Clinical-stage oncology company Prescient Therapeutics (ASX:PTX) has announced the US FDA has lifted the clinical hold placed on the company’s Phase 1b trial of PTX- 200 in patients with platinum resistant ovarian cancer.
Prescient said it is now preparing to resume recruitment of patients in the trial.
The company paused its three clinical trials of PTX-200 following a serious adverse event in a patient with late stage breast cancer who experienced liver failure and passed away.
"These severe adverse event are not unusual in oncology clinical studies where patients are very ill and where existing standard therapies can have potentially serious adverse effects," said the company in a statement.
"Prescient has responded to the FDA’s requests for the ovarian cancer trial, including an updated risk mitigation plan, to the FDA’s satisfaction, and removal of the clinical hold allows the trial to resume," it said.
This development follows the FDA lifting the clinical hold on the company’s trial of PTX-200 in patients with refractory or relapsed Acute Myeloid Leukaemia (AML), announced on September 4.
The remaining clinical hold is the PTX-200 trial in patients with metastatic and locally advanced HER2 negative breast cancer, which Prescient said it is addressing. This trial had successfully completed the Phase 1b study prior to it being placed on hold.
According to Prescient’s CEO and managing director, Steven Yatomi-Clarke, “We are pleased to resume our trial of PTX-200 in ovarian cancer, which represents a significant unmet medical need, particularly for women affected by platinum resistant forms of the disease. Our team is addressing our last remaining clinical hold, and will continue to work with the FDA in a similar process until it is resolved. In the meantime, Prescient has a busy and exciting schedule of clinical activity with PTX-200 in AML and ovarian cancer, as well as activities for PTX-100 in RhoA mutant lymphomas.”