October 24, 2008
RegeneRx Sponsors “Walk a Mile in My Shoes” for National Epidermolysis Bullosa Awareness Week
REGENERX BIOPHARMACEUTICALS, INC. (AMEX:RGN) (www.regenerx.com) announced today that it is a major sponsor of "Walk a Mile in My Shoes," the signature event of National Epidermolysis Bullosa (EB) Awareness Week. The "Walk a Mile in My Shoes" program coordinates events that include rallies, meetings and walk-a-thons in an effort to raise awareness about EB. This year, the EB Medical Research Foundation and DebRA of America are again community charity partners in the program that will take place in Illinois, Florida, New Jersey, Utah, Ontario, Canada and Mexico. Additional community charity partners are DebRA Canada and DebRA Mexico, who will promote this campaign in their respective countries.
RegeneRx has been involved in EB research since 2000 and is sponsoring a major Phase II clinical trial at fourteen medical centers in the United States for EB patients using RGN-137, a topically administered drug candidate based on Thymosin Beta 4 (TB4). RGN-137 is being used to treat the most severely affected patients and the trial has been funded, in part, by the U.S. Food and Drug Administration.
TB4 is a synthetic version of a naturally occurring peptide present in virtually all human cells. It is a first-in-class drug candidate that promotes several key biological activities thought to be critical to wound healing, including the promotion of laminin-5, an adhesive protein often deficient in EB patients. EB patients and their families can learn more about the study by contacting RegeneRx directly, or consulting the www.clinicaltrials.gov web site to locate the nearest physician investigator.
"If there is an effective wound treatment to be had for EB, we are all for it. One of our objectives is to help EB patients increase their quality of life by improving the healing of their wounds and creating as many pain-free days as possible," according to Gena Brumitt Gruschovnik, the event's organizer.
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About Epidermolysis Bullosa
EB is a group of genetic disorders characterized by exceptionally fragile skin and chronic, painful wounds and blisters caused by the slightest trauma, even normal day-to-day activities. This circumstance is caused by missing or damaged proteins that cause a breakdown between skin layers, resulting in skin that can slip off as easily as that of a ripe peach. The disease affects people of both genders and every ethnicity. It is believed that several hundred thousand people worldwide suffer from one of the forms of EB, and carriers of the mutated gene are more prevalent than one might guess. It is an "orphan disorder," meaning the condition itself affects less than 200,000 Americans, most likely between 20,000 - 50,000.
Common occurrences in severe forms of EB include open wounds, disfiguring scars, musculoskeletal deformities causing restricted function, internal and external blistering, malnutrition, and deterioration of the eyes and teeth. It is often disabling and life-threatening, requiring daily wound care similar to that given to acute burn patients. Checking wounds for infection is a necessity, so baths and bandaging are a daily occurrence - an ordeal that is often so excruciating that it requires strong pain medication.
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. The Company is also developing RGN-457 for use in pulmonary indications such as cystic fibrosis. These product candidates are based on TB4, 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.
About Thymosin beta 4 (TB4)
TB4 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 TB4 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 U.S., have published numerous scientific articles indicating TB4's in vitro and in vivo efficacy in accelerating wound healing and tissue protection under a variety of conditions. Key publications related to TB4's cardio-protective effects have been published in Nature and Circulation. Abstracts of these and other scientific papers related to TB4's mechanisms of action may be viewed at RegeneRx's web page: www.regenerx.com.
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 may be identified by the words "project,""believe,""anticipate,""plan,""expect,""estimate,""intend,""should,""would,""could,""will,""may" or other similar expressions and include statements regarding the safety and efficacy of RGN-137, RGN-259, RGN-352, and RGN-457. Actual results may differ materially from those indicated or implied by such forward-looking statements because the Company's product candidates may not demonstrate safety and/or efficacy in current or future clinical trials such as for epidermolysis bullosa or as a result of various important factors 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, 2007 filed with the SEC on March 28, 2008 and other periodic reports filed 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.