Gene Signal Announces Publication of Phase I Data Highlighting Safety of GS-101 for Diseases of the Eye
GS-101 Being Evaluated in Phase III to Prevent Corneal Graft Rejection
Gene Signal, a company focused on developing innovative drugs to manage angiogenesis based conditions, announced publication of data from a phase I study demonstrating that the antisense oligonucleotide GS-101 (eye drops) is safe, with no signs of intolerability following administration to healthy volunteers. GS-101 is an antisense oligonucleotide that acts by blocking the production of insulin receptor substrate 1 (IRS-1), a protein required for the formation and growth of new blood vessels. The data were published in the British Journal of Clinical pharmacology (Vol. 68 (2) pp169-173) by researchers led by Dr. Hermann Kain, University Hospital Basel, Basle, Switzerland.
“This publication describes the excellent safety data we obtained from our first-in-man study with GS-101,” noted Eric Viaud, CEO of Gene Signal. “We have moved GS-101 through clinical evaluation and are now conducting an international phase III trial for the prevention of pathologic corneal neovascularisation, a major risk factor in corneal graft rejection, the most common transplantation procedure that saves the sight of approximately 46,000 people worldwide each year.”
The phase I open-label study was designed to investigate the safety, tolerability and bioavailability of GS-101 (eye drops) in 14 healthy volunteers. Initially, one single low dose of GS-101 was administered into one eye. If no signs of intolerance were observed, subjects then received escalating doses of GS-101 (3 times daily) in one eye for 14 days. GS-101 was found to be safe and well tolerated by all 14 subjects in escalating doses (43 to 430 µg/day).
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