iCo Therapeutics Announces Final Eight Month Patient Visit in Phase 2 iDEAL Study
VANCOUVER, March 5, 2014 /PRNewswire/ – 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
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.
No regulatory authority has approved or disapproved the content of this
press release. Neither the TSX Venture Exchange nor its Regulatory
Services Provider (as that term is defined in the policies of the TSX
Venture Exchange) accepts responsibility for the adequacy or accuracy
of this press release.
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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
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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.
SOURCE iCo Therapeutics Inc.