VANCOUVER, Canada— iCo Therapeutics Inc. (TSX-V: ICO) is pleased to announce that its Phase I clinical trial for iCo-007 in patients with diffuse diabetic macular edema has met its primary end point. The primary objective of the phase I, open-label, dose escalation trial was to evaluate the ocular safety and tolerability of iCo-007 following a single intravitreal administration. Secondary objectives included assessment of systemic pharmacokinetics, retinal thickness using optical coherence tomography (OCT) measurements, and visual acuity.
The Phase I trial was conducted at four clinical sites in the United States administering a single injection of iCo-007 in patients with diffuse diabetic macular edema and involved a 24 week follow-up period. Four dosage levels of iCo-007 were utilized in a total of 15 patients. iCo-007 was administered as an intravitreal injection with doses of either 110 ug, 350 ug, 700 ug, or 1000 ug.
Intravitreal injections of iCo-007 were well tolerated with a good safety profile, ultimately progressing to the highest dose of 1000 µg based on positive safety evaluation committee meetings two months post each dosing level. Analysis of blood plasma in patients demonstrated that iCo-007 was not detectable in the blood plasma with any of the doses used in the Phase I trial. There were signs of biological activity in responsive patients at 24 weeks with a reduction of retinal thickness ranging between 149 and 743 microns (and 115 to 743 microns if one additional patient followed only to week 18 is included). Mean change in retinal thickness for all patients completing the 24 week follow-up (12 of 15 patients) was minus 169 microns (or 40% reduction of excess retinal thickness), a positive trend. In a number of subjects there was a transient increase in retinal edema preceding biological effect. Approximately 69% of patients completing a 24 week follow up (13 of 15 patients) had stable or improved vision, defined as -5 letters or better compared to baseline and 23% of patients experienced greater than or equal to 5 letters of visual improvement. The highest dose seemed to show a smaller biological effect than lower doses. The first three doses appeared to display some dose-related biological effect, warranting further exploration of dosing and treatment regimen in a Phase II clinical trial.
“We are extremely pleased that iCo-007 successfully met the primary endpoint for our Phase I trial”, commented Andrew Rae, iCo’s President and CEO. “In addition, we have seen signs of biological activity in a very difficult to treat patient population refractory to many other treatments, including anti-VEGF agents in some cases. The safety and secondary endpoint information we have gleaned from this trial, including the biological activity we have seen at various dose levels, will be extremely useful and fully supports advancing to a Phase II clinical trial program which is currently in the planning stage”.
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.
About iCo-007
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.
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, in Phase I for the treatment of DME, iCo-008, a human monoclonal antibody targeting eotaxin-1, a product with Phase II clinical history to be developed for age-related macular degeneration and severe ocular allergies; and iCo-009, an oral formulation 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 was recently awarded a Gold Leaf Award as the Early Stage Company of the Year from BIOTECanada and trades on the TSX-Venture exchange under the symbol “ICO”. For more information, visit the company website at: icotherapeutics.cdmail.biz
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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.