CHTP 5.50 Chelsea Therapeutics Initiates CH-1504 Bioequivalence Study
Study to Determine Comparable Doses of New Disodium Salt Formulation of CH-1504 and Provide Intended Dose Range for Global Phase II Trial in Rheumatoid Arthritis
Jun 27, 2007 8:00:00 AM
2007 PrimeNewswire, Inc.
CHARLOTTE, N.C., June 27, 2007 (PRIME NEWSWIRE) -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) has begun dosing volunteers in its bioequivalence study of CH-1504, an orally available metabolically inert antifolate which has demonstrated potential anti-inflammatory and anti-tumor properties.
The bioequivalence study, being conducted at Swiss Pharma in Basel, Switzerland, is intended to determine a comparable dose range for Chelsea's new disodium composition of CH-1504 and will consist of escalating oral doses of CH-1504 administered in cohorts of healthy male volunteers. Each cohort will receive a single dose of CH-1504 with evaluation up to 14-days post-dose. When target plasma levels have been reached, Chelsea will conduct a multiple dose evaluation of the final doses intended for a Phase II study in rheumatoid arthritis (RA).
Based on the planned dosing schedule, Chelsea anticipates the study will require approximately 5 cohorts and yield definitive results late in the third quarter 2007. Results from this study combined with the existing body of preclinical and clinical data are expected to enable the Company to initiate Phase II trials of CH-1504 in RA during the fourth quarter 2007.
"Establishing bioequivalence for our new disodium salt formulation is the last remaining step in this reformulation process, following which we eagerly anticipate moving ahead in our clinical evaluation of CH-1504 as a safe and effective treatment alternative to methotrexate in our planned Phase II trial in the fourth quarter," commented Dr. Simon Pedder, Chelsea's President and Chief Executive Officer. "Based on the formulation analysis to date and preliminary primate data indicating a nearly four-fold improvement in bioavailability of the disodium salt composition, we are optimistic that the bioequivalence study will show that significantly lower doses of CH-1504 will be required to achieve the therapeutic benefit previously demonstrated by the compound while simultaneously demonstrating reduced variability in plasma levels."
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.
Chelsea reported positive preliminary results from its U.K. Phase I trials for all oral indications of CH-1504 in December 2005 and anticipates the initiation of a Phase II trial for RA in 2007. Additionally, an independent six-month pilot clinical study compared CH-1504 to MTX 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 MTX. Preclinical animal models have also indicated that CH-1504 may have superior efficacy and a greater therapeutics window than MTX.
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 a strategic partnership with Active Biotech AB for the joint development of a portfolio of therapeutics targeting immune-mediated inflammatory disorders and transplantation. In addition to its autoimmune pipeline, Chelsea has received approval for the designation of Droxidopa in the US as an Orphan Drug. Droxidopa is 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.
CONTACT: Chelsea Therapeutics
Nick Riehle, Chief Financial Officer
704-341-1516 x101
Kathryn McNeil, Investor/Media Relations
718-788-2856
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