RegeneRx reports phase II venous stasis trial results

Mar 29 2009

RegeneRx Biopharmaceuticals Inc. has announced the results of its Phase II clinical trial evaluating the safety and wound-healing efficacy of RGN-137 for the treatment of patients with venous stasis ulcers.

RGN-137 is a topical gel formulation of thymosin beta 4 peptide (Tbeta4). The drug candidate was found to be safe and well-tolerated at all three dose levels, with no dose-limiting or drug-related adverse events, which was the primary objective of the trial. Like the previously reported Phase II pressure ulcer trial, the mid-dose level of RGN-137 appeared to be the most active of the three doses and induce more rapid initiation of wound healing compared to placebo.

Two key parameters were evaluated in the primary efficacy population (all 72 randomized patients receiving at least one dose of drug or placebo): (1) percent of patients with complete wound healing and (2) time to complete wound healing. Thirty-three percent (33%) of the patients in the mid-dose group had complete healing compared to 24% in the placebo group, 16% in the low-dose group, and 17% in the high-dose group. Of those patients in the mid-dose group with complete healing, it was observed that RGN-137 decreased the median time to complete healing by approximately 40% compared to placebo. The differences between the active dose groups and placebo were not deemed to be statistically significant.

"We are pleased the trial met the primary objective of safety, and that we were able to see evidence of wound healing activity in patients with venous ulcers, which are very difficult to treat. We believe that the observations in the mid-dose group, along with data obtained from our recently completed Phase II pressure ulcer trial, provide important information suggesting that the mid-dose of RGN-137 initiated the wound healing process earlier than the low-dose, high-dose or placebo. The observation of Tbeta4's acceleration of wound healing is consistent with animal data reported by National Institutes of Health (NIH) researchers that served as the basis for our clinical program. We believe that they also provide the rationale to consider RGN-137 for the treatment of other wounds such as lower extremity diabetic ulcers, burns, and possibly acute wounds. We will continue to analyze these data and consider their impact on potential future clinical activities," stated David Crockford, RegeneRx's vice president for clinical and regulatory affairs.

The trial was sponsored by RegeneRx and conducted in Italy and Poland by its partner and largest stockholder, Sigma-Tau Group. Eight clinical sites in Italy and Poland enrolled and treated 72 patients in the double-blind, placebo-controlled, Phase II clinical trial to evaluate the safety, tolerability, and wound healing effects of three escalating concentrations of Tbeta4 (0.01%, 0.03%, and 0.1%) compared to placebo. All patients were randomized to receive standard of care, plus drug or placebo applied topically, once daily for up to 84 consecutive days. The average age of the patients was 60 years.

About Venous Stasis Ulcers

Venous stasis ulcers affect 500,000 to 600,000 people in the United States every year and account for 80 to 90% of all leg ulcers. They are caused by problems in the veins of the lower leg caused by leaky valves, obstructions, or regurgitation disturbing the flow of blood from the lower extremities back to the heart. The blood collects in the lower leg and damages the tissues and causes wounds. Venous ulcers are located below the knee and are primarily found on the inner part of the leg, just above the ankle. The base of a venous ulcer is usually red. It may also be covered with yellow fibrous tissue or there may be a green or yellow discharge if the ulcer is infected. Fluid drainage can be significant with this type of ulcer. The skin may also have brown or purple discoloration about the lower leg. Venous stasis ulcers are common in patients who have a history of leg swelling, long standing varicose veins, or a history of blood clots in either the superficial or the deep veins of the legs. Ulcers may affect one or both legs.

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 Tbeta4, 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.

RegeneRx Technology Background

Tbeta4 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 Tbeta4 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 Tbeta4'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 Tbeta4's mechanisms of action may be viewed at RegeneRx's web page: www.regenerx.com .