iCo Therapeutics Provides Phase 1 Diabetic Macular Edema (DME) Clinical Trial Update and Phase 2 Trial Guidance
VANCOUVER, Dec. 11 /CNW/ - iCo Therapeutics Inc. (TSX-V: ICO) - iCo Therapeutics ("iCo") is pleased to announce that its Phase 1 clinical trial of iCo-007, having enrolled all patients in four cohorts of increasing concentration (110ug, 350ug, 700ug, 1000ug), has to date demonstrated a positive safety profile. A Safety Evaluation Committee recently convened to review early data from the fourth and final cohort, which represented an approximately 10-fold increase in concentration from the first dosing level and concluded there were no drug-related serious adverse events. Based on the safety profile and additional encouraging data seen so far, iCo has now entered the planning stage for Phase 2 clinical studies. Stated Dr. David Boyer: "I am pleased with the results of the Phase I clinical trial to date. The Safety Evaluating Committee's experience with iCo-007 indicates that the drug has been well tolerated by patients and there were no drug-related significant adverse events noted to date even at the highest dosing level. I look forward to working with iCo in the planning and design of Phase 2 trials for iCo-007." In early Q1 2010 iCo expects a last patient visit (month six) followed by data lock and analysis. iCo expects to present final data in Q2 2010.
The primary objective of the phase I, open-label, dose escalation study was to evaluate the safety and tolerability of a single intravitreal injection of iCo-007 in patients with diffuse DME. Secondary objectives included assessment of systemic pharmacokinetics, changes in retinal thickness using OCT measurements, and changes in visual acuity.
"To move to completion of a clinical trial in the United States and to planning for our Phase 2 trials represents a major milestone for the company. Ophthalmology represents one of the most exciting arenas in drug development and partnering today and the retinal market remains underserved, particularly for those areas such as DME," stated Andrew Rae, President and CEO.
About Diffuse DME
Currently, there are no approved therapeutics for DME, which affects approximately 1.6 million people in the U.S. alone. The underlying disease, Diabetes, is forecast to increase by almost 50% in the U.S. by 2025. 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. Diffuse DME is caused by dilated retinal capillaries and it is typically more difficult to handle than focal DME.
Designed and discovered by ISIS Pharmaceuticals Inc., (NASDAQ: ISIS), iCo-007 is a second-generation antisense inhibitor targeting c-Raf kinase mRNA for the treatment of DME and Diabetic Retinopathy (DR).
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 is a second generation antisense candidate licensed from Isis Pharmaceuticals. iCo-007 is currently in a Phase I trial in Diabetic Macular Edema patients with compelling early data. iCo-008 is a human monoclonal antibody against eotaxin-1 with Phase II clinical history, licensed from AstraZeneca/MedImmune. iCo-009 is an oral reformulation of a generic anti-fungal and anti-parasitic intravenous drug licensed from the University of British Columbia. To date, iCo has reported positive preclinical results for iCo-009. iCo Therapeutics trades on the TSX-Venture exchange under the symbol "ICO". For more information, visit the company website at: www.icotherapeutics.com<http://www.icotherapeutics.com>
No regulatory authority has approved or disapproved the content of this release. The TSX Venture Exchange does not accept responsibility for the adequacy or accuracy of this release.
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.
For further information: Business Development: Dr. John Clement, CBO, (604) 602-9414 x 222; Finance: Mr. John Meekison, CFO, (604) 602-9414 x 224
Posted: December 2009