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 dose, was completed with no serious adverse events or dose-limiting toxicity reported. Dosing for the second group is expected to begin during the first quarter of 2018.
“Initiating patient recruitment of the second dosing group of our first Prolanta clinical trial is an important milestone for the company,” Michael T. Redman, chief executive officer of Oncolix, said in a press release.
“Recently, we have been focused on meeting our objectives to strengthen our public company infrastructure. Now we are moving forward with our primary objective and core value driver, which is to evaluate Prolanta in ovarian cancer patients with the ultimate goal of demonstrating its efficacy and safety and providing it as a breakthrough treatment option to patients,” Redman said.
“We look forward to begin dosing patients during the first quarter of 2018 and to complete dosing prior to the end of the year.”
Prolanta is being developed for the treatment of ovarian, uterine, breast, and other cancers. Oncolix has received U.S. Food and Drug Administration (FDA) clearance of an investigational new drug (IND) application for the therapy candidate as a treatment for ovarian cancer.
The FDA also granted orphan drug status to Prolanta for the treatment of ovarian cancer, which gives Oncolix the opportunity for reduced regulatory filing fees, federal tax credits, and seven years of marketing exclusivity in the U.S.
The Phase 1 clinical trial is currently recruiting adult women with advanced ovarian, primary peritoneal, or fallopian tube cancer. More information on trial sites and inclusion criteria is available here.