Date: 2015-04-29
Type of information: Initiation of the trial
phase: 2
Announcement: initiation of the trial
Company: Tyrogenex (USA - Fl)
Product: X-82
Action
mechanism: protein inhibitor/VEGF inhibitor/PDGF inhibitor. X-82 is an orally administered, dual inhibitor of vascular endothelial growth factor (VEGF) and platelet-derived growth factor (PDGF) in development for treatment of wet age-related macular degeneration (AMD) and solid tumors. Preliminary data show that X-82 does not exhibit dose-limiting toxicity.
Disease: wet age-related macular degeneration (AMD)
Therapeutic area: Ophtalmological diseases
Country: UK, USA
Trial
details: APEX is a randomized, double-masked, placebo-controlled, dose-finding phase 2 study being conducted throughout the U.S. at 20 sites and five sites in the U.K. The study is designed to evaluate the safety and efficacy of X-82 in the prevention of vision loss due to wet AMD. APEX is expected to enroll 132 subjects. The primary endpoint of the APEX study is the mean change in visual acuity score from day 1 to 52 weeks after randomization. Another key endpoint is the reduction of the number of injections needed for the duration of the study. Additionally, systemic and ocular safety will be evaluated by assessing ECG, laboratory analyses, adverse events and serious adverse events. (NCT02348359)
Latest
news: * On April 29, 2015, Tyrogenex, a privately held company focused on the development of next-generation targeted therapeutics for cancer and ophthalmology, announced the initiation of a phase 2 study referred to as “APEX,” for wet AMD in Previously treated Eylea patients with X-82. For ophthalmology, a phase 1 study showed X-82 was able to maintain or improve vision in all subjects who received the drug for the six-month study duration and most subjects did not require any rescue injections during that time. There were no dose-limiting toxicities encountered during the study.
