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Interim clinical trial results show promise in the treatment of Acute Promyelocytic Leukaemia (APL)

The Australasian Leukaemia and Lymphoma Group (ALLG) are pleased to announce the launch of the APML5 interim clinical trial results at the 24th Congress of the European Hematology Association (EHA) in Amsterdam in June 2019.

The interim results show promise for an oral arsenic formulation for treatment of Acute Promyelocytic Leukemia (APL) which is a subtype of acute myeloid leukemia (AML), and accounts for only 10% of all AML diagnoses. It is a rare disease, with an incidence rate of less than 100 newly diagnosed cases in Australia each year[1].

Clinical trial APML5, led by Professor Harry Iland and Associate Professor Andrew Wei, opened with the first phase of the trial in 2017, to determine the bioavailability of an oral capsule formulation of arsenic trioxide (ATO) relative to intravenous administration.

ALLG Scientific Advisory Committee representative, Professor David Ritchie said, “the oral capsule by Phebra was an exciting development and testament to the innovation in new treatment options for blood cancer patients.”

 “The results indicate that the formulation of arsenic studied by the ALLG is efficiently absorbed and provides circulating arsenic levels comparable to those achieved with intravenous infusions that typically require administration over 2 hours.”

“Data collected and analysed from the first phase of this trial has resulted in the establishment of an appropriate oral dose for continuation into the subsequent second phase of the study.”

“The promising evidence will lead the way in establishing the global efficacy and safety of oral ATO in the continuing treatment of APL”, said Prof Ritchie.

Phebra CEO, Dr Eutick, said that “having intimate knowledge of the chemistry of arsenic metal complexes and a good understanding of the treatment regimens employed to treat APL, it was clear to Phebra that an oral formulation of arsenic trioxide would be highly beneficial for patients.”

“We are excited that the oral arsenic capsule has the potential to provide people suffering with acute promyelocytic leukaemia an effective treatment delivered in a more convenient manner”, he added.