Iconic Therapeutics Announces Phase 1 Wet AMD Study Results
Dr. Christine Gonzales to present data at AAO Retina Subspecialty day in Chicago
ATLANTA--(BUSINESS WIRE)--Nov 8, 2012 - Iconic Therapeutics, Inc. announced today that Dr. Christine Gonzales will present the results of its recently completed Phase 1 study of hI-con1TM in wet adult macular degeneration (wet AMD) patients at the American Academy of Ophthalmology Retina Subspecialty Day on Saturday, November 10, 2012 in Chicago.
Dr. Gonzales, a Phase 1 investigator with the Retina and Vitreous Center of Southern Oregon, said “hI-con1TM has an entirely new and exciting mechanism of action for treatment of wet AMD. As an investigator in the phase 1 clinical trial, I was particularly impressed by the profound and early gains in vision and the significant reduction in OCT retinal thickness seen after a single intravitreal injection of the drug. In patients who received hI-con1TM with an anti-VEGF agent, the results were remarkable. I am very encouraged by the initial study results and look forward to the Phase 2 clinical trial.”
Dr. Steven Schwartz, Ahmanson Professor of Ophthalmology, Jules Stein Eye Institute at the University of California in Los Angeles, an investigator in multiple phase 1 wet AMD studies and a consultant to Iconic Therapeutics, remarked, “While one must be careful not to over-interpret data from Phase 1 studies, these results are very encouraging. There was a clear biologic effect when hI-con1TM was used alone, or in conjunction with current anti-VEGF therapies. It's been many years since I've seen this kind of effect in a Phase 1 study.”
The purpose of the Phase 1 study was to evaluate the safety and tolerability of hI-con1TM in wet AMD patients. The prospective, multi-center clinical study evaluated the safety and tolerability of a single, intravitreal injection of three different doses of hI-con1TM in a total of 18 patients.
hI-con1TM was very well tolerated by all patients: no ocular or systemic safety signals were observed at any dose. A single injection of hI-con1TM produced no dose limiting toxicities when used alone or when used with bevacizumab or ranibizumab. Notably, there were clear indications of dose-related, biologic activity in a number of patients, as indicated by increased visual acuity, reduced retinal thickness and CNV regression. Evidence of hI-con1TM biological activity was observed both in previously untreated patients as well as patients not previously responding well to bevacizumab or ranibizumab (so-called “sub-responders”).
Mr. Kirk Dornbush, CEO of Iconic Therapeutics, said “Our Phase 1 study met its primary safety endpoint and there were some very intriguing biologic signals in both treatment naïve and anti-VEGF sub-responders. These data give us many exciting avenues to explore in our Phase 2 studies.”
hI-con1TM is an all-human, bifunctional protein composed of a targeting portion designed to attach tightly and specifically to the inner surface of the choroidal neovascularization (CNV), the pathological blood vessels characteristic of wet AMD, while the second portion triggers immune destruction of the CNV. hI-con1TM is also thought to interfere with the VEGF pathway.
Iconic Therapeutics is an Atlanta, Georgia based biopharmaceutical company that holds an exclusive license from Yale University for all therapeutic uses of hI-con1TM. To learn more, visit www.iconictherapeutics.com.
Contact: Iconic Therapeutics
Kirk Dornbush, 404-522-8577
Posted: November 2012