Tyrogenex Presents Final Results from Phase 1 Study of X-82 for Wet AMD at the 2015 Annual American Academy of Ophthalmology Meeting

In Phase 1 study, wet AMD patients demonstrated vision maintenance with orally administered X-82

Nov 13, 2015, 20:01 ET from Tyrogenex

NEEDHAM, Mass. and PALM BEACH GARDENS, Fla., Nov. 13, 2015 /PRNewswire/ -- Tyrogenex, a privately held company focused on the development of targeted therapeutics for cancer and ophthalmology, today announced data from its phase 1 open-label study of orally-administered X-82 in patients for wet age-related macular degeneration (AMD).  The data was presented today during the American Academy of Ophthalmology Annual Meeting 2015 in Las Vegas, NV.

Dr. Nauman Chaudhry, a partner at New England Retina Associates in Connecticut, presented final-results of the phase 1 trial. Dr. Chaudhry has authored more than 90 papers and abstracts in peer-reviewed ophthalmology journals.

"This shows a great new potential, which can decrease the number of injections and may change people's lives," said Dr. Chaudhry.

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 AMD and advanced solid tumors. Data from the 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. 

The open-label dose-escalating phase 1 study tested X-82 in 35 adult patients with wet AMD to evaluate safety and preliminary efficacy. Six treatment regimens at four dose levels of X-82 was evaluated. The outcomes showed an overall trend toward higher visual acuity of +4.3 letters of the Early Treatment Diabetic Retinopathy Study chart, and a trend toward decreased foveal thickness of -48 µm at 24 weeks (average of all patient data up to injection or dropout). Of the 25 patients completing 24-weeks on X-82, 15 required no intravitreal injections of anti-VEGF and had a mean visual acuity improvement of +5.3 letters. X-82 was generally well tolerated, with 25 of 35 patients completing the full 24-week treatment period.

Study Design
Phase 1, open-label, dose-escalation trial performed to evaluate the safety study and preliminary efficacy of X-82 in 35 adult patients with wet AMD.  Preliminary efficacy was assessed by evaluation of best-corrected visual acuity (BCVA), change from baseline in central retinal thickness and area of choroidal neovascularization based on fundus examination, fundus photography, fluorescein angiography and optical coherence tomography (OCT).  Safety was assessed with evaluating the number and percentage of 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.

About X-82
Tyrogenex's lead compound is X-82.  X-82 inhibits both VEGF and PDGFR. Tyrogenex believes X-82 targets the basic mechanisms of neovascular eye diseases, including angiogenesis, fibrosis and inflammation.  X-82 is currently being evaluated for wet AMD and solid tumors.

About Tyrogenex
Tyrogenex is a biopharmaceutical company focused on improving the lives of patients with wet AMD and advanced solid tumors by discovering medicines to help provide additional treatment options. Tyrogenex's lead compound is X-82.

For more information, visit www.tyrogenex.com

Forward-Looking Statements
This press release contains forward-looking statements that are based on company management's current beliefs and expectations and are subject to currently unknown information, risks and circumstances and actual results may vary from what is currently projected.

Corporate Contact:
Teri Swift
Tyrogenex Corporate Communications
(561) 406-9705
teri@tyrogenex.com

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SOURCE Tyrogenex



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