With forthcoming data on the breast cancer 1b clinical trail due early 2H 2016, I thought a re-post of the February update might refresh our minds and make new members aware of proceedings (so back to the science).
ASX Release
17 February 2016
PTX-200 Breast Cancer Trial Progresses
• Phase Ib breast cancer trial enters expansion cohort
• H. Lee Moffitt Cancer Center joins trial recruitment
Melbourne, Australia 17 February 2016: Clinical stage oncology company Prescient Therapeutics Ltd (PTX) is
pleased to announce that the last patient (patient 17) has been dosed in the escalation stage of its Akt
inhibition Phase Ib breast cancer trial at the Montefiore Cancer Center of Albert Einstein University in New
York (Albert Einstein University) under the guidance of Professor Joseph Sparano. The trial is targeting
women with metastatic and locally advanced HER2 negative breast cancer.
This last patient received treatment on the third dose level and had no dose limiting toxicity (DLT). As a result,
the recommended Phase II dose (RPTD) for this trial has been determined as 35 mg/m2 PTX-200, together with
chemotherapy.
As part of this expansion stage, PTX is pleased to announce that the H. Lee Moffitt Cancer Center (Moffitt) in
Tampa, Florida will shortly join Albert Einstein University in the Phase Ib expansion cohort and the Phase II
trial, and is expected to soon commence recruitment.
Dr. Heather Han, a medical oncologist specializing in breast cancer in The Center for Women’s Oncology at
Moffitt, will conduct the study.
PTX’s Chief Medical Officer, Terrence Chew, M.D. said “We are making good progress with this trial under
Professor Sparano’s guidance and I am delighted that a physician of Dr Han’s caliber has agreed to join the
trial.”
Professor Sparano said “We have amended the protocol to expand the inclusion criteria to include patients
with metastatic breast cancer and prior anthraycline exposure plus patients with stage IIB-
Keys.
Toxicity levels....non significant
Phase 2 dose level.....set
Cohort expansion....yes
Luck to all who hold....
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