iCo Therapeutics Receives FDA Clearance to Initiate Clinical Trial in Diabetic Macular Edema
January 22, 2007
VANCOUVER, Canada – 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.
About iCo Therapeutics Inc.
iCo Therapeutics Inc. is a Vancouver-based reprofiling company focused on redosing or reformulating drugs with clinical history for new or expanded indications. iCo has exclusive worldwide rights to three products, iCo-007, in Phase I for the treatment of Diabetic Macular Edema, iCo-008, a product with Phase II clinical history to be developed for severe ocular allergies, and iCo-009, a oral reformulation of Amphotericin B for sight and life – threatening diseases. iCo-009 also represents a new drug delivery technology with the potential to reprofile other parenteral administered drugs to the oral route of administration.
iCo Therapeutics trades on the TSX-Venture exchange under the symbol “ICO”.
No regulatory authority has approved or disapproved the content of this release. The TSX Venture Exchange does not accept responsibility for the adequacy or accuracy of this release.
Forward Looking Statements
Certain statements included in this press release may be considered forward-looking. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by such statements, and therefore these statements should not be read as guarantees of future performance or results. All forward-looking statements are based on iCo Therapeutics’ current beliefs as well as assumptions made by and information currently available to iCo Therapeutics and relate to, among other things, anticipated financial performance, business prospects, strategies, regulatory developments, market acceptance and future commitments. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Due to risks and uncertainties, including the risks and uncertainties identified by iCo Therapeutics in its public securities filings; actual events may differ materially from current expectations. iCo Therapeutics disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
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