Phase 1 Trial for Prolanta in Advanced Ovarian Cancer Recruiting for Second Dose Group

Phase 1 Trial for Prolanta in Advanced Ovarian Cancer Recruiting for Second Dose Group
Oncolix has started enrolling patients for the second dosing group in a Phase 1 trial of Prolanta for the treatment of advanced ovarian cancer. In the first dose group, Prolanta caused no serious adverse events or dose-limiting toxicity. Prolanta is a prolactin receptor antagonist (or blocker) that has been shown to be effective in cancer mouse models by triggering autophagy, or cell death. Autophagy is the natural, tightly-regulated mechanism of the cell that disassembles unnecessary or dysfunctional components. This mechanism allows the orderly degradation and recycling of cellular components. The Phase 1 study (NCT02534922) is designed to establish a preliminary human safety, tolerability, and pharmacokinetic profile (how the drug is processed in the body) of Prolanta in patients with recurrent or persistent ovarian, primary peritoneal, or fallopian tube cancer. Oncolix believes Prolanta may be administered continuously as a monotherapy or in conjunction with chemotherapy. Biomarkers related to the activity of human prolactin will also be examined in tumor samples obtained before the study and at the end of treatment with Prolanta. The study will divide patients into three dosing groups, or cohorts. Each sequential group is designed to evaluate a higher dose of Prolanta. In each group, patients are evaluated over a 99-day period. Initial dosing lasts 28 days, followed by a two-week assessment period, and then continues for 56 days if no toxicities are observed. The first cohort, treated with the lowest
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