October 28, 2008
Chelsea Therapeutics Completes Enrollment in Phase II Trial of CH-1504 in Rheumatoid Arthritis; Top Line Data Expected in First Quarter 2009
CHARLOTTE, N.C., Oct. 28, 2008 (GLOBE NEWSWIRE) -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) announced that it has completed patient enrollment in its Phase II trial comparing the efficacy and tolerability of daily oral doses of CH-1504, a novel metabolically inert antifolate, to a standard weekly dose of methotrexate in rheumatoid arthritis patients.
"Having recently received a favorable recommendation from an independent data safety monitoring board and now having completed full enrollment, we continue to be very pleased with the progress of this trial and look forward to providing top line data in the first quarter of 2009," commented Dr. Simon Pedder, President and Chief Executive Officer of Chelsea Therapeutics.
A total of 200 patients were enrolled in this 12-week, 4-arm, parallel group Phase II clinical trial designed comparing 0.25 mg, 0.5 mg and 1.0 mg once daily oral doses of CH-1504 versus a 20 mg once weekly oral dose of methotrexate (MTX) in a MTX naive RA patient population. The primary efficacy endpoint of this study is to determine the percent of patients with ACR 20 response at the end of 12 weeks. An ACR 20 response is a standard efficacy measure that requires at least a 20% improvement in a number of different measures of disease activity. As the improved safety and tolerability of CH-1504 is expected to be a significant advantage over MTX, the trial will also compare a cluster of gastrointestinal system related adverse events, such as nausea, vomiting, and diarrhea, frequently seen with MTX use as well as closely monitor the results of standard liver function tests across dose groups.
CH-1504 is the lead product candidate in Chelsea's portfolio of novel antifolate compounds developed by Dr. Gopal Nair and licensed by the company in 2004. An orally available and metabolically inert antifolate with potent anti-inflammatory and anti-tumor properties, CH-1504 potently inhibits several key enzymes that are required for cell proliferation. Preclinical and clinical data to date suggests superior safety and tolerability, as well as increased potency versus MTX, currently the leading antifolate treatment and standard of care for a broad range of abnormal cell proliferation diseases. Diseases that may potentially benefit from the compound include RA, psoriasis, inflammatory bowel disease, cancer and other immunological disorders.
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. The Company is currently developing a library of metabolically inert antifolate compounds engineered to have potent anti-inflammatory and anti-tumor activity to treat a range of immunological disorders. Early clinical data suggests that Chelsea's lead antifolate compound, CH-1504, is a safe and effective treatment alternative to methotrexate for RA and may have further applications for psoriasis, IBD and certain cancers. Chelsea's antifolate program is complemented by the development of the I-3D portfolio of therapeutics targeting immune-mediated inflammatory disorders and transplantation. In addition to its autoimmune pipeline, Chelsea is developing Droxidopa, an orally active synthetic precursor of norepinephrine, for the treatment of neurogenic orthostatic hypotension. Currently approved and marketed in Japan, Droxidopa has accumulated over 15 years of proven safety and efficacy, historically generating annual revenues of approximately $50 million in Japan.
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 reliance on collaborations and licenses, risks and costs of drug development, regulatory approvals, intellectual property risks, our reliance on our lead drug candidate, our history of losses and need to raise more money, 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.
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CONTACT: Chelsea Therapeutics Nick Riehle, Chief Financial Officer 704-973-4201 Investor/Media Relations: Kathryn McNeil 718-788-2856