March 10, 2008
VANCOUVER, Canada— iCo Therapeutics Inc. (TSX-V: ICO) is pleased to provide a clinical update on iCo-008, a human monoclonal antibody targeting eotaxin-1. iCo licensed iCo-008 from MedImmune of Cambridge, UK (formerly Cambridge Antibody Technology). iCo-008 has been in 126 patients in Phase I and II clinical trials.
iCo plans to develop iCo-008 for Vernal Keratoconjunctivitis (VKC), a severe ocular allergy that may pose a threat to vision. Eotaxin, a chemo-attractant for eosinophils and a ligand for chemokine receptor 3 (CCR3), represents a well-established target for multiple allergic conditions. iCo-008’s pre-clinical and clinical history indicates that iCo-008 may be effective in several large market systemic indications, including severe asthma, food allergies and allergic rhinitis. iCo plans to out-license systemic indications on a worldwide basis, and has sufficient antibody manufactured to enable a partner in certain additional Phase II indications.
“iCo-008 is an excellent example of iCo’s reprofiling strategy at work”, stated Andrew Rae, President & CEO of iCo. “iCo-008’s systemic indications lay outside of iCo’s core expertise; however these potential billion dollar markets would serve as a valuable near-term Phase II program for a partner.”
iCo has received iCo-008 drug substance from Lonza, which was manufactured in its cGMP facilities in Slough, UK. Subsequently iCo moved the drug substance to a fill-finish site for the final stage of manufacturing. iCo is pleased to report that the iCo-008 drug product is within specifications and contains a high antibody yield. Lonza is one of the world’s leading suppliers to the pharmaceutical industry in the production of active pharmaceutical ingredients. Lonza holds iCo’s master cell bank, carried out process development on the program and has previous experience manufacturing iCo-008.
iCo-008’s Clinical Advisory Team
iCo Therapeutics is also pleased to announce a scientific and clinical advisory team that will help guide the development of iCo-008. Dr. Santa Ono, iCo’s Chief Scientific Officer, is a leading authority in the fields of immunology and ophthalmology. Professor Ono has directed multiple research and development programs, including that of iCo-008 (formerly known as CAT-213). Dr. Ono is currently Vice Provost for Academic Initiatives and Deputy to the Provost at Emory University.
Dr. Andrea Leonardi is Assistant Professor of Ophthalmology in the Department of Neuroscience, University of Padua. Dr. Leonardi is an internationally sought opinion leader in ocular allergy and immunology. He has published widely and been involved in clinical development in the area of VKC.
iCo-008 targets eotaxin-1, which is associated with the chemokine receptor CCR3. iCo believes eotaxin-1 plays an important role in mast cell degranulation and attracting eosinophils to inflammation sites – a condition called eosinophilia. Eosinophilia can occur in a number of disorders, such as allergic ocular disease, severe asthma, allergic rhinitis, atopic dermatitis, and other inflammatory disorders, such as inflammatory bowel disease and Crohn’s disease. Blocking eotaxin-1 has been shown to be effective in inhibiting early phase mast cell activation as well as late phase eosinophilia. This broad spectrum mechanism of action is unique and differentiates iCo-008 from other available agents.
About iCo Therapeutics Inc.
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 I for the treatment of Diabetic Macular Edema, iCo-008, a product with Phase II clinical history to be developed for severe ocular allergies, and iCo-009, a oral reformulation of Amphotericin B for sight and life – threatening diseases. iCo-009 also represents a new drug delivery technology with the potential to reprofile other parenteral administered drugs to the oral route of administration.
iCo Therapeutics trades on the TSX-Venture exchange under the symbol “ICO”.
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.
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