NEW YORK, Sept. 18 Intra-Cellular Therapies todayannounced it has developed a novel series of non-hormonal compounds that showpromise in the treatment of female sexual dysfunction (FSD). These smallmolecule agents are specific and potent inhibitors designed to regulateneuronal activity in selected regions of the brain. The Company believesthese compounds may have utility in the treatment of hypoactive sexual desiredisorder (HSDD), a condition that affects a significant percentage of older,peri- and post-menopausal women and is one of the disorders commonlyclassified as "female sexual dysfunction."
ITI's molecules have demonstrated promising activity in animal models ofsexual behavior, specifically eliciting enhanced female sexual interest andactivity. The Company's lead compounds show behavioral effects equivalent tothose observed after treatment with progesterone, the gold standard forhormonal treatment, in a rodent model of female sexual behavior. In addition,the compounds potently and robustly increase solicitation behaviors in afemale rodent model at doses that do not otherwise disrupt normal behaviors.Studies have shown compounds from this novel chemical series are orallybioavailable and penetrate into the brain after oral administration.Follow-on studies are being conducted to support preclinical safety andtoxicology testing.
"Decreases in hormone levels with menopause can bring about a number ofserious consequences in women's general health and sexual well-being," saidSharon Mates, Ph.D., Chairman and Chief Executive Officer of Intra-CellularTherapies. "Today, these symptoms are treated with hormonal replacementtherapies that can be associated with adverse side-effects. We are encouragedby the results of our studies with these non-hormonal compounds and arehopeful they will yield treatment alternatives to hormonal replacementtherapies for women in this underserved market."
About Female Sexual Dysfunction (FSD)
There are an estimated 40 million women in the United States currentlyexperiencing the transition from peri-menopausal to post-menopausal states.In the next decade an additional 20 million women are expected to reach thislife milestone. Unfortunately, this transitional state is associated with anumber of troubling signs and symptoms that impact the quality of life,including hot flashes, night sweats, osteoporosis, sleep disorders, and lossof libido. Hypoactive sexual desire disorder (HSDD), commonly classified as acomponent of female sexual dysfunction (FSD), is characterized as a persistentabsence of sexual fantasies or thoughts and/or desire for and receptivity tosexual activity that causes distress.
About Intra-Cellular Therapies
Intra-Cellular Therapies, Inc. (ITI), is a biopharmaceutical company thatis developing novel drugs for the treatment of diseases and disorders of thecentral nervous system (CNS). Building on the science generated from theNobel Prize winning laboratory of Dr. Paul Greengard at The RockefellerUniversity, the Company develops compounds that have the potential to treat awide range of diseases associated with the CNS including schizophrenia, sleepdisorders, Parkinson's and Alzheimer's disease, cognitive deficits inschizophrenia, depression and female sexual dysfunction and other disorderspertaining to women's health. To aid in the development process, the Companyincorporates its CNSProfile(TM), a state-of-the-art platform that allows ITIto choose compounds with the strongest potential to succeed in these difficultto treat diseases.
Earlier this year, ITI initiated Phase I clinical programs forschizophrenia and sleep maintenance disorders. ITI-007, the Company'sfirst-in-class dual 5HT2A receptor antagonist/dopamine receptor phosphoproteinmodulator (DPPM) is being studied for the treatment of schizophrenia.ITI-722, a low dose formulation of ITI-007 with selective