New TÎ²4 Eye Data to be Presented at ARVO Meeting
ROCKVILLE, Md.--(BUSINESS WIRE)--Apr 8, 2010 - RegeneRx Biopharmaceuticals, Inc. (NYSE Amex:RGN) (www.regenerx.com) announced today that Tβ4, a synthetic version of a naturally occurring peptide that is the basis for the company’s product candidates, will be the subject of three poster presentations at the annual meeting of the Association for Research in Vision and Ophthalmology (ARVO) to be held in Fort Lauderdale, Florida from May 2-6, 2010. The presentations will review results of research performed using Tβ4 in the field of ophthalmology and will describe potential uses of Tβ4, including for the first time, as a drug embedded in a bandage contact lens.
In the first presentation, “Developing a Bandage Contact Lens Delivery System for Controlled Release of Thymosin Beta 4 to the Corneal Epithelium,” Dr. Gabriel Sosne and his research team at Wayne State University School of Medicine in Detroit, Michigan will describe research performed to evaluate the potential for extended release of Tβ4 for more than 100 hours. The researchers concluded that a bandage contact lens delivery system would be a novel, feasible and potentially useful way to promote direct application and extended release of Tβ4 to the surface of the eye. Dr. Sosne is Associate Professor of Ophthalmology at Wayne State University School of Medicine, Department of Ophthalmology and Anatomy/Cell Biology in Detroit, Michigan. He is also a member of RegeneRx's scientific advisory board.
The second presentation, “Antioxidative Effect of Thymosin Beta 4 for Porcine Trabecular Meshwork,” will discuss results of research that was designed to evaluate the antioxidative effect of administering Tβ4 to trabecular meshwork cells in a pig model. These cells make up tissue inside the anterior (front) part of the eye that is responsible for draining most of the fluid from the eye. The degree of fluid drainage and oxidative stress may be associated with increased intraocular pressure and glaucoma, which can injure the optic nerve. The researchers in this study determined that extracellular Tβ4 has an antioxidative effect for hydrogen peroxide in the porcine trabecular meshwork cells. These findings may be relevant to reducing oxidative stress in these cells, which could potentially reduce the damage to the eye from glaucoma. The research was conducted at the departments of Ophthalmology and Visual Sciences, Kyoto University Graduate School of Medicine in Kyoto, Japan and Kumamoto University Graduate School of Medicine in Kumamoto, Japan.
A third presentation, “A Randomized, Double-Mask, Placebo-Controlled, Dose-Response, Phase 2 Study of the Safety and Efficacy of Thymosin beta 4 in the Treatment of Diabetic Patients’ Corneal Wounds Resulting from Epithelial Debridement During Vitrectomy,” will report on the clinical results from the company’s Phase 2 clinical trial of its product candidate RGN-259 in patients with corneal wounds. The particular patients for whom results will be reviewed were those patients who received either the lowest dose of Tβ4 or placebo in the trial. The study was closed by RegeneRx after enrollment of the low-dose cohort due to slow patient accrual, in addition to emerging proof-of-concept data generated in compassionate-use clinical trials in patients with non-healing eye ulcers. As previously reported, the research team observed no serious adverse events following administration of RGN-259 and no statistical differences in the time to wound healing when comparing Tβ4 to placebo. The researchers did note that there appeared to be increased thickening of the corneal epithelium and reduced inflammation (cell and flare) seen in Tβ4-treated patients. These observations would be indicative of corneal re-epithelialization and wound healing and are consistent with known cell migratory and anti-inflammatory properties of Tβ4. The principal investigator of the study was Dr. Benni H. Jeng, Chief, Department of Ophthalmology at the San Francisco General Hospital and Associate Professor and Co-Director, Cornea Service, University of California San Francisco Department of Ophthalmology and Francis I. Proctor Foundation.
“Taken together, the rapidly progressing research advancements in the eye with Tβ4 are bringing the goal of making Tβ4 a novel therapy for a number of ocular disorders closer to reality,” commented Dr. Sosne.
About RegeneRx Biopharmaceuticals, Inc.
RegeneRx is focused on the discovery and development of novel molecules for tissue and organ protection, repair and regeneration. Currently, RegeneRx has formulated three product candidates in clinical development: RGN-137, a topically applied gel for chronic dermal wounds and reduction of scar tissue that is currently in a Phase 2 clinical trial for the treatment of epidermolysis bullosa; RGN-259, a sterile, preservative-free topical eye drop for ophthalmic indications that is currently being supported in compassionate use studies; and RGN-352, an injectable formulation for systemic delivery to treat cardiovascular diseases, central nervous system diseases, and other medical indications that require administration by injection, that has completed a Phase 1 clinical trial. RegeneRx is initially targeting RGN-352 for the treatment of patients who have suffered an acute myocardial infarction, or heart attack, although recent animal research suggests that this formulation may also benefit patients with multiple sclerosis and stroke. RegeneRx has a fourth product candidate, RGN-457, which is an inhaled formulation targeting cystic fibrosis and other pulmonary diseases, in pre-clinical development. These product candidates are based on Tβ4, a synthetic copy of a 43-amino acid, naturally occurring peptide that is the subject of an exclusive worldwide license from the National Institutes of Health. In addition to the four pharmaceutical product candidates described above, RegeneRx is pursuing the commercial development of peptide fragments of Tβ4 for potential cosmeceutical use. RegeneRx holds over 60 worldwide patents and patent applications related to its product candidates.
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, and collagen deposition, while down-regulating inflammation. Tβ4 appears to play a major role in stem cell and progenitor cell differentiation as demonstrated in a number of scientific publications. RegeneRx has also 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 throughout the world, 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 in the myocardium, central nervous system and cornea.
Any statements in this press release that are not historical facts are forward-looking statements made under the provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements 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. These forward-looking statements include statements regarding the efficacy, safety and intended utilization of our product candidates. You are urged to consider statements that include the words “project,” “believe,” “anticipate,” “plan,” “expect,” “estimate,” “intend,” “should,” “would,” “could,” “will,” ”may,” “potential” or the negative of those words or other similar expressions words to be uncertain and forward-looking. Factors that may cause actual results to differ materially from any future results expressed or implied by any forward-looking statements include the risks and uncertainties inherent in our business, including, without limitation the risk that our product candidates do not demonstrate safety and/or efficacy in future clinical trials; risks related to our ability to obtain financing to support our operations on commercially reasonable terms; the progress, timing or success of our clinical trials; difficulties or delays in development, testing, obtaining regulatory approval for producing and marketing our product candidates; regulatory developments; the size and growth potential of the markets for our product candidates and our ability to serve those markets; the scope and validity of patent protection for our product candidates; competition from other pharmaceutical or biotechnology companies; and other risks described in the Company’s filings with the Securities and Exchange Commission (“SEC”), including those identified in the "Risk Factors" sections of the annual report on Form 10-K for the year ended December 31, 2009, filed with the SEC on March 31, 2009, as well as other filings it makes with the SEC. Any forward-looking statements in this press release represent the Company’s views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. The Company anticipates that subsequent events and developments may cause its views to change, and the Company specifically disclaims any obligation to update this information, as a result of future events or otherwise, except as required by applicable law.
Contact: RegeneRx Biopharmaceuticals, Inc.
Lori Smith, 301.208.9191
Posted: April 2010