March 5, 2014, Vancouver, Canada — iCo Therapeutics Inc. (“iCo” or “the Company”) (TSX-V: ICO) (OTCQX: ICOTF) has announced the final month eight patient visit in the iDEAL Study. This US Phase 2 investigator-sponsored study is evaluating the efficacy and safety of iCo-007 after repeated injections in patients with Diabetic Macular Edema (DME). The study’s primary endpoint is change in visual acuity from baseline to month eight, followed by secondary endpoints at month twelve. Next steps include data queries and subsequent data lock. Once these activities are complete, the results will be analyzed and top-line results will be made public.
“We are pleased to have completed follow up on the last patient reaching the eight month visit on schedule,” said Andrew Rae, President & CEO of iCo Therapeutics. “This achievement is largely due to the tremendous support and commitment we have received from our study Chair, participating clinical sites and our partner JDRF. We currently expect to announce top-line primary endpoint data before the end of April and secondary endpoint data before the end of the third quarter.”
iDEAL Trial Design
The iDEAL trial explores whether varying combinations and concentrations of iCo-007 are effective in improving visual acuity in people with DME—the leading cause of functional vision loss among working Americans, in which leakage of fluid from blood vessels in the eye causes the retina to swell, leading to blurred vision and blindness. The Phase 2 clinical trial is a multi-center study, with recruitment at 28 clinical sites across the United States.
The study follows patients for a 12 month period. During the trial, patients were randomized into one of the following four groups:
- Mono-therapy using repeated intravitreal dosing of iCo-007 at 350 µg, at day one and month four.
- Mono-therapy using repeated intravitreal dosing of iCo-007 at 700 µg, at day one and month four.
- Combination therapy using repeated intravitreal dosing of iCo-007 at 350 µg with laser photocoagulation. iCo-007 at day one followed seven days later by laser photocoagulation, then iCo-007 at month four and if the eye meets retreatment criteria, it will also receive the second laser photocoagulation seven days later.
- Combination therapy using repeated intravitreal dosing of iCo-007 at 350µg with ranibizumab (Lucentis®) at 0.5 mg. Lucentis® at day one, iCo-007 at two weeks, then Lucentis® at month four and iCo-007 two weeks following.
Some patients may be eligible for a third dose at month 8 based on a retinal thickness measurement and evaluation by the clinical investigator.
To be eligible for the trial, participants must have type 1 or type 2 diabetes, baseline best corrected visual acuity between 20/32 and 20/320 and DME with central retinal thickness equal to or greater than 250 microns measured by optical coherence tomography (OCT).
This is an investigator-sponsored study and there is some reliance on the Coordinating Center and Study Chair to continue to meet stated goals for timing of data delivery.
For information about this study, please visit www.clinicaltrials.gov.
About Diabetic Macular Edema (DME)
DME occurs when blood vessels in the retina of patients with diabetes begin to leak into the macula, the part of the eye responsible for detailed central vision. These leaks cause the macula to thicken and swell, progressively distorting acute vision. While the swelling may not lead to blindness, the effect can cause a severe loss in central vision. DME is the major cause of vision loss in people with diabetic retinopathy. People with diabetes have a 10 percent risk of developing the condition during their lifetime. It is estimated that close to 1,000,000 people in the United States have DME.
A second-generation antisense inhibitor targeting C-raf kinase may prevent the signaling of multiple growth factors, which in turn prevent the production of new and permeable blood vessels in the back of the eye. Recent publications have shown that the pathways activated by Ras/Raf may play a crucial role in diabetes-associated complications including diabetic retinopathy. Due to its mechanism of action iCo-007 may eventually be applicable to neovascular form of age-related macular degeneration (AMD) and other ocular indications, as well as DME.
About iCo Therapeutics
iCo Therapeutics in-licenses and redefines existing drug candidates or generics by employing reformulation and delivery technologies for new or expanded use indications. The Company has exclusive worldwide rights to two drug candidates – iCo-007 for Diabetic Macular Edema (DME) and iCo-008 for other sight-threatening diseases. iCo-007 is in Phase 2 clinical studies for DME. With Phase 2 clinical history, iCo-008 is targeted for the treatment of keratoconjunctivitis and wet age-related macular degeneration. In addition, iCo holds worldwide rights to an oral drug delivery platform. The first platform candidate is the Oral Amp B Delivery system, utilizing a known anti-fungal drug to treat life-threatening infectious diseases. iCo trades on the TSX Venture Exchange under the symbol “ICO” and the OTCQX under the symbol “ICOTF”. 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 statements” within the meaning of applicable securities laws. Forward-looking statements can be identified by words such as: “anticipate,” “intend,” “plan,” “goal,” “seek,” “believe,” “project,” “estimate,” “expect,” “strategy,” “future,” “likely,” “may,” “should,” “will,” and similar references to future periods and includes, but is not limited to, statements about the intended use of proceeds of the Offering. 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’s current beliefs as well as assumptions made by and information currently available to iCo 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 are based only on information currently available to iCo and speak only as of the date of this press release. Due to risks and uncertainties, including the risks and uncertainties identified by iCo in its public securities filings and on its website, actual events may differ materially from current expectations. iCo disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
Mr. John Meekison, CFO
604-602-9414 x 224
Michael Moore, Investor Relations