PLANS FOR CLINICAL STUDIES

Efforts are in progress to evaluate hI-con1™ as therapy for wet AMD and cancer.

Iconic is targeting 4Q10 to begin its phase 1/2a study designed to evaluate safety, tolerability and initial efficacy of hI-con1 administered by intravitreal injection to wet AMD patients. Iconic has recruited top ophthalmology clinical investigators. Phase 1 will be an open-label, dose escalation study designed to evaluate 3 dose levels of hI-con1 in 15 patients. Primary endpoints will be safety and tolerability. Secondary endpoints will include CNV regression (measured by analyzing fluorescein angiograms), visual acuity (measured by EDTRS, IOP and OCT) and retreatment frequency.

In the Phase 2 study, 45 subjects will be randomized (1:1:1 ratio) to receive three intravitreal injections of one of two doses of hI-con1 or Lucentis® administered one month apart. The doses of hI-con1 will consist of the Maximum Tolerated Dose and the next lower dose. Study subjects will be evaluated for safety and initial efficacy. These studies are expected to last 9-12 months.