MELBOURNE, AUSTRALIA: November 07, 2012 — Senz Oncology Pty Ltd (“Senz”)
announced today that the ?rst patient has commenced treatment in a Phase I/II clinical
evaluation of VAL-1000 in patients with acute leukaemias (protocol SO-2012-1).
The single-arm, open-label clinical trial will be conducted under the guidance of
Principal Investigator, Dr Andrew Wei, Head of Leukaemia Services at The Alfred
Hospital, Melbourne, Australia.
“We are very pleased to have Dr Wei as Principal Investigator for the VAL-1000 Phase I/
II clinical trial,” said Dr Ian Nisbet, Executive Director, Senz Oncology. “Dr Wei’s input
into the preclinical studies provided new scienti?c insights and the clinical rationale for
VAL-1000 in acute leukaemias”
The primary objective of the trial is to evaluate the safety and tolerability of VAL-1000
in adult patients with acute leukaemias that are unsuitable for treatment with standard
The trial will also evaluate secondary objectives including assessing patient related
efcacy outcomes, measuring VAL-1000 pharmacokinetics and de?ning a dose level
for testing in subsequent Phase II clinical trials.
Approximately 900 patients are diagnosed with Acute Myeloid Leukaemia (AML) in
Australia annually. The majority will relapse, especially those over the age of 60 and
with poor risk cytogenetic and molecular characteristics. Patients falling into these
categories have very limited treatment options once standard approaches have been
According to Dr Anthony Filippis, Executive Director, Senz Oncology, “The trial will be
the ?rst time that VAL-1000 has been tested clinically for the treatment of acute
leukaemias; if ultimately shown to be safe and efcacious it could provide a completely
new treatment option for patients.”
About Senz Oncology
Senz Oncology Pty Ltd (www.senzoncology.com) is a private drug development company
leveraging the Australian regulatory framework and taxation environment to conduct time and
cost efective development of new cancer therapies.
VAL-1000 is a synthetic derivative of a natural alkaloid. It has a history of safe use in humans
but has not been tested previously in acute leukaemias. It is an orally bioavailable, small
molecule drug that is active in vitro against both primary human leukaemia cells and leukaemia
cell lines. VAL-1000 induces cell death of leukaemic cells by a mechanism of action that is
distinct from other chemotherapeutic drugs.
About the SO-2012-1 clinical trial
SO-2012-1 is an open-label, Phase I/II clinical trial to evaluate VAL-1000 in acute leukaemias.
It is being conducted at a single site, The Alfred Hospital, under the Clinical Trials Noti?cation
(CTN) scheme. Dr Andrew Wei is the Principal Investigator.
The primary objective of the trial is to evaluate the safety and tolerability of VAL-1000 in adult
patients with acute leukaemias that are unsuitable for treatment with standard chemotherapy
treatments. Eligible patients include patients with acute myeloid leukaemia (AML), acute
lymphocytic leukaemia (ALL) or high risk myodysplastic syndrome (MDS) who are unsuitable for
treatment with standard chemotherapeutic regimens, such as patients who are elderly (>70
years), poor risk (adverse risk karyotype) or who have failed up to three lines of intensive
The trial will also evaluate secondary objectives including assessing patient related efcacy
outcomes, measuring VAL-1000 pharmacokinetics and de?ning a dose level for testing in
subsequent Phase II clinical trials.
The study design includes a dose escalation component (four dose levels of three to six
patients) to identify a maximum tolerated dose (MTD), followed by an expansion of the MTD
patient cohort. Patients will be able to receive up to 48 weeks of treatment with VAL-1000. Up
to 30 evaluable patients will be enrolled in the trial.
Dr Anthony Filippis, Executive Director, Senz Oncology
Phone: +61 (0) 419 507 880
Dr Andrew Wei, Head of Leukaemia Services, The Alfred Hospital