PLANS FOR CLINICAL STUDIES

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

The Company is focusing on the administration of I-con1™ protein as a therapeutic for wet AMD. Unlike the chimeric (mouse-human) version of the I-con1™ protein that has been used in the rodent model experiments described, the Company anticipates evaluating clinically in wet AMD patients the all-human counterpart protein I-con1™ (“hI-con1™”). This protein has been prepared, tested and shown to be active in the pig wet AMD model system. In preparation for beginning clinical testing with hI-con1™, the Company has contracted with companies that have generated mammalian clonal cell lines that make hI-con1™ protein and produced a so-called Master Cell Bank, which will be used in the manufacturing process for clinical-grade protein. A contract manufacturer has developed a scaled-up process for purifying the amounts of hI-con1™ protein required for clinical testing. Technology transfer is currently in progress at a contract manufacturer licensed to prepare clinical-grade protein according to Good Manufacturing Practices as set forth by the Food and Drug Administration.

Based on animal studies demonstrating that replication-defective adenovirus carrying the gene for I-con1™ has strong antitumor activity without obvious adverse effects on normal blood vessels or normal tissues, Dr. Albert Deisseroth, President of the Kimmel Cancer Center at the University of California, San Diego (http://www.skcc.org), is preparing to lead a team of clinical oncologists in human clinical proof-of-principle trials administering  hI-con1™ using the adenovirus approach. Although these proposed studies are to be conducted independently of the Company, Iconic’s license to I-con™ technology entitles the Company to viral- or other gene-based I-con™ therapy, and thus Iconic will have the opportunity to develop such approaches should the Company choose to do so.