iCo Therapeutics Inc. Receives Health Canada Clearance To Conduct Phase II DME Trial With iCo-007

Main Category: Eye Health / Blindness
Also Included In: Clinical Trials / Drug Trials;  Diabetes
Article Date: 27 Jul 2010 - 0:00 PDT

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iCo Therapeutics Inc. (TSX VENTURE:ICO) is pleased to announce that the Therapeutic Products Directorate, a division of Health Canada, has issued a No Objection Letter response to the Company regarding its iCo-007 Phase II Diabetic Macular Edema (DME) Clinical Trial Application (CTA). "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," stated Dr. Peter Hnik, iCo's Chief Medical Officer. "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."

"The success of our CTA brings iCo one step closer to creating an effective treatment for diabetic macular edema," stated iCo's CEO, Andrew Rae. "We look forward to initiating a Phase II clinical trial for this potentially debilitating condition in the near future."

About Diabetic Macular Edema

Approximately 45% of patients with diabetes will suffer from diabetic retinopathy - a condition resulting from changes in the blood vessels in the eye. Diabetic macular edema is a swelling of the small area in the centre of the retina and causes difficulty in seeing fine details clearly. The swelling is caused by fluid leaking from abnormal or fragile blood vessels and can result in conditions from mild vision loss to blindness.

About iCo-007

Designed and discovered by ISIS Pharmaceuticals Inc., (NASDAQ:ISIS), iCo-007 is a second-generation antisense drug targeting c-Raf kinase for the treatment of DME and diabetic retinopathy. The Company's 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. Four U.S. clinical sites participated.

Source:
iCo Therapeutics

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