PLANS FOR CLINICAL STUDIES
Efforts are in progress to evaluate I-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 I-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 I-con1 in 15 patients. Phase 2a will enroll 45 patients (15 patients per arm) in a double-blind, randomized study using the two highest tolerable doses of I-con1 with Lucentis® as the control. Primary endpoints will be safety, CNV regression (measured by analyzing fluorescein angiograms), visual acuity (measured by EDTRS, IOP and OCT) and retreatment frequency. The studies are expected to last 9-12 months.
Beginning in 4Q10, Iconic will explore the anti-tumor activity of I-con1 in vivo, using SCID mice models with human gynecologic cancers, the VX-2 carcinoma rabbit model and other models. Additional GLP toxicology studies are also planned to support the filing of an IND for cancer indications and subsequent clinical trials. It is anticipated that clinical testing of I-con1 in cancer will begin in 2012. |