Gene Signal, a company focused on developing innovative drugs to manage angiogenesis based conditions, has 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 August 2009 issue of 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.”
Study Data
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).
About Corneal Grafts and GS101