Key Developments For Chelsea Therapeutics International, Ltd.
Chelsea Therapeutics International, Ltd. (CHTP.O) (Consolidated Issue listed on NASDAQ Capital Market)
Chelsea Therapeutics International Ltd. Presents Metabolically Inert Autoimmune Portfolio At The 2009 ACR Annual Scientific Meeting
Chelsea Therapeutics International Ltd. announced that it will present results from Chelsea's two clinical stage product candidates in its portfolio of metabolically inert antifolate molecules at the 2009 American College of Rheumatology (ACR) Annual Scientific Meeting in Philadelphia, Pennsylvania. The presentations will include previously reported results from a Phase II, proof-of concept study of CH-1504 and a Phase I trial of CH-4051. Dr. Edward Keystone, Professor of Medicine, Rheumatology Division at The University of Toronto, Canada, and principal investigator for the study, will present detailed findings from Chelsea's 12-week proof-of-concept study in methotrexate (MTX) naive rheumatoid arthritis (RA) patients. The findings demonstrate that CH-1504 has comparable efficacy to MTX and may be safer and better tolerated. In addition to Dr. Keystone's platform presentation, Chelsea will present safety, tolerability and pharmacokinetic data from its recently completed Phase I trial of CH-4051, the more potent L isomer of the racemic mixture CH-1504.
Chelsea Therapeutics International Ltd. Announces Additional Analysis Confirms Significant Symptomatic Benefit Of Droxidopa In Treatment Of Neurogenic Orthostatic Hypotension
Chelsea Therapeutics International Ltd. announced that continued analysis of previously reported results from Study 302, the first of two pivotal Phase III trials in Chelsea's registration program of Droxidopa for the treatment of symptomatic, neurogenic orthostatic hypotension (NOH), confirm statistically significant benefits across five clinically relevant assessment criteria that reflect symptomatic improvements and corroborate other supportive symptom data. The collective dataset also supports the exceptional safety and tolerability of Droxidopa.
Chelsea Therapeutics International Ltd. Announces Preliminary Phase III Data of Droxidopa For Treatment of Symptomatic Neurogenic Orthostatic Hypotension
Dow Jones reported that Chelsea Therapeutics International Ltd. announced top line results from Study 302, the first of two Phase III trials of Droxidopa for the treatment of symptomatic neurogenic orthostatic hypotension (NOH). While Study 302 demonstrated that Droxidopa showed a strong symptomatic benefit during the open-label dose titration and run-in phase of the trial, a preliminary review of the data indicates it did not demonstrate a statistically significant improvement relative to placebo, as measured by the mean score of Item 1 (dizziness or light-headedness) of the Orthostatic Hypotension Symptom Assessment (OHSA) during the double-blind phase of trial, the study's primary endpoint. Droxidopa was safe and well tolerated, with no significant related adverse events reported. Patients demonstrating both a symptomatic benefit and blood pressure improvement following titration continued on open-label Droxidopa for a 1-week run-in period prior to being randomized on a 1:1 basis to continue on active drug or be withdrawn to placebo. The 101 patients enrolled in the blinded study had a mean score on Item 1 of the OHSA scale of 2.1 at randomization. At the end of the 14-day blinded treatment period, patients in the placebo arm had an average OHSA score of 4.0, or a mean change (increase) of 1.9 units from randomization.
Chelsea Therapeutics International Ltd.'s Hypotension Drug Likely To Meet Trial Goal-Reuters
Reuters reported that Chelsea Therapeutics International Ltd.'s experimental neurological disorder drug, which is already approved in Japan, is expected to show high efficacy and a clean safety profile in a U.S. late-stage trial. Data from the first of two late-stage trials for Chelsea Therapeutics International Ltd.'s drug, Droxidopa, is expected in late September and the stock has risen more than 3 times over the last six months in anticipation of positive news. Droxidopa, which aims to treat symptomatic neurogenic orthostatic hypotension (NOH), a neurological disorder that causes blood pressure to drop when the afflicted person assumes a standing position has a fast track status from U.S. health regulators.
Chelsea Therapeutics International Ltd. Completes $13.3 Million In Registered Direct Offering
Chelsea Therapeutics International Ltd. announced that it has completed its previously announced registered direct offering. The final offering of approximately 3.3 million shares of common stock priced at $4.00 per share was fully subscribed and resulted in gross proceeds of $13.3 million, and net proceeds, after deducting the placement agents' fees and offering expenses of $12.4 million.
