Rexahn Pharmaceuticals Submits Serdaxin Phase IIb Protocol to FDA for Major Depressive Disorder (MDD)
ROCKVILLE, Md.--(BUSINESS WIRE)-- Rexahn Pharmaceuticals, Inc. (NYSE Amex: RNN), a clinical stage pharmaceutical company developing and commercializing potential best in class oncology and CNS therapeutics, today announced that it has submitted a Phase IIb protocol to the U.S. Food and Drug Administration (FDA) for the clinical study of Serdaxin for the treatment of major depressive disorder (MDD).
The Phase IIb study will assess Serdaxin's efficacy as a treatment for major depressive disorder in approximately 300 subjects. The planned double blind, randomized, placebo-controlled trial will be conducted at multiple sites in the U.S. and will measure the change from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) as the primary efficacy endpoint.
"We look forward to starting this Phase IIb clinical trial and further investigating how Serdaxin's novel action as a dual serotonin and dopamine enhancer may be able to provide a broader therapeutic effect with fewer side effects compared to currently marketed antidepressants," said Dr. Chang Ahn, Rexahn's Chief Executive Officer.
In recent comments made about the promise of Serdaxin, Dr. Michael Thase, Professor of Psychiatry and Chief of the Division of Mood and Anxiety Disorders Treatment and Research Program at the University of Pennsylvania and Chairman of Rexahn's scientific advisory board in MDD, said, "In my opinion, Serdaxin's novel mechanism, which targets both serotonin and dopamine, coupled with the promising results of the recent proof of concept study, provide strong support for further clinical development of this well tolerated drug for treatment of depression."
About Serdaxin(R)
Serdaxin is Rexahn's lead CNS therapeutic and potential market leader. Serdaxin may work as a dual enhancer of serotonin and dopamine in the brain through a novel mechanism of action. In Rexahn's Phase IIa proof of concept study, Serdaxin showed numerical differences versus placebo for response and remission rates, as well as significance in the severe patient population versus placebo. The trial also demonstrated Serdaxin to be safe and well tolerated without the appearance of serious side effects that are commonly linked to currently marketed antidepressants. Rexahn plans to initiate a larger phase IIb clinical trial, involving approximately 300 patients, in the second half of 2010. Rexahn has recently established a Scientific Advisory Board composed of leading international opinion leaders in the study and treatment of depression who will collaborate with the company on the clinical development of Serdaxin in MDD. Additionally, Serdaxin has shown neuroprotective potential in animals treated with neurotoxins, and may have important applications in the treatment of human neurodegenerative disorders such as Parkinson's disease (PD) and Alzheimer disease (AD). Moreover, animal model studies also suggest that Serdaxin reduces aggressive behavior and relieves anxiety.
About Rexahn Pharmaceuticals, Inc.
Rexahn Pharmaceuticals is a clinical stage pharmaceutical company dedicated to developing and commercializing first in class and market leading therapeutics for cancer, CNS disorders, sexual dysfunction and other unmet medical needs. Rexahn currently has three drug candidates in Phase II clinical trials, Archexin(R), Serdaxin(R), and Zoraxel(TM) - all potential best in class therapeutics - and a robust pipeline of preclinical compounds to treat multiple cancers and CNS disorders. Rexahn also operates key R&D programs of nano-medicines, 3D-GOLD, and TIMES drug discovery platforms. For more information, please visit www.rexahn.com.
Safe Harbor
To the extent any statements made in this press release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about Rexahn's plans, objectives, expectations and intentions with respect to future operations and products and other statements identified by words such as "will," "potential," "could," "can," "believe," "intends," "continue," "plans," "expects," "anticipates," "estimates," "may," other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause Rexahn's actual results to be materially different than those expressed in or implied by Rexahn's forward-looking statements. For Rexahn, particular uncertainties and risks include, among others, the difficulty of developing pharmaceutical products, obtaining regulatory and other approvals and achieving market acceptance; the marketing success of Rexahn's licensees or sublicensees; the success of clinical testing; and Rexahn's need for and ability to obtain additional financing. More detailed information on these and additional factors that could affect Rexahn's actual results are described in Rexahn's filings with the Securities and Exchange Commission, including its most recent annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. All forward-looking statements in this news release speak only as of the date of this news release. Rexahn undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
Source: Rexahn Pharmaceuticals, Inc.
Released September 7, 2010