Senz Oncology Pty Ltd (Senz) has announced that the first patient has commenced treatment in a Phase I/II clinical evaluation of VAL-1000 in patients with acute leukemias (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 Leukemia 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 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 leukemias that are unsuitable for treatment with standard chemotherapy treatments.
The trial will also evaluate secondary objectives including assessing patient related efficacy outcomes, measuring VAL-1000 pharmacokinetics and defining a dose level for testing in subsequent Phase II clinical trials.
Approximately 900 patients are diagnosed with Acute Myeloid Leukemia (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 efficacious it could provide a completely new treatment option for patients.”
Click here for the complete issue.