June 18, 2013, Vancouver, Canada—iCo Therapeutics Inc. (“iCo” or “the Company”) (TSX-V: ICO) announced today that it has completed enrollment of its Phase 2 iDEAL study evaluating the efficacy and safety after repeated injections of iCo-007 in patients with Diabetic Macular Edema (DME). The study has shown a good safety profile with no drug-related serious adverse events to date.
“The last patient was enrolled and treated on June 17,” said Andrew Rae, President & CEO of iCo. “Our principal investigators were interested in extending the timeline in the interest of enrolling as many patients as possible. We look forward to announcing data from the study’s primary endpoint early in 2014.”
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 visual 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 chaired by Quan Dong Nguyen, MD, MSc, Professor and Chair of Ophthalmology and Director of the Stanley M. Truhlsen Eye Institute at University of Nebraska Medical Center (“UNMC”) (previously Associate Professor of Ophthalmology at the Wilmer Eye Institute of the Johns Hopkins University School of Medicine). Recruitment took place at 27 clinical sites across the United States. In addition, the Retinal Imaging Research and Reading Center (RIRRC) based at the UNMC serves as the Reading Center for the iDEAL Study.
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
- Mono-therapy using repeated intravitreal dosing of iCo-007 at 700 µg
- Combination therapy using repeated intravitreal dosing of iCo-007 at 350 µg with laser photocoagulation
- Combination therapy using repeated intravitreal dosing of iCo-007 at 350µg with ranibizumab (Lucentis®) at 0.5 mg
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 byoptical coherence tomography (OCT).
For information about this study, please visit www.clinicaltrials.gov.
About Diabetic Macular Edema
Diabetic macular edema 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 (ribonucleic acid – mRNA) and preventing the signaling of multiple growth factors (not just VEGF), which in turn prevents the production of new and permeable blood vessels in the back of the eye. Recent results have shown that the pathways activated by Ras/Raf 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”. For more information, visit the Company website at: www.icotherapeutics.com.
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 statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. 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. 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.
|Mr. John Meekison, CFO
604-602-9414 x 224
|Michael Moore, Investor Relations