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Gene Signal is currently developing GS-101 (an antisense oligonucleotide or short DNA strand). GS-101 is a topical medication in the form of eye drops, and is currently being researched for the management of excessive vascular growth in the cornea, also known as “neovascularisation”
GS-101 is a copy of a naturally occurring human gene and acts by inhibiting the expression of IRS-1, a protein required for the formation and growth of new blood vessels. By blocking the expression of this protein in pro-angiogenic conditions (in this case, those with excessive vascular growth), GS-101 inhibits and regresses corneal neovascularisation, which interferes with vision and may be the cause of graft rejection.
Phase I and Phase II clinical studies have been completed for Gene Signal’s GS-101 in the management of Corneal Graft Rejection associated with Neovascularisation (excessive vascular growth of the cornea).
The Phase I trial evaluated the safety of GS-101 is healthy male volunteers – which is typically what is done in phase I studies. During Phase II trials, a drug is typically tested for safety and efficacy in a larger numbers of people who are actually afflicted with the disease or condition for which the drug is being developed. Gene Signal has also completed this step, and results will soon be shared first with the medical community at upcoming scientific events, and shortly after with the patient community on this site or on the site of Ophthalmic Patient Advocacy Groups
A Phase III study is the third and last round of testing before final drug approval by the relevant authorities, and is conducted on large populations of affected patients. Phase III trials usually provide the information included in the drug’s package insert and labeling.
If you would like to consider participating in the GS 101 Phase III trial, please speak to your physician or contact Orphanet.net where you can find information on a medical professional who can inform you accordingly.
