Rexahn Pharmaceuticals Enrolls First Patient in Serdaxin® Phase IIb Clinical Trial
25 Januar 2011 - 2:00PM
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 enrolled the first patient in its Phase IIb clinical trial
of Serdaxin to treat major depressive disorder (MDD). The
randomized, double blind, and placebo-controlled study will recruit
up to 300 patients and will be conducted at 40 sites in the United
States. Serdaxin will be administered as an oral, extended release
tablet. Patient enrollment will occur through the first half of
2011, with preliminary data expected in late 2011.
Rick Soni, President of Rexahn, commented, “This clinical
milestone represents another important advance in the development
of Serdaxin. Data from our Phase IIa study in MDD suggest that
Serdaxin has the potential to improve symptoms of depression
without the side effects commonly associated with currently
marketed antidepressants, and we look forward to further assessing
Serdaxin in patients with MDD.”
About Serdaxin®
Serdaxin® is a potential market-leading CNS neuroprotective
agent and antidepressant. Rexahn is currently investigating
Serdaxin as a treatment for depression, in a large Phase II
clinical trial. Serdaxin may achieve greater and broader
therapeutic coverage and appears to be safe and well tolerated
without the appearance of serious side effects that are commonly
linked to currently marketed antidepressant drugs, such as
selective serotonin uptake inhibitors (SSRI),
serotonin-norepinephrine reuptake inhibitors (SNRI), and tricyclic
antidepressants (TCA). Serdaxin has a well-established, excellent
human safety profile. 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 disease and
neurodegenerative illnesses, neuroprotection and biodefense
uses.
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®,
Serdaxin®, and Zoraxel™ - 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
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, 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.
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