January 21, 2008
VANCOUVER, Canada— iCo Therapeutics Inc. (TSX-V: ICO) is pleased to provide an update on the Company’s iCo-009 program, an oral reformulation of Amphotericin B (AmpB) for the treatment of systemic fungal infections and Visceral Leishmaniasis. AmpB 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. 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.
Research studies conducted by Dr. Kishor M. Wasan’s laboratory at UBC continue to indicate that orally-administered iCo-009 reaches therapeutic levels in the bloodstream and exhibits dramatic knock-down of fungal infection with reduced or no kidney toxicity in animal models.
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). According to the FDA, this approach is “intended to encourage innovation without creating duplicate work” and reflects the principle that “it is wasteful and unnecessary to carry out studies to demonstrate what is already known about a drug”. This approach can potentially reduce the development time and expense for approval of a drug such as iCo-009, which is based upon a drug with a 50-year history.
Dr. Wasan recently published an article in Nature Reviews Drug Discovery (Wasan, KM. et al. “Impact of lipoproteins on the biological activity and disposition of hydrophobic drugs: implications for drug discovery” published in the January 2008 Issue with a feature on the cover page). Dr. Wasan’s article further identifies the need for a novel formulation of AmpB and demonstrates his laboratory’s leadership in developing a formulation that seems to be safe, can be stored in a more stable form and be taken orally, greatly increasing the accessibility of AmpB treatment.
“We are thrilled to be working with a scientist of Dr. Wasan’s caliber and the results coming out of his laboratory continue to excite us,” stated Andrew Rae, President & CEO of iCo Therapeutics. “The opportunity to reprofile an existing drug into a more accessible and efficacious formulation is precisely what we are hoping to achieve with iCo’s business model.”
Dr. Wasan is Professor and Chair of Pharmaceutics and Biopharmaceutics, a Distinguished University Scholar at UBC, and Canadian Institutes of Health Research University-Industry Research Chair in Drug Development in the Faculty of Pharmaceutical Sciences.
About Fungal Infections & Leishmaniasis
It has been estimated that fungal infections may account for up to 30% of deaths in immunocompromised individuals, particularly those patients with cancer, AIDS, diabetes, and organ transplant recipients. Amphotericin B remains one of the most effective agents in the treatment of systemic fungal infections. In the developing world, AmpB is also an effective weapon against Leishmaniasis, a parasite contracted by approximately 2 million people a year, with 12 million presently infected worldwide. If left untreated, Visceral Leishmaniasis can have a fatality rate as high as 100% within two years (World Health Organization). iCo is committed to UBC’s global access objectives, which include broadening the societal impact of, and global access to, UBCtechnologies.
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.