Kazia completes recruitment of patients for phase I clinical study of Cantrixil in ovarian cancer

Kazia Therapeutics Limited (ASX: KZA; NASDAQ: KZIA), an Australian oncology-focused biotechnology company, is pleased to announce that it has completed recruitment of patients into Part B of its phase I clinical study of Cantrixil in ovarian cancer.

Dr James Garner, Chief Executive Officer of Kazia Therapeutics commented, “Part B of the Cantrixil study has recruited well and we are now following patients through to completion of their treatment. We are grateful for the excellent efforts of the participating clinicians, and of the study team. The first part of the study has shown some very promising signals, and the data from Part B will significantly enhance our understanding of the drug. We will be presenting data at the ESMO conference at the end of September, and this will be valuable opportunity to move forward our partnering discussions for Cantrixil.”

Key Points

• Part A of the study collected data from an initial 14 patients, who received escalating doses of Cantrixil to determine safety and tolerability. A maximum tolerated dose of 5 mg/kg was achieved, and this data was reported at the American Association of Cancer Research conference on 1 April 2019.
• Part B was designed to enrol 12 patients, all of whom receive Cantrixil at a dose of 5 mg/kg. Part B was designed to seek preliminary signals of potential efficacy for the drug.
• Initial data from Part B is expected in the fourth quarter of calendar 2019, with final completion of the study in 2020.
• Kazia was pleased to present positive data from the first part (Part A) of the study at the American Association of Cancer Research (AACR) on 1 April 2019. The data showed that, of nine patients evaluable for efficacy, five (56%) achieved a best observed response of stable disease after two cycles of Cantrixil monotherapy. One of these five patients subsequently
  achieved a partial response when Cantrixil was administered with chemotherapy. The study also determined a Maximum Tolerated Dose (MTD) of 5 mg/kg, which is the dose that is being used for all patients in Part B of the study.

Final data from these nine patients in Part A, including from the off-treatment follow-up period, has been selected for presentation at the European Society of Medical Oncology Annual Meeting in Barcelona, Spain on 27 September – 1 October 2020.

The phase I study of Cantrixil commenced on December 2016 and is registered on clinicaltrials.gov as NCT02903771. The study is being conducted at six hospitals in the United States and Australia:

Approximately 240,000 women are diagnosed with ovarian cancer each year worldwide and it is the eighth most common cause of cancer death in women. Conventional treatment typically includes surgery, radiotherapy, and chemotherapy. However, the five-year survival rate remains low, at approximately 45%, reflecting the fact that the disease is often advanced at the time of diagnosis.

About Kazia Therapeutics Limited

Kazia Therapeutics Limited (ASX: KZA, NASDAQ: KZIA) is an innovative oncology-focused biotechnology company, based in Sydney, Australia. Our pipeline includes two clinical-stage drug development candidates, and we are working to develop therapies across a range of oncology indications.

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