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Cantrixil is currently being developed for treatment of ovarian cancer and is being trialled in hospitals across Australia and the United States under an Investigational New Drug application which was approved by the US FDA in 2016.
Ovarian cancer is the seventh most common cancer in women and has the lowest survival rate of any women's cancer. It affects about one in 100 women worldwide, with about 240,000 new cases each year.
The Global market for ovarian cancer therapies is around US$ 500M, projected to grow to US$ 1B over next 5 years (Decision Resources).
The survival rate for this disease is poor because of the high rate of relapse after standard-of-care treatment and the late stage at which the disease tends to be diagnosed. When ovarian cancer relapses the disease is often not responsive to standard chemotherapy agents.
Cantrixil is thought to target chemotherapy-resistant tumor-initiating cells that are thought to be responsible for disease relapse.
Cantrixil consists of the active molecule, a third-generation benzopyran named TRXE-002-01, encapsulated in a cyclodextrin.
Cantrixil is a first-in-class development candidate which targets the entire spectrum of cancer cells, including tumour-initiating cells cells thought to cause cancer recurrence.
The novelty of this agent is its ability to kill the cancer stem cell / tumor-initiating cells and their daughter cancel cells that are responsible for cancers originating, metastasizing and relapsing. These slower-growing tumour-initiating cells are often resistant to other types of chemotherapies. Cantrixil has the potential to revive the use of intra-peritoneal (IP) chemotherapy and invigorate the use of this mode of administration for ovarian cancer patients. It has the opportunity to become a standard front-line agent, complementing the use of platinum therapy for a group of gynecological cancer. Cantrixil is currently in phase I clinical trials at six trial sites across Australia and the United States.
Cantrixil has been successfully taken into an international phase I clinical trial under a US IND, only three years after discovery. The phase I trial is being conducted in two parts; a dose escalation component (Part A), which seeks to understand the safety profile of the drug and to determine the maximum tolerated dose, and a dose expansion cohort (Part B), which seeks to explore initial signals of efficacy.
Preliminary data from Part A has been released; in general the drug has encountered few dose-limiting toxicities. Part A concluded in October 2018 and Part B commenced at that time. More information about the trial and recruitment can be found at: https://www.clinicaltrials.gov/ct2/show/NCT02903771.
Intra-peritoneal (IP) administration of first-line chemotherapy to women with advanced stage ovarian cancer immediately after their debulking surgery has been recommended by the National Institute of Health in the USA since 2006. This mode of administration exposes residual tumor cells after surgery to higher doses of chemotherapy for longer periods compared with chemotherapy administered intravenously. Improvements in survival time with IP chemotherapy have lead national health and consumer advisory groups to continue to recommend this mode of administration for eligible groups of ovarian cancer patients.
More Publications and Presentations
Second Half of 2016
November 2015 - May 2016
Formulation and stability testing of GMP product for Phase 1 clinical trial.
January - December 2015
Formal toxicity studies to assess safety of Cantrixil.
August - November 2015
Manufacture of cGMP grade Cantrixil drug substance for Phase 1 clinical trial – completed.
January -August 2015
Scale-up of manufacture of GLP-grade drug substance and drug product for toxicity studies – completed.
Cantrixil proves highly effective in preclinical tests of refractory ovarian cancer.
Researchers at Yale University confrm potency in ovarian stem cell model.