Gene Signal Announces Publication of Data on GS-101, Start of Phase III Study to Prevent Corneal Neovascularization

August 17, 2009

Gene Signal announced the publication of Phase I data that demonstrated that their experimental drug antisense oligonucleotide GS-101 is safe, with no signs of intolerability following administration to healthy volunteers. The study was published in the August 2009 issue of the British Journal of Clinical Pharmacology. Gene Signal also announced that they have moved into Phase III trials with GS-101 in the prevention of corneal neovascularization in corneal transplant patients.

GS-101 is an antisense oligonucleotide that acts by blocking the production of insulin receptor substrate 1 (IRS-1), a protein that is required for the formation and growth of new blood vessels. With GS-101 which benefits from orphan designation in Europe, Gene Signal aims to block the pathways leading to the formation of blood vessels in the cornea.

In the Phase I study, GS-101 was tested in 14 healthy volunteers to determine the safety, tolerability and bioavailability of the drug. GS-101 was first administered in one eye then the patients then received escalating doses in one eye for 14 days. GS-101 was found to be safe and well tolerated in all subjects.

This drug may also show some promise in neovascular glaucoma and retinopathy of premautrity and Phase II trials are ongoing.

Read the study and the press release.




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