NEEDHAM, Mass. & PALM BEACH GARDENS, Fla.–(BUSINESS WIRE)–July 9, 2015–
Tyrogenex, a privately held company focused on the development of next-generation targeted therapeutics for cancer and ophthalmology, is pleased to announce that data from its phase 1 safety study of orally-administered X-82 in patients for wet age-related macular degeneration (AMD) was presented today at the 12th International Symposium on Ocular Pharmacology and Therapeutics (ISOPT) Clinical in Berlin.
X-82 is a dual inhibitor of vascular endothelial growth factor (VEGF) and platelet-derived growth factor (PDGF) in development for treatment of wet AMD and solid tumors. Data from this phase 1 study support the recently initiated phase 2 study referred to as “APEX” for wet AMD in Previously treated Eylea patients with X-82.
“Anti-VEGF and anti-PDGF therapies for wet AMD require injections into the eye currently,” said Michael D. Webb, Tyrogenex President and CEO. “This data from our phase 1 study has captured the interest of eye specialists because X-82 is the only orally-administered therapeutic in development for wet AMD, and it has the potential to offer an alternative to frequent eye injections and affect the quality of life on how patients with wet AMD are treated.”
The data from the phase 1 study of X-82 was presented by Jason S. Slakter, MD, of the Vitreous-Retina-Macula Consultants of New York, during his presentation entitled, “New Drugs in Development for Wet AMD.” Dr. Slakter is a Scientific Advisory Board Member for Tyrogenex.
About the APEX Trial
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.
About Wet AMD
AMD is the leading cause of blindness for people over the age of 50 in the United States and Europe. There are two forms of the disease, namely “dry” and “wet” AMD. Wet AMD is characterized by the growth of new blood vessels into the central region of the retina. These new and abnormal blood vessels cause severe central vision loss due to retinal damage caused by leakage of the blood vessels and subsequent scar formation. Anti-VEGF therapies and photodynamic therapies have been approved for wet AMD.
Tyrogenex is developing X-82, as a targeted therapeutic for ophthalmological diseases and solid tumors. Preliminary data from a phase 1/2 pilot study show that X-82 is well tolerated and did not exhibit any dose-limiting toxicity during the study.
For ophthalmology, a phase 1 study shows 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.
In oncology, VEGFR tyrosine kinase inhibitors, such as X-82, typically have demonstrated benefit in a variety of cancers though dosage, and use of this class in combination with other therapies, has been limited by side effects. Phase 1 data presented at American Society of Clinical Oncology show that X-82 could a have a significantly lower toxicity profile, which may make it an ideal candidate for combination therapy.
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