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Protein targets tissue factor, angiogenesis in CNV related to AMD
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MIAMI — A protein that targets tissue factor in neovascular age-related macular degeneration was well tolerated in a phase 1 study, a speaker told colleagues here.
Carl D. Regillo, MD, reviewed results of a phase 1 study of ICON-1 (Iconic Therapeutics) in the treatment of neovascular AMD at Angiogenesis, Exudation, and Degeneration 2016.
Carl D. Regillo
“There were no ocular or systemic dose-limiting toxicities identified in the study. There were no unexpected [adverse events] or anything related to the drug of significance,” Regillo said.
ICON-1 is a human immunoconjugate fusion protein that targets tissue factor. In pathology, tissue factor overexpression triggers angiogenesis, tumor growth and metastasis, and promotes an inflammatory immune environment via extra- and intracellular signaling. Tissue factor is involved in fibrin formation and growth of the CNV complex, Regillo said.
The study included 18 patients with active choroidal neovascularization related to AMD. Six patients received a single 60-µg injection of ICON-1, six patients received a single 150-µg injection of ICON-1, and six patients received a single 300-µg injection of ICON-1.
About half of the patients were previously treated, and about half were treatment-naïve. At the investigators’ discretion, patients were allowed to receive injections of Lucentis (ranibizumab, Genentech) starting at 2 weeks after ICON-1 injection.
One serious adverse event and one severe adverse event occurred. Ocular adverse events were mild to moderate, Regillo said.
A single dose of ICON-1, alone or followed by ranibizumab injections, showed potential dose-related signals of biologic activity.
Enrollment has begun for the phase 2 EMERGE study, which will evaluate the safety, efficacy and pharmacokinetic profile of repeated ICON-1 injections alone and in combination with ranibizumab compared with ranibizumab alone in eyes with treatment-naïve CNV related to AMD.
The EMERGE study will include 90 patients randomized to three arms: a 300-µg injection of ICON-1 plus sham injection (30 patients), a 300-µg injection of ICON-1 plus 0.5-mg ranibizumab (30 patients) and 0.5-mg ranibizumab plus sham injection (30 patients). – by Matt Hasson and Kristie L. Kahl
Disclosure: Regillo reports he receives research grant support from and is a consultant for Iconic Therapeutics.