iCo Therapeutics Announces iCo-009 (Oral Amphotericin B) FDA Meeting
April 21, 2008
VANCOUVER, Canada— iCo Therapeutics Inc. (TSX-V: ICO) announces the granting of a Pre-IND meeting by the United States Food and Drug Administration (FDA) for its iCo-009 formulation. iCo-009 is a novel oral formulation of the generic drug Amphotericin B, offering potential safety and dosing benefits in pre-clinical testing conducted to date.
Pre-IND meetings represent a unique opportunity to gain FDA guidance in regards to overall clinical development plans. In this instance a clinical path and proposed 505(b)(2) strategy for iCo-009 will be discussed.
“iCo continues to be impressed by the pre-clinical data generated by the Wasan lab at the University of British Columbia (UBC)” stated Andrew Rae, President & CEO of iCo Therapeutics. “Input from the FDA will allow us to further refine and optimize our proposed clinical plan and ensure we are on the most efficient roadmap to approval.”
The Pre-IND meeting will be held on Friday May 2nd, 2008.
About iCo-009
iCo-009 represents a new drug delivery technology with the potential to reprofile other parenteral drugs to the oral route of administration.
