iCo-007, the experimental intravitreal injection for the treatment of diabetic macular oedema (DME), has produced pleasing interim trial results and been approved to progress to the third stage of the Phase I study, according to a statement released by the drug's licence holder, iCo Therapeutics Inc.
iCo-007, the experimental intravitreal injection for the treatment of diabetic macular oedema (DME), has produced pleasing interim trial results and been approved to progress to the third stage of the Phase I study, according to a statement released by the drug's licence holder, iCo Therapeutics Inc.
iCo-007 - designed and discovered by ISIS Pharmaceuticals Inc for the treatment of DME and diabetic retinopathy (DR) - is a second-generation antisense inhibitor, which targets not vascular endothelial growth factor (VEGF) but the Raf isoform c-Raf kinase mRNA, and may also prove to be a viable treatment for certain oncology indications.
The open-label, dose-escalation study, which is assessing the mechanism of iCo-007 in sufferers of diffuse DME and not healthy volunteers, has a primary endpoint of establishing safety and tolerability in diffuse DME patients; the study will also monitor pharmacokinetics, retinal thickness and visual acuity. At this mid-point of the trial, administration of iCo-007 is not associated with any serious adverse events.