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.
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: https://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.