“The commencement of this trial represents a further step in Novogen’s transition to a clinical stage development company, and we are excited to be working with leading clinicians in the U.S. and Australia on this critical project,” Dr. Kimberley Lilischkis, clinical and regulatory affairs director, said in a press release.
“Novogen is focused on developing treatments for patients with the highest unmet medical need and those who are inadequately served by existing therapies,” she said. “We hope that Cantrixil will have the potential to offer a meaningful new treatment option for patients with ovarian cancer.”
The first-in-human Phase 1 study (NCT02903771) aims to determine the safety and feasibility of weekly intra-peritoneal administration of Cantrixil in up to 60 women with persistent or recurrent ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, who have failed at least two prior lines of chemotherapy.
The study also aims to determine the maximum tolerated dose of Cantrixil in these patients when administered alone or in combination with other approved therapies, to see the drug’s ability to be used in combination with standard-care chemotherapy regimens. Patients will initially receive Cantrixil in a low dose, which will be systematically increased until a maximum tolerated dose is determined.
The trial is currently recruiting patients across six clinical facilities in the United States and Australia, and is expected to take about 18 months to complete.
“I would like to congratulate the entire Novogen team for achieving this important milestone in Novogen’s efforts to develop therapeutic advances for patients suffering cancer,” said Dr. Gordon Hirsch, the company’s chief medical officer. “The study has commenced on schedule, in line with the company’s prior guidance of a start in the fourth quarter. We look forward to progressing the study, while also moving forward as swiftly as possible with the other molecules in our pipeline.”
Cantrixil is a first-in-class drug that targets the entire spectrum of cancer cells, including tumor-initiating cells, thought to cause cancer recurrence. Preclinical studies have shown that Cantrixil has a broad-based evidence of activity in ovarian cancer. In September, the U.S. Food and Drug Administration (FDA) approved Novogen’s Investigational New Drug (IND) submission, allowing Cantrixil to enter clinical development.