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COTI-2 Receives Favourable Independent Pre-Investigational New Drug Gap Analysis Report
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 INDenabling 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.
About TD2 - www.td2.org
TGen Drug Development (TD2), a wholly owned subsidiary of the Translational Genomics Research Institute (TGen), is a 501(c) 3 nonprofit organization. TD2 provides innovative services for oncology focused biopharmaceutical companies using a dedicated team of professionals with broad experience and understanding in drug development. TD2 is uniquely positioned to support the need for improved and accelerated development of new chemical entities (NCE's) for lifethreatening diseases. TD2 uses a unique combination of experience gained through its contract research organization business, and an integrated suite of proprietary and nonproprietary tools, preclinical study execution, regulatory affairs assistance, clinical trial design and management, and drug development experts to successfully move therapeutics towards regulatory approval. TD2 is dedicated to reducing the risks and uncertainty inherent in the drug development process.
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Information contained in this press release may contain certain statements which constitute "forward- looking statements" within the meaning of the Securities Act (Ontario) and applicable securities laws. For example, the statement "intends to begin the remaining INDenabling studies with the intention of commencing a Phase 1 clinical trial in 2011" is a forwardlooking statement. Forwardlooking statements, by their nature, are not guarantees of future performance and are based upon management's current expectations, estimates, projections and assumptions. COTI operates in a highly competitive environment that involves significant risks and uncertainties which could cause actual results to differ materially from those anticipated in these forwardlooking statements. Management of COTI considers the assumptions on which these forwardlooking statements are based to be reasonable, but as a result of the many risk factors, cautions the reader that actual results could differ materially from those expressed or implied in these forwardlooking statements. Information in this press release should be considered accurate only as of the date of the release and may be superseded by more recent information disclosed in later press releases, filings with the securities regulatory authorities or otherwise.
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