NEW YORK, NY--(Marketwired - Jan 8, 2014) - LifeSci Advisors, LLC, a leading provider of investment research and investor relations services in the life sciences sector, today announced that it has initiated coverage of Palatin Technologies, Inc. (NYSE MKT: PTN), whose lead clinical candidate bremelanotide is set to enter Phase III trials in 2014 for female sexual dysfunction (FSD). Bremelanotide is an on-demand melanocortin receptor agonist that acts in the central nervous system to positively impact sexual response. The treatment is being developed for the large FSD indication that includes up to 20% of women in the US, but for which there is no FDA-approved drug treatment.
"Palatin's bremelanotide has a history of positive clinical trial data and a mechanism of action that directly impacts sexual response," said Andrew I. McDonald, Ph.D., Founding Partner at LifeSci Advisors. "The lack of competition in the FSD market coupled with a near-term Phase III trial gives Palatin an edge as bremelanotide moves closer to market."
Bremelanotide was most recently tested in a Phase IIb randomized, double-blind trial that examined three doses of drug versus placebo. The trial enrolled approximately 400 women experiencing hypoactive sexual desire disorder or female sexual arousal disorder. After establishing a baseline over a 4-week period of at-home self-dosing of placebo, patients were randomized to bremelanotide (0.75 mg, 1.25 mg, or 1.75 mg) or placebo. Administration was performed at home using a prefilled syringe prior to anticipated sexual activity. The trial met the primary endpoint of increase from baseline to end of study in satisfying sexual events (SSEs), with the 1.75 mg dose achieving statistical significance (p=0.022). The data set the stage for an upcoming Phase III registration trial planned to begin in the first half of 2014.
In a 42 page Initiation Report by LifeSci Advisors, we explain the development path and clinical trial data from Palatin's programs. The report discusses the history of product development for female sexual dysfunction, the lessons learned from previous development efforts, and the potential advantages of bremelanotide. We also explore Palatin's pipeline of early-stage candidates targeting a number of additional indications.
Dr. McDonald's full Initiation Report is available to download at no cost at the LifeSci Advisors website, www.lifesciadvisors.com. In addition to this Initiation Report, LifeSci Advisors will also provide ongoing coverage and event-based research updates on the Company as developments occur.
The LifeSci Advisors research team is led by Dr. Andrew I. McDonald, an industry veteran with more than 15 years of healthcare industry experience. Prior to co-founding LSA, Dr. McDonald was the Senior Biotechnology Analyst at Great Point Partners, a leading health care investment firm with over $500 million under management. Before Great Point, he was Co-Head of Healthcare Research and Lead Biotechnology Analyst at ThinkEquity Partners, a boutique investment banking firm focused on growth companies. Dr. McDonald holds a Ph.D. in organic chemistry from the University of California, Irvine, and, earlier in his career, worked as a medicinal chemist at both Pfizer and Cytokinetics.
About LifeSci Advisors:
LifeSci Advisors (LSA) is a leading research firm and communications consultancy dedicated to the life sciences industry. The firm provides strategic counsel, customized marketing communications, comprehensive research reports and investor relations services to companies that specialize in the discovery, development and commercialization of drugs, drug delivery systems, medical devices and diagnostics. To learn more about LSA, visit the company's website, www.lifesciadvisors.com.
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