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 investigator.
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.
About iCo-007
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.
Forward Looking Statements
Certain statements included in this press release may be
considered forward-looking statements" within the meaning of
applicable securities laws. 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 and includes, but is not
limited to, statements about the intended use of proceeds of the
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 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, except as required by
law.
SOURCE iCo Therapeutics Inc.
