CHARLOTTE, N.C., June 7, 2005 (PRIMEZONE) -- The United Kingdom's Medicines and Healthcare products Regulatory Agency, or MHRA, has approved a Clinical Trial Authorization, or CTA, application from Chelsea Therapeutics, Inc. (parent holding company Ivory Capital) (OTCBB:IVRC), for the human clinical testing of CH-1504, an orally available antifolate that has potential anti-inflammatory and anti-tumor properties.
This CTA approval moves Chelsea forward into the next stage of CH-1504's development as a safe and effective alternative treatment to methotrexate for rheumatoid arthritis, or RA, and as a potential treatment for psoriasis, inflammatory bowel disease, also known as IBD, asthma and certain cancers. The CTA approval was granted based on the preclinical chemistry, manufacturing, toxicology and safety data submitted to the MHRA by the Company.
Dr. Simon Pedder, Chelsea's President and Chief Executive Officer, commented, "This approval to begin Phase I clinical trials is a tremendous step forward in the development of CH-1504, which may be clinically superior to methotrexate in treating RA, psoriasis and certain cancers."
Chelsea expects to commence a Phase I clinical trial in the United Kingdom this month. The Phase I clinical trial will be a double-blinded, placebo controlled trial designed to evaluate the safety and tolerability of defined doses of orally administered CH-1504 in adults. Chelsea plans to initiate Investigational New Drug, or IND, submissions for both RA and Psoriasis with the FDA later this year to initiate Phase II trials in the United States.
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.