- Cancer treatment company Race Oncology (RAC) comes out of a trading halt to announce the completion of the first phase of its Zantrene combination study
- The study, conducted in Israel, dosed six patients with relapsed acute myeloid leukaemia (AML), with one patient showing a complete response — meaning there were no signs of cancer
- Two more patients showed a partial response, two showed no response, and one was non-assessable after sadly passing away from infection
- The company will now progress trials to phase two, which will see a four-day schedule of Zantrene in up to 17 patients
- RAC shares are up 0.29 per cent and trading at $1.74 at 12:30 pm AEST.
Cancer treatment company Race Oncology (RAC) has completed the latest stage of its first-phase trial for its Zantrene product, with one patient showing a complete response.
This stage of the trial, conducted at the Chaim Sheba Medical Centre in Israel, saw a dose-escalation on six patients who had a relapse of acute myeloid leukaemia (AML) and were defined as being “heavily pre-treated”, receiving between two and eight lines of AML treatment.
Out of the six patients, one patient showed a complete response — meaning there were no signs of cancer in response to the treatment. Two patients showed a partial response, two showed no response, and one patient was non-assessable due to death caused by infection.
Race said the aim of this initial phase of the trial was to establish the dosing level to be used in the next phase of the clinical trial.
In the latest phase, two of the six patients treated had reported dose-limiting toxicities. The company said these two patients had both received the highest lines of pre-treatment, being five and eight.
One of the two had grade-three elevated liver enzymes while the other patient developed a grade five infection and unfortunately passed away. Race said infection is a known side-effect of intensive chemotherapy and was a leading cause of death in AML patients.
Three of the five patients, who notably had received the lowest lines of pre-treatment (sub-five) were then bridged to an allogeneic stem cell transplant, which the company said was an important positive outcome as it had the potential to provide long-term remission.
The trial is now set to move onto phase two efficacy, which will use a four-day schedule of Zantrene, recruiting up to 17 patients.
“We are very excited about the positive data from the first stage of this trial in such a heavily pre-treated R/R AML population, and we now look forward to the next phase, where we expect to see more patients respond favourably and with a consistently tolerable side effect profile,” Race Clinical Advisory Board Chair Prof Borje Andersson said.
“It appears that bridging to transplantation with long-term disease control can be achieved with confidence, given we can since perceive that the side effects reverse within a few weeks of the course being completed.”
RAC shares were up 0.29 per cent and trading at $1.74 at 12:30 pm AEST.