RegeneRx Biopharmaceuticals, Inc. (NYSE Amex:RGN) (“the
Company” or “RegeneRx”) today announced that the following letter
to stockholders will be posted today to the investor relations
section of the Company’s web site at www.regenerx.com:
To Our Stockholders,
As we enter the final quarter of 2010, we would like to review
our Company’s recent progress while providing a blueprint for the
coming months. We are proud of the tremendous strides made by
RegeneRx Biopharmaceuticals in advancing the development of
Thymosin beta 4 (Tβ4) in a number of clinical applications.
Tβ4 is a novel therapeutic peptide for tissue and organ
protection, repair and regeneration. RegeneRx is developing a
synthetic copy of this conserved molecule for pharmaceutical use.
In preclinical studies Tβ4 was shown to promote progenitor cell
differentiation and migration in the heart and central nervous
system, promote angiogenesis in cardiac and dermal tissues,
increase keratinocyte migration and collagen deposition and
decrease inflammation by down-regulating inflammatory
cytokines.
Each of our three products in clinical development – RGN-352,
RGN-259 and RGN-137 – is a unique formulation of Tβ4.
RGN-352
RGN-352 is an injectable formulation of Tβ4 to treat
cardiovascular and central nervous system diseases, as well as
other medical conditions. Based on a large body of preclinical
efficacy data, we initially are targeting RGN-352 for the treatment
of acute myocardial infarction (AMI), or heart attack. We recently
completed a Phase 1 trial, which showed RGN-352 to be safe and
well-tolerated. Planning for the Phase 2 trial began in the second
quarter of this year, a contract research organization (CRO) has
been retained to manage the trial and the clinical protocol is
expected to be submitted to the U.S. Food and Drug Administration
(FDA) shortly. We anticipate enrolling the first of 100 patients
during the first quarter of 2011 at approximately 25 clinical sites
in the U.S., Israel and Russia with the goal of completing
enrollment in the trial by the end of 2011. We will also have an
interim evaluation at the midpoint of the trial. We recently
received a $3 million, three-year development grant from the
National Institutes of Health (NIH) to support our AMI program.
In addition, recent preclinical data suggest that RGN-352 may
benefit patients with multiple sclerosis (MS) by remyelinating the
damaged myelin nerve sheaths that wrap around and protect the
nerve’s axons, as well as reducing inflammation associated with the
disease. We are supporting a Phase 1/2 physician-sponsored clinical
trial in MS patients that is expected to begin in 2011. Preclinical
work has also suggested that RGN-352 may be of use in treating
stroke and traumatic brain injury.
RGN-352 is intended to address large and growing markets. For
example, based on our independent research and market analysis, we
believe that the peak market value for RGN-352 in the AMI
indication is between $800 million and $900 million, given a U.S.
population of 650,000 treatable patients annually.
RGN-259
RGN-259 is a sterile, preservative-free topical eye drop
formulation of Tβ4 for ophthalmic indications. Based on recent
human clinical data, we are supporting a physician-sponsored Phase
2 trial in dry eye associated with graft versus host disease
(GvHD). Dry eye is a common complication of GvHD and significantly
affects quality of life. Patients experience chronic
conjunctivitis, blurry vision, foreign body sensation, burning or
dry sensation and severe light sensitivity, and may ultimately
experience corneal erosion and blindness. The treating physicians
have received FDA and institutional review board (IRB) approval to
begin this 20-patient study and the first patients are expected to
be enrolled this quarter, with the trial to be completed by the end
of 2011.
We have publicly reported results from previous human studies
and recently submitted a report to the FDA. Under compassionate use
INDs, seven patients with non-healing corneal ulcers were treated
with RGN-259, five of whom had complete healing and two of whom had
substantial healing of their ulcers. Treatment of three additional
patients with corneal defects called punctate keratitis showed no
evidence of healing, although they did report a reduction in eye
inflammation and increased comfort. We believe that these
observations are encouraging and support the commercial use of
RGN-259 in an array of dry-eye indications.
Although the market for RGN-259 in dry eye associated with GvHD
is limited, we believe that the small number of patients with this
form of the disease would qualify it as an orphan drug. Orphan
drugs often have a faster path to commercialization, orphan
products are entitled to seven years of market exclusivity in the
U.S. and 10 years in the E.U. and companies developing such
products are eligible to receive tax benefits and other incentives,
all of which make commercial development a compelling proposition.
We also believe that if the ongoing Phase 2 trial generates
positive patient outcomes, we and/or a partner would have a strong
rationale to develop RGN-259 in other dry eye indications that
offer much larger commercial potential. Further to that goal, we
have commissioned additional non-clinical dry eye efficacy studies
to support this effort, which are commonly used to evaluate
potential products.
RGN-137
We are evaluating RGN-137, a topical gel formulation of Tβ4, in
a Phase 2 trial for the treatment of epidermolysis bullosa (EB). EB
is an inherited group of skin conditions whose hallmark is
blistering and dermal sloughing in response to minor injury, heat,
or friction from rubbing or scratching. Depending on disease
severity, EB may be debilitating and ultimately fatal. We have
received orphan drug designation from the FDA for RGN-137 for the
treatment of EB. We estimate the prevalence of EB in the U.S. to be
between 20,000 and 30,000 patients, with only approximately 5,000
patients eligible for inclusion in our Phase 2 clinical trial. As a
result, recruiting patients into the trial has been slow. We need
six more patients to complete the trial and are bringing in
patients from the U.K. to help complete enrollment. However,
because EB can be so debilitating and patient numbers so small, in
the event that the Phase 2 trial shows robust efficacy, we have
scheduled a meeting with the FDA to ask the agency to consider
converting the trial to a pivotal trial, which could allow us to
file for regulatory approval of RGN-137 without the need for
additional clinical trials. RegeneRx previously received $675,000
in grants from the FDA Office of Orphan Products to support this
trial.
Based on other non-clinical data and observations from patients
whose wounds were treated with RGN-137, we are evaluating
additional potential clinical applications for RGN-137, including
the reduction of scar tissue resulting from surgery, trauma or
disease. In that regard, we intend to submit an application for a
Small Business Innovation Research grant to the NIH to fund
additional research.
Research & Development,
Intellectual Property
RegeneRx currently has more than 20 active research
collaborations under Material Transfer Agreements. These
collaborations generate data that provide the basis for our
clinical programs and are an effective way to leverage our
available resources for important research and development
projects. Our collaborators include 16 U.S. universities, medical
schools and hospitals; four European universities, research centers
and hospitals; the U.S. military, the NIH, a pharmaceutical
company, a cosmetics company and a Canadian university. The
collaborations have multiple areas of clinical focus, including
neurology and stroke, cardiovascular and cardiac repair,
ophthalmology, dermatology, pulmonology, tropical diseases,
thrombosis and cosmeceuticals.
We have 75 issued patents and 261 patent applications submitted
throughout the world. These patents and applications are critical
for protection of our intellectual property and necessary for
future strategic partnerships. We have also submitted patents in
countries such as China and India where we believe our products may
be marketed in the future.
The Coming Months
We are excited about the potential to improve the lives of
patients while creating value for our stockholders, and we face
multiple milestones in the coming months. As you know, in July we
submitted an application for a federal grant of up to $5 million
under the Patient Protection and Affordable Care Act, a $1 billion
program for small biotechnology companies with less than 250
employees. Awards are expected to be announced by October 31st and
would provide an excellent source of non-dilutive financing. It is
not known how many applicants have applied for such grants, which
means it is uncertain how much, if any, capital each company will
receive under the program.
Also, as we have previously indicated, we are in various stages
of discussion with several potential pharmaceutical partners for a
number of clinical indications. Each negotiation is unique with
different objectives required to obtain mutually satisfactory
terms. We realize the value of a pharmaceutical strategic partner
and will continue to work diligently to reach a successful
conclusion.
With respect to our listing on the NYSE Amex, (the Exchange) as
you know we have been operating under a plan of compliance intended
to meet certain of the Exchange’s continued listing standards by
October 25, 2010. We believe that we may not have achieved
sufficient progress against our compliance plan as of this date
and, therefore, expect that we will receive notification from the
Exchange. If we receive such notice, we intend to request a hearing
with the Exchange. Until the hearing, our stock will continue to be
traded on the NYSE Amex. In the event we are not able to maintain
our continued listing, we expect our stock would be traded on an
“over the counter” market such as the OTC Bulletin Board or the
OTCQB market.
We look forward to keeping you apprised of our progress.
Sincerely,
Allan L. Goldstein, Ph.D. J.J. Finkelstein
Chairman Chief Executive Officer
Forward-Looking
Statements
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. 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,
and the quarterly report on Form 10-Q for the quarter ended June
30, 2010, 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.
Regenerx Biopharm In (AMEX:RGN)
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Regenerx Biopharm In (AMEX:RGN)
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