CRANBURY, N.J., Jan. 3, 2018 /PRNewswire/ -- Palatin
Technologies, Inc. (NYSE MKT: PTN), a biopharmaceutical company
developing targeted, receptor-specific peptide therapeutics for the
treatment of diseases with significant unmet medical need and
commercial potential, today announced that the U.S. Food and Drug
Administration (FDA) has notified Palatin that it may proceed with
its clinical investigation of subcutaneous injection PL-8177 as a
potential treatment for patients with ulcerative colitis. The
notice to proceed was received following Palatin's submission of an
investigational new drug (IND) application for this program.
Palatin expects to commence a Phase 1 single and multiple ascending
dose study in the current quarter.
PL-8177, a selective melanocortin receptor 1 (MC1r) agonist
peptide, is Palatin's lead clinical development candidate for
ulcerative colitis and other inflammatory bowel diseases. Agents
that modulate the MC1r system may have therapeutic potential in a
variety of inflammatory disease indications.
"The FDA's acceptance of this IND application is an important
milestone for Palatin, as we accelerate our drug discovery programs
following the successful licensing of bremelanotide for hypoactive
sexual desire disorder," said Carl
Spana, Ph.D., president and chief executive officer of
Palatin Technologies. "We are excited about the potential of
modulating the melanocortin system in the treatment of a wide
variety of diseases, and have multiple programs to develop
melanocortin based therapeutics for patients with inflammatory
diseases."
PL-8177 is a cyclic peptide that has demonstrated efficacy in
animal inflammatory bowel disease models. Palatin has
developed an oral formulation of PL-8177 that has been validated in
animal studies, and is scheduled to be explored in future clinical
investigations. PL-8177 is highly specific for MC1r, with
sub-nanomolar affinity binding and EC50 functional
values.
About Palatin Technologies, Inc.
Palatin Technologies,
Inc. is a biopharmaceutical company developing targeted,
receptor-specific peptide therapeutics for the treatment of
diseases with significant unmet medical need and commercial
potential. Palatin's strategy is to develop products and then form
marketing collaborations with industry leaders in order to maximize
their commercial potential. For additional information regarding
Palatin, please visit Palatin's website at
www.Palatin.com.
Forward-looking Statements
Statements in this press
release that are not historical facts, including statements about
future expectations of Palatin Technologies, Inc., such as
statements about potential clinical indications for PL-8177,
clinical trial results with PL-8177, potential actions by
regulatory agencies including the FDA, regulatory plans,
development programs, proposed indications for product candidates
and market potential for product candidates, are "forward-looking
statements" within the meaning of Section 27A of the Securities Act
of 1933, Section 21E of the Securities Exchange Act of 1934 and as
that term is defined in the Private Securities Litigation Reform
Act of 1995. Palatin intends that such forward-looking statements
be subject to the safe harbors created thereby. Such
forward-looking statements involve known and unknown risks,
uncertainties and other factors that could cause Palatin's actual
results to be materially different from its historical results or
from any results expressed or implied by such forward-looking
statements. Palatin's actual results may differ materially from
those discussed in the forward-looking statements for reasons
including, but not limited to, results of clinical trials,
regulatory actions by the FDA and the need for regulatory
approvals, Palatin's ability to fund development of its technology
and establish and successfully complete clinical trials, the length
of time and cost required to complete clinical trials and submit
applications for regulatory approvals, products developed by
competing pharmaceutical, biopharmaceutical and biotechnology
companies, commercial acceptance of Palatin's products, and other
factors discussed in Palatin's periodic filings with the Securities
and Exchange Commission. Palatin is not responsible for updating
for events that occur after the date of this press release.
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SOURCE Palatin Technologies, Inc.