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
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 I for the treatment of Diabetic Macular Edema, iCo-008, a product with Phase II clinical history to be developed for severe ocular allergies, and iCo-009, an oral reformulation of Amphotericin B for sight and life - threatening diseases. iCo-009 also represents a new drug delivery technology with the potential to reprofile other parenterally administered drugs to the oral route of administration. iCo Therapeutics trades on the TSX-Venture exchange under the symbol “ICO”. For more information, visit the company website at: www.icotherapeutics.com
