FDAnews
www.fdanews.com/articles/88630-targegen-initiates-study-of-topical-amd-drug

TARGEGEN INITIATES STUDY OF TOPICAL AMD DRUG

November 6, 2006

TargeGen has begun a single-site Phase I clinical trial involving TG100801, a small-molecule, topically applied, multitargeted kinase inhibitor for the treatment of age-related macular degeneration (AMD) and other debilitating diseases of the eye. The trial, involving approximately 45 subjects, is expected to be completed by the end of the first quarter of 2007. The company hopes to initiate Phase II studies with TG100801 in mid-2007.

TG100801, applied daily in eyedrop form, is designed to suppress disease-related edema, angiogenesis and inflammation. Edema, angiogenesis and inflammation are pathological hallmarks of macular degeneration, diabetic macular edema and proliferative diabetic retinopathy. Currently approved therapies for macular degeneration require repeated injection into the eye and typically act on only VEGF-mediated retinal leakage.

TargeGen believes that TG100801 may offer equal or superior efficacy to injectable agents, while offering patients the greater convenience and potential safety advantages of noninvasive delivery. In published preclinical studies conducted by outside retinal disease experts, TG100801 demonstrated the ability to reduce VEGF-mediated retinal leakage, angiogenesis and inflammation after topical instillation. TG100801 is the second internally discovered TargeGen compound to enter clinical trials.