Phase 1 clinical trial of iCo-007 demonstrates positive safety profile

Dec 12 2009

iCo Therapeutics Inc. (TSX-V: ICO) - 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.

The primary objective of the phase I, open-label, dose escalation study was to evaluate the safety and tolerability of a single intravitreal injection of iCo-007 in patients with diffuse DME. Secondary objectives included assessment of systemic pharmacokinetics, changes in retinal thickness using OCT measurements, and changes in visual acuity.

"To move to completion of a clinical trial in the United States and to planning for our Phase 2 trials represents a major milestone for the company. Ophthalmology represents one of the most exciting arenas in drug development and partnering today and the retinal market remains underserved, particularly for those areas such as DME," stated Andrew Rae, President and CEO.