December 11, 2009 - iCo Therapeutics (“iCo”) is pleased to announce that its Phase 1 clinical trial of iCo-007, having enrolled all patients in four cohorts of increasing concentration (110ug, 350ug, 700ug, 1000ug), has to date demonstrated a positive safety profile. A Safety Evaluation Committee recently convened to review early data from the fourth and final cohort, which represented an approximately 10-fold increase in concentration from the first dosing level and concluded there were no drug-related serious adverse events. Based on the safety profile and additional encouraging data seen so far, iCo has now entered the planning stage for Phase 2 clinical studies. Stated Dr. David Boyer: “I am pleased with the results of the Phase I clinical trial to date. The Safety Evaluating Committee’s experience with iCo-007 indicates that the drug has been well tolerated by patients and there were no drug-related significant adverse events noted to date even at the highest dosing level. I look forward to working with iCo in the planning and design of Phase 2 trials for iCo-007”. In early Q1 2010 iCo expects a last patient visit (month six) followed by data lock and analysis. iCo expects to present final data in Q2 2010....
About iCo-007
Designed and discovered by ISIS Pharmaceuticals Inc., (NASDAQ: ISIS), iCo-007 is a second-generation antisense inhibitor targeting c-Raf kinase mRNA for the treatment of DME and Diabetic Retinopathy (DR)... iCo Therapeutics' Press Release -
