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PT-141's Sexual Stimulation of Female
Rats Grabs the Headlines
July 1, 2004 – Male sexual dysfunction has received
most of the headlines in the last few years, much of it generated by the
battle between drugs, like Viagra, that promise to solve the problem of
poor sexual performance. But the headlines this week were grabbed by
PT-141, a new treatment that reportedly increased sexual activity in
female rats.
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Media Hypes PT-141 as Female Aphrodisiac of the
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Developer's stock soars as it enters next phase of
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Dec. 5, 2005 – There is nothing really new in the
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has been a media frenzy of stories, watched carefully by seniors
citizens, on the possible aphrodisiac of the 21st Century. The only real
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The study evaluated PT-141 in two rat models of
female sexual behavior. PT-141 had a significant effect on the
“solicitation behavior” of the female animals in both models.
Specifically, PT-141 increased the number of solicitations performed by
the female in the presence of a male partner. In these animal models,
solicitation is a sexual behavior used by females to arouse the male
prior to copulation. The effect showed a dose response and did not
affect the copulatory behavior of the females, according to the company. (see
company report)
Palatin Technologies, Inc. (AMEX:
PTN) announced yesterday the publication of a
manuscript in The Proceedings of The National Academy of Sciences (PNAS)
detailing the results of preclinical studies evaluating PT-141 effects
on the sexual behavior of female rats. The research that resulted in
the manuscript titled “Selective Facilitation of Sexual Solicitation in
the Female Rat by a Melanocortin Agonist” was conducted in collaboration
with scientists at Concordia
University in
Montreal,
Quebec Canada.
PT-141 is Palatin’s lead drug candidate under development for the
treatment of both male and female sexual dysfunction (FSD).
James Pfaus, Ph.D. Associate Professor at
Concordia
University and the lead
author of the manuscript stated, “I am particularly excited by the
results reported here because they show a dramatic effect on
solicitation or precopulatory sexual behaviors in animals. This may
indicate that PT-141 will have effects on desire in human females. Our
current thinking is that potential treatments for FSD need to affect
desire if they are going to show broad efficacy in human females.”
Carl Spana, Ph.D., President and Chief Executive
Officer of Palatin Technologies stated, “We are excited by the potential
of PT-141 as a treatment for FSD. The results of this preclinical
research presented in the PNAS manuscript, in conjunction with our
clinical studies in normal women, indicate that PT-141 is a promising
drug development candidate. Our next step is to evaluate PT-141 in
women with FSD during a Phase 2 clinical trial that will be initiated in
the next few weeks.”
About Female Sexual Dysfunction
Female Sexual Dysfunction (FSD) is a multifactorial
condition that has anatomical, physiological, medical, psychological and
social components. Studies estimate FSD is prevalent in approximately
50% of women over the age of 30 and that greater than 35 million women
in the United States
may be afflicted with some form of FSD. FSD includes disorders
associated with desire, arousal, orgasm and pain.
About PT-141
Palatin’s research suggests that PT-141 works
through activation of melanocortin receptors in the central nervous
system (CNS) rather than
acting directly on the vascular system. Activation of melanocortin
receptors by PT-141 results in the specific stimulation of
vasodilatation in the male and female genitalia. Based on PT-141’s
CNS
site of activity, animal studies and early clinical work may be
effective in treating the desire as well as arousal components of FSD.
PT-141 is also in development as a treatment for Erectile Dysfunction
(ED). Clinical data from phase 2 studies indicates that PT-141 may be
effective in treating a broad range of patients suffering from erectile
dysfunction. The nasal formulation of PT-141 being developed is as
convenient as oral treatments, is more patient friendly than invasive
treatments for ED, such as injections and trans-urethral pellets, and
appears to result in a more rapid onset of action than is seen following
the oral administration of treatments for ED.
About Palatin Technologies, Inc.
Palatin Technologies, Inc.
(AMEX: PTN) is a development-stage biopharmaceutical company focused on
discovering and developing melanocortin (MC)-based therapeutics. The
company is currently conducting clinical investigations with its lead
drug PT-141, an MC receptor agonist, for the treatment of male and
female sexual dysfunction. Palatin is also developing a product,
NeutroSpec™, for infection imaging, based on a proprietary radiolabeled
monoclonal antibody. Palatin’s patented drug discovery platform, MIDAS™,
streamlines the drug design process with an efficient approach to
identify lead compounds from protein targets for drugs. For further
information, visit the Palatin web site at
www.palatin.com.
The research is reported in the
Proceedings of Proceedings of the National Academy of Sciences.
The Progress and Goals of
PT-141
Information from Palatin Technologies Website
The aging of the "baby boom" generation has brought
sexual dysfunction into prominence as a medical concern. Men and women
who suffer sexual dysfunction are a large and growing market not
satisfied with current treatments. According to the Massachusetts Male
Aging Study, more than 50% of men aged 40-70 report episodes of ED and
more than 30 million men in the US suffer ongoing ED. The current market
size in dollars is estimated to be from $1.5-3.0 billion, with several
products already competing in the male ED market segment. The statistics
for women are not well defined, yet sexual dysfunction is clearly a
concern for a large number of women.
For nearly a decade, there have been mechanical
methods for treating ED, such as vacuum constriction devices or
surgically implanted penile prostheses. However, recent advances in
understanding the molecular physiology of penile erection have led to
development of pharmaceutical treatments for ED. The first generation of
such products mainly focused on the vascular physiology (blood flow) of
penile erection. For example, PDE-5 inhibitors and PGE1 prostaglandin
hormones induce smooth muscle relaxation to cause penile blood vessels
to fill. This initiates erection. These drugs cause similar effects
elsewhere in the body as well. In contrast, PT-141 appears to work on
the Central Nervous System (CNS), interacting more fundamentally with
the underlying brain and nervous system aspects of sexual arousal and
response, hence initiating penile erection through a more natural
mechanism.
What is PT-141?
PT-141 is a new, nasally administered peptide in
development for the treatment of sexual dysfunction. Palatin research
suggests that PT-141 works through a mechanism involving the central
nervous system (CNS) rather than directly on the vascular system. As a
result, it may offer significant safety and efficacy benefits over
currently available products. Palatin has completed a series of Phase I
clinical studies in both males and females and a series of Phase II
efficacy studies for erectile dysfunction (ED) in males. The company
also plans to initiate a Phase II clinical study in female sexual
dysfunction.
How does PT-141 work?
Approximately 30 minutes before intercourse, the
patient will take a single nasal dose of PT-141. The rapid onset of
PT-141 activity should be preferable to patients when compared to the 1+
hours that current oral ED therapies require. In addition, the nasal
formulation of PT-141 is as convenient as oral treatments, and more
patient friendly than invasive treatments for ED, such as injections and
trans-urethral pellets.
PT-141 Clinical Development Status
Phase 2B "At-Home" Study - Males: Data
presented at the 8th Annual Leadership Conference on Sexual,
Cardiovascular and Metabolic Syndrome Related Therapies in Los Angeles
on November 1, 2003 demonstrated both safety and efficacy of PT-141.
Specifically, selected doses of PT-141 produced clinically and
statistically significant improvement in erectile function across a wide
range of erectile dysfunction (ED) patients with acceptable
tolerability.
Phase 2A Studies - Males: Data presented in
May, 2003 at the American Urological Association meeting. Based on
studies conducted in men with mild, moderate and severe ED, including
patients with hypertension, hyderlipidemia, diabetes and depression,
PT-141 produced a statistically significant improvement in erectile
function with no clinically significant adverse effects.
Phase 1B Study - Females: PT-141 was
administered to premenopausal women without sexual dysfunction and was
shown to be safe and well tolerated. A secondary endpoint in this study
was to assess PT-141's affect on vaginal blood flow. Results showed a
significant difference in the increase in vaginal blood flow in subjects
treated with PT-141 versus placebo.
Pre-clinical Studies: Study data indicate
that PT-141 is a remarkably potent inducer of penile erection and that
PT-141 activates neurons in the hypothalamus, the area of the brain
responsible for sexual arousal. Preclinical toxicity and safety studies
indicate that it is well tolerated with intranasal dosing. Additionally,
researchers have noted no treatment-related effects on hemodynamic or
cardiac functions.
PT-141 Clinical Development - Future Plans
Palatin plans on advancing the PT-141 male erectile
dysfunction development program toward Phase 3 trials. Phase 3 trials
are scheduled to begin in 2005.
Palatin also plans to
conduct a Phase 2 study of PT-141 in female patients with sexual arousal
disorder in 2004.
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