Australian company Prescient Therapeutics (ASX:PTX), a clinical-stage oncology company, has started a Phase 1b trial of its second targeted anti-cancer drug PTX-100 in Australia.
PTX-100 a targeted cancer therapy PTX-100 is a first-in-class drug candidate that works by blocking a common cancer growth enzyme which plays a key role in malignant cell transformation. It disrupts the oncogenic Ras pathways by inhibiting the activation of Rho, Rac and Ral circuits in cancer cells, leading to the death of cancer cells.
The company said the new study is designed to rapidly identify the optimal dose and treatment schedule of PTX-100 in a variety of malignancies including myeloma, T-cell lymphomas, gastric and pancreatic cancers with Ras and RhoA mutations.
The open-label, non-randomised trial will enrol up to 24 participants to evaluate the pharmacokinetics and pharmacodynamics of the drug as well as safety and efficacy of two different doses in patients with advanced malignancies.
"Researchers will monitor the mutational status of patients’ malignancies and, using a small sample size, seek to correlate this status with clinical activity," said the company, adding it will also study several cancer biomarkers to identify patients most likely to respond to PTX-100 therapy.
One of the world’s leading cancer researchers, Melbourne-based Professor H. Miles Prince AM, will be the lead investigator.
An earlier clinical study conducted at Pennsylvania State University and Indiana State University in patients with advanced solid tumours showed that PTX-100 was well-tolerated and achieved stable disease in patients.
Unlike conventional clinical trials, the new study will take a ‘basket’ approach to assess the drug on multiple cancers with a view to addressing specific mutations, rather than tumour origin.
This strategy has been successfully pioneered by several companies, including Loxo Oncology, which was recently acquired by Eli Lilly for US$8 Billion.
According to Professor Prince, “Molecularly targeted therapy is the way forward in treating cancers. We know the pathway that is targeted by PTX-100 is critical to the survival of the cancers included in this study. As a cancer specialist I want to see PTX-100 added to the tool-box of targeted treatments.”
Professor Prince and his team will treat patients at the Epworth Hospital in Melbourne.
Prescient Therapeutics Managing Director and CEO Steven Yatomi-Clarke said, “Commencing this novel study is a significant milestone for Prescient. Not many companies can boast a drug that is first-in-class entering the clinic. PTX-100 is a truly differentiated and unique inhibitor, and this further demonstrates Prescient’s ability to progress important new therapies for cancer patients. It is another big step forward in our goal of building a robust pipeline of personalized therapies against cancer.
“Furthermore, it is a significant coup for Prescient to have an outstanding authority in Professor Miles Prince lead this study, and speaks to the quality of the clinical faculty leading Prescient’s trials.”