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news.Critical Outcome Technologies has reported that it intends to prepare Phase I B Health Canada clinical trial submission based on positive preclinical results for its small cell lung cancer drug, COTI-2.
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Preclinical results demonstrated that COTI-2 inhibited Akt/PKB phosphorylation in cancer cells resulting in apoptosis or programmed cell death and has shown excellent in vitro activity in several human cancer cell lines including small cell lung cancer (SCLC). Based on these encouraging preclinical results Critical Outcome Technologies (COTI) is moving forward immediately with its plans to complete the necessary animal pharmacokinetic and toxicity testing (PK/Tox) required for the submission of an investigational new drug application to Health Canada within the next 12-15 months.
The company anticipates that the first patient will be registered in the Phase I B trial in 12-15 months. COTI-2 is a novel, easily synthesized small molecule originally designed and optimized for oral treatment of SCLC.
Wayne Danter, president and chief scientific officer of COTI, said: “COTI-2 shows efficacy against multiple cancers and low toxicity.”