CHARLOTTE, N.C., May 25, 2006 (PRIMEZONE) -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) announced that an article entitled, "Controlled Trial of Methotrexate versus CH-1504 in the Treatment of Rheumatoid Arthritis" by Dr. Oswaldo Castaneda and Dr. Gopal Nair was published in the May 2006 issue of the Journal of Rheumatology, an international, peer-reviewed publication.
The article documents the results of a pilot clinical study of CH-1504 conducted by Dr. Castaneda in Lima, Peru. CH-1504 is a novel, metabolically stable antifolate that is neither hydroxylated nor polyglutamylated. This non-blinded, non-randomized trial compared CH-1504 to methotrexate (MTX) in 20 patients with advanced rheumatoid arthritis. Two groups of 10 patients fulfilling the American College of Rheumatology (ACR) criteria for active rheumatoid arthritis (RA) were assigned to receive either 6.67 mg daily oral dosing of CH-1504 or 10mg once weekly oral dosing of MTX for a period of 24 weeks. Patients were monitored monthly for safety and tolerance as demonstrated by clinical biochemistry and hematology evaluations as well as adverse event reporting. Patients were also evaluated for efficacy using standard parameters to determine the ACR response rate.
The results of this clinical study showed no elevation in liver enzymes and a lack of gastrointestinal related side-effects in patients treated with CH-1504 suggesting that it may possess an improved safety and tolerance profile compared to MTX, the current standard of care for RA. In addition CH-1504 demonstrated striking efficacy, with 60% of patients responding to therapy within 4 weeks and 90% responding by the end of the study.
About CH-1504
CH-1504 is the lead product candidate in Chelsea's portfolio of novel antifolate compounds developed by Dr. Gopal Nair and licensed by the company in 2004. An orally available and metabolically inert antifolate with potent anti-inflammatory and anti-tumor properties, CH-1504 potently inhibits several key enzymes that are required for cell proliferation. Preclinical and clinical data to date suggests superior safety and tolerability, as well as increased potency versus MTX, currently the leading antifolate treatment and standard of care for a broad range of abnormal cell proliferation diseases. Diseases that may potentially benefit from the compound include RA, psoriasis, inflammatory bowel disease, cancer and other immunological disorders.
Chelsea reported positive preliminary results from its U.K. Phase I trials for all oral indications of CH-1504 in December 2005 and anticipates the initiation of Phase II trials for RA in 2007. Additionally, an independent six-month pilot clinical study compared CH-1504 to MTX in 20 RA patients in Peru. Although this pilot study will not be used as a part of the U.S. regulatory approval process, the results of this study 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.
RA affects approximately two million Americans, almost 1% of the population, and the global market for pharmaceuticals to treat RA was estimated at $6.3 billion in 2004. MTX is currently the most commonly prescribed treatment for RA and had sales of approximately $500 million in 2004. Psoriasis, another condition that may be positively impacted by treatment with CH-1504, is an immune-mediated chronic skin disease that affects more than 4.5 million Americans.
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 develops technologies that address important unmet medical needs or offer improved, cost-effective alternatives to current methods of treatment. Early clinical data suggests that Chelsea's lead product candidate, CH-1504, may support a safe and effective treatment for rheumatoid arthritis and may have further applications for psoriasis, certain cancers and other immunological disorders.
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 CH-1504, 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.