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news.The Therapeutic Products Directorate, a division of Health Canada, has issued a no objection letter response to the iCo Therapeutics regarding its iCo-007 Phase II diabetic macular edema (DME) clinical trial application (CTA).
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iCo Therapeutics said that iCo-007 is designed and discovered by ISIS Pharmaceuticals, iCo-007 is a second-generation antisense drug targeting c-Raf kinase for the treatment of DME and diabetic retinopathy.
iCo Therapeutics’ open label, dose escalating Phase I trial investigating the safety of iCo- 007, with visual acuity and measures of retinal thickness serving as secondary endpoints, successfully concluded earlier this year.
Peter Hnik, chief medical officer of iCo Therapeutics, said: “Based on our successful submission iCo may now proceed into a Phase II clinical trial for this indication in Canada, marking an enormous milestone for the company.
“Our Phase I clinical study indicated encouraging results in patients refractory to other treatment options and now we will be able study drug safety and efficacy in a broader patient population.”
Andrew Rae, CEO of iCo Therapeutics, said: “The success of our CTA brings iCo one step closer to creating an effective treatment for diabetic macular edema. We look forward to initiating a Phase II clinical trial for this potentially debilitating condition in the near future.”