Race Oncology Ltd (ASX:RAC) has added five new clinical trial sites in Italy and Spain in an expansion of its BISECT (RAC-006) Phase 1b/2a clinical trial assessing Zantrene in the treatment of extramedullary Acute Myeloid Leukaemia (EMD AML) and Myelodysplastic Syndromes (MDS).
Extramedullary AML occurs when leukaemia spreads from the bone marrow and forms solid tumours in tissues such as the skin, breast, kidney, brain or other organs.
MDS is a group of blood cancers that affects the production of normal blood cells in the bone marrow.
These include chronic myelomonocytic leukaemia (CMML), atypical chronic myeloid leukaemia (aCML) and myelodysplastic/myeloproliferative neoplasms unclassifiable (MDS/MPN).
RAC signed a clinical support agreement with global clinical research organisation Parexel International to support the additional trial monitoring activities, intending to accelerate patient recruitment and respond to European investigator interest in both Zantrene and EMD AML and MDS.
Trial garners interest from European clinicians
“We are pleased that we have received strong interest in our BISECT (RAC-006) EMD AML and MDS study from experienced European haematologists,” Race Oncology chief medical officer Dr David Fuller said.
“These clinicians identify a significant unmet need for the treatment of EMD AML and MDS and want to be actively involved in EMD clinical research.
“We look forward to activating these sites once we have cleared the necessary European Regulatory and Ethics approval process.”
Shares up
Shares have been as much as 4.88% higher intraday to A$1.72.
BISECT (RAC-006) is an open label Phase 1b/2a clinical trial in patients with EMD AML and MDS.
The trial’s endpoints will be complete response (CR) and complete response with incomplete haematological recovery (CRi), with the clinical aim of bridging the patient to an allogeneic hematopoietic stem cell transplant (Stratum 1), and safety and tolerability of the decitabine/Zantrene regimen (Stratum 2).
Secondary endpoints include safety and tolerability of Zantrene, overall and event-free survival, and the correlation of FTO expression or other biomarkers with response to treatment.
“This study supports our Pillar 3 FDA registration ambitions and builds on Zantrene’s historical safety and efficacy in AML,” Race Oncology CEO and managing director Phillip Lynch said.
“The clinical use of Zantrene using superior drug combinations offers hope to patients with difficult to treat forms of AML and MDS.”