Australian-based oncology firm Prescient Therapeutics has temporarily paused enrolment in the clinical trials of its product candidate PTX-200 to further investigate a serious adverse event (SAE) that occurred in one of the trials.
PTX-200 is an anti-proliferative, pro-apoptotic, selective Akt activation inhibitor that acts by binding to Akt’s PH domain.
The firm reported that during a Phase Ib trial evaluating the drug in combination with paclitaxel for the treatment of breast cancer, the last patient passed away after experiencing an undisclosed SAE.
The trial recruited a total of 29 patients and the incident followed the preliminary safety and efficacy analyses in a female patient with stage IV metastatic triple negative breast cancer who experienced hepatic (liver) failure.
At the time, the patient was also undergoing treatment with paclitaxel, which is said to affect liver metabolism.
According to its operating procedures, the firm has ceased the recruitment to each of its PTX-200 trials until the US Food and Drug Administration (FDA) formally lifts the clinical hold.
In response to the hold, Prescient had notified and submitted a report to the FDA, which will be aiding the firm in updating its risk mitigation plan to enhance efficacy and patient safety.
Prescient Therapeutics CEO and managing director Steven Yatomi-Clarke said: “We are in close dialogue with the FDA and expect to incorporate its recommendations and modifications into the trial protocols so that recruitment can re-commence at the earliest opportunity.”
In addition to the Phase Ib/II trial for breast cancer, PTX-200 is being studied in another Phase Ib/II trial to treat relapse and refractory acute myeloid leukaemia and in a third Phase Ib/II trial for recurrent or persistent platinum-resistant ovarian cancer.