10 Dec 2012, BioSpectrum Bureau , BioSpectrum
Singapore: Senz Oncology announced that the ﬁrst 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 the 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 scientiﬁc 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 chemotherapy treatments. The trial will also evaluate secondary objectives including assessing patient related efcacy outcomes, measuring VAL-1000 pharmacokinetics and deﬁning a dose level for testing in subsequent phase II clinical trials.
Approximately 900 patients are diagnozed 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 exhausted.
According to Dr Anthony Filippis, executive director, Senz Oncology, "The trial will be the ﬁrst 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."