Bioavailable Oral Ampho B

http://www.aquariusbio.com/wp-content/uploads/2013/04/CAmB-Focus-Phase-1-Post...

• Encochleated Amphotericin B was well-tolerated at single oral doses of 200 and 400 mg.
• Plasma concentrations of amphotericin were obtained from this oral dosage form and are comparable to prior results from animal toxicology studies.
• Adverse events primarily affected the gastrointestinal tract and were mild in all cases at the 200 and 400 mg dose levels. There were no serious adverse events and no withdrawals due to adverse events.
• No abnormalities in laboratory or other safety testing were observed, including those associated with renal function.
• This study provides support for multi-dose pharmacokinetic studies and Phase II efficacy studies for oral administration of Encochleated Amphotericin B.