November 7, 2008
VANCOUVER, Canada— iCo Therapeutics Inc. (TSX-V: ICO) is pleased to report that oral administration of iCo-009, iCo’s oral formulation of Amphotericin B, displays a dramatic knock-down of a parasitic infection that causes Visceral Leishmaniasis (VL). The studies were undertaken at an independent research laboratory in the United States with significant experience with VL animal models.
Dosages of 10mg/kg and 20mg/kg of iCo-009 were tested. In both cases, iCo-009 resulted in greater than 99% eradication of parasitic infection.
“These results are extremely exciting”, stated Andrew Rae, iCo’s President & CEO. “The preclinical work in three distinct animal models to date provides iCo with mounting confidence in the program and its potential to fight not only Visceral Leishmaniasis, but also systemic fungal infections in the developed world in human and animal health.”
The development of a safe, effective and accessible treatment for Visceral Leishmaniasis remains a key goal of several global health organizations. While Amphotericin B is an effective weapon against Leishmaniasis, current marketed formulations can only be delivered by intravenous (IV) infusion. Oral delivery of Amphotericin B would greatly increase access to this potentially lifesaving treatment.
Leishmaniasis is a parasite contracted by approximately 2 million people each year, with 12 million presently infected worldwide. If left untreated, Visceral Leishmaniasis can have a fatality rate of 100% within two years (World Health Organization).
In animal models, oral administration of iCo-009 has been shown to result in blood levels that are comparable to a known IV Amphotericin B product currently on the market. In both aspergillus fumigatus and candida albicans rat models, iCo-009 has also shown significant antifungal activity with no observable kidney toxicity as assessed by plasma creatinine concentrations. iCo-009 was developed by Drs. Kishor & Ellen Wasan at the University of British Columbia. iCo Therapeutics acquired the worldwide exclusive rights to iCo-009 from UBC in May 2008.
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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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.