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iCo Therapeutics Inc. Announces Top-Line Primary Endpoint Data From iCo-007 Phase 2 Ideal Study In Diabetic Macular Edema



6/9/2014 6:40:00 AM

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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.

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.



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