Biotech Completes Dose Escalation Part of Phase 1 Study of COTI-2 in Gynecological Cancers

Biotech Completes Dose Escalation Part of Phase 1 Study of COTI-2 in Gynecological Cancers
The dose escalation part of a Phase 1 trial evaluating COTI-2 in women with advanced gynecological cancers who did not respond to standard therapy has been completed, according to the drug's manufacturer, Critical Outcome Technologies Inc. (COTI). The COTI2-101 Phase 1 study (NCT02433626) will now progress to include patients with head and neck squamous cell carcinoma (HNSCC) and determine the recommended Phase 2 dose for these patients. “The completion of this dose-escalation study in gynecological malignancies marks an important milestone in the clinical development of our lead asset, and advances COTI-2 into a second indication in our Phase 1 program,” Alison Silva, president and CEO of COTI, said in a press release. "Based on safety and tolerability data to date, we will continue developing COTI-2 as a novel therapy for the treatment of p53- mutant solid tumors," she said. "We are excited to announce that we have launched the HNSCC expansion arm of our Phase 1 program for COTI-2 at MD Anderson Cancer Center and we look forward to reporting secondary and exploratory endpoint data from the gynecological arm of our Phase 1 study by year-end." The Phase 1 study (NCT02433626) was designed to determine the safety and tolerability of COTI-2 in patients with recurrent, metastatic, or unoperable ovarian, fallopian tube, primary peritoneal, endometrial, o
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