Bremelanotide Phase 2a Trial Results

NOTE: Phase IIa Bremelanotide trial results conducted initially with pre-menopausal women with FSD (female sexual dysfunction) followed by post-menopausal women results published in August. Pre-menopausal test results are summarized below and a brief summary of post-menopausal group results can be found in the "Update" at the end of this post.

Phase IIb Bremelanotide trials were conducted with both diabetic and non-diabetic males experiencing mild to severe ED (erectile dysfunction). Bremelanotide Phase IIb results can be found here.

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On June 22, 2006, it was revealed Palatin Technologies and King Pharmaceuticals, Inc. will publish a manuscript entitled "An Effect on the Subjective Sexual Response in Premenopausal Women with Sexual Arousal Disorder by Bremelanotide (PT-141), a Melanocortin Receptor Agonist" in the July issue of the Journal of Sexual Medicine.

Below is a summary of the associated press release, plus additions from the Journal of Sexual Medicine report (in blue), followed by the full release....
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The purpose of Part 1 of the 2-Part Phase IIa pilot study was to evaluate the effect of bremelanotide in 18 premenopausal women, ages 22 to 44 years old, diagnosed with female sexual arousal disorder (FSAD). The diagnosis of FSAD was established upon examination by an expert sexual health clinician.

Subjects were required to have a previous history of a normal and satisfying sexual response. No attempt was made to differentiate FSAD due primarily to lack of subjective excitement or lack of genital response.

They received a 20 mg dose (2 x 10 mg) of bremelanotide or placebo during the first in-clinic session and the alternate medication in the second in-clinic session. The patient's vaginal pulse amplitude (VPA) was used to monitor vaginal vasocongestion (definition: "An accumulation of blood in the genital region (causing swelling or erection) due to sexual excitation.") 20 minutes before and 60 minutes after the dosing.

During each treatment session, scheduled 2–7 days apart, subjects viewed a 20-minute neutral video, which began 5 minutes after administration of study drug, followed 10 minutes later by a 20-minute sexually explicit video depicting nude, heterosexual couples engaging in consensual foreplay and intercourse.

All subjects viewed the same set of videos (two neutral, two sexually explicit) in a random order in a private room at a clinical research center.

After a 24-hour at-home period, they completed a questionnaire assessing their sexual activity and their subjective evaluation of sexual desire and sexual arousal.

Although there were no changes in VPA during the first hour, the questionnaire did reveal significant results in the 24-hour at-home period...

On a 14-item questionnaire:

• 67 percent of women on bremelanotide reported an increased level of sexual desire while only 22 percent of women responded similarly after placebo treatment.*
  
• 72 percent of the women reported an increased level of genital arousal while on bremelanotide compared with 39 percent of women on placebo.*

Overall, most women remarked that the quality of the sexual experience following bremelanotide treatment was either comparable to, or better than that experienced prior to the onset of FSD, and, importantly, that it was better than sexual encounters experienced since the onset of FSD.

Some common adverse events reported included nausea and headache - something they'll likely work on fixing between now and its release.

All adverse events were mild in nature, with the exception of one subject who experienced moderate nausea, and all adverse events resolved without treatment or intervention.

Note: although this press release came out June 22, Bremelanotide Bulletin readers saw these results two weeks earlier in our June 9 post "Bremelanotide at the International Sexologists Conference". :-)

* Regarding the placebo results (22% and 39% reporting some arousal), I recently read a quote from Vivienne Cass, a clinical psychologist, sex therapist and author of The Elusive Orgasm, who said:

"When we give women a placebo in a sexual trial, we know this will improve [their] sex lives by 40 per cent. [Because] if you get women to focus on their sexuality in any sense of the word, they will actually become more aroused," she says.

Of course she may be referring to long term experiments with placebos, whereas this specific Bremelanotide group were rated within a relatively short 24 hour period.

Additionally, Dr. Michael A. Perelman, Co-Director of the Human Sexuality Program at Weill Medical College of Cornell University, New York stated after observing the above trial results:

"Clinical and pre-clinical data, taken collectively, evoke a cautious optimism leading me to strongly encourage the sponsor to continue evaluation of bremelanotide for the treatment of female sexual dysfunction,"

"The potential use of this centrally acting compound to treat FSAD is the most interesting development in sexual medicine research in years."

Palatin Technologies and King Pharmaceutical plan to jointly announce the results of the second part of the Phase IIa pilot study in 25 post-menopausal FSAD patients (the above test was done with pre-menopausal women) in the second-half of 2006.

Additionally, the companies have initiated a 100 patient, Phase IIb at-home clinical trial in pre-menopausal FSAD patients. Patients are currently being enrolled in this Phase IIb study at approximately twenty clinical sites throughout the United States.

... no word on exactly what cities are having these trials nor if there are any openings.


UPDATE: In August 2006, Palatin Technologies reported a successful Phase 2A clinical trial in post-menopausal women diagnosed with FSD.

Results revelaed women reported an increased level of genital arousal and sexual desire and reported a higher incidence of engaging in sexual activity while on bremelanotide compared to placebo.

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Here is the complete Press Release, summarized above...

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CRANBURY, N.J. and BRISTOL, Tenn., June 22 /PRNewswire-FirstCall/ -- Palatin Technologies, Inc. (Amex: PTN - News) and King Pharmaceuticals, Inc. (NYSE: KG - News) announced today the publication of a manuscript entitled "An Effect on the Subjective Sexual Response in Premenopausal Women with Sexual Arousal Disorder by Bremelanotide (PT-141), a Melanocortin Receptor Agonist" in the Journal of Sexual Medicine July 2006 - Vol. 3, Issue 4.

The purpose of Part 1 of this 2-Part Phase IIa pilot study was to evaluate the effect of bremelanotide, a first-in-class melanocortin agonist, in 18 premenopausal women, ages 22 to 44 years old, diagnosed with female sexual arousal disorder (FSAD). These patients received an intranasal 20 mg dose (2 x 10 mg) of bremelanotide or placebo during the first in-clinic session and the alternate medication in the second in-clinic session. The patient's vaginal pulse amplitude (VPA) was monitored 20 minutes before dosing until 60 minutes following dosing. After a 24-hour at-home period, the patients completed a questionnaire assessing their sexual activity and their subjective evaluation of sexual desire and sexual arousal.

Although there were no changes in VPA during the immediate post-dose period when comparing bremelanotide to placebo, the data indicated a positive correlation between sexual desire and genital arousal in patients receiving bremelanotide treatment in the 24-hour at-home period. Exploratory results showed that on a 14-item questionnaire, 67 percent of women on bremelanotide reported an increased level of sexual desire while only 22 percent of women responded similarly after placebo treatment. Seventy-two percent of the women reported an increased level of genital arousal while on bremelanotide compared with 39 percent of women on placebo. Common adverse events reported included nausea and headache.

"Clinical and pre-clinical data, taken collectively, evoke a cautious optimism leading me to strongly encourage the sponsor to continue evaluation of bremelanotide for the treatment of female sexual dysfunction," states Dr. Michael A. Perelman, Co-Director of the Human Sexuality Program at Weill Medical College of Cornell University, New York. "The potential use of this centrally acting compound to treat FSAD is the most interesting development in sexual medicine research in years. Once concluded, I look forward to reviewing data from the ongoing clinical trials."

Palatin and King plan to jointly announce the results of the second part of the Phase IIa pilot study in 25 post-menopausal FSAD patients in the second-half of 2006. Additionally, the companies have initiated a 100 patient, Phase IIb at-home clinical trial in premenopausal FSAD patients. Patients are currently being enrolled in this Phase IIb study at approximately twenty clinical sites throughout the United States.

About Bremelanotide

Bremelanotide is the first compound in a new drug class called melanocortin receptor agonists under development to treat sexual dysfunction. This new chemical entity is being evaluated in Phase IIb clinical trials studying the efficacy and safety profile of varying doses of this novel compound in men experiencing erectile dysfunction (ED) and women experiencing female sexual dysfunction (FSD).

The mechanism of action of bremelanotide may offer important benefits over currently available products for the treatment of ED because it acts on the pathway that controls sexual function without acting directly on the vascular system. Clinical data indicates that bremelanotide may be effective in treating a broad range of patients suffering from ED. The nasal formulation of bremelanotide currently under development 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 rapid onset of action.

Although the current ED market is primarily served by PDE-5 inhibitors which target the vascular system, a substantial unmet medical need for alternative sexual dysfunction therapies exists. Many patients are contraindicated for, or non-responsive to, PDE-5 inhibitors. In addition, current literature indicates that about one half of all patients who receive an initial prescription for a PDE-5 inhibitor do not renew the prescription due chiefly to adverse side effects, drug interaction issues, and/or the lack of an acceptable level of responsiveness.

About FSD

Female sexual disorder is defined by the American Foundation for Urologic Disease as: "The persistent or recurrent inability to attain or maintain sufficient sexual excitement, causing personal distress. It may be expressed as a lack of subjective excitement or a lack of genital or other somatic responses."

FSD consists of four components, hypoactive sexual desire disorder, female sexual arousal disorder (FSAD), dyspareunia or painful intercourse and anorgasmia. To establish a diagnosis of FSD, these components must be associated with personal distress, as determined by the affected woman. A February 10, 1999 study published in the Journal of the American Medical Association, JAMA, titled, "Sexual Dysfunction in the United States: Prevalence and Predictors," states that some form of FSD appears to be prevalent in approximately 43 percent of the female population.

About Palatin Technologies, Inc.

Palatin Technologies, Inc. is a biopharmaceutical company developing melanocortin-based therapeutics. The Company has a pipeline of product candidates in development. The Company's internal research and development capabilities, anchored by its proprietary MIDAS(TM) technology, are fueling product development.

Palatin's strategy is to develop products and then form marketing collaborations with industry leaders in order to maximize their commercial potential. To date, the Company has formed partnerships with Tyco Healthcare Mallinckrodt and King Pharmaceuticals. For additional information regarding Palatin, please visit Palatin Technologies' website at http://www.palatin.com.

About King Pharmaceuticals, Inc.

King, headquartered in Bristol, Tennessee, is a vertically integrated branded pharmaceutical company. King, an S&P 500 Index company, seeks to capitalize on opportunities in the pharmaceutical industry through the development, including through in-licensing arrangements and acquisitions, of novel branded prescription pharmaceutical products in attractive markets and the strategic acquisition of branded products that can benefit from focused promotion and marketing and product life-cycle management.

Forward-looking Statements

This release contains 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. These forward-looking statements reflect managements' current views of future events and operations, including, but not limited to, statements pertaining to the proposed indications for bremelanotide; the significance of the results from the clinical trials of bremelanotide; and the expected date of completion of clinical trials.

Some important factors which may cause results to differ materially from such forward-looking statements include dependence on the actual results of the companies' bremelanotide development activities; dependence on the companies' abilities to fund development of bremelanotide; dependence on the companies' abilities to complete clinical trials as anticipated; dependence on the availability and cost of raw materials; dependence on the unpredictability of the duration and results of the U.S. Food and Drug Administration's ("FDA") review of Investigational New Drug Applications ("IND"), New Drug Applications ("NDA"), and supplemental New Drug Applications, ("sNDAs") and/or the review of other regulatory agencies worldwide; dependence on compliance with FDA and other government regulations that relate to King's and Palatin's respective businesses; dependence on King's and Palatin's abilities to successfully manufacture bremelanotide; and dependence on changes in general economic and business conditions; changes in current pricing levels; changes in federal and state laws and regulations; changes in competition; unexpected changes in technologies and technological advances; and manufacturing capacity constraints.

Other important factors that may cause actual results to differ materially from the forward-looking statements are discussed in the "Risk Factors" section and other sections of King's Form 10-K for the year ended December 31, 2005 and Form 10-Q for the quarter ended March 31, 2006, and Palatin's Form 10-K for the year ended June 30, 2005 and Form 10-Q for the quarters ended September 30, 2005, December 31, 2005 and March 31, 2006, which are on file with the U.S. Securities and Exchange Commission. The companies do not undertake to publicly update or revise any of their forward-looking statements even if experience or future changes show that the indicated results or events will not be realized.

Source: Palatin Technologies, Inc.; King Pharmaceuticals, Inc.

Full Journal of Sexual Medicine Report