CHARLOTTE, N.C., Oct. 20, 2009 (GLOBE NEWSWIRE) -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) will present results from Chelsea's two clinical stage product candidates in its portfolio of metabolically inert antifolate molecules at the 2009 American College of Rheumatology (ACR) Annual Scientific Meeting in Philadelphia, Pennsylvania. The presentations will include previously reported results from a Phase II, proof-of concept study of CH-1504 and a Phase I trial of CH-4051.
Dr. Edward Keystone, M.D., FRCP(C), Professor of Medicine, Rheumatology Division at The University of Toronto, Canada, and principal investigator for the study, will present detailed findings from Chelsea's 12-week proof-of-concept study in methotrexate (MTX) naive rheumatoid arthritis (RA) patients. The findings demonstrate that CH-1504 has comparable efficacy to MTX and may be safer and better tolerated. In addition to Dr. Keystone's platform presentation, Chelsea will present safety, tolerability and pharmacokinetic data from its recently completed Phase I trial of CH-4051, the more potent "L" isomer of the racemic mixture CH-1504.
Chelsea's novel, orally available and metabolically inert antifolate compounds are engineered to have potent autoimmune, anti-inflammatory and anti-tumor properties. These compounds may potentially be used to treat such diseases as rheumatoid arthritis, psoriasis, inflammatory bowel disease, cancer and other immunological disorders. Additionally, they are metabolically inert and therefore believed to have fewer harmful and unpleasant side effects than those typically associated with classical antifolates such as MTX, currently the standard of care for a broad range of abnormal cell proliferation diseases.
Both CH-1504 and CH-4051 inhibit dihydrofolate reductase, an enzyme required for cell proliferation. However, due to their lack of metabolism, the compounds appear to be devoid of the liver and kidney toxicities related to the formation of the metabolites and observed with long-term use of MTX.
Presentation Details are as follows:
Title: CH-1504, a Metabolically Inert Antifolate, Is An
Effective and Well-Tolerated Treatment for Patients
with Moderate to Severe Rheumatoid Arthritis
Session: Rheumatoid Arthritis Therapy: Novel Therapies in
the Pipeline
Date/Time: Tuesday, October 20, 2009 at 3:45 PM Eastern Time
Presentation: 1927
Location: Auditorium - Pennsylvania Convention Center
Title: Phase I Single and Multiple Ascending Dose Studies
to Investigate the Safety, Tolerance and
Pharmacokinetics of CH-4051 in Healthy Male
Subjects
Session: Rheumatoid Arthritis Treatment: Steroids,
Methotrexate, and Novel Targets
Date/Time: Sunday, October 18, 2009 from 9:00 AM - 11:00 AM
Eastern Time
Poster: 431
Location: Hall D - Pennsylvania Convention Center
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. Chelsea's most advanced drug candidate, Droxidopa, is an orally active synthetic precursor of norepinephrine initially being developed for the treatment of neurogenic orthostatic hypotension. In addition to Droxidopa, Chelsea is also developing a portfolio of metabolically inert oral antifolate molecules engineered to have potent anti-inflammatory and anti-tumor activity to treat a range of immunological disorders, including two clinical stage product candidates: CH-1504 and CH-4051. Preclinical and clinical data suggest superior safety and tolerability, as well as increased potency versus methotrexate (MTX).
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 our need to raise operating capital, our history of losses, risks and costs of drug development, risk of regulatory approvals, our reliance on our lead drug candidates Droxidopa and CH-1504, reliance on collaborations and licenses, intellectual property risks, competition, market acceptance for our products if any are approved for marketing and reliance on key personnel including specifically Dr. Pedder.