CRANBURY, N.J., Aug. 4, 2016 /PRNewswire/ -- Palatin
Technologies, Inc. (NYSE MKT: PTN) today announced that the last
patient visits in the Company's reconnect studies,
consisting of two pivotal Phase 3 clinical trials of bremelanotide
for the treatment of female hypoactive sexual desire disorder
(HSDD), have been completed.
"We are very excited with the completion of the last patient
visits in our Phase 3 reconnect studies," said Carl Spana, Ph.D., President and Chief Executive
Officer of Palatin. "Patient enrollment and last patient out
of the studies were concluded on time. We now look forward to data
verification and database lock, which we anticipate occurring in
late September, with topline data announced shortly
thereafter."
Each Phase 3 study is a multicenter (~80 sites), randomized,
placebo controlled, parallel-group, eight month trial with an
open-label extension phase. The studies are designed to evaluate
the efficacy and safety of subcutaneous bremelanotide, delivered by
an autoinjector pen, in premenopausal women with HSDD as an
on-demand, as-needed treatment.
About Bremelanotide for Hypoactive Sexual Desire
Disorder
Palatin is developing bremelanotide, a centrally-mediated
medication, as a subcutaneous, on-demand treatment for
premenopausal women diagnosed with HSDD. Bremelanotide, which
is a melanocortin 4 receptor agonist drug candidate, is a synthetic
peptide analog of the naturally occurring hormone alpha-MSH
(melanocyte-stimulating hormone).
Bremelanotide is dosed as an as-needed (not chronic) medical
treatment. This treatment is unlike flibanserin (ADDYI®) and
some other female sexual dysfunction treatments in development that
require daily administration and life style modifications.
About Female Sexual Dysfunction and HSDD
Female sexual dysfunction (FSD) covers multi-factorial
conditions that have anatomical, physiological, medical,
psychological and social components. We plan to seek approval
of bremelanotide for HSDD, which is the largest category of
FSD.
HSDD is a medical condition marked by low desire for sexual
activity and a lack of sexual thoughts or fantasies, which causes a
woman personal distress or puts a strain on the relationship with
her partner, and cannot be accounted for by another medical,
physical or psychiatric condition, or as a result of other
medication. It is estimated that as many as one in 10 premenopausal
women may have the signs of HSDD at some point in their life, and
as such a treatment for HSDD represents a major opportunity to
address a significant medical need.
About Palatin Technologies
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
http://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 clinical trial results,
potential actions by regulatory agencies, financings and projected
operations 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 nonclinical,
preclinical and toxicology studies, result of clinical trials,
regulatory actions by the Food and Drug Administration and the need
for regulatory approvals, the availability of suitable financing on
acceptable terms, regulatory actions by the United States Patent
and Trademark Office, 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.