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EpiAxis Clinical Trials

Clinical trials are research studies aimed at finding a better way to prevent, treat or manage a particular disease. These trials are considered to be part of best practice medicine and are one of many options for treatment of a disease or illness.

Our Clinical Program

EpiAxis Therapeutics is pursuing a clinical drug development program directed at the prevention of metastatic disease by targeting the pivotal enzyme controlling the proliferation of circulating tumour cells. The research identifying this target and the intellectual property that resulted from this was developed by Professor Sudha Rao and colleagues at the University of Canberra, Australia.

Results from laboratory studies have shown that combining the oncology drug (Abraxane®) with Nardil®, a drug that is currently approved as an antidepressant, is more effective than Abraxane® alone in stopping the abnormal transformation of healthy cells into cancer cells. Specifically, they were found to stop a 'molecular switch' in breast cancer cells that influences aberrant cell growth, which is characteristic of this disease. Both drugs have been used in clinical care for more than a decade and it is likely that they have been used together in routine clinical care but not intentionally combined together for the purpose of cancer therapy. Although the safety and tolerability profiles of both Abraxane® and Nardil® are well-established, their safety and tolerability have not previously been evaluated in combination.

Thus, the purpose of this clinical trial is to investigate whether Nardil® can be combined with your standard clinical therapy - Abraxane®. This will determine whether it is safe to use as a novel cancer treatment and whether it will decrease the number of circulating tumour cells (CTCs).

What we are hoping to achieve

  • The drug combination will be safe and well tolerated in a small population of women with metastatic breast cancer
  • The treatment will reduce the burden of CTCs. Any reduction in the metastatic burden of circulating tumour cells would be expected to increase life expectancy.

Overall, this could lead to the development of a new intervention and prolong remission for metastatic breast cancer patients.

Accessing the Trial - Patients

EpiAxis Phase 1B clinical trial in metastatic breast cancer is now open for immediate recruitment. If you are interested in participating you should review the participant criteria and consult your oncologist to determine if this trial would be best for you.

In parallel with the EpiAxis clinical trial, both healthy volunteers, as well as patients with metastatic breast cancer, are also invited to participate in a study to develop a blood test that detects CTCs. The aim of this study is to develop a liquid biopsy that has the capabilities to track cancer progression in real-time. This patient-specific information can be used by oncologists to help inform treatment choice, moving towards a future of personalised medicine.

Accessing the Trial - Clinicians

The EpiAxis novel Phase 1B clinical trial for patients with metastatic breast cancer, particularly those with the triple negative (TNBC) subtype, is now open for recruitment. Participants in the multi-centre clinical study will be offered a new combination therapy, comprising the standard of care chemotherapeutic drug Abraxane® with a second PBS listed drug Nardil®. This new combination is designed to test the hypothesis that metastatic disease can be treated with the addition of an LSD1 inhibitor to Abraxane®.

Further information on the clinical trial and how to get involved can be found on the EpiAxis Therapeutics website.

Details of the clinical trial, the outcomes and the criteria of participants can be found on the Clinical Trial Registry.