CHARLOTTE, N.C., Oct. 29, 2008 (GLOBE NEWSWIRE) -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) announced that Horacio Kaufmann, M.D. will present initial data from the open-label portion of Chelsea's Phase III trial of Droxidopa in neurogenic orthostatic hypotension (NOH) at the 19th Annual International Symposium on the Autonomic Nervous System in Kauai, Hawaii.
Dr. Kaufmann, Felicia B. Axelrod Professor of Dysautonomia Research at NYU School of Medicine and a principle investigator for the study, will present findings related to the first 30 patients to enter dose titration in study 302 on Saturday, November 1, 2008 in a talk entitled "Ongoing clinical trials of Droxidopa, an interim update."
"The unique enrichment design of our Phase III trials is intended to not only identify responders to Droxidopa treatment but also optimize treatment among the diverse patient population suffering from symptomatic neurogenic orthostatic hypotension," commented Dr. Simon Pedder, President and CEO of Chelsea Therapeutics. "This first look at the dose titration data from study 302 should provide us with meaningful insight related to both the magnitude of symptomatic response seen in each patient group as well as the sensitivity of the scale being used for our primary outcome measure."
About Study 302
Study 302 the one of two on-going pivotal Phase III trials designed to demonstrate efficacy and support U.S. marketing approval of Droxidopa in neurogenic orthostatic hypotension. It is a randomized, placebo-controlled, parallel-group, withdrawal-design Phase III study with an initial open-label dose titration and 7 day open-label treatment period, followed by a 14-day double-blind randomized withdrawal period. During the open label dose titration period, all patients will be titrated to maximum therapeutic benefit with up to 600 mg t.i.d. of Droxidopa and must demonstrate both a blood pressure and symptomatic improvement. Patients not responding to treatment during the titration period will be excluded from the trial. Patients demonstrating improvement remain on their respective effective doses of active drug for 1 week. An equal number of patients (N=59) will then continue receiving Droxidopa or be randomized to placebo for two weeks. At the end of the two-week period, patients are evaluated for changes in symptomatic benefit relative to that recorded at randomization.
The primary endpoint will be the relative symptomatic change, as measured by the mean score of Item 1 (dizziness or light-headedness) of the Orthostatic Hypotension Symptom Assessment (OHSA), 14 days following randomization either to continued therapy with Droxidopa or to placebo. 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. Study 302 will evaluate up to 118 patients and is powered to detect a mean relative change of 1.6 units as measured by item 1 of the OHSA.
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. The Company is currently developing a library of metabolically inert antifolate compounds engineered to have potent anti-inflammatory and anti-tumor activity to treat a range of immunological disorders. Early clinical data suggests that Chelsea's lead antifolate compound, CH-1504, is a safe and effective treatment alternative to methotrexate for RA and may have further applications for psoriasis, IBD and certain cancers. Chelsea's antifolate program is complemented by the development of the I-3D portfolio of therapeutics targeting immune-mediated inflammatory disorders and transplantation. In addition to its autoimmune pipeline, Chelsea is developing Droxidopa, an orally active synthetic precursor of norepinephrine, for the treatment of neurogenic orthostatic hypotension. Currently approved and marketed in Japan, Droxidopa has accumulated over 15 years of proven safety and efficacy, historically generating annual revenues of approximately $50 million in Japan.
This press release contains forward-looking statements regarding future events. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include reliance on collaborations and licenses, risks and costs of drug development, regulatory approvals, intellectual property risks, our reliance on our lead drug candidate, our history of losses and need to raise more money, competition, market acceptance for our products if any are approved for marketing, reliance on key personnel including specifically Dr. Pedder, management of rapid growth, and the need to acquire or develop additional products.