– Provides Additional Guidance on Study Timelines and Further Updates –
January 3, 2013, Vancouver, Canada — iCo Therapeutics Inc. (“iCo” or “the Company”) (TSX-V: ICO), today announced that at the midpoint of its Phase 2 iDEAL study for the treatment of diabetic macular edema (DME), there have been no drug related serious adverse events among patients receiving repeat doses of iCo-007. The company also announced that it has exceeded its recruitment threshold of patients for statistical analysis of the study and expects to announce final data for the primary endpoint in the fourth quarter of 2013.
“Systemic and local safety will be an important differentiator of products for diabetic patients, including drug candidates for diabetic macular edema, and we are pleased with the current safety profile of iCo-007 in patients in both our previous single dose Phase 1 and current multi-dose Phase 2 clinical studies,” stated Dr. Peter Hnik iCo’s Chief Medical Officer.
“With experience in 149 patients to date and differentiators from the only currently approved drug, such as multiple growth factor targets and duration of treatment, we’re very excited about the opportunity for iCo-007 and what this can mean for the millions of DME patients around the world,” said Andrew Rae, President & CEO of iCo Therapeutics. “We remain on track to provide a second clinical update in Q2 2013 and report on primary endpoint data for all iDEAL study patients in the fourth quarter of this year”.
Diabetic macular edema 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. DME is the leading cause of blindness in working-age adults and 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. There is currently only one approved drug for DME – ranibizumab, also known as Lucentis – which requires monthly injections.
The trial explores whether varying combinations and concentrations of iCo-007 are effective in improving visual acuity in DME patients. The Phase 2 clinical trial is studying patients at 26 clinical sites across the United States.
The iDEAL study follows patients for a 12 month period. During the trial, patients are randomized into one of the following four groups:
· iCo-007 monotherapy (350ug)
· iCo-007 monotherapy (700ug)
· iCo-007 (350ug) and laser photocoagulation
· iCo-007 (350ug) and ranibizumab (0.5mg)
The primary endpoint of the iDEAL trial is a change in visual acuity from baseline to month eight. Secondary endpoints include: visual acuity at month 12; retinal thickness as measured by optical coherence tomography (OCT) at month eight and 12; duration of the effect of iCo-007 at month 12; and safety.
In keeping with good clinical practice, iCo management has not requested, examined or analyzed any efficacy or primary or secondary endpoint data, other than safety reports that are related to our reporting requirements. For more Phase 2 iDEAL study information, including frequently asked questions, please refer to:
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. iCo-007 completed an open label, dose escalating Phase I trial with safety as the primary endpoint, and visual acuity and measures of retinal thickness serving as secondary endpoints. Importantly, iCo saw no drug-related serious adverse events, no signs of ocular inflammation, no intraocular pressure issues and no systemic exposure. In August 2011, iCo announced the initiation of a US physician-sponsored Phase 2 clinical trial involving iCo-007, titled the iDEAL study, which is being conducted across multiple sites throughout the United States.
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. 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 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; 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.