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8-K - FORM 8-K - REGENERX BIOPHARMACEUTICALS INC | c14252e8vk.htm |
Exhibit
99.1
RegeneRx Phase 2 AMI Trial on Clinical Hold due to GMP
Compliance Issues at Contract Manufacturer
Compliance Issues at Contract Manufacturer
Rockville, Md., March 16, 2011 RegeneRx Biopharmaceuticals, Inc. (OTC Bulletin Board: RGRX)
(the Company or RegeneRx) announced that it has received a notice from the U.S. Food and Drug
Administration (FDA) indicating that, due to non-compliance with FDAs current Good Manufacturing
Practice (cGMP) regulations by its contract manufacturer, the Companys Phase 2 clinical trial of
RGN-352, its injectable formulation of Thymosin beta 4 for the treatment of acute myocardial
infarction (AMI), has been placed on clinical hold. RegeneRx is currently unable to estimate the
length of time that the trial will be on clinical hold. The Company was scheduled to begin
enrolling patients in the trial in the coming weeks. The Company will provide additional
information as it becomes available.
The clinical hold is limited to cGMP compliance issues at a specific contract manufacturing site
and is not directed at the safety of RGN-352, the Companys Phase 2 AMI protocol or its clinical
development plan, nor does it affect any other RegeneRx clinical trial or drug candidate.
About RegeneRx Biopharmaceuticals, Inc. (www.regenerx.com)
RegeneRx is focused on the development of a novel therapeutic peptide, Thymosin beta 4, or Tβ4, for
tissue and organ protection, repair and regeneration. RegeneRx currently has three drug candidates
in clinical development and has an extensive worldwide patent portfolio covering its products.
RGN-352 is an injectable formulation to treat cardiovascular and central nervous system diseases,
as well as other medical indications. RegeneRx has successfully completed a Phase 1 clinical trial
with RGN-352 in which the drug candidate was found to be safe and well-tolerated. The company has
initiated a Phase 2 clinical trial at approximately 20 clinical sites in the U.S., Israel, and
Russia, although this trial is currently on an FDA-imposed clinical hold. RegeneRx recently
received a $3 million, three-year development grant from the NIH to support the companys acute
myocardial infarction program.
RGN-259 is a sterile, preservative-free topical eye drop for ophthalmic indications. Based on
recent human clinical data, RegeneRx is currently supporting a physician-sponsored Phase 2 dry eye
study with RGN-259. Previously, seven patients with non-healing corneal ulcers were treated with
RGN-259 under compassionate use INDs. Five had complete healing and two had substantial healing of
their wounds. Three additional patients with corneal defects, called punctate keratitis, had no
evidence of healing although they did report reduction in eye inflammation and increased comfort.
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RGN-137, a topical gel formulation, is currently being evaluated by RegeneRx in a Phase 2 clinical
trial for the treatment of the orphan skin disease epidermolysis bullosa. Other potential uses for
RGN-137 include the treatment of chronic dermal wounds and reduction of scar tissue.
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. These
forward-looking statements include statements concerning the outcome of the FDA-imposed clinical
hold on the Companys Phase 2 AMI clinical trial, the length of the clinical hold, the timing for
enrollment in the clinical trial, and the plans for future development of RGN-352. 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 estimate,
will, may, potential or the negative of those words or other similar expressions 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 risks related to
uncertainties inherent in our business, including, without limitation the risk that the FDA may
require the destruction of placebo and drug candidate produced by the supplier and that the Company
may need to locate an alternate manufacturer. Additional risks include the risk that our product
candidates do not demonstrate safety and/or efficacy in current clinical trials or future
non-clinical or 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 Companys filings with the Securities and
Exchange Commission (SEC), including those identified in the Risk Factors section of the annual
report on Form 10-K for the year ended December 31, 2009, filed with the SEC on March 31, 2010, and
the quarterly report on Form 10-Q for the quarter ended September 30, 2010, as well as other
filings it makes with the SEC. Any forward-looking statements in this press release represent the
Companys 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.
# # #
For RegeneRx:
Lippert/Heilshorn & Associates, Inc.
Kim Golodetz
212.838.3777
kgolodetz@lhai.com
Kim Golodetz
212.838.3777
kgolodetz@lhai.com
or
Bruce Voss
310.691.7100
bvoss@lhai.com
310.691.7100
bvoss@lhai.com
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