CHARLOTTE, N.C., June 9, 2005 (PRIMEZONE) -- Chelsea Therapeutics, Inc. (OTCBB:IVRC) has begun dosing volunteers in its first Phase I clinical trial of CH-1504, an orally available inert antifolate which has demonstrated potential anti-inflammatory and anti-tumor properties. The trial will evaluate the safety and tolerability of defined doses of orally administered CH-1504 in healthy volunteers and is being conducted in the United Kingdom at Guy's Hospital in London, under the Clinical Trial Authorization (CTA) issued earlier this month by the Medicines and Healthcare Products Regulatory Agency (MHRA), the UK's Health Authority.
The main object of the trial is to see how safe and well-tolerated CH-1504 is in individuals who take different doses of the new medication under controlled conditions. The trial will be placebo-controlled and double-blinded to enhance the scientific outcome of the study and the clinical data generated. Chelsea anticipates that the safety and pharmacokinetic data from its U.K. Phase I clinical trial will enable the Company to initiate Investigational New Drug (IND) submissions for CH-1504 for both RA and Psoriasis with the U.S. FDA later this year to initiate Phase II trials in the United States.
"The initiation of dosing in our U.K. Phase I clinical trial is an important milestone in our development of CH-1504 as a safe and effective treatment alternative to methotrexate," commented Dr. Simon Pedder, Chelsea's President and Chief Executive Officer. "We believe there is a significant unmet market need for an effective antifolate therapy that can slow disease progression, as in the case of RA, without the liver and kidney toxicity and tolerability issues associated with methotrexate, currently the standard of care for RA. Based on our preclinical and pilot clinical study results to date, we believe CH-1504 may be clinically superior to methotrexate in treating not only RA, but also psoriasis, inflammatory bowel disease and certain cancers."
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. CH-1504 continues successful progress in its development as a treatment for RA, psoriasis, IBD, cancer and other immunological disorders. RA affects approximately two million Americans, almost 1% of the population, and is two to three times more prevalent in women than men. Psoriasis, another condition that may be positively impacted by treatment with CH-1504, is an immune-mediated chronic skin disease that also affects millions of Americans.
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 was not conducted in compliance with the standards necessary for its use in the U.S. regulatory approval process, the results of this study suggest that CH-1504 has lower toxicity and improved tolerability, as well as increased effectiveness versus methotrexate. Preclinical animal models have also indicated that CH-1504 may have superior efficacy, less toxicity and increased tolerability compared to methotrexate, which currently accounts for almost half of the prescriptions written for the RA market.
About Chelsea Therapeutics, Inc.
Chelsea Therapeutics is a development stage pharmaceutical company that acquires and develops innovative products for the treatment of a variety of human diseases. Chelsea's strategy is to develop technologies that address important unmet medical needs or offer improved, cost-effective alternatives to current methods of treatment. Specifically, we concentrate our efforts on acquiring and developing technologies for the treatment of rheumatoid arthritis, psoriasis, cancer 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, 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.