iCo Therapeutics Receives FDA Clearance to Initiate Clinical Trial in Diabetic Macular Edema

Announced today that the United States Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) application for iCo-007 to treat diabetic macular edema.

VANCOUVER, Canada | Jan 22, 2007 |
iCo Therapeutics Inc. announced today that the United States Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) application for iCo-007 to treat diabetic macular edema.

"The success of our IND application brings iCo one step closer to creating an effective treatment for diabetic macular edema," stated Andrew Rae, President and CEO of iCo Therapeutics. "We look forward to initiating our Phase I clinical trial for diffuse diabetic macular edema in the first half of this year."

Designed and discovered by Isis Pharmaceuticals Inc., iCo-007 is a second-generation antisense drug that targets c-Raf kinase messenger RNA. iCo-007 is expected to decrease the edema in the retina by decreasing the signaling of various growth factors such as VEGF that signal through the c-raf kinase / MAP kinase pathway. iCo Therapeutics licensed the product in August 2005.

Diabetic Macular Edema

About 45% of diabetics 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.

iCo Therapeutics Inc. is an emerging, Vancouver-based biotechnology company focused on developing pre-existing drugs for a range of new conditions affecting isolated biological environments - areas such as the eye, spinal cord, or joints - where locally-administered application of these therapies would have minimal systemic distribution and fewer safety issues.

SOURCE: iCo Therapeutics Inc

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