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RegeneRx Biopharmaceuticals, Inc. (OTCBB:RGRX,
http://www.regenerx.com/) announced
that its lead therapy, Thymosin Beta 4 (Tß4), which promotes tissue growth
and wound repair, can also stimulate hair growth in laboratory animals.
According to a National Institutes of Health (NIH) study, "Tß4 exerts a
profound hair-promoting effect through a combined action on several critical
events in hair follicle growth." The findings are published in the December
2003 online issue of the journal of the Federation of American Societies for
Experimental Biology.
According to Dr. Allan Goldstein, Chairman of Biochemistry and Molecular
Biology at The George Washington University School of Medicine and Chief
Scientific Advisor to RegeneRx, "The most important features of the NIH
studies are:
- Corroborating data on the mechanism of action of Tß4 (including:
angiogenesis, cell migration, cell differentiation and remodeling of the
extra-cellular matrix); and
- Evidence that Tß4, which accelerates tissue regeneration by regulating
actin, accelerates hair growth in existing hair follicles by promoting the
migration of stem cells to the base of the follicles, among other key
events."
"The formulation and method of administration of Tß4 in the NIH studies
were significantly different than those used for wound healing," emphasized
Goldstein. "To that end, Tß4, or Tß4 combined with other hair growth agents,
may provide a new therapeutic approach for treating alopecia and other skin
disorders associated with hair loss."
"This is very exciting, although not entirely unexpected," added J.J.
Finkelstein, RegeneRx President and CEO. "We in-licensed the rights to Tß4
two years ago for promoting hair growth, so the newly published scientific
data confirm our expectations. Meanwhile, we are evaluating a whole new set
of business opportunities available to us and quite apart from our current
focus on developing Tß4 for the wound-healing market."
Tß4 is a naturally occurring 43-amino acid peptide that is vital for the
repair and remodeling of injured tissues. Tß4 exhibits potent
anti-inflammatory properties, is non-toxic, active systemically and
topically and can be produced synthetically at low costs. Unlike other
prospective wound treatments it is not a growth factor. Previously, it has
been reported by NIH that Tß4 was effective in accelerating the healing of
dermal wounds in normal, aged, diabetic and steroid-suppressed laboratory
animals as well as ocular wounds in several animal models.
RegeneRx Biopharmaceuticals, Inc. is developing Tß4 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 patent applications pending. The Company also
holds a separate, exclusive world-wide license related to Tß4 and its use
for hair regeneration and treatment of alopecia (loss of hair). The Company
has successfully completed Phase I human clinical trials with Tß4 for the
treatment of chronic dermal wounds and expects to begin Phase II trials in
the first half of 2004.
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 regulatory approval process and the
ongoing and prospective development and commercialization of Tß4 and
possible future benefits to the Company, its shareholders, and patients. Due
to the nature of clinical trials, product development and the regulatory
approval process, the forward-looking statements contained in this press
release 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.
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