CHARLOTTE, N.C., Oct. 20, 2005 (PRIMEZONE) -- Chelsea Therapeutics International, Ltd. (OTCBB:CHTP), has successfully completed the Phase Ia trial of its leading drug candidate, CH-1504, an orally available, metabolically inert, anti-inflammatory and anti-tumor agent for the treatment of rheumatoid arthritis (RA), psoriasis, inflammatory bowel disease and certain cancers. In this single ascending dose study, the compound was safe and well tolerated across a broad dose range with no clinically significant observations noted.
The study objectives were to evaluate the safety, tolerability, and pharmacokinetics of escalating single oral doses of CH-1504 in healthy male volunteers. The study was a randomized, double-blind, placebo-controlled evaluation conducted at Guy's Hospital in London, including 30 subjects in 6 cohorts. In this escalating dose study, each cohort of subjects received a higher dose of the drug than the preceding cohort with the objective of exploring a wide range of doses, including and exceeding those believed to be therapeutically relevant. No clinically significant alterations were seen at any of the dose levels tested. Pharmacokinetic data from this trial suggest that CH-1504 is suitable for daily administration at dosage levels that are predicted to be therapeutically effective.
Based on the successful completion of this study, Chelsea has moved forward in its Phase I clinical program and is currently testing multiple ascending doses of CH-1504 in healthy subjects to further assess the drug's safety tolerability and pharmacokinetics. In the Phase Ib study it is anticipated that 24 volunteers, in 3 cohorts of 8 subjects, will receive either placebo or CH-1504 in repeat doses for 7 consecutive days. The company anticipates releasing combined clinical results from these Phase I trials in the first quarter of 2006.
"We are very pleased to see the results of our single ascending dose study remain highly consistent with the results of our preclinical data and pilot clinical study of CH-1504," commented Dr. Simon Pedder, Chelsea's President and Chief Executive Officer. "We believe these results, combined with our existing body of data, provide early support for our hypothesis that CH-1504 may be a clinically superior, safer and better tolerated alternative to methotrexate for treating not only RA, but also psoriasis, inflammatory bowel disease and certain cancers. Clearly these results indicate that CH-1504 merits further clinical development."
Preliminary results from the Company's Phase Ia trial will be addressed this morning during a presentation by Chelsea's Chief Executive Officer, Dr. Simon Pedder at BIO InvestorForum 2005 at 11:20 AM PST at the Palace Hotel in San Francisco. Members of the financial community, the media and other interested parties can access a live webcast of the presentation via a link on Chelsea's corporate website, www.chelseatherapeutics.com. An archive of the webcast will be available on the Company's web site following the presentation.
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.
An independent six-month pilot clinical study compared CH-1504 to methotrexate, the current standard of care, in 20 RA patients in Peru. 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.