March 17, 2008
VANCOUVER, Canada— iCo Therapeutics Inc. (TSX-V: ICO) is pleased to announce that iCo-009 has been highlighted in a leading drug delivery journal, Advanced Drug Delivery Reviews. The paper discusses the development of a novel oral Amphotericin B (AmpB) formulation (“iCo-009”) with significant antifungal activity, minimal kidney toxicity, and enhanced oral absorption of AmpB.
The publication, “Enhanced drug absorption using lipids: A case study presenting the development and pharmacological evaluation of a novel lipid-based oral Amphotericin B formulation for the treatment of systemic fungal infections”, provides further detail on the potential mechanisms by which oral iCo-009 knocks down fungal infections.
• iCo-009 significantly decreased (95%) organ fungal concentration of Aspergillus fumigatus compared to controls in the brain and the spleen, two organs where Aspergillus fumigatus typically localizes in this animal model.
• iCo-009 shows enhanced gastrointestinal tract absorption, plasma concentration, and tissue distribution.
• iCo-009 shows minimal renal toxicity.
• iCo-009 significantly decreased plasma galactomannan antigen levels. Detection of galactomannan in the blood can be used to diagnose Aspergillus fumigatus infections in humans.
“iCo continues to be impressed by the work of Drs. Kishor & Ellen Wasan,” stated Andrew Rae, President & CEO of iCo Therapeutics. “Their work continues to improve upon the iCo-009 formulation represented in the paper, with newer formulations showing even more dramatic anti-fungal activity and bioavailability. iCo-009 has the potential to treat not just systemic fungal infections, but also parasitical diseases such as Leishmaniasis in the developing world. iCo remains very committed to UBC’s global access policy and we look forward to proceeding with development in both markets.”
iCo has an option agreement with The University of British Columbia (UBC) for iCo-009’s development, which also represents a new drug delivery technology with the potential to reprofile other IV administered drugs to the oral route of administration. iCo plans to develop iCo-009 under the 505(b)(2) section of the Federal Food, Drug, and Cosmetic Act, which expressly permits the FDA to reference safety data not developed by the applicant for approval of a New Drug Application (NDA).
The paper is available in the March 17, 2008 edition of Advanced Drug Delivery Reviews. K. Sachs-Barrable, S. Lee, E. Wasan, S. Thornton, K. Wasan. Advanced Drug Delivery Reviews 60 (2008) 692–701.
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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