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 development based company focused on in-licensing drugs with clinical history redosing or reformulating for new or expanded indications. iCo has exclusive worldwide rights to three products. iCo-007, a second generation antisense candidate licensed from Isis Pharmaceuticals, is currently in a Phase I trial in Diabetic Macular Edema patients with compelling early data. iCo-008 is a human monoclonal antibody targeting eotaxin-1 with Phase II clinical history, licensed from AstraZeneca/MedImmune. iCo-009 is a proprietary oral formulation of amphotericin B 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: http://www.icotherapeutics.com
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