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

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During June, we were excited to announce that a number of our clinical trials were being featured at the 24th Congress of the European Haematology Association (EHA) in Amsterdam.


The Annual Congress is a forum for haematologists to get together and share original research data, innovative ideas, and disseminate evidence-based knowledge for better standards of care for patients with blood cancer. As Europe’s leading and largest conference for blood disorders, over 12,000 Hematologists attended, representing over 60 countries, participating in scientific, clinical and educational sessions.

ALLG was represented through 6 poster presentations including: CLL06 (Prof David Gottlieb, A/Prof Constantine Tam, and Prof Stephen Mulligan), MM17 (Prof Andrew Spencer, and Dr Anna Kalff) , ALL6&CLL6 laboratory (Prof Alexander a Morley), NHL29 (Prof Judith Trotman and Dr Emma Verner) , ALL6 (Dr Matthew Greenwood and Dr Luciano Dalla-Pozza) and APML5 (Prof Harry Iland, and A/Prof Andrew Wei).

As part of the EHA conference, Prof Harry Iland launched the APML5 interim clinical trial results, a comparative bioavailability study of oral sodium hydrogen diarsenic tetroxide and intravenous arsenic trioxide in Acute Promyelocytic Leukemia (APL) patients undergoing consolidation therapy.

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 year1.

Led by Prof Harry Iland and A/Prof Andrew Wei, the trial 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, Prof 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.

1 Leukaemia Foundation Accessed April 2018