CHARLOTTE, N.C., Nov. 10, 2005 (PRIMEZONE) -- Chelsea Therapeutics International, Ltd. (OTCBB:CHTP) announced that Dr. Oswaldo Castaneda will present results of a pilot clinical trial of the company's lead therapeutic compound, CH-1504, at the American College of Rheumatology 2005 Annual Scientific Meeting. Dr. Castaneda will be available at the poster from 7:30 AM-9:30 AM PST on November 16th to discuss his findings.
In a poster entitled, "An Open-Label, Non-Randomized, Pilot Clinical Trial of A Novel, Metabolically Stable Antifolate, CH-1504 in the Treatment of Advanced Rheumatoid Arthritis," Dr. Castaneda will detail the results of his pilot clinical study conducted in Lima, Peru. The study was designed to test the clinical safety, tolerance and efficacy of CH-1504, which is neither hydroxylated nor polyglutamylated, in patients with advanced rheumatoid arthritis. Groups of 10 patients fulfilling the ACR criteria for RA and on stable doses of NSAIDs and low dose steroids were assigned to receive either 6.67 mg daily oral dosing of CH-1504 or 10mg once weekly oral dosing of methotrexate (MTX) for a period of 24 weeks. Patients were evaluated 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 suggest that the novel, non-metabolized antifolate, CH-1504, may possess an improved safety and tolerance profile when compared to MTX, the current standard of care for rheumatoid arthritis. In addition significant efficacy was reported although with small numbers.
The full poster presentation will be available on the company's website at www.chelseatherapeutics.com.
In a special session following Dr. Castaneda's poster session at ACR, Chelsea Therapeutics will host a luncheon to provide interested media and investors with the opportunity to speak with Dr. Castaneda and Chelsea's management team to learn more about the on-going clinical development of CH-1540. This session is scheduled to begin at 12:00 PM PST and will be held in the Torrey 3 meeting room at the San Diego Marriott Hotel and Marina. Attendance to this special session is by reservation only. Those interested in attending are requested to contact Kathryn McNeil by phone: 718-788-2856 or email: mcneil@chelseatherapeutics.com by Tuesday, November 15, 2005.
About CH-1504
In March 2004, Chelsea acquired the exclusive rights to a number of antifolate compounds, including CH-1504, its lead product candidate. These compounds lack the specific metabolism associated with side effects known to occur with marketed antifolates such as methotrexate (MTX). Chelsea is continuing to develop CH-1504 as a treatment for RA, psoriasis, IBD, cancer and other immunological disorders.
Although the 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 methotrexate. Preclinical animal models have also indicated that CH-1504 may have superior efficacy and a greater therapeutics window than methotrexate. Methotrexate currently accounts for almost half of the prescriptions written for the RA market.
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 also 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 risks and costs of drug development, our history of losses and need to raise more money, regulatory approvals, intellectual property risks, our reliance on our lead drug candidate CH-1504, 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.