Gene Signal Enters Phase III Clinical Tests For The Prevention Of Corneal Graft Rejection

Main Category: Eye Health / Blindness
Also Included In: Clinical Trials / Drug Trials
Article Date: 10 Nov 2008 - 9:00 PDT

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Gene Signal, a biotech company registered in Switzerland, is currently starting the Phase III study of GS-101, its most advanced therapeutic ophthalmic solution, for the prevention of corneal graft rejection.

Every year, over 40'000 corneal grafts are performed worldwide to cure or prevent blindness, thus making this procedure the most frequently performed transplant surgery. However, the 5 year failure rate for corneal grafts is currently around 35%. As many other graft procedures, donor grafts are always in limited supply. A failure is even more "wasteful" in this context of long waiting lines (6 months - 2 years).

One of the main reasons for graft failure is the immune response of the body. Normally, the cornea is avascular (i.e. deprived of blood vessels), protecting the donor cornea from being rejected. However, under certain circumstances, new blood vessel creation (neovascularization) occurs, inducing an immune response to the donor graft that can lead to immunological corneal graft rejection.

Currently, there is no therapy available. Gene Signal is working on new ways to prevent this syndrome. With its antisense oligonucleotide approach, it 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 a protein that is required for the formation and growth of new blood vessels.

GS 101 eye drops have successfully completed the phase II study. The results show a significant regression of corneal neovascularization, whereas the placebo group all showed an increase in new vessels.

"These interim results (of a phase II study) suggest GS101 eye drops to be an effective and safe approach to specifically inhibit and regress active corneal neovascularization, a major risk factor for corneal graft rejection", indicated Professor Claus Cursiefen, of the Department of Ophthalmology, Friedrich Alexander University, in Germany.

"Compared to the placebo group with 100% ongoing progression of corneal neovascularisation over the 3-month period, the optimal treatment group achieved 86% regression and progression in only 14%", he added.

Prof. Cursiefen will take advantage of the world's largest gathering for ophthalmologists, the Annual Meeting of the American Association of Ophtalmologist in Atlanta, USA, on November 8 - 11, 2008, to present these promising results.

In parallel, Gene Signal is developing a diverse pipeline of novel antisense oligonucleotides, proteins and monoclonal antibodies to treat a range of angiogenesis based diseases. It is evaluating three new drugs in ophthalmology as well as in dermatology and is in the discovery phase with four more molecules addressing indications in the field of vascular disease and oncology.

About Gene Signal

Gene Signal is a biotechnology company focused on discovering genes involved in the regulation of angiogenesis. Founded in 2000, the company has assembled an outstanding leadership team that includes scientific, medical, regulatory, and business professionals with successful track records in developing and bringing to market state of the art drugs. Gene Signal continues to develop its angiogenesis modulating technology and has built a significant intellectual property portfolio, as well as a robust clinical and preclinical pipeline. The company's Headquarter will soon move to Lausanne, Switzerland, with its research program in France, and product development in Canada. Gene Signal is currently looking for licensing partners to either commercialize or co-develop our therapeutic portfolio.

Gene Signal

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