Clinical stage oncology company Prescient Therapeutics (ASX: PTX) announced what it said were encouraging early clinical data from its ongoing Phase 1b/2 study of novel cancer drug PTX-200 in breast, lung and esophageal cancer.
The Investigator Sponsored Trial (IST), which has been partially funded by the US National Cancer Institute, is led by Professor Joseph Sparano of the Montefiore Medical Center and the Albert Einstein College of Medicines and Cancer Centre.
Professor Sparano said PTX-200 is a promising oncology compound.
"In the phase 2 study that will begin upon completion of the expansion cohort, we will determine the pathologic response rate after PTX-200 plus paclitaxel therapy in patients with locally advanced breast cancer - this model has been used in other trials to identify promising new agents and advance their development in a rapid and efficient manner," he said.
The company said 14 patients with advance cancer have been treated with PTX-200 in combination with weekly paclitaxel, "with evidence of antitumor activity noted."
"PTX-200 inhibits an important tumor survival pathway known as AKT, which plays a key role in the development of many tumors, and contributes to paclitaxel resistance," said the company. "Dose escalation of PTX-200 has proceeded to the third and final dose level, and the researchers will soon initiate an expansion cohort in 12 patients at the recommended phase II dose of PTX-200 to better characterize the safety profile of the combination."
According to Prescient CEO, Dr Rob Crombie, "One must always be cautious in interpreting data from such a small patient number, however we are sufficiently encouraged that we are positioned to move into expansion phase of the study.
"To this end, we are pleased to advise that one of the world's largest cancer centres, the Moffitt Cancer Center, will now join the study under the direction of lead Investigator Dr Heather Han."
The company said a previous Phase I clinical study using PTX-200 as a single agent in patients with advanced leukaemia showed stabilisation of disease in 17 of 32 patients after a single round of treatment, with three patients showing a decrease in the number of leukaemic blast cells and one patient showing a marked reduction in leukocytosis and spleen size.
An additional Phase 1b/2 clinical trial of PTX-200 is underway in patients with recurrent of persistent platinum resistant ovarian cancer. Prescient said it is planning a Phase 1b/2 trial evaluating PTX-200 in combination with cytarabine in acute leukemia.