BUSINESS WIRE
GS-101 Being Evaluated in Phase III to Prevent Corneal Graft
Rejection
LAUSANNE, Switzerland--(BUSINESS WIRE)--Gene Signal, a company focused on developing innovative drugs to manage
angiogenesis based conditions, today 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
Every year, approximately 46,000 corneal grafts are performed worldwide
to cure or prevent blindness making this procedure the most frequently
performed transplant surgery. However, the 5 year failure rate for
corneal grafts is currently around 35%. As with many other graft
procedures, donor grafts are always in limited supply, with waiting
times for the procedure ranging from 6 months to 2 years. One of the
main reasons for graft failure is the natural immune response of the
body.
Normally, the cornea is avascular, or deprived of blood and lymphatic
vessels, protecting the donor cornea from being rejected. However, under
certain circumstances, abnormal new blood vessel creation or
neovascularisation occurs, inducing an immune response against the donor
graft that can lead to immunological corneal graft rejection.
As currently there is no therapy available, Gene Signal is working on
new ways to prevent this syndrome. With GS-101, its antisense
oligonucleotide approach, which benefits from orphan designation in
Europe, the company aims to block the pathways leading to the formation
of blood vessels in the cornea. This approach uses short DNA fragments
that specifically target and block the production of IRS-1, a protein
required for the formation and growth of new blood vessels.
About Gene Signal
Gene Signal (www.genesignal.com)
is developing a robust pipeline of novel antisense oligonucleotides,
proteins and monoclonal antibodies to treat a range of conditions based
on its innovative angiogenesis modulating technology. The company’s most
advanced therapeutic product is GS-101, an antisense oligonucleotide
currently in phase III trials for the prevention of corneal graft
rejection as well as clinical trials for additional angiogenesis based
ophthalmology and dermal indications. Gene Signal’s diverse pipeline
also includes four molecules at the discovery stage addressing
indications in the field of vascular disease and oncology.
Through world leading expertise in discovering genes involved in the
regulation of angiogenesis, Gene Signal has built a significant
intellectual property portfolio that has relevance in multiple disease
areas. Gene Signal plans to license out its therapeutic portfolio of
candidate drugs for co-development and commercialisation. The company
was founded in 2000 and has assembled an outstanding leadership team
that includes scientific, medical, regulatory and business professionals
with successful track records in developing and commercialising state of
the art drugs. Gene Signal’s headquarters are in Lausanne, Switzerland,
with its research programs based in France and product development in
Canada.