VANCOUVER, June 18, 2013 /PRNewswire/ - 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
DMEthe 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.
About iCo-007
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 mechanim 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.
SOURCE iCo Therapeutics Inc.
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