Biotech Values

[bladerunner1717]

re: CHTP

(Can someone help me interpret this? Do the findings justify a 16% haircut in the share price?)




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(Printer friendly version) Chelsea Therapeutics Reports Findings From Open-Label Titration Phase of Pivotal Phase III Trials

Feb 17, 2009 (GlobeNewswire via COMTEX) --


* Data from Study 302 continued to demonstrate robust effect with
mean reduction in symptomatic score of 4.2 units and increase of
25mmHg in standing systolic blood pressure * Preliminary analysis of similar data from Study 301 supports filing
a protocol amendment to study 302 to tighten the standard deviation
used to calculate the trial sample size from 3.0 to 2.5, thereby
reducing the target number of randomized patients 118 to 82
patients
CHARLOTTE, N.C., Feb. 17, 2009 (GLOBE NEWSWIRE) -- Chelsea Therapeutics
International, Ltd. (Nasdaq: CHTP) announced that the Company has completed a
second analysis of data from the open-label titration portion of its Phase III
Study 302 which demonstrated patients treated with Droxidopa, a synthetic
precursor to norepinephrine, showed a similarly robust reduction in the severity
of symptoms associated with neurogenic orthostatic hypotension (NOH) and a
improvement standing systolic blood pressure as reported in November 2008.Patients identified as responders during the open-label titration phase of the
study, and therefore eligible for inclusion in the double-blind, randomized
trial, demonstrated a mean improvement of 4.2 units on Item 1 (dizziness or
light-headedness) of the Orthostatic Hypotension Symptom Assessment Scale (OHSA)
during titration and a mean improvement in standing systolic blood pressure
(SBP) of 25 mmHg. The average baseline OHSA score for responders prior to
treatment was 6.3 and the average score at the end of the titration was 2.1. The
OHSA scale is a validated scale designed to rate symptoms occurring specifically
as a result of low blood pressure and uses an 11-point scale (zero to 10), with
more severe symptoms scoring higher. The same measure will be used as the
primary endpoint in the blinded study to determine the relative difference in
symptomatic benefit between Droxidopa and placebo 14 days post-randomization.In addition to the efficacy analysis of titration data from Study 302, Chelsea
conducted a preliminary review of data from Study 301, a similarly designed
concurrent Phase III trial of Droxidopa in NOH, and based on corroborating data
from this analysis reviewed its statistical plan for Study 302. Consequently,
Chelsea has opted to file an amendment to the trial protocol for Study 302 to
allow for a standard deviation of 2.5 compared to the prior standard deviation
of 3.0 used to calculate the trial size. As a result of this change to the
standard deviation, the number of patients to be randomized in the trial would
be reduced from 118 to 82 patients. The study, in evaluating up to 84 patients,
would remain powered to detect a mean relative change of 1.6 units or greater on
the OHSA scale between treatment and placebo groups with a standard deviation of
2.5."I am pleased to report that our second analysis of titration data from a larger
patient set affirms the robust effect that we initially reported in November
and, while the magnitude of response demonstrated during titration may not be
predictive of final results, we remain confident that the trial is well-designed
to demonstrate a statistically significant benefit in patients treated with
Droxidopa," commented Dr. Simon Pedder, President and CEO of Chelsea
Therapeutics. "I am also pleased that a review of our statistical plan for study
302 suggests we can adjust our standard deviation assumptions and consequently
reduce the number of patients required to demonstrate statistical significance
in our final study results. As is often the case for orphan indications, patient
enrollment has been a critical factor in completion of our study and we expect
this adjustment in trial size to be of significant benefit to the timely
completion of our Phase III program. With our revised enrollment target for
Study 302 and recruitment in both Phase III studies to date, we anticipate
completing enrollment for both study 301 and 302 late in the second quarter of
2009 with data available in the third quarter and allowing for an NDA filing by
year-end 2009 as planned."Study 302 is one of two Pivotal Phase III trials comparing Droxidopa to placebo
for the treatment of symptomatic neurogenic orthostatic hypotension. The other
trial, Study 301, was reviewed by the U.S. Food and Drug Administration (FDA)
and awarded a Special Protocol Assessment (SPA) in February 2008. An SPA
provides a binding agreement that the study design, including trial size,
clinical endpoints and/or data analyses is acceptable to support regulatory
approval. In addition to the SPA, the FDA has awarded Chelsea Fast Track
designation for its pivotal program in NOH. Fast Track designation is designed
to facilitate the review of products that address serious or potentially
life-threatening conditions for which there is an unmet medical need and allows
a company to file a New Drug Application (NDA) on a rolling basis. This permits
the FDA to review the filing as it is received, expediting the review process.About Droxidopa and Symptomatic Neurogenic Orthostatic Hypotension (NOH)Symptomatic NOH is a neurogenic disorder resulting from a deficient release of
norepinephrine, the neurotransmitter used by sympathetic autonomic nerves to
send signals to the blood vessels and the heart. This deficiency results in
decreased blood pressure when a person assumes a standing position and is
characterized by lightheadedness, dizziness, blurred vision and syncope.
Droxidopa, an orally active synthetic precursor of norepinephrine, increases the
supply of norepinephrine available for delivery to its receptors to improve
orthostatic blood pressure and alleviate symptoms of orthostatic hypotension.Chelsea estimates that nearly 300,000 patients suffer from chronic symptomatic
NOH in the U.S. and EU combined. In addition to creating significant health care
costs, symptomatic NOH has a dramatic impact on the quality of patient life.
Midodrine, currently the only FDA approved treatment for orthostatic
hypotension, not only fails to treat the underlying cause of symptomatic NOH but
is limited in its use by a pronounced side-effect profile and black box warning
for supine hypertension. Given the chronic nature of symptomatic NOH and the
proven safety and tolerability of Droxidopa, Chelsea expects that daily oral
treatment with Droxidopa should provide a significant improvement in the
long-term treatment of symptomatic NOH.



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