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- Agreement on conducting clinical study on ovarian cancer treatment.
- Evaluating narmafotinib in combination with standard-of-care chemotherapy.
- Ovarian cancer a major target for inhibition therapy.
- Study to enrol patients with high-grade serous ovarian cancer.
Amplia Therapeutics (ASX:ATX) and the Australia New Zealand Gynaecological Oncology Group (ANZGOG) have entered into an agreement to conduct a new clinical study into ovarian cancer.
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The study will investigate Amplia’s lead drug narmafotinib for treating ovarian cancer.
Narmafotinib is a best-in-class focal adhesion kinase (FAK) inhibitor currently undergoing clinical development in pancreatic cancer where it is showing promising efficacy combined with good tolerability.
The study will be led by Dr Gwo Yaw Ho of Monash Health and Monash University and sponsored and coordinated through ANZGOG, an international cooperative clinical trials network spanning major hospitals across Australia and New Zealand.
The study is expected to enrol approximately 15 to 20 patients with high-grade serous ovarian cancer (HGSOC) who demonstrate poor response to up-front standard-of-care platinum-based chemotherapy prior to planned interval debulking surgery.
Called the PRROSE trial it will evaluate the safety of narmafotinib in combination with standard-of-care chemotherapy (carboplatin and paclitaxel) in this patient population.
Approximately one in five ovarian cancer patients do not respond adequately to initial chemotherapy, limiting their ability to undergo surgery and contributing to poor clinical outcomes.
Dr Chris Burns, CEO and MD, said the study is designed to address this significant unmet medical need.
The study will also explore whether the addition of narmafotinib can increase the proportion of patients eligible for successful surgical resection. Extensive tissue and blood biomarkers will be examined for insight into narmafotinib’s mechanism of action to further enrich data provided from the study.
“We are very pleased to be collaborating with ANZGOG and Dr Ho on this promising study. Based on the compelling biological rationale for the potential of FAK inhibitors in ovarian cancer, a clinical program in this indication is clearly warranted.
“Patients with ovarian cancer who do not respond to initial chemotherapy have very limited treatment options and this study will provide an opportunity to assess whether narmafotinib can improve outcomes for these patients. This trial also represents an important step in broadening the clinical utility of our FAK inhibitor program.”
ATX is up 7.69% to 14.0¢. Mkt cap $66.69M.
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