Chelsea Therapeutics 2nd Clinical Trial Pending Results

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From Wikinvest: Chelsea Therapeutics (CHTP) traded higher Friday closing at 5.06 +0.94 for a 22% gain. I am showing some caution for Chelsea Therapeutics as this Clinical Trial was previously rejected last September. News from that rejection from Sept. 2009: Chelsea Therapeutics (CHTP) Dives After Trial Did Not Demonstrate Statistically Significant Improvement Versus Placebo. For more information on the 2009 Clinical Trial you can read more about it here: Chelsea Therapeutics Reports Preliminary Phase III Data of Droxidopa for Treatment of Symptomatic Neurogenic Orthostatic Hypotension

The catalyst that pushed Chelsea higher this past Friday was based on an Upgrade of Chelsea pending a 2nd Phase III clinical trial results.

Wedbush on Today’s Rally in Chelsea Therapeutics’ (CHTP) Shares: Traders Getting in Ahead of Results from 2nd Phase 3 Trial on Northera
September 17, 2010 2:32 PM EDT

Responding to a sharp move higher in shares of Chelsea Therapeutics (Nasdaq: CHTP) earlier today, Wedbush believes that the rally is related to the expected release of “potentially transforming clinical results from the second Phase 3 trial testing Northera…” The firm notes that as Chelsea previously suggested that the trial results would be out in mid-to-late September, traders may now be buying in ahead of the news.

Wedbush is modeling for a 75% chance of positive Phase 3 results by the end of September. The firm points out that “although the first Phase 3 trial did not achieve statistical significance for the primary endpoint of dizziness, management redesigned the second Phase 3 trial to have more patients (150 from 118), more statistical powering (86% from 80%) to show a 1.2 unit change in the Orthostatic Hypotension Questionnaire–which was a statistically significant secondary composite endpoint in the first trial…”

The firm maintains an Outperform rating and $10 fair value estimate.

I still show some caution for Chelsea Therapeutics as this drug was previously rejected. The company is strongly promoting this second clinical trial, but until I see the results I would be extremely cautious of this stock. I am just warning people ahead of time. That doesn't mean that the 2nd trial won't work but I just would like to see more data first. Be aware that the FDA is extremely conservative this year under the Obama administration.---->  Although Afterwards I regret saying some of this as the New Clinical Trial Did Show Some Optimism.

More info on Chelsea Therapeutics and their Clinical Trials can be found with the following links:
-Seeking Alpha: Chelsea Therapeutics
-Motley Fool--CHTP
-Chelsea Therapeutics (CHTP) Annoucnes Updates to NOH Phase III Registration Program; Preliminary U.S. FDA Approval for Northera--From Feb 2010

Chelsea Therapeutics Achieves Target Enrollment in Phase III Trial of Northera in Neurogenic Orthostatic Hypotension

Press Release Source: Chelsea Therapeutics On Wednesday June 30, 2010, 7:30 am EDT

•Top-line Data Expected in Q3 10

CHARLOTTE, N.C., June 30, 2010 (GLOBE NEWSWIRE) -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP - News) has successfully reached its target enrollment of 150 patients in its Northera(TM) (Droxidopa) pivotal Phase III Study 301 for the treatment of symptomatic, neurogenic orthostatic hypotension (NOH). Results from the trial are expected in September 2010 and the full registration program is on track to initiate a new drug application (NDA) in the first half of 2011.

NOH is a disorder of the nervous system 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 lightheadedness, dizziness, blurred vision and fainting episodes when a person assumes a standing position. Northera, an oral compound which the body converts directly to norepinephrine, is the only therapeutic treatment to specifically target the underlying cause of NOH: norepinephrine deficiency.

"We are delighted to have reached our target enrollment in Study 301 and are confident the trial will capture the full therapeutic benefit of Northera in symptomatic NOH," commented Dr. Simon Pedder, president and CEO of Chelsea Therapeutics. "We are grateful to all the clinicians and patients for their continued strong support and participation in this trial. We look forward to seeing the top-line results from this trial in September and continuing to work with the clinical investigators and their staff throughout the year to complete our other on-going Phase III trial and file a new drug application next year."

Study 301 was reviewed by the U.S. Food and Drug Administration (FDA) and awarded a Special Protocol Assessment (SPA) in February 2008. The FDA subsequently confirmed that the SPA remained in effect following the protocol amendments approved by the FDA late last year. 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 provides the option 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 Neurogenic Orthostatic Hypotension

NOH is a neurogenic disorder resulting from deficient release of norepinephrine, the neurotransmitter used by sympathetic autonomic nerves to send signals to the blood vessels and the heart to regulate blood pressure. This deficiency results in decreased blood pressure when a person assumes a standing position and is characterized by lightheadedness, dizziness, and fainting episodes. Symptoms of chronic NOH can be incapacitating -- not only putting patients at high risk for falls and associated injuries and generating significant health care costs -- but also severely affecting the quality of life of patients and their loved ones. The only FDA-approved treatment for orthostatic hypotension has a black box warning indicating that the drug has not been shown to be effective in alleviating the symptoms of the condition and is associated with a pronounced side-effect profile including significant supine hypertension.

About Northera(TM)

Northera (Droxidopa), the lead investigational agent in Chelsea Therapeutics' broad pipeline, is currently in Phase III clinical trials for the treatment of symptomatic neurogenic orthostatic hypotension (NOH) in patients with primary autonomic failure -- a group of diseases that includes Parkinson's disease, multiple system atrophy (MSA) and pure autonomic failure (PAF). Droxidopa is a synthetic catecholamine that is directly converted to norepinephrine (NE) via decarboxylation, resulting in increased levels of NE in the nervous system, both centrally and peripherally. Droxidopa is also being studied for the treatment of fibromyalgia in an ongoing phase II trial and completed a phase II trial in intradialytic hypotension (IDH) study with positive results.

About Chelsea Therapeutics

Chelsea Therapeutics is a biopharmaceutical development company that acquires and develops innovative products for the treatment of a variety of human diseases. Chelsea's most advanced drug candidate, Northera(TM) (Droxidopa), is an orally active synthetic precursor of norepinephrine initially being developed for the treatment of neurogenic orthostatic hypotension. In addition to Northera, Chelsea is also developing a portfolio of metabolically inert oral antifolate molecules engineered to have potent anti-inflammatory and anti-tumor activity to treat a range of immunological disorders, including two clinical stage product candidates: CH-1504 and CH-4051. Preclinical and clinical data suggest superior safety and tolerability, as well as increased potency versus methotrexate (MTX).

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