CRANBURY, N.J., Dec. 10, 2015 /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 needs and
commercial potential, today announced it has achieved its patient
enrollment target in its two pivotal phase 3 clinical studies of
bremelanotide for the treatment of female sexual dysfunction
(FSD).
"We are pleased to achieve this major milestone in the
development of bremelanotide," stated Carl
Spana, Ph.D., President and CEO of Palatin. "We are
grateful for the enthusiastic response from our clinical
investigators and strong interest from patients to participate in
our Phase 3 reconnect study program." Dr. Spana
further stated that, "This puts us on target to release top-line
data results in the third quarter of calendar year 2016."
Each North American (primarily U.S.) reconnect
study is a multicenter (~80 sites), randomized, placebo
controlled, parallel-group, eight month trial with an open-label
extension phase. The clinical trials are designed to randomize
approximately 1100 women (~550 each trial) to evaluate the efficacy
and safety of subcutaneous bremelanotide in premenopausal women
with hypoactive sexual desire disorder (HSDD) as an on-demand,
as-needed treatment. More information on the trial protocol,
including trial design and inclusion/exclusion criteria, can be
found at http://clinicaltrials.gov.
About Bremelanotide for Female Sexual
Dysfunction
Palatin is developing bremelanotide as a
subcutaneous, on-demand treatment of FSD in premenopausal women
diagnosed with HSDD. Bremelanotide, which is a melanocortin
agonist (a compound which binds to a cell receptor and triggers a
response) drug candidate, is a synthetic peptide analog of the
naturally occurring hormone alpha-MSH (melanocyte-stimulating
hormone).
Bremelanotide is an as-needed (not chronic), centrally-mediated
medication, unlike flibanserin (ADDYI®) or certain other
FSD treatments in development that require daily administration.
Studies have shown that bremelanotide starts working within 30 to
60 minutes of administration and remains effective for
approximately eight hours, providing women with greater control and
flexibility in their treatment as well as a quick response.
About Female Sexual Dysfunction
Female Sexual
Dysfunction covers multi-factorial conditions that have anatomical,
physiological, medical, psychological and social components.
We plan to seek approval of bremelanotide for the largest
category of FSD, hypoactive sexual desire disorder (HSDD).
HSDD is a medical condition marked by a lack of sexual thoughts
and desire for sexual activity, which causes a woman 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
one in 10 women may have the signs of HSDD at some point in their
life, and as such HSDD represents a major opportunity to address a
tremendous 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 potential clinical trial results with
bremelanotide, potential actions by regulatory agencies relating to
bremelanotide, regulatory plans, development programs and the
market potential of bremelanotide 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, the ability of Palatin to enter into one or more agreements
relating to the commercialization of bremelanotide, results of
nonclinical, preclinical and toxicology studies, result of clinical
trials, regulatory actions by the FDA and other regulatory agencies
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.
Logo -
http://photos.prnewswire.com/prnh/20150212/175291LOGO
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/palatin-technologies-achieves-target-patient-enrollment-in-pivotal-phase-3-studies-for-bremelanotide-for-female-sexual-dysfunction-300191004.html
SOURCE Palatin Technologies, Inc.