September 22, 2008
VANCOUVER, Canada— iCo Therapeutics Inc. (TSX-V: ICO) is pleased to report interim results from iCo’s ongoing iCo-007 clinical trial. The phase I, open-label, dose escalation study is evaluating the safety, tolerability, and pharmacokinetics of a single intravitreal injection of iCo-007 in patients with diffuse diabetic macular edema (DME).
The primary objective of the study is to evaluate the safety and tolerability of intravitreal iCo-007 in patients with diffuse DME. Other objectives include assessment of systemic pharmacokinetics, changes in retinal thickness using OCT measurements, and changes in visual acuity. The advancement from one cohort to the next is dependent upon the trial’s Safety Evaluation Committee approval. iCo is mid-way through the trial and the Safety Evaluation Committee has approved advancement to the third cohort. To date, there have been no adverse events of concern.
“We are greatly encouraged by the rolling data we are seeing from the trial,” stated Andrew Rae, iCo’s President & CEO. “As this trial is in diffuse DME patients rather than healthy volunteers, we are able to get a better indication of the potential of iCo-007 compared to traditional Phase I trials.”
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 throughout the posterior pole 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.
iCo-007 may also be a potential treatment for certain oncology indications, as c-Raf kinase is the predominant Raf isoform responsible for regulating cellular growth in ovarian cancer.
About iCo Therapeutics Inc.
iCo Therapeutics Inc. is a Vancouver-based development based company focused on in-licensing drugs with clinical history redosing or reformulating for new or expanded indications. iCo has exclusive worldwide rights to three products. iCo-007, a second generation antisense candidate licensed from Isis Pharmaceuticals, is currently in a Phase I trial in Diabetic Macular Edema patients with compelling early data. iCo-008 is a human monoclonal antibody targeting eotaxin-1 with Phase II clinical history, licensed from AstraZeneca/MedImmune. iCo-009 is a proprietary oral formulation of amphotericin B 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: http://www.icotherapeutics.com
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Forward Looking Statements
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