For Immediate Release July 7, 2009
VANCOUVER, Canada— iCo Therapeutics Inc. (TSX-V: ICO) is pleased to report that the Safety Evaluation Committee for iCo’s ongoing iCo-007 clinical trial has approved the advancement of the trial into the fourth and final cohort. There have been no drug-related serious adverse events to date.
Results from the first two cohorts have been presented at international ocular conferences by two leading investigators involved in the trial. The fourth cohort represents an approximately 10-fold increase in concentration from the first dosing level.
The primary objective of the phase I, open-label, dose escalation study is to evaluate the safety and tolerability of a single intravitreal injection of iCo-007 in patients with diffuse Diabetic Macular Edema (DME). Secondary objectives include assessment of systemic pharmacokinetics, changes in retinal thickness using OCT measurements, and changes in visual acuity.
About Diffuse DME
DME is the swelling of the retina in diabetes patients due to leaking blood vessels within the macula, the central portion of the retina that is critical for daytime vision. Diffuse DME is caused by dilated retinal capillaries and it is typically more difficult to handle than focal DME.
There are currently no approved therapeutics for DME, the leading cause of blindness in working age adults. DME affects approximately 1.6 million people in the U.S. alone, a number that is expected to grow as Diabetes is forecast to increase by almost 50% in the US by 2025.
Designed and discovered by ISIS Pharmaceuticals Inc., (NASDAQ: ISIS), iCo-007 is a second-generation antisense inhibitor targeting c-Raf kinase mRNA for the treatment of DME and Diabetic Retinopathy (DR). iCo licensed the worldwide exclusive rights to all therapeutic applications of iCo-007 from ISIS in 2005. DR and DME are characterized by new blood vessel growth and increased vascular permeability. Drug products that prevent the growth of new blood vessels and inhibit increased vascular permeability may have the potential to treat neovascular diseases, including diabetic retinopathy and diabetic macular edema. It is becoming more apparent that multiple growth factors are implicated in the etiology of diabetic macular edema and diabetic retinopathy and not only VEGF.
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 is a second generation antisense candidate licensed from Isis Pharmaceuticals. iCo-007 is currently in a Phase I trial in Diabetic Macular Edema patients with compelling early data. iCo-008 is a human monoclonal antibody against eotaxin-1 with Phase II clinical history, licensed from AstraZeneca/MedImmune. iCo-009 is an oral reformulation of a generic anti-fungal and anti-parasitic intravenous drug licensed from the University of British Columbia. To date, iCo has reported positive preclinical results for iCo-009. iCo Therapeutics 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.