Rexahn Pharmaceuticals, Inc. Initiates Clinical Trial Of SerdaxinTM To Treat Depression

Main Category: Depression
Also Included In: Clinical Trials / Drug Trials
Article Date: 04 Feb 2009 - 0:00 PDT

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Rexahn Pharmaceuticals, Inc. (NYSE Alternext US: RNN), a leader in development of innovative therapeutics for life-threatening and life-debilitating diseases, announced today that it has initiated a Phase IIa clinical trial for SerdaxinTM, for the treatment of major depressive disorder (MDD). The Serdaxin Phase IIa study calls for the recruitment of up to 100 patients to evaluate its preliminary efficacy in treating MDD.

Rexahn's Phase IIa clinical trial for Serdaxin is designed as a randomized, double blind, dose ranging and placebo-controlled study and will be conducted at multiple sites in the U.S. Serdaxin will be administered as an oral, extended release tablet. Patient enrollment will occur throughout 2009, with preliminary data expected in early 2010.

"We believe that successfully bringing Serdaxin to market will mark a significant development in the treatment of depression and related mood disorders," said Dr. Chang Ahn, CEO of Rexahn Pharmaceuticals. "Also, we are excited about Serdaxin's potential as a potent neuroprotective agent as demonstrated in two validated animal models of neurodegenerative diseases where depression is a major co-morbidity and patients still face serious unmet needs."

Serdaxin's mechanism is distinct from standard of care antidepressants (e.g. reuptake inhibitors such as SSRIs) by acting as a dual enhancer of serotonin and dopamine levels in the brain, and achieving onset of effect in less than two days based on animal studies.

About SerdaxinTM

SerdaxinTM is a potential market leading CNS neuroprotective agent and antidepressant. Among lead indications, we are investigating Serdaxin for depression in Phase II clinical trials. Serdaxin may achieve greater and broader therapeutic coverage, and appears to have no serious side effects such as nausea, vomiting, insomnia, weight gain, sexual dysfunction, cognitive deficit or motor impairment that are linked to existing antidepressant drugs. Serdaxin has well-established and excellent human safety. In preclinical studies, Serdaxin had onset of action in less than two days. Based on its novel mechanism as a dual serotonin and dopamine enhancer, it is a potential treatment for multiple CNS disorders where these neurotransmitters are depleted or implicated in CNS-based illnesses, such as Parkinson's disease (PD). Serdaxin has the potential to address both non-motor and motor events of PD by serving as a neuroprotective agent and addressing loss of dopaminergic neurons that lead to loss of control of movements; and further, enhancing serotonin and dopamine levels that are involved in depression and mood disorders. Rexahn has multiple clinical programs planned for investigating Serdaxin in the treatment of anxiety disorders, Parkinson's disease, Alzheimer's and neurodegenerative illnesses, neuroprotection and biodefense uses.

About Major Depressive Disorder (MDD)

Major depressive disorder is the leading cause of disability in the United States for ages 15 to 44, according to the World Health Organization (WHO), and is expected to become the second leading cause of disability worldwide by the year 2020. MDD is prevalent in approximately 45 million Americans. There are 154 million cases of depression reported worldwide annually, and it is nearly twice as prevalent in women than in men. Depression is characterized by a pervasive low mood and loss of interest or pleasure in normal activities, feelings of extreme sadness, hopelessness, withdrawal from social situations and frequent thoughts of death or suicide. Major depression frequently coexists with other psychiatric problems, and may be a major co-morbidity in progressive or degenerative conditions prevalent in aging populations.

About Rexahn Pharmaceuticals, Inc.

Rexahn Pharmaceuticals is a clinical stage pharmaceutical company dedicated to commercializing first in class and market leading therapeutics for cancer, CNS disorders, sexual dysfunction and other unmet medical needs. For more information please visit http://www.rexahn.com.

Safe Harbor

This press release contains forward-looking statements. Rexahn's actual results may differ materially from anticipated results, and expectations expressed in these forward-looking statements, as a result of certain risks and uncertainties, including Rexahn's lack of profitability, its auditor's going concern qualification and the need for additional capital to operate its business to develop its product candidates; the risk that Rexahn's development efforts relating to its product candidates may not be successful; the possibility of being unable to obtain regulatory approval of Rexahn's product candidates; the risk that the results of clinical trials may not be completed on time or support Rexahn's claims; demand for and market acceptance of Rexahn's drug candidates; Rexahn's reliance on third party researchers and manufacturers to develop its product candidates; Rexahn's ability to develop and obtain protection of its intellectual property; and other risk factors set forth from time to time in our filings with the Securities and Exchange Commission. Rexahn assumes no obligation to update these forward-looking statements.

Rexahn Pharmaceuticals, Inc.

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