COTI announces favourable independent pre-IND gap analysis report for novel oncology drug candidate

Critical Outcome Technologies Inc. (COTI) (TSX Venture: COT) announced today that it received a favourable Pre-Investigational New Drug (pre-IND) gap analysis report from an independent team that reviewed its novel oncology drug candidate COTI-2.  This represents an important milestone as the Company draws closer to a Phase 1 clinical trial.

This gap analysis is conducted prior to an initial meeting with the U.S. Food and Drug Administration (FDA) to identify potential deficiencies in the preclinical development program of a new chemical entity being considered for human clinical trials.  A thorough analysis of the preclinical data package for COTI-2 by an independent team of scientific and regulatory consultants revealed no deficiencies in the COTI-2 program. 

As a result, TGen Drug Development (TD2), and its investigator, Dr. Daniel Von Hoff will work with COTI to arrange an initial meeting with the FDA.  COTI intends to begin the remaining IND-enabling studies with the intention of commencing a Phase 1 clinical trial in 2011.  COTI will share this development with parties who have expressed a licensing interest in COTI-2, including all parties the Company met with at BIO 2010, held last week in Chicago, IL.

"We are quite pleased with this important development.  We can now proceed with completing the IND enabling experiments and we look forward to our initial meeting with the FDA regarding the COTI-2 clinical development program," said Dr. Wayne R. Danter, COTI's President and Chief Scientific Officer.