VANCOUVER,
June 9, 2014 /PRNewswire/ - iCo
Therapeutics Inc. ("iCo" or "the Company") (TSX-V: ICO) (OTCQX:
ICOTF) today announced top-line results related to the eight month
visual acuity (VA) primary endpoint for subjects enrolled in the
Phase 2 iDEAL Study, conducted in collaboration with JDRF,
evaluating the efficacy and safety after repeated injections of
iCo-007 in patients with Diabetic Macular Edema (DME).
Statistical methods employed included both Last
Observation Carry Forward ("LOCF") and Multiple Imputation ("MI")
analyses given the departure of patients from the study prior to
their eight month visit. Using both statistical methods, mean
changes in visual acuity measures in all four groups at both month
four and month eight were negative. Using the LOCF method, mean
change in VA at eight months was approximately minus 11 letters
(350 µg monotherapy), minus 21 letters (700 µg monotherapy), minus
14 letters (350 ug + laser arm) and minus 14 letters (350 µg +
Lucentis).
Some patients in each cohort did show
improvements in mean change in VA. At eight months using the LOCF
analysis, roughly 20% of patients in the 350 µg monotherapy arm
gained five letters or greater of vision versus 13% in the 700 µg
monotherapy arm, 12% in the 350 µg + laser arm and 11% in the 350
µg + Lucentis arm. At four months, patients gaining five letters or
more for the 350 µg, 700 µg, 350 µg + laser and 350 µg + Lucentis
arms were approximately 24%, 18%, 21% and 30%, respectively.
Using the LOCF method it was observed that at
month eight there was an inverse statistically significant
difference in mean VA change from baseline between 350 µg
monotherapy and 700 µg monotherapy arms, meaning there was greater
loss of VA in the 700 µg monotherapy cohort. There was no
statistically significant difference in mean VA between the 350 µg
monotherapy and either 350 µg + laser or 350 µg + Lucentis arms.
When using MI analysis there was no statistically significant
difference observed between 350 µg monotherapy and each of the
700 µg monotherapy, 350 µg + laser and 350 µg + Lucentis
arms.
At eight months, in the 700 µg monotherapy arm,
64% of patients experienced a 15 letter or greater loss of vision,
compared to 33% in the 350 µg monotherapy arm, 33% in the 350 µg +
laser arm, and 41% in the 350 µg + Lucentis arm. At four months the
corresponding numbers were 29%, 9%, 9%, and 14%, respectively.
"Quite simply, we don't yet know enough about
our patient groups and the sub-group populations to determine what
exactly this data means. To this end, further data analysis
at twelve months including secondary endpoints will be necessary to
better understand the viability of iCo-007 in DME" said
Andrew Rae, President & CEO of
iCo Therapeutics. "There were patients that responded to
treatment and others that didn't respond. Central retinal
thickness and sub group analyses represent just a few examples of
outstanding data sets that are required to give clarity to the VA
data we have generated at eight months. No clear conclusions can be
reached at this time though it appears the patient population
represents a difficult to treat population overall and therefore
analysis of factors such as patient resistance to drugs like
Lucentis and patient history of cataracts and progression in the
study need to be thoroughly analyzed".
iDEAL Trial Design & Demographics
The iDEAL trial of 187 randomized patients 18 years and older (185
treated), explores whether varying combinations and concentrations
of iCo-007, alone or in combination, are effective in improving
visual acuity in persons with DME.
For more information regarding baseline patient
demographics please refer to the following ARVO 2014 poster related
to iCo-007:
http://www.arvo.org/webs/am2014/abstract/sessions/238.pdf
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").
Recruitment took place at 28 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:
- Cohort 1: Mono-therapy using repeated intravitreal dosing
of iCo-007 at 350 µg at day 0, month 4 and if required at month
8
- Cohort 2: Mono-therapy using repeated intravitreal dosing
of iCo-007 at 700 µg at day 0, month 4 and if required at month
8
- Cohort 3: Combination therapy using repeated intravitreal
dosing of iCo-007 at 350 µg with laser photocoagulation at day 0,
month 4 and if required at month 8 (laser at month 4 if
required)
- Cohort 4: Combination therapy using repeated intravitreal
dosing of iCo-007 at 350µg with ranibizumab (Lucentis®) at 0.5 mg
(Lucentis® at day 0 followed by iCo-007 at week 2, Lucentis® at
month 4 followed iCo-007 two weeks later and again if required at
month 8)
To be eligible for the trial, participants must
have type 1 or type 2 diabetes, baseline best corrected visual
acuity (BCVA) 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).
For information related to study design, please
visit www.clinicaltrials.gov.
Safety Data
All patients in the study have received their final iCo-007
injections and the last patient 12 month follow-up visit is
expected in June 2014. A Drug Safety
Monitoring Committee ("DSMC") has periodically reviewed relevant
safety data from the clinical trial and iCo currently expects to
report overall safety, and other secondary endpoints, in Q4
2014.
Secondary Endpoints
Secondary endpoints of the iDEAL Study will be announced in
Q42014.
- Change in visual acuity from baseline to 12 months
- Change in central retinal thickness from baseline to month 8
and month 12
- Duration of effect during 12 month follow up period
- Safety of repeated injections
- Pharmacokinetic assessments (PK)
Data Presentation
The company expects that the full data set will be presented at a
medical conference later this year.
About Diabetic Macular Edema
Diabetic macular edema (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
(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 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 JDRF
JDRF is the leading global organization funding type 1 diabetes
(T1D) research. JDRF's goal is to progressively remove the
impact of T1D from people's lives until we achieve a world without
T1D. JDRF collaborates with a wide spectrum of partners and
is the only organization with the scientific resources, regulatory
influence, and a working plan to better treat, prevent, and
eventually cure T1D. As the largest charitable supporter of
T1D research, JDRF is currently sponsoring $568 million in scientific research in 17
countries. For more information, please visit www.jdrf.org.
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.
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is defined in the policies of the TSX Venture Exchange) accepts
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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 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
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SOURCE iCo Therapeutics Inc.