CHARLOTTE, N.C., May 21, 2009 (GLOBE NEWSWIRE) -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) announced that data from the Company's Phase II trial of Droxidopa in intradialytic hypotension (IDH) will be presented at the World Congress of Nephrology 2009 in Milan, Italy on Sunday, May 24 at 10:30 AM local time.
A poster entitled, "Droxidopa is a safe and effective treatment for dialysis-induced hypotension: a double-blind, randomized, placebo controlled phase II study," will detail the results of Chelsea's recently completed Phase II trial in which Droxidopa, a synthetic precursor of norepinephrine, demonstrated a dose dependent, statistically significant benefit across multiple, clinically relevant assessment criteria for IDH.
Following presentation at the meeting, the full poster will be available on Chelsea's website at www.chelseatherapeutics.com.
About Droxidopa and Intradialytic Hypotension (IDH)
Intradialytic hypotension, or IDH, is the most common adverse event during routine hemodialysis. IDH is often defined as a decrease in systolic blood pressure by 20 mm Hg or a decrease in mean arterial pressure by 10 mmHg. IDH has been reported in approximately 20% of all hemodialysis patients, with elderly patients reporting higher incidences. Many adverse hemodialysis events, including headaches, lightheadedness, nausea, cramps, and seizures, are associated with IDH. These complications can often interrupt dialysis sessions, resulting in insufficient uremia toxin removal and necessitating repetition of the procedure. Interruptions due to IDH increase the costs of both the dialysis treatment sessions and the long-term care of less healthy hemodialysis patients.
Pivotal clinical studies conducted by Dainippon Sumitomo Pharmaceuticals (DSP) have demonstrated the efficacy of Droxidopa in the treatment of vertigo, dizziness and weakness associated with hypotension in hemodialysis patients. Subsequently, in 2000, after showing benefit in clinical trials, DSP received expanded marketing approval in Japan for this indication.
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, Droxidopa, is an orally active synthetic precursor of norepinephrine initially being developed for the treatment of neurogenic orthostatic hypotension. Currently approved and marketed in Japan for the treatment of symptomatic orthostatic hypotension, freezing gait in Parkinson's disease and intradialytic hypotension, Droxidopa has accumulated over 15 years of proven safety and efficacy, historically generating annual revenues of approximately $50 million in Japan. In addition to Droxidopa, 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 suggests superior safety and tolerability, as well as increased potency versus methotrexate (MTX), currently the leading antifolate treatment and standard of care for a broad range of abnormal cell proliferation diseases including RA.
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 our need to raise operating capital, our history of losses, risks and costs of drug development, risk of regulatory approvals, our reliance on our lead drug candidates droxidopa and CH-1504, reliance on collaborations and licenses, intellectual property risks, competition, market acceptance for our products if any are approved for marketing, reliance on key personnel including specifically Dr. Pedder.