Chelsea Therapeutics International, Ltd, of Charlotte, NC, announced that it has completed a private placement of its common stock, resulting in gross proceeds of approximately $21.5 million, which will be used in part to move its lead compound, CH-1504, through phase II clinical trials and reach proof of concept in both rheumatoid arthritis (RA) and psoriasis.  

Preclinical and clinical data for CH-1504, an orally available and metabolically inert antifolate with potent anti-inflammatory and anti-tumor properties, suggests superior safety and tolerability, as well as increased potency versus methotrexate (MTX). In December 2005, Chelsea reported positive preliminary results from its UK phase I trials for all oral indications of CH-1504, and anticipates the initiation of phase II trials for RA and psoriasis early in 2006.  

Additionally, an independent 6-month pilot clinical study compared CH-1504 to MTX in 20 RA patients at Universidad Peruana Cayetano Heredia in Lima, Peru. Although this nonpivotal study will not be used as a part of the US regulatory approval process, the results suggest that CH-1504 has lower toxicity and improved tolerability, as well as potentially increased efficacy versus MTX. Preclinical animal models have also indicated that CH-1504 may have superior efficacy and a greater therapeutics window than MTX.

Chelsea Therapeutics is a biopharmaceutical development company that acquires and develops innovative products for the treatment of a variety of human diseases. The company exclusively licensed CH-1504 from Dr. M. Gopal Nair, PhD, at the University of South Alabama College of Medicine.

—A. Techman