Chelsea Therapeutics Announces Approval to Open Enrollment Into 3.0 mg Arms of CH-4051 Phase II Trial in Rheumatoid Arthritis (CHTP)

Chelsea Therapeutics International, Ltd. CHTP announced that an independent Data Safety Monitoring Board recently met to review patient safety data for Chelsea's Phase II trial of CH-4051 in rheumatoid arthritis and recommended that each on-going arm of the study continue as planned and that enrollment be initiated into the 3.0 mg dose groups of the trial. "We are very encouraged that this DSMB review provided us with a recommendation to open enrollment into our high dose groups," commented Dr. Simon Pedder, President and CEO of Chelsea Therapeutics. "We believe this trial will validate earlier clinical and pre-clinical findings by demonstrating CH-4051 has superior efficacy to methotrexate while maintaining both improved safety and tolerability. There is significant market opportunity for an oral disease modifying agent that could be used as an important therapeutic alternative prior to or in combination with injectable biologics or other oral disease modifying agents. We are eagerly looking forward to the unblinded interim data from this trial next quarter and the full results during the second quarter 2012."