No worries psych always great to discuss various views, it maybe the wording is ambiguous as a few posters have commented. I take this as no additional CR's with this latest cohort however safety has improved with no dose limiting toxicity events, enabling dose escalation in view of expanding on responses so far.
The 3 CR's as described in this Ann: - 'As previously reported, the three patients have achieved complete responses in the study so far'.
Were achieved sometime back, 27th November 2019: -ASX Announcement
Third complete response in PTX-200 AML Trial
MELBOURNE Australia, 27 November 2019: Prescient Therapeutics Limited (ASX: PTX) (“Prescient”), a clinical stage company developing personalised medicine approaches to cancer, today announced it would expand its Phase 1b study in patients with acute myeloid leukemia (AML), following an encouraging third complete response (total eradication of disease).
Three of a total of 15 patients experienced complete responses in the study in relapsed or refractory AML patients, which is a difficult to treat cancer population. The three patients had between 25-35mg/m2 PTX-200, together with 200-400mg/m2 cytarabine.
In consultation with the study investigators, Prescient is making a protocol amendment to change the dosing schedule of PTX-200 in relation to the administration of chemotherapy agent cytarabine with the aim of minimizing overlapping drug interactions. In a previous Phase 1b study in acute leukemias using PTX-200 as a single agent no such side effects were observed, suggesting that the effects seen in the current study may be due to the overlapping interaction of chemotherapy agent cytarabine and PTX-200. Generally, most patients receiving treatment on the study by group have tolerated planned dose levels. Transaminase elevation was observed in three patients, although only one was dose limiting. The amendment will go through usual FDA and ethics committee reviews and the study should be able to re-start enrolment in early 2020.
Prescient’s Chief Medical officer, Dr Terrence Chew said, “The three complete responses observed are very encouraging in a hard to treat patient population. Through this protocol
Three patients had total eradication of their cancer (complete response)
AML study to expand with protocol amendment to optimize dosing and schedule of PTX-200 & cytarabine based on recent results
amendment, we aim to get more patients through more cycles of therapy, with the hope of expanding upon these responses. Our investigators are very supportive of these amendments, as they are encouraged by these results in a patient population that is very difficult to treat and who currently have few treatment options.”
The study is led by world-renowned leukemia expert Professor Jeffrey Lancet at the H. Lee Moffitt Cancer Center in Florida; and also includes Kansas University Medical Center and Yale Cancer Center.
- Ends -
Cheers,
AMS
