Senz recruits first patient for leukaemia trial

Melbourne start-up Senz Oncology has recruited the first patient for a phase I/II trial of oral chemotherapeutic VAL-1000 in acute leukaemia.

The single-arm, open-label trial will be spearheaded by principal investigator Dr Andrew Wei, head of leukaemia services at Melbourne's Alfred Hospital.

The trial will involve up to 30 evaluable adult patients with acute leukaemias such as acute myeloid leukaemia or acute lymphocytic leukaemia.

Eligible patients will be unsuitable candidates for standard chemotherapies, whether through age, poor risk profile or those who have failed up to three lines of intensive chemotherapy.

It will primarily be a safety and tolerability study, but the secondary objectives include efficacy outcomes, pharmacokinetic profile and establishing a dose level for subsequent phase II trials.

Senz Oncology executive director Dr Anthony Filippis said the study marks a milestone for the company. “The trial will be the first time that VAL-1000 has been tested clinically for the treatment of acute leukaemias,” he said.

“If ultimately shown to be safe and efficacious it could provide a completely new treatment option for patients.”

VAL-1000 is a synthetic derivative of a natural alkaloid with a history of safe use in humans, but which has yet to be tested in acute leukaemia.

Senz was established in February to develop VAL-1000 as a leukaemia treatment, and secured seed investment for the development from US-based CoValence in August.