Recruitment Exceeds Expectations as Patient Enrollment Nears 75%
Full Enrollment to be Completed Third Quarter 2008
CHARLOTTE, N.C., July 16, 2008 (PRIME NEWSWIRE) -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) announced that it has completed nearly 75% of the planned enrollment in its Phase II trial of CH-1504 in rheumatoid arthritis (RA) initiated in January 2008. CH-1504 is the lead drug candidate in Chelsea's portfolio of orally available, non-metabolized antifolate compounds engineered to provide the same potent efficacy as methotrexate (MTX) without the liver and kidney toxicities or tolerability related side effects associated with chronic therapy.
To date, Chelsea has enrolled 147 of the planned 200 patients for this 12-week, 4-arm, parallel group trial comparing 0.25 mg, 0.5 mg and 1.0 mg once daily oral doses of CH-1504 to a 20 mg once weekly oral dose of MTX. Of the 147 patients currently enrolled in the trial, 41 have completed treatment. Based on current rate of recruitment, enrollment and treatment completion, Chelsea anticipates that the trial will be fully enrolled and that half of the patients (100) will have completed drug treatment by the end of September, enabling the data safety monitoring board to conduct its planned review early in the fourth quarter.
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.
"We are delighted by the rate of patient enrollment in this trial, which has so far exceeded our expectations," commented Dr. Simon Pedder, President and CEO of Chelsea Therapeutics. "We believe this trial will further establish CH-1504's efficacy and favorable safety profile in a direct comparison to methotrexate."
In parallel to its development of CH-1504, Chelsea has also begun validating the potency of additional compounds in its library of metabolically inert antifolates. In March of 2008, the Company reported significant efficacy of CH-4051, the second compound from this portfolio, in the reduction of collagen-induced arthritis in an animal model. Following completion of the remaining IND-enabling toxicology studies, Chelsea intends to begin a Phase I human safety study in the fourth quarter of 2008.
About CH-1504
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 CH-1504, 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.