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, or cervical cancer, for which no effective therapies existed. It was also designed to establish a recommended dose for future studies.
The trial enrolled 24 participants who received one of four dose levels ranging from 0.25 mg per kilogram body weight (mg/kg) to 1.7 mg/kg, once daily. Data from the study showed that COTI-2 was safe and well-tolerated up to doses of 1.7 mg/kg. Adverse events included nausea, vomiting, fatigue, and abdominal pain.
Based on the results, COTI decided to expanded the trial to include patients with HNSCC. The next steps are to determine the safety and tolerability of COTI-2 in these patients, and to establish the maximum tolerated dose or recommended Phase 2 dose.
After reviewing the clinical data from the studies, the dose escalation committee decided to start the next phase of the trial by treating HNSCC patients at an initial dose of 1.0 mg/kg.
COTI-2 exhibits anti-cancer activity through a p53-dependent mechanism, which is one of the most powerful tumor suppressors in the body and is mutated in more than half of cancers. Preclinical research has shown significant efficacy of COTI-2 in the treatment of cancers with p53 mutations.
COTI-2 has been granted orphan drug status in the United States for the treatment of ovarian cancer. In 2018, the company hopes to expand the COTI-2 program by evaluating the effectiveness of COTI-2 in combination with conventional chemotherapy and radiation therapy in patients with gynecological cancers and HNSCC.
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