Graft rejection therapy enters Phase III

GS-101, Gene Signal's experimental topical ophthalmic solution designed to prevent the rejection of corneal grafts, has entered Phase III trials. The solution, an antisense oligonucleotide, inhibits the expression of insulin-receptor substrate-1 (IRS-1), which is essential for corneal neovascularization.

The results of the multicentre, double-blind, randomized Phase II trial, presented at this year's meeting of the American Academy of Ophthalmology (AAO) by Professor Claus Cursiefen of the department of ophthalmology at Germany's Friedrich Alexander University, demonstrated the safety and efficacy of the solution in suppressing the formation of new blood vessels in the cornea. Over the three month study period, in which 40 patients were treated, corneal neovascularization progressed in 100% of subjects receiving placebo therapy; patients treated with GS-101 twice daily (at doses of 43 µg, 86 µg and 172 µg) achieved up to 86% regression.

In addition to the Phase III trial of GS-101, Gene Signal is developing several other antisense oligonucleotides for the treatment of diseases related to angiogenesis.