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Critical Outcome Technologies planning phase I trial of COTI-2 in recurrent head and neck cancers

Critical Outcome Technologies, the biopharmaceutical company that uses machine learning to rapidly develop targeted therapies, announced today that it has executed a material transfer agreement ("MTA") with Dr. John Yoo, MD, FRCSC, FACS, and his team at the London Health Sciences Centre's London Regional Cancer Program and Western University, for the continued evaluation of COTI-2 for the treatment of patients with recurrent head and neck squamous cell cancer ("HNSCC").

"We have tested over 1,500 chemotherapeutic agents in our head and neck cancer cell lines and COTI-2 is the most active drug that we have ever seen in our lab by an exponential factor," said Dr. John Yoo, Chair and City-wide Chief, Department of Otolaryngology – Head and Neck Surgery at the London Hospitals and the Schulich School of Medicine & Dentistry, Western University.

"Based on extremely promising cell line and animal studies, the next logical step is to try to help patients. We are eager to study COTI-2 in patients with recurrent HNSCC as well as other types of cancers."

"COTI-2 represents a potential breakthrough treatment for recurrent head and neck cancers," said Dr. Wayne Danter, President and CEO.

"We are energized by the potential for COTI-2 given the central importance of p53 gene mutations in the most difficult to treat HNSCC tumors. Based on our preclinical test data and the substantial unmet medical need, we are now in the planning stages for a Canadian Phase 1 clinical trial of oral COTI-2 in patients with recurrent HNSCC, led by the Head and Neck Surgical Oncology team at Western’s Schulich School of Medicine & Dentistry."

Dr. Yoo has focused his group’s translational research on the personalized treatment of head and neck cancers, evaluating the impact of novel drugs and drug candidacy on human HNSCC and other cancers of the head and neck. As a surgical oncologist and the Chief of the Division of Head & Neck Oncology and Reconstructive Surgery, he has seen first-hand the results of his group’s evaluation of the effectiveness of more than 1,500 compounds in the context of cancer gene mutation profiling.

Their preliminary findings with single agent COTI-2 in HNSCC in vitro tumor models show tremendous promise with results indicating that human HNSCC cells that express p53 mutations as well as those with wild type p53 are both highly-sensitive to COTI-2. This cellular sensitivity is consistent with previous results from Dr. Jeff Myers lab in HNSCC at MD Anderson Cancer Center and the p53-dependent mechanism of action confirmed by Dr. Mills at MD Anderson in gynecological cancers.