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news.Critical Outcome Technologies (COTI) has received a favourable pre-investigational new drug (pre-IND) gap analysis report from an independent team that reviewed its new oncology drug candidate COTI-2. This represents an important milestone as the company draws closer to a Phase 1 clinical trial.
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Critical Outcome Technologies said that the gap analysis is conducted prior to an initial meeting with the FDA to identify potential deficiencies in the preclinical development program of a new chemical entity being considered for human clinical trials.
Reportedly, 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.
TGen Drug Development (TD2) and its investigator, Daniel Von Hoff is expected to 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 is expected to 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.
Wayne Danter, president and chief scientific officer of COTI, said: “We are quite pleased with this 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.”