–Trial that aims to address the leading cause of blindness in people with type 1 diabetes and type 2 diabetes being led by Johns Hopkins investigators–
iDEAL Phase II Study Update
March 28, 2012, Vancouver, Canada—iCo Therapeutics (TSX-V: ICO), a Vancouver-based drug reprofiling company and JDRF, the largest charitable funder of type 1 Diabetes (T1D) research have joined forces to investigate a potential new treatment for one of the most common complications of diabetes, diabetic macular edema (DME). The iDEAL study is a Phase II clinical trial to evaluate whether the drug iCo-007 could help to treat DME in people with either T1D or type 2 diabetes. The study is being conducted at the Wilmer Eye Institute of the Johns Hopkins University School of Medicine.
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 II clinical trial is a multi-center study chaired by Quan Dong Nguyen, MD, MSc, Associate Professor of Ophthalmology at the Wilmer Eye Institute of the Johns Hopkins University School of Medicine, and will study as many as 208 patients with DME at up to 30 clinical sites across the United States. In addition, the Retinal Imaging Research and Reading Center (RIRRC) at the Wilmer Eye Institute serves as the Reading Center for the iDEAL Study.
“The iDEAL trial for iCo-007 is one of the largest studies of its kind currently investigating DME,” said Andrew Rae, President and CEO of iCo Therapeutics. “We believe iCo-007 represents an exciting new treatment paradigm for patients suffering from this disease and we look forward to announcing further updates, in collaboration with JDRF.”
“Diabetic macular edema is both devastating and prevalent, and yet today’s treatments are insufficient,” said Aaron Kowalski, Ph.D., assistant vice president of treatment therapies for JDRF. “JDRF is committed to improving the lives of all people with type 1 diabetes, and this involves accelerating both the development and the delivery of better treatments for the disease and its complications. That is why we have placed retinopathy as a high priority research area, and why collaborations like this one are so important. Should iDEAL be successful, iCo-007 could be introduced as a potential new therapy to help preserve vision in people with diabetes.”
The iDEAL study, which is in the process of recruiting participants, follows patients for a 12 month period. During the trial, patients are randomized into one of the following four groups: either one of two mono-therapy arms using repeated intravitreal dosing of two different concentrations of iCo-007; or one of two combination arms using iCo-007 with laser photocoagulation or iCo-007 and ranibizumab. To be eligible for the trial, participants must have T1D or type 2 diabetes, baseline visual acuity between 20/32 and 20/320 on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart, and DME with central subfoveal thickness greater than 250 microns on optical coherence tomography (OCT).
“Using both a monotherapy as well as combination therapy approach should uncover the potential of this novel drug for treatment of a wider DME patient population,” said Peter Hnik, MD, MHSc., Chief Medical Officer of iCo. “The primary endpoint of the iDEAL trial is a change in visual acuity from baseline to month eight. Secondary endpoints include: visual acuity at month 12; retinal thickness as measured by OCT at month eight and 12; duration of the effect of iCo-007 at month 12; and safety.”
JDRF and iCo Therapeutics expect to provide a further study update, including patient recruitment status, during the second half of 2012. To inquire about participation, please contact Quan Dong Nguyen, MD, MSc, Associate Professor of Ophthalmology at the Wilmer Eye Institute of the Johns Hopkins University School of Medicine.
Designed and discovered by ISIS Pharmaceuticals Inc., (NASDAQ: ISIS), iCo-007 is a second-generation antisense drug targeting c-Raf kinase for the treatment of DME and diabetic retinopathy. iCo-007 completed an open label, dose escalating Phase I trial with safety as the primary endpoint, and visual acuity and measures of retinal thickness serving as secondary endpoints. Importantly, iCo saw no drug-related serious adverse events, no signs of ocular inflammation, no intraocular pressure issues and no systemic exposure. In August 2011, iCo announced the initiation of a US physician-sponsored Phase II clinical trial involving iCo-007, titled the iDEAL study, which is being conducted across multiple sites throughout the United States. The iDEAL Study is being led by the clinician scientists who are investigators in the trial and is being coordinated at Johns Hopkins University.
About DME (Diabetic Macular Edema)
DME is the swelling of the retina in diabetes patients due to leaking blood vessels within the macula, the central portion of the retina that is critical for daytime vision. DME is the leading cause of blindness in working age adults and affects approximately 1.6 million people in the U.S. alone, a number that is expected to grow as Diabetes is forecast to increase by almost 50% in the US by 2025.
In T1D, a person’s pancreas stops producing enough insulin to survive. People with T1D must currently monitor their blood sugar levels and administer insulin via shots or an insulin pump, multiple times every day. Even vigilant management does not ward against T1D complications such as heart attack, stroke, blindness, and amputation.
JDRF is the leading global organization focused on type 1 diabetes (T1D) research. Driven by passionate, grassroots volunteers connected to children, adolescents, and adults with this disease, JDRF is the largest charitable supporter of T1D research. The goal of JDRF is to improve the lives of every person affected by T1D by accelerating progress on the most promising opportunities for curing, better treating, and preventing T1D. JDRF collaborates with a wide spectrum of partners who share this goal. Since its founding in 1970, JDRF has awarded more than $1.6 billion to T1D research. More than 80 percent of JDRF’s expenditures directly support research and research-related education. Past JDRF research efforts have helped to significantly improve the care of people with this disease, and have expanded the critical scientific understanding of T1D. JDRF will not rest until T1D is fully conquered. For more information, please visit www.jdrf.org.
About the Wilmer Eye Institute of Johns Hopkins University
The Wilmer Eye Institute at Johns Hopkins University (Baltimore, Maryland, USA), founded in 1925, is an internationally-renowned eye institution that specializes in the diagnosis and management of complex medical and surgical eye disease; and serves as a preeminent provider of routine eye care and refractive, optical, cosmetic, and eye trauma services for the Mid-Atlantic region. Wilmer is also recognized as a national and international leader in research, especially in the conducts of novel, early clinical trials to evaluate therapeutic options for ophthalmic diseases, and in the training of medical students, residents, fellows, and ophthalmic technicians. As the largest department of ophthalmology in the United States, the Wilmer Eye Institute has earned recognition for bringing together ophthalmologists and clinician scientists consistently regarded as the finest in the field of vision and ophthalmology.
About iCo Therapeutics
iCo Therapeutics Inc. is a Vancouver-based reprofiling company focused on redosing or reformulating drugs with clinical history for new or expanded indications. iCo has exclusive worldwide rights to three products: iCo-007, in Phase 2 for the treatment of Diabetic Macular Edema (DME), iCo-008 (Bertilimumab), a product with Phase 2 clinical history to be developed for sight threatening diseases; and an oral Amphotericin B delivery system for life-threatening infectious diseases. Immune Pharmaceuticals licensed systemic rights to iCo-008 in June 2011. iCo trades on the TSX Venture Exchange under the symbol “ICO”. For more information, visit the Company website at: www.icotherapeutics.com.
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Forward Looking Statements
Certain statements included in this press release may be considered forward-looking. 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 Therapeutics’ current beliefs as well as assumptions made by and information currently available to iCo Therapeutics 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 speak only as of the date of this press release. Due to risks and uncertainties, including the risks and uncertainties identified by iCo Therapeutics in its public securities filings; actual events may differ materially from current expectations. iCo Therapeutics disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.