Navigation Links
Palatin Technologies, Inc. Announces Dosing of Subcutaneous Bremelanotide Trial in Men
Date:2/9/2010

CRANBURY, N.J., Feb. 9 /PRNewswire-FirstCall/ -- Palatin Technologies, Inc. (NYSE Amex: PTN) today announced the completion of first cohort dosing in a placebo-controlled, multiple dose study of bremelanotide, its experimental treatment for sexual dysfunction.  The primary endpoint in this double-blind safety study is evaluation of blood pressure effects of subcutaneous bremelanotide in men between 45 and 65 years old.  The study will also evaluate consistency of plasma exposure of bremelanotide given as repeated subcutaneous injections.

Palatin anticipates completing the study in the current calendar quarter, with data analysis completed in the next calendar quarter.

"The current study is designed to validate our hypothesis that increases in blood pressure and gastrointestinal events seen with intranasally administered bremelanotide were primarily related to high intranasal absorption in a subset of patients. The results from this study in the male demographic we are targeting for commercialization, combined with results from our study reported last August, are intended to further address concerns raised by the Food and Drug Administration," said Trevor Hallam, Ph.D., Executive Vice President of Research and Development of Palatin.

Data from this study will be submitted to the Food and Drug Administration.  Palatin intends to initiate a Phase 2, at-home, study of subcutaneous bremelanotide in men with erectile dysfunction who are not responsive to therapies with drugs such as Viagra®, a brand of sildenafil citrate, in the second half of this calendar year.  The Phase 2 bremelanotide erectile dysfunction program is designed to provide the data required to initiate Phase 3 registration trials.

"The commercial opportunity for bremelanotide is significant with an estimated market of $500 million to $600 million per year.  About 35% of patients with erectile dysfunction do not respond to approved oral therapies, and with limited treatment options these patients are ideal candidates for subcutaneous bremelanotide," stated Carl Spana, Ph.D., President and CEO of Palatin.

About Erectile Dysfunction

Erectile Dysfunction is the consistent inability to attain and maintain an erection sufficient for sexual intercourse. It is estimated that some degree of erectile dysfunction affects half of all men over the age of 40 and that 150 million men worldwide suffer from erectile dysfunction. Up to 35% of men with erectile dysfunction are non-responsive to standard therapies with phosphodiesterase-5 inhibitors.

Bremelanotide Indications

Palatin is developing subcutaneous bremelanotide as a therapeutic for treatment of men with erectile dysfunction who are non-responsive to standard therapies with phosphodiesterase-5 inhibitors such as Viagra and for treatment of women with female sexual dysfunction.

About Bremelanotide

Bremelanotide, a synthetic peptide developed and solely owned by Palatin Technologies, is believed to act through activation of melanocortin receptors in the central nervous system. Nasal formulations of bremelanotide have been extensively studied, including Phase 2B studies for erectile dysfunction in both non-diabetic and diabetic patients and Phase 2A studies for female sexual dysfunction in both pre- and post-menopausal women. Increases in blood pressure observed in some patients receiving nasally administered bremelanotide, coupled with significant variation in plasma levels, lead to discontinuation of nasally administered bremelanotide as a first-line therapy for sexual dysfunction. In studies to date with subcutaneous administration of bremelanotide variability in plasma exposure has been significantly reduced, with no statistically significant difference in mean changes in blood pressure seen in subjects receiving bremelanotide compared to placebo.

About Palatin Technologies, Inc.

Palatin Technologies, Inc. is a biopharmaceutical company dedicated to the development of peptide, peptide mimetic and small molecule agonists with a focus on melanocortin and natriuretic peptide receptor systems. Palatin's internally developed drug pipeline utilizes proprietary approaches to discover potent rigid conformers from flexible peptide starting points. 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 Technologies' website at www.palatin.com.

Forward-looking Statements

Statements about future expectations of Palatin Technologies, Inc., including statements about its development programs, proposed indications for its product candidates, pre-clinical activities, marketing collaborations, and all other statements in this document other than historical facts, 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. Palatin's actual results may differ materially from those discussed in the forward-looking statements for various reasons, including, but not limited to Palatin's ability to fund development of its technology, ability to establish and successfully complete clinical trials and pre-clinical studies and the results of those trials and studies, dependence on its partners for certain development activities, need for regulatory approvals and commercial acceptance of its products, ability to protect its intellectual property, and other factors discussed in the Palatin's periodic filings with the Securities and Exchange Commission. Palatin is not responsible for updating regarding events that occur after the date of this press release.

SOURCE Palatin Technologies, Inc.

RELATED LINKS
http://www.palatin.com

'/>"/>

SOURCE Palatin Technologies, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Palatin Technologies to Present at 8th Annual BIO Investor Forum
2. Palatin Technologies Presents PL-3994 Clinical Trial Results at the 12th Annual Scientific Meeting of the Heart Failure Association of America
3. Palatin Technologies Initiates Phase 2 Hypertension Clinical Study With PL-3994
4. Palatin Technologies, Inc. Reports Initiation of Human Trials for the Treatment of Congestive Heart Failure
5. King Pharmaceuticals and Palatin Technologies Delay Immediate Plans for Phase 3 Clinical Program With Bremelanotide for Erectile Dysfunction
6. Wound Management Technologies, Inc. Engages Miller Tabak, A National Investment Banking Firm Specializing in the Healthcare Market Space
7. Wound Management Technologies, Inc. Targets Multi-Billion Dollar Biomaterials Market; Releases Update on Resorbable Orthopedics
8. AVAX Technologies, Inc. Closes Bridge Financing
9. Axsun Technologies, A Wholly-Owned Subsidiary of Volcano Corporation, Announces Breakthrough Integrated Light Source Architecture for Optical Coherence Tomography (OCT) Imaging
10. Wound Management Technologies, Inc. Signs Agreement with Major Sales Representative Organization for Increased Marketing of CellerateRx(R); Third Quarter Sales Up
11. Instacare Moves to Secure Patents for Its Newest Technologies, Announces Parallel Strategies for Its Revolutionary MD@Hand Cell-Centric Products
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/19/2017)... 19, 2017 Pfizer joins ... Milner Therapeutics Consortium   Major research ... Cambridge   The Milner Therapeutics ... ) as a partner to the Milner Therapeutics Consortium. ... the efficient transfer of materials between industry and academia ...
(Date:1/19/2017)... , Jan. 18, 2017  ViewRay, Inc. (Nasdaq: ... first and only clinical MRI-guided radiation therapy system, announced ... of approximately $26.1 million through a private placement ... Management led the financing and was joined by ... LLC and Kearny Venture Partners, and an additional ...
(Date:1/19/2017)... 18, 2017 The Academy of Managed ... Administration (FDA) for its release today of draft ... decision makers can proactively share clinical and economic ... as emerging therapies awaiting FDA approval. ... that AMCP developed during two multi-stakeholder meetings last ...
Breaking Medicine Technology:
(Date:1/19/2017)... ... January 19, 2017 , ... Next week after January 20th, the fear ... political games that circumvent health needs of over 30 million. Many interviews with Dr. ... and needs government public servants were suppose to prioritize. Interviews provided below. ...
(Date:1/19/2017)... ... January 19, 2017 , ... WhoHaha , a digital ... the American Heart Association (AHA) to produce a three-part video series that uses humor ... as part of the launch of AHA’s Healthy For Good™ movement, which is designed ...
(Date:1/19/2017)... ... 19, 2017 , ... Dr. Andrew Lian-Jie Li ... trained Mohs and cosmetic surgeon. After extensive dermatology research training at the National ... in internal medicine at the Emory University and dermatology training at the University ...
(Date:1/19/2017)... Beach, CA (PRWEB) , ... January 19, 2017 ... ... Oral Health, is now offering treatments for patients with sleep apnea and TMJ ... consequences for dental and physical health. Dr. Rassouli provides personalized care to reduce ...
(Date:1/19/2017)... ... January 19, 2017 , ... Rountree Brady Insurance Agency, ... communities throughout eastern Georgia, is embarking on a charity effort to raise awareness ... more Americans every year than anything else, yet risk factors associated with heart ...
Breaking Medicine News(10 mins):