VANCOUVER, Canada - iCo Therapeutics Inc. (TSX-V: ICO) today announced the completion of drug product manufacturing activities as part of its Phase 2 clinical program investigating multiple doses and injections of iCo-007 in patients with diabetic macular edema (DME). Currently the market for this unmet medical condition is estimated to be US $800 million to US $1 billion in the United States alone.
iCo is evaluating potential clinical activities in several regulatory jurisdictions, including Canada, where the Company has received a No Objection Letter from Health Canada's Therapeutic Products Directorate related to its submitted Phase 2 DME clinical trial plan.
"We are pleased to have completed this critical stage", stated Andrew Rae, iCo's President & CEO. "An impressive array of clinicians from multiple clinical sites have been identified and solicited for their inputs and potential involvement in our next stage of development. iCo also continues to build strong relationships with philanthropic organizations and advocacy groups as a means of maximizing the potential data derived from the iCo-007 program but also return on capital to our shareholders.
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. iCo-007 completed an open label, dose escalating Phase 1 trial with safety as the primary endpoint, and visual acuity and measures of retinal thickness serving as secondary endpoints. Importantly, iCo saw no drug-related serious adverse events, no signs of ocular inflammation, no intraocular pressure issues and no systemic exposure. Encouraging trends in measured secondary endpoints warrant further investigation. Four U.S. clinical sites participated in the trial.
About iCo Therapeutics
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, moving into Phase 2 for the treatment of DME, iCo-008; a product with Phase 2 clinical history to be developed for severe ocular allergies and age-related macular degeneration; and iCo-009, an oral formulation of Amphotericin B for sight and life-threatening diseases. iCo granted a license option for iCo-008 systemic uses to Immune Pharmaceuticals in December 2010. 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 was recently awarded a Gold Leaf Award as the Early Stage Company of the Year from BIOTECanada and is a Canada's Top 10T Competition winner. iCo trades on the TSX Venture Exchange under the symbol "ICO". For more information, visit the Company website at: www.icotherapeutics.com
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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.
Dr. John Clement, CTDO
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Mr. John Meekison, CFO
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