CHARLOTTE, N.C., Dec. 21, 2005 (PRIMEZONE) -- Chelsea Therapeutics International, Ltd. (OTCBB:CHTP) has successfully completed the Phase Ib 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. Data from this multiple ascending dose study demonstrates that CH-1504 is safe and well tolerated at all evaluated doses, with no clinically significant abnormalities observed.
The study objectives were to evaluate the safety, tolerability, and pharmacokinetics of multiple ascending 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. In this escalating dose study, 24 volunteers in 3 cohorts of 8 subjects received either placebo or CH-1504 in repeat doses ranging from 7.5mg to 15mg once daily for 7 consecutive days. Pharmacokinetic data from this trial suggest that CH-1504 is suitable for daily administration at dosage levels that are predicted to be therapeutically effective. Preliminary analysis of the pharmacokinetic data from this study suggest that CH-1504 kinetics are predictable and stable over a 7 day dosing period and that the drug will be suitable for daily administration.
Protocol requires that Chelsea conduct an evaluation of all volunteers 30 days post dosing. The Company will report further on the results of this Phase I study following this final evaluation and expect these results to available early in the first quarter of 2006.
"We are pleased to see the results of this Phase I trial validate the superior safety and tolerability CH-1504 demonstrated in earlier pre-clinical and pilot clinical studies comparing CH-1504 to Methotrexate, the leading prescription treatment for RA," commented Dr. Simon Pedder, Chelsea's President and Chief Executive Officer. "The solid results of this trial will be included in our U.S. IND submissions for both RA and Psoriasis. We continue to expect approval on both INDs and the subsequent initiation Phase II trials for both indications in early 2006."
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 are not subject to the metabolism thought to be associated with side effects known to occur with marketed antifolates such as methotrexate (MTX). Chelsea is developing 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 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 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 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.