2012 News Releases

iCo Therapeutics receives funding from the Government of Canada for the pre-clinical and clinical development of its Oral Amphotericin B Delivery System for the treatment of HIV/AIDS

Highlights:

·         $1.1 Million non-repayable contribution from the National Research Council of Canada Industrial Research Assistance Program (NRC-IRAP), under the Canadian HIV Technology Development (CHTD) Program

·         Testing of Oral Amphotericin B as possible treatment and cure for HIV, used in concert with current HIV/AIDS drugs

·         Funds to be used for feasibility testing, further IND enabling studies and clinical trials

·         Positive studies would mean iCo’s anti-fungal and anti-parasitic applications also advance into human clinical trials, providing enormous leverage across programs

May 31, 2012 – Vancouver, Canada – iCo Therapeutics Inc. (TSX-V: ICO), a Vancouver-based drug reprofiling company, is pleased to announce that the company has been awarded a $1.1Million non-repayable financial contribution from the National Research Council of Canada to support iCo’s Oral Amphotericin B (Amp B) delivery system as novel treatment for patients with Human Immunodeficiency Virus (HIV). 

The funding will support feasibility testing and pre-clinical toxicology studies, as well as human safety and efficacy clinical trials to examine the role of the Amp B delivery system in potentially treating patients with latent HIV reservoirs.   The Oral Amp B technology was developed by Drs. Kishor and Ellen Wasan at the University of British Columbia (UBC).

The funding for the 3-year project comes from the NRC Industrial Research Assistance Program (NRC-IRAP) under the CHTD Program, which aims to encourage and support the participation of small and medium-sized enterprises in the development of an HIV vaccine and other technologies related to the prevention, treatment, and diagnosis of HIV. The program is part of the Canadian HIV Vaccine Initiative (CHVI), a collaboration between the Government of Canada and the Bill & Melinda Gates Foundation.

Although current treatment regimes, such as highly active anti-retroviral therapy (HAART) have been very successful in managing and stabilizing HIV in patients, HIV can also persist by slowly replicating in tissue macrophages and blood monocytes. The long-lived HIV reservoirs enable long-term persistence of the infection during otherwise effective HAART and constitute a major roadblock to the complete eradication of HIV.  To date, attempts to eliminate the virus from these reservoirs have been unsuccessful and the economic burden of HIV infection in the United States alone remains significant. The US Centre for Disease Control estimates the total lifetime treatment cost for HIV patients based on new diagnoses in 2009 at $16.6 billion.

However, independent studies have demonstrated that Amphotericin B may be efficient at reactivating HIV-1 infection in THP89GFP cells, a model of HIV-1 latency in macrophages.  Therefore, trans-reactivation strategies may hold the key to reactivating latent HIV-1 infections, in effect “flushing” the virus from the reservoirs and enhancing the effectiveness of existing therapies.

 “This important support from NRC-IRAP further validates the importance of this technology in treating a range of indications and is a major step toward the clinical development of the Oral Amp B product," said Dr. Kishor Wasan, R.PH., Ph.D., FAAPS, FCAHS, Professor and Associate Dean of Research and Graduate Studies at UBC.  “As a UBC Neglected Global Disease lead program, we are grateful to iCo for their continuing support and efforts in moving this technology to the clinic".

“We are excited to be working with NRC-IRAP and UBC to support the continued development of our Oral Amp B delivery system,” stated Andrew Rae, President & CEO of iCo Therapeutics. “This technology continues to provide new opportunities for expansion across a variety of disease indications.  If our HIV program is successful, we will have taken a significant step forward in contributing to the treatment and possible cure ofpatients with HIV”.

About iCo’s Oral Amp B Delivery System

Amphotericin B, the gold standard for systemic antifungal drugs, is a highly efficacious drug that has a 50+ year history of intravenous therapy; yet no oral formulations are currently commercially available.  Preclinical research indicates that iCo’s Oral Amp B formulations are highly efficacious and exhibit no toxicity within the dosage range required for the treatment of systemic fungal infections and visceral leishmaniasis (VL).

About iCo Therapeutics

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 2 for the treatment of Diabetic Macular Edema (DME), iCo-008 (Bertilimumab), a product with Phase 2 clinical history to be developed for sight threatening diseases; and an Oral Amp B delivery system for life-threatening infectious diseases.  Immune Pharmaceuticals licensed systemic rights to iCo-008 in June 2011.     iCo trades on the TSX Venture Exchange under the symbol “ICO”.  For more information, visit the Company website at: www.icotherapeutics.com.

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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