Date Posted: 04 November 2009
Gene Signal [www.genesignal.com] based in Lausanne, Switzerland, have reported interim results of a randomized Phase II clinical study on their lead drug candidate, GS-101. The drug, an antisense oligonucleotide targeting a component of the VEGF pathway, is being used to treat corneal graft associated neovascularisation.
While the cornea is normally deprived of blood, neovascularisation occurs prior to graft procedures in 25% of cases and in about 40-50% of post graft procedures increasing the overall risk of graft rejection by 25-50%. The antisense oligo under development targets insulin receptor substrate 1 mRNA (IRS1) which the company claims has activity only in the disease state and therefore represents a more selective angiogenesis target than VEGF.
Gene Signal published their findings in the journal Ophthalmology showing that a dose of 86µg per day of GS-101 eye drops produced a significant inhibition and regression of corneal neovascularisation. The company had tested three doses, 43 µg, 86 µg and 172 µg but could not find any apparent benefit from the higher dose. The company have already started Phase III testing and are anticipating completion of the studies by mid 2010.
Corneal graft associated neovascularisation is not the only target for GS-101. The company propose to use their lead candidate in five ocular indications â€" corneal, neovascular glaucoma, ROP, AMD and DR. Phase I trials are underway in four of these indications. According to the company's Chief Executive, Eric Viaud, the indication of host corneal vascularisation was attractive as a first target because the small number of patients (40) and the relatively shorter trial for corneal vascularisation (a Phase III of 18 months) made it a little easier to obtain proof-of-concept. The company has raised almost $22M dollars since 2000 and is now hoping to find a partner to help drive value from GS-101 in the other valuable indications. The company additional plans to target other indications in the field of vascular disease and oncology and claims to control a patent portfolio of 94 genes involved in the angiogenic process.
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