5 expression in laboratory animal models. Both of these types of wounds are superficial compared to Stage III or IV pressure ulcers," commented David Crockford, RegeneRx's vice president of clinical and regulatory affairs. RegeneRx expects data to be reported for the venous stasis trial this quarter and for the EB trial in late 2009.

About Pressure Ulcers

Pressure ulcers affect approximately 3 million individuals in the United States. High rates of incidence are reported for the elderly, the acutely ill, and those who have sustained spinal cord injuries. The standard care of treatment for these patients involves relief of pressure, nutritional support, debridement of necrotic tissue, wound cleansing, application of appropriate wound dressings, and surgical treatment as a final choice. Healing of pressure ulcers is a lengthy process that requires a large amount of health care resources, and the recurrence rate can be high. Pressure ulcers develop when soft tissues are compressed between bony prominences and contact surfaces or when friction (e.g., rubbing against clothing or bedding) or shearing forces (which develop when skin clings to surfaces) cause erosion, tissue ischemia, and infarction. Pressure ulcers most frequently develop over the sacrum, ischial tuberosities, trochanters, malleoli, and heels, but they can develop elsewhere, including behind the ears when nasal cannulae are used for prolonged periods. Pressure ulcers can develop in as little as 3 to 4 hours in some settings. Pressure ulcers are worsened when skin is overly moist and macerated (e.g., from perspiration or incontinence).

About RegeneRx Biopharmaceuticals, Inc.

RegeneRx is focused on the discovery and development of novel peptides to accelerate tissue and organ repair. Currently, RegeneRx is developing three product candidates, RGN-137, RGN-259 and RGN-352 for dermal, ophthalmic, and cardiovascular tissue repair, respectively. RegeneRx is also developing RGN-457 for use in pulmonary indications such as cystic fibrosis. These product candidates are based on Tβ4, a synthetic copy of a 43-amino acid, naturally occurring peptide, in part, under an exclusive world-wide license from the National Institutes of Health. RegeneRx holds over 60 world-wide patents and patent applications related to novel peptides and is currently sponsoring three Phase II chronic dermal wound healing clinical trials, a Phase II ophthalmic wound healing clinical trial, and a Phase I parenteral (injectable) clinical trial supporting systemic delivery of RGN-352 for acute cardiovascular indications.

RegeneRx Technology Background

Tβ4 is a synthetic version of a naturally occurring peptide present in virtually all human cells. It is a first-in-class multi-faceted molecule that promotes endothelial cell differentiation, angiogenesis in dermal tissues, keratinocyte migration, collagen deposition, and down-regulates inflammation. RegeneRx has identified several molecular variations of Tβ4 that may affect the aging of skin, among other properties, and could be important candidates as active ingredients in pharmaceutical and consumer products. Researchers at the National Institutes of Health, and at other academic institutions in the U.S., have published scientific articles indicating Tβ4's in vitro and in vivo efficacy in accelerating wound healing and tissue protection under a variety of conditions. Abstracts of scientific papers related to Tβ4's mechanisms of action may be viewed at RegeneRx's web page: regenerx.

Forward-Looking Statements

This press release contains certain forward-looking statements that 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. Examples of such forward-looking statements include statements concerning the estimated schedule for the release of data related to RegeneRx's Phase II venous stasis ulcer clinical trial and its Phase II EB clinical trial, any future development efforts for RGN-137 as a treatment for pressure ulcers and Tβ4's impact or potential impact on the treatment of dermal wounds, including pressure ulcers, the results of future trials involving Tβ4 and pressure ulcers, and the therapeutic potential of Tβ4 for other dermal, ophthalmic and cardiovascular wounds, pulmonary indications, or cancer, or its use in other pharmaceutical or consumer products. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include the risk that RegeneRx's product candidates may not demonstrate safety and/or efficacy in its ongoing or future clinical trials and other development efforts, including its trials and/or other development efforts related to RGN-137, RGN-259, RGN-352 and RGN-457, the risk that RegeneRx or its collaborators will not obtain approval to market RegeneRx's product candidates in the U.S. or abroad, the risks associated with RegeneRx's need for additional financing to meet capital requirements necessary for the further development and commercialization activities relating to RegeneRx's product candidates, the risks associated with protecting RegeneRx's intellectual property, or that RegeneRx will not be able to obtain patent protection, or that its issued patents will be infringed, and such other risks described in RegeneRx's quarterly report on Form 10-Q for the period ended September 30, 2008, and other filings RegeneRx makes with the SEC. Any forward-looking statements are made pursuant to Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and, as such, speak only as of the date made. RegeneRx undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.


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