Oral Delivery System: Amphotericin B

iCo Therapeutics owns the worldwide exclusive rights to an oral delivery system: Amphotericin B (Amp B), for life-threatening infections. The drug delivery technology also has the potential to reprofile other drugs that would benefit from either oral administration and/or selective targeting of the lymphatic system.

Amphotericin B, the gold standard for systemic antifungal drugs, is one example of a well established, highly efficacious systemic antifungal drug that has a 50 year history of intravenous therapy. Amphotericin B, formulated as liposomal Amphotericin (Ambisome®) for IV use, remains one of the most effective agents in the treatment of systemic fungal infections, yet no oral formulations are currently commercially available.

The ability to allow patients to self administer treatment for systemic fungal infections may significantly increase the quality of life in developed nations, where the rates of opportunistic fungal infections such as candidiasis, histoplasmosis and aspergillosis are climbing, particularly within patients with cancer, organ transplant recipients, diabetics and HIV/AIDS.

In developing nations, the need for oral therapies is not a matter of convenience or cost, but instead is one of survival. The benefit of developing oral therapies is illustrated by the protozoan Leishmania donovani, an insidious parasite that is transmitted by the bite of an infected sand fly that affects over 200 million people from 62 countries.

The laboratory of Dr. Kishor Wasan has made significant strides toward the development of a proprietary, lipid-based AmpB formulation for oral administration. Initial data from both cell lines and in vivo research indicate that it is highly efficacious and exhibits low toxicity within the dosage range required for the treatment of diseases such as disseminated fungal infections and Leishmaniasis.

The oral delivery system: Amphotericin B has been granted Orphan Drug status for the treatment of Visceral Leishmaniasis (VL) by the US Food and Drug Administration (FDA). In vitro testing with study partners in Montreal examined the role of this formulation in targeting latent HIV reservoirs which remain in individuals despite enormous therapeutic advances in the treatment of HIV/AIDS. Recruitment of eight HIV-infected subjects successfully treated with highly active antiretroviral therapy (HAART) with detectable latent viral reservoir produced positive study results in H2 2014.
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