Prescient’s “BASKET” Approach Transforming Future Clinical Trials

  • Jan 30, 2020 AEDT
  • Team Kalkine
Prescient’s “BASKET” Approach Transforming Future Clinical Trials

Clinical-stage oncology company, headquartered in Melbourne, Australia, Prescient Therapeutics (ASX:PTX) (“Prescient”), develops personalised medicines to defeat cancer taking an approach to address mutations that cause cancer.

Current “one size fits all” approaches are associated with serious risks and lead to poor outcome and without precision medicine, all patients are treated the same irrespective of the differences between individuals. Prescient’s personalised medicine approach focuses on individual tumour variability considering different tumours have different drivers and is more effective way of treating cancer patients. It is a huge area with the industry expected to grow to US$93 billion by 2023.

Prescient’s Deep Clinical Pipeline

Prescient is known for its deep clinical pipelines, with two novel lead drug candidates, PTX-100 and PTX-200, well backed by renowned cancer centers in the United States.

Prescient’s innovative PTX-100; a targeted cancer therapy

Prescient’s unique, First-In-Class PTX-100 has a distinctive mode of action that inhibits the post-translation modification of Rho, Ral, and Rac where Rho is required for their activation, eventually disrupting the Ras pathway downstream.

Mode of action of PTX-100. Source: Company Presentation

PTX-100 Phase 1 b Trial

The Company initiated Phase 1b trial of PTX-100 in July 2019, in patients with multiple cancers. It is an open-label, non-randomized trial in which up to 24 patients would be registered for evaluating pharmacokinetics and pharmacodynamics of PTX-100. The study is aimed to identify the optimum time & dose-dependent effect of PTX-100 given in multiple doses to patients having advanced tumours. To achieve this, the safety and efficacy of up to three different PTX-100 doses would be determined, wherein the drug would be given via intravenous infusion over 60 minutes on days 1-5 in a 14- day cycle for 4 cycles till the time drug toxicity is detected.

It was further notified that Prescient would pursue this study to identify the mutational status of each patients’ malignancies and would pursue to correlate this status with any clinical activity within the limitations of a small sample size. To identify patients that may be most likely to respond to PTX-100 treatment, several cancer biomarkers would be investigated.

Prescient Therapeutics in November 2019 announced that the first patient has been administered with Prescient’s second targeted anti-cancer drug, PTX-100 in the ongoing Phase 1b clinical trial, for Prescient’s first-in-class cancer therapy.

Previously, the Phase 1 trial of PTX-100 conducted in the US at Pennsylvania State University and Indiana State University in patients with advanced solid tumours have been completed which demonstrated that PTX-100 was well-tolerated and exhibited clinical activity.

“BASKET” studies, like Prescient’s approach for PTX-100, are revolutionising the future of clinical trials

In contrast to conventional clinical trials, Prescient is pursuing a development program using a “BASKET” approach while grouping patients’ based on mutational profile of the tumour, instead of the tumour origin. “Basket” trial bundles recognises patients who carry this mutation and turns it off with a specific targeted therapy.

Basket studies have been successfully pioneered by several US companies, such as Loxo Oncology, Inc., which was taken over by Eli Lilly and Company in January 2019 for US$8 Billion. This strategy offers shorter developmental path as these studies have quickly identified patient populations who may possibly benefit from the investigational drug, sometimes leading to fast track approval.

PTX 100 Phase 1b basket trial is being conducted at Epworth HealthCare in Melbourne under the guidance of a globally recognised oncologist, Professor Miles H. Prince AM.

Prescient’s Managing Director & CEO Steven Yatomi-Clarke is pleased with Prescient’s productive collaboration with Professor Prince and his team at Epworth aimed to advance this vital clinical program. He further stated that in attempts to develop effective new treatments for a range of hard to treat cancers, dosing the first patient in this study is an important milestone.

PTX-100 trial is well- funded underpinned by life-science focused funds in Australia and the United States.

With a market capitalisation of $22.08 million and 394.26 million outstanding shares, PTX settled the day’s trade at $0.054, on 30 January 2020.

To know more about Prescient Therapeutics Limited, click here.

To stay updated with PTX company activities and announcements, please update your details on their investor centre.


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