Phase 1 Study Showing COTI-2 Safe in Potentially Treating Advanced Ovarian and Other Cancers

Phase 1 Study Showing COTI-2 Safe in Potentially Treating Advanced Ovarian and Other Cancers
Initial data from an early clinical trial in patients with advanced ovarian and other cancers found a potential oral therapy, COTI-2, to be safe at varying doses, supporting a more advanced Phase 2 trial in these people, Critical Outcome Technologies announced. “We are encouraged to see these PK [pharmacokinetic] data from our Phase 1 trial in gynecological malignancies,” Alison Silva, president and chief executive officer of Critical Outcome Technologies, said in a press release. “These promising PK signals … reinforce our commitment to the continued advancement of COTI-2 through clinical development. COTI-2 is a novel small molecule that acts on the TP53 gene – a major tumor suppressor protein. TP53 is often mutated in cancer and contributes to metastasis and drug resistance in these cells. COTI-2 is designed to act on mutated p53 to make it function more as a normal, wild-type protein, helping to suppress cancer growth and spread. The Phase 1 study (NCT02433626) is assessing the safety and tolerability of COTI-2 in patients with advanced and recurrent gynecologic cancers, and head and neck cancers. The trial, which began in late 2015 and ends in December 2018, also aims to identify the maximum tolerated dose for further Phase 2 studies. Secondary endpoints included patients’ clinical response and progression-free survival. The trial ha
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