I cant find any Announcement in Jun 2019 about PTX 100. There is this one from Jul 2019, but it makes no mention of any readout date:
Prescient Therapeutics Initiates Phase 1b Clinical Trial for
First-in -Class Anti-Cancer Drug PTX-100
in Patients with Multiple Cancers
Highlights:
• Innovative ‘basket’ study design will assess drug in multiple cancers
• Precision medicine approach offers a potentially faster development route
• International cancer expert Prof Miles H. Prince, AM is lead investigator
• Growing oncology industry interest in Ras pathways
MELBOURNE Australia, 11 July 2019: Prescient Therapeutics Limited (ASX: PTX), a clinical
stage oncology company, today announced the start of a Phase 1b trial of its second targeted
anti-cancer drug PTX-100 in Australia. 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. Researchers will
monitor the mutational status of patients’ malignancies and, using a small sample size, seek to
correlate this status with clinical activity. They 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. Professor Prince is an internationally renowned oncologist, with a
highly respected reputation in cancer research, and has worked successfully on the development
of many cancer drugs.
An earlier clinical study conducted at Pennsylvania State University and Indiana State University
in patients with advanced solid tumors 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 tumor origin. This
strategy has been successfully pioneered by several US companies like Loxo Oncology, Inc
(acquired by Eli Lilly and Company for US$8 Billion in January 2019) as a faster way to identify
cancer patients who will potentially benefit from the therapy.
Professor Prince said, “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.”
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 open-label, non-randomized 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. Patients will receive the drug by
intravenous infusion over 60 minutes on days one to five of a 14-day cycle for four cycles unless
toxicity is observed. The aim is to identify the optimal time and dose-dependent effect of multiple
doses of PTX-100.
Professor Miles H Prince AM
Professor Prince is involved in major clinical research programs ranging from the use of stem
cells to the mechanism of the immune systems control of blood and cancer growth. He holds
major Australian, American and European research grants and has published over 300 journal
articles. He is a member of Australian, American and European Societies of Haematology and
Oncology, and is on the boards of International Society of cutaneous lymphoma, International
Waldenstrom's Macroglobulinemia Foundation and chairman of the Medical Scientific Advisory
Group of Myeloma Australia. Professor Prince has recently been appointed Director of Molecular
Oncology and Cancer Immunology at the Epworth Hospital.
Industry focus on Ras pathways
Although Ras has long been identified as an important target driving cancer, successful inhibition
of Ras has proven elusive, due to a lack of binding sites on the molecule. In May 2019,
multinational biopharmaceutical company Amgen announced encouraging Phase 1 studies with
its Ras inhibitor AMG-510, which targets a small proportion of Ras with a particular mutation. This
has led to a surge in industry interest in Ras.
Unlike other attempts at direct Ras inhibition, PTX-100 disrupts the Ras pathway downstream. It
blocks the cancer growth enzyme known as geranylgeranyl transferase-1 (GGT-1) which
inactivates Rho, Rac and Ral circuits in cancer cells downstream of Ras. PTX-100 is able to
target not only cancers with Ras mutations, but also cancers with Rho mutations. PTX-100 is the
only Rho inhibitor in clinical development worldwide.
PTX-100 is licensed by Prescient from Yale University, and was invented by Prescient Chief
Scientific Officer, Professor Said Sebti, and Professor Andrew Hamilton, now President of New
York University.
ENDS
The next announcement about PTX 100 Is to announce the dosing of the First patient in Nov 2019. Once again there is no indication of any readout dates.
There are several updates re PTX 100 throughout 2020 as higher dosing thresholds are started.
And then on the 24 Nov 2020 the following announcement was delivered, it contains a timeline of all that was delivered by PTX during the year:
PRESCIENT THERAPEUTICS LIMITED (ASX
TX) - Ann: AGM Presentation, page-1 - HotCopper | ASX Share Prices, Stock Market & Share Trading ForumPTX-100 trial
– a great
“problem” to have!
• Patients are staying on therapy
much longer (and at earlier
cohorts) than we anticipated
• Requires manufacturing
additional PTX-100 and managing
patient enrolment
• May push study dates out, but for
a good reason!
This is taken from the above announcement.
So raiizo, it would seem your concerns are not actually based on any fact.
