September 4, 2008
VANCOUVER, Canada—iCo Therapeutics Inc. (TSX-V: ICO) is pleased to provide an update on the progress of iCo-009 and outline a path to a Phase I clinical trial. iCo-009 is an oral formulation of Amphotericin B, a drug that has been successfully used to treat systemic fungal infections for over 50 years though its use is limited due to toxicity and intravenous administration.
“iCo-009 represents a near term value driver for iCo”, stated Andrew Rae, iCo Therapeutics’ President & CEO. “Preliminary data currently supports iCo’s expedited clinical development path, and potentially shortens the time and expense to reach approval. Amphotericin B possesses a therapeutic benefit that is well known. If iCo can show that iCo-009 reaches therapeutic levels in the bloodstream and favourable organ distribution, iCo-009 may possess a much lower risk profile than traditional drug programs at this stage of development.”
The path to an iCo-009 Phase I clinical trial initiation entails five key steps:
1. Establishing safety and efficacy in a model of Aspergillus fungal infection.
In a press release dated March 17, 2008, iCo provided results from an Aspergillus fumigatus rat model. The study showed significant antifungal activity, minimal kidney toxicity, and enhanced oral absorption of AmpB.
2. Confirming safety and efficacy in a model of Candida fungal infection.
In a press release dated June 26, 2008, iCo provided results from a Candida albicans rat model. Significant antifungal activity was seen at dosage levels where no kidney toxicity was observed. Aspergillus and Candida rat models are widely accepted as predictive of what might be observed in a clinical setting.
3. Generating plasma pharmacokinetic (PK) and tissue concentration data.
Pharmacokinetic tests employing iCo-009 are currently underway, including studies profiling the tissue distribution, (kidney, liver, spleen, lung, brain and heart), in appropriate pre-clinical models.
4. Communicating with the FDA
On May 2, 2008, iCo held a Pre-IND meeting with the FDA to provide further guidance as to the regulatory path moving forward, including the filing of an IND. iCo continues to consult with the FDA concerning the proposed design of the toxicology studies in the very near future.
5. Concluding CMC /Manufacturing, Safety Toxicology and a Phase I trial
iCo is currently in the process of assessing manufacturers and safety toxicology studies to complete a single dose escalation safety and tolerability clinical trial.
Assuming an expedited approach is pursued, bioequivalency rather than superiority to existing Amphotericin B formulations will represent iCo’s clinical focus in order to seek regulatory approvals. iCo-009 was developed by Drs. Kishor & Ellen Wasan at the University of British Columbia (UBC). 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
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.