First patient doses in Prescient PTX-100 study


Prescient Therapeutics (ASX:PTX), an Australian clinical-stage oncology company, has announced treatment of the first patient with its second targeted anti-cancer drug, PTX-100, in a Phase 1b trial enrolling patients with multiple cancer types.

The company said the first patient dosed is a multiple myeloma patient, who successfully completed a week of therapy with PTX-100 without any notable drug-related side effects.

It said the study will seek to determine the safety, dose regimen and treatment schedule of PTX100, a first in class drug, in several cancers where Ras and RhoA mutations are prevalent.

"These mutations are present in many cancer types, but there remains no approved therapy against either Ras or RhoA mutant cancers. As a result, there remains a significant yet unserved market opportunity for treatments addressing Ras and RhoA mutant cancers, which has drawn strong attention from industry, clinicians and researchers," it said.

The study at Epworth HealthCare in Melbourne is led by Professor Miles Prince AM, an internationally renowned oncologist who has contributed to the successful development of several new breakthrough cancer therapies.

Prescient said it will seek to identify the mutational status of each patients’ malignancies and, within the constraints of a small sample size, seek to correlate this status with any clinical activity.

Several cancer biomarkers will be investigated with the aim of identifying patients that may be most likely to respond to PTX-100 therapy.

The new study takes a ‘basket’ approach to assess the drug on multiple cancers with a view to addressing specific mutations, rather than tumour origin. Basket studies pioneered by several US companies have quickly identified patient populations who could benefit from the investigational drug, sometimes leading to fast track approval.

Professor Prince said, "All of us working to treat cancer are excited to see the first patient dosed in Australia with this compound and the prospect of advancing a new molecularly targeted therapy for people who currently have few medical options.”

According to Prescient’s managing director and CEO, Steven Yatomi-Clarke, "Dosing the first patient in this study is a pivotal milestone in our efforts to develop effective new treatments for a range of hard to treat cancers. We are very pleased with our productive collaboration with Professor Prince and his team at Epworth in advancing this important clinical program.”

PTX-100 is licensed by Prescient from Yale University, and was invented by Prescient Chief Scientific Officer, Professor Said Sebti, recently appointed as Associate Director of Basic Research at Virginia Commonwealth University Massey Cancer Center, and Professor Andrew Hamilton, the President of New York University.