Prescient Therapeutics improves manufacturing route for PTX-100
Clinical-stage oncology company, Prescient Therapeutics Ltd (ASX:PTX) has today advised it has identified an improved manufacturing route for PTX-100 for use in its upcoming pharmacokinetic (PK) and pharmacodynamic (PD) clinical trial.
The new route has several advantages over the previous method, which are:
- Yielding twice as much drug product;
- Enabling a more meaningful number of patients to be treated in the upcoming study;
- Similar cost to the old method; and
- Regulatory compliance for all phases of study (whereas the old method was suitable only for phase 1).
Given that the manufacture of PTX-100 is a complex process, the company — led by Dr Mike Preigh, VP Chemistry, Manufacturing & Controls — has worked hard to achieve this improved manufacturing route, while at the same time keeping down the extensive costs that would otherwise be incurred.
PTX is planning a program for PTX-100 which will advance the asset towards a crucial PK and PD study for several malignancies, with the company expecting a PK/PD trial to initiate in early 2019. This trial will involve a more meaningful number of patients and will therefore be a more informative and productive study, and conducted to a higher regulatory standard.
The company is also in the planning stages for the manufacture of a new batch of active pharmaceutical ingredient (API) as a precursor to manufacturing additional PTX-200 drug product required for ongoing clinical trials, with the process proceeding on schedule.
Prescient CEO and Managing Director, Steven Yatomi-Clarke commented on today’s update: “Chemistry, Manufacturing and Controls (CMC) are a crucial part of drug development and clinical trials, although often unseen and under-appreciated.
“Prescient has invested in robust CMC programs for both assets which will hold it in good stead going forward,” he said.
Of course, it should be noted that PTX is still a speculative stock and anything can happen. Investors should seek professional financial advice if considering this stock for their portfolio.
Last week, the small cap updated the market on its trial of PTX-200 with cytarabine in relapsed or refractory acute myeloid leukaemia (AML).
Encouraging efficacy signals were seen as PTX looks to expand the current study to optimise Akt inhibition in the combination therapy.