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 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.
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.
