Press Release
iCo Therapeutics Provides Interim Trial Results (Diffuse Diabetic Macular Edema)
September 22, 2008
For Immediate Release 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.
About iCo-007
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 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 parenterally 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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