i****s
发帖数: 1152 | | h*****8
发帖数: 4754 | 2 再次证明割肉要快。
最好带上STOP跑。
不怕错过，就怕套牢。
【在 i****s 的大作中提到】
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| e*n
发帖数: 1511 | 3 我狂晕。
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| t*******o
发帖数: 1464 | 4 我考，跌回我几天前捶胸顿足出手的价格了...
Rexahn Pharmaceuticals Announces Phase IIa Study Results of Serdaxin in
Major Depressive Disorder (MDD)
Statistical Significance Achieved on MADRS Change From Baseline (p<0.041) in
Subgroup Analysis of Severe Patients
NEW YORK, Apr 13, 2010 (GlobeNewswire via COMTEX) -- Rexahn Pharmaceuticals,
Inc. /quotes/comstock/14*!rnn/quotes/nls/rnn (RNN 1.88, -1.77, -48.49%) , a
clinical stage pharmaceutical company developing potential best in class
oncology and central nervous system (CNS) therapeutics, today announced
clinical results with its investigational new drug, Serdaxin(R)for the
treatment of major depressive disorder (MDD).
The randomized, double blind, placebo controlled and dose ranging clinical
trial enrolled 77 patients at multiple sites in the United States. The
results of the subgroup analysis are compelling and warrant further study in
a larger phase 2 trial.
In the subgroup analysis, the study showed that patients with severe MDD
taking 5 mg of Serdaxin had significant improvement in Montgomery-Asberg
Depression Rating Scale (MADRS) scores after 8 weeks of treatment, compared
to placebo. Among the 77 patients, 53 patients were classified as having
severe MDD. Of the 14 patients treated with 5 mg of Serdaxin MADRS scores
improved by 55.6%, compared to only 34.0% in the placebo group (n = 14),
which was statistically significant (p<0.041) on an intent to treat basis.
In addition, 64.3% of patients with severe MDD treated with the 5 mg of
Serdaxin were considered Responders compared to 28.6% in the placebo group (
p<0.0581). A Responder is a patient with a change from baseline in MADRS
score of greater than or equal to 50% after treatment. Additionally, 42.9%
of patients in the treatment group were in remission with a MADRS score of
less than or equal to 12 after treatment, at 8 weeks versus 14.3% in the
placebo arm (p<0.209).
The trial also validates the earlier results which demonstrated Serdaxin 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). Even though
the overall study did not achieve statistical significance, we believe,
based on the statistically significant subgroup results, Rexahn plans to
commence a Phase IIb clinical trial in the second half this year.
"For the millions of people who are debilitated by depression, the promise
of Serdaxin is worthy of further investigation and development. This
clinical study demonstrated that Serdaxin is well tolerated, does not yet
appear to have some of the side effects typically associated with other anti
-depressants and improves patients' MADRS scores. The notable effect of
Serdaxin on patients with severe depression is also very encouraging," said
Robert A. Riesenberg, a nationally recognized psychiatrist and principal
investigator for this trial at the Atlanta Center for Medical Research.
"We are pleased with outcome of this Phase IIa clinical trial of Serdaxin.
We look forward to further investigating how Serdaxin's novel action as a
dual serotonin and dopamine enhancer may be able to provide greater efficacy
, fewer side effects, and potentially reduced relapse of MDD," said Dr.
Chang Ahn, Rexahn's Chairman and Chief Executive Officer.
Rexahn is currently in discussions with several major pharmaceutical
companies with the goal of identifying a potential strategic partner to
assist in the development and commercialization of Serdaxin. However, there
can be no assurances that these discussions would result in a commercial
arrangement.
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