June 26, 2008
VANCOUVER, Canada— iCo Therapeutics Inc. (TSX-V: ICO) is pleased to provide further preclinical results supporting the accelerated development of iCo-009, the company’s oral reformulation of Amphotericin B (Amp B). Amp B is a generic drug that has been in use for approximately 50 years, however its use is limited as it is currently administered intravenously and has significant infusion related side effects and kidney toxicity.
The studies were conducted in a rat fungal model of Candida albicans in the laboratory of Dr. Kishor Wasan at UBC. Kidney and organ colony forming units (CFU) were used as an indicator of antifungal activity, and kidney toxicity was indirectly assessed by determining creatinine concentration in plasma. Significant antifungal activity was seen at dosage levels where no kidney toxicity was observed. The results will be submitted to a scientific journal in the coming months.
“This data serves as further validation of iCo-009’s ability to safely kill fungal infections without the need to intravenously infuse Amphotericin B,” stated Andrew Rae, President & CEO of iCo Therapeutics. “These results not only corroborate those generated by Dr. Kish Wasan’s lab in the rat Aspergillus fumigatus model, but show an increasingly positive trend.”
iCo-009 has the potential to treat not only systemic fungal infections, which have emerged as important causes of morbidity and mortality in immunocompromised patients (e.g., AIDS, cancer chemotherapy, organ or bone marrow transplantation), but also parasitical diseases such as Leishmaniasis in the developing world. 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). This approach can potentially reduce the development time and expense for approval of a drug.
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.
Business Development Contact:
Dr. John Clement, CTO
604.602.9414 × 222
Mr. John Meekison, CFO
604.602.9414 × 224
Frederica Bell, Director, Corporate Development
604.602.9414 × 228