CRANBURY, N.J., Feb. 20, 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 that it has launched a
clinical trial website (https://www.reconnectstudy.com) in support
of its phase 3 reconnect study with bremelanotide for
the treatment of female sexual dysfunction (FSD).
"We are pleased to launch reconnectstudy.com, a website where
women suffering from FSD can go to learn more about their symptoms
and a potential new treatment option," said Carl Spana, President and Chief Executive
Officer of Palatin. "There are no approved treatments for
female sexual dysfunction, which affects more than 40% of women in
the United States. We hope women find reconnectstudy.com to
be a valuable resource."
The website provides a wealth of information for women,
including FAQs on study design, qualification, participation and
how to start the enrollment process. It explains that
decreased sexual desire is a real medical condition, and provides
several personal experiences of women who currently suffer from
FSD. It raises awareness of female sexual health and provides
information for women interested in participating in a clinical
research study designed to evaluate the safety and effectiveness of
bremelanotide, a take "as needed" investigational medication for
premenopausal women with decreased sexual desire. More
information is available at reconnectstudy.com.
Palatin initiated Protocols 301 and 302 of its phase 3 clinical
trial reconnect study in the
United States and Canada
for the treatment of FSD in December
2014 and January 2015. Each
pivotal trial of the 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 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 subcutaneous
for the treatment of FSD in premenopausal women diagnosed with FSD.
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).
About Female Sexual Dysfunction
Female Sexual
Dysfunction covers multi-factorial conditions that have anatomical,
physiological, medical, psychological and social components.
We will seek approval of bremelanotide for the largest
category of FSD, hypoactive sexual desire disorder. To
establish a diagnosis of FSD, one or more of the disorders making
up FSD must be associated with personal distress, as determined by
the affected women.i A study of more than
30,000 U.S. women in 2008 reported an age-adjusted point prevalence
of sexual difficulties causing personal distress in 12 percent of
respondents.ii
There are no drugs in the United
States approved for the treatment of FSD. Bremelanotide is
an on-demand, as-needed treatment and has the potential to
transform the treatment of patients with FSD.
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 in
the United States or Europe 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.
i Frank J et al. Diagnosis and Treatment of Female
Sexual Dysfunction. AmFam Physician 2008; 77(5):
635-642.
ii Shifren JL et al. Sexual Problems and Distress in
United States Women: Prevalence
and Correlates. ObstetGynecol 2008;112 (5); 968-9.
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SOURCE Palatin Technologies, Inc.