BUSINESS WIRE
BETHESDA, Md.--(BUSINESS WIRE)--REGENERX BIOPHARMACEUTICALS, INC. (NYSE Alternext US:RGN)
announced today that based on encouraging “Compassionate Use” data
showing RGN-259’s potential healing effects in patients with non-healing
corneal ulcers, the company will close its current double blind, placebo
controlled, Phase II clinical trial targeting a small subset of diabetic
patients undergoing vitrectomy (DV) surgery in order to focus on a
patient population with broader market potential.
The small proof-of-concept DV trial had been enrolling slowly due to
newer surgical procedures that have resulted in a decreasing number of
vitrectomy procedures in the U.S. where partial removal of the corneal
surface is required. The trial has completed patient treatment with the
lowest dose of RGN-259. These patients will be evaluated as part of the
trial closure, which is expected to take approximately 60 days to
complete. There have been no reported drug related adverse events. The
company estimates it will save approximately $1.8 million in future
costs associated with the DV trial.
The company is also reporting that Dr. Steven Dunn, the principal
investigator holding the “Compassionate Use” IND, has sought permission
from the Institutional Review Board to expand enrollment to ten
patients, allow a longer treatment period if necessary, and include
patients with punctate keratitis (numerous small corneal wounds commonly
affecting comfort and vision). The patients will be evaluated for both
corneal healing and improved visual acuity. On November 17, 2008, the
company reported that RGN-259 had been used to treat four patients with
non-healing eye ulcers for 28 days with “striking” results according to
Dr. Dunn.
“Now that we have seen the clinical activity of RGN-259 in neurotrophic
keratopathy patients receiving treatment for their corneal ulcers, we
believe it makes sense to close the diabetic vitrectomy trial and seek
to focus on a larger commercial opportunity. Supporting data from both
studies may allow RegeneRx to accelerate the clinical development of
RGN-259 by conducting a Phase II/III trial and, if warranted, requesting
‘fast track’ status for marketing approval by the FDA,” stated David
Crockford, vice president of clinical and regulatory affairs.
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 (one of which was recently
completed), a Phase II ophthalmic clinical trial that is the subject of
this press release, 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 throughout the U.S., have published
numerous scientific articles indicating Tβ4’s in vitro and in
vivo efficacy in accelerating wound healing and tissue protection
under a variety of conditions. Key publications related to Tβ4’s effects
in the eye have been published in Investigative
Ophthalmology and Visual Science, Experimental
Cell Research, and Experimental
Eye Research, among others. Abstracts of these and other
scientific papers related to Tβ4's mechanisms of action may be viewed at
RegeneRx's web page: www.regenerx.com.
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
projected cost savings from closing the RGN-259 DV trial, the size of
the market for any alternative ophthalmic indications that the company
may elect to focus on, including non-healing neurotrophic keratitis
ulcers, the expansion of enrollment in the compassionate use study from
four to ten patients and the inclusion of patients with corneal
punctuate keratitis in the compassionate use study, the potential impact
of the closing of the DV trial on the speed of the development or
commercialization of RGN-259, requests to conduct a Phase II/III
clinical trial involving RGN-259 or to request “fast-track” status for
RGN-259, the safety and efficacy of RGN-259, the company’s ability to
enter into any collaborations with respect to the development or
commercialization of any of its product candidates, and the therapeutic
potential of Tβ4 for dermal, ophthalmic, and cardiovascular wounds and
pulmonary indications. 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 the compassionate use
results were based on a very small number of patients and such results
may not be observed in a larger patient population, although Tβ4 has
demonstrated potential therapeutic benefit, the company’s product
candidates may not demonstrate safety and/or efficacy in clinical
trials, the risk that the company or its collaborators will not obtain
approval to market the company’s product candidates in the U.S. or
abroad, the risks associated with the company’s need for additional
financing to meet capital requirements necessary for the further
development and commercialization activities relating to its product
candidates, the risks associated with protecting the company’s
intellectual property, or that the company will not be able to obtain
patent protection, or that its issued patents will be infringed, and
such other risks described in the company’s quarterly report on Form
10-Q for the period ended September 30, 2008, and other filings it 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. The company undertakes no obligation to
publicly update any forward-looking statements, whether as a result of
new information, future events or otherwise.