- After demonstrating the safety at a dose of 1,000 mg/m2, Phase 1b study of PTX-100 will proceed to the increased dose of 2,000 mg/m2.
- Two patients from the first 500 mg/m2 cohort had reported with stable disease or better at the end of four cycles of PTX-100.
- Phase1b study aims to identify the optimal time and dose-dependent effect of multiple doses of PTX-100.
- PTX-100 will be administered to the patients by intravenous infusion (IV) over sixty minutes on days one to five of a 14-day cycle for four cycles unless any toxicity is examined.
ASX-listed clinical-stage oncology company Prescient Therapeutics Limited (ASX:PTX) continues to move ahead progressively with its Phase 1b basket study after demonstrating the safety of PTX-100 at a dose of 1,000 mg/m2.
First-in-class Ras pathway inhibitor PTX-100 was initially tested for 500 mg/m2, following the amount proved safe, Phase 1 Basket Study moved to the next dose level of 1,000 mg/m2.
On 12 August 2020, Prescient announced that the Phase 1b study of PTX-100 will proceed to the increased dose of 2,000 mg/m2. Post announcement on ASX, PTX was trading at A$0.064 up by 10.345% at AEST 2:35 PM.
Prescient is currently conducting a Share Purchase Plan (SPP) at 5.5c which closes on 17 August 2020 at 5 PM AEST. Click here to request personalised SPP forms.
First-in class Ras pathway inhibitor, PTX-100 at a glance-
PTX-100 is licensed by Prescient Therapeutics from Yale University, and is a first-in-class drug that works by disruption of the oncogenic Ras pathway by impeding the activation of three proteins- Rho, Rac and Ral, leading to cancer cells death.
In a prior study conducted at Pennsylvania State University and Indiana State University in the United States, PTX-100 was well-tolerated and accomplished stable disease status in patients with advanced solid tumors.
PTX100 Phase 1b Basket Study Progressed to Dose Escalation To 2000mg/m2
Prescient Therapeutics revealed that the Phase 1b study of PTX-100 will proceed to the next dose level after successfully completing the second cohort of patients and exhibiting acceptable safety.
The Phase 1b study of PTX-100 is being conducted at Melbourne’s Epworth Healthcare and Peninsula & South Eastern Haematology and Oncology Group.
Additionally, the follow-up investigations on patients in the 1st group at a dose of 500 mg/m2 of PTX-100 has revealed two patients with partial response and stable disease.
The basket study of PTX-100 is for determination of the safety, dose regimen as well as its treatment schedule as a single agent, in various cancers with prevalent Ras and RhoA mutations.
Ras and RhoA mutations appear in many cancer types, yet there are no approved therapies against Ras or RhoA mutant cancers.
PTX100 Dose 1,000 mg/m2 Demonstrated Safe-
Prescient disclosed that the three patients enrolled and treated in the 2nd study cohort were heavily pre-treated patients having advanced pancreatic cancer, peripheral T cell lymphoma and Angioimmunoblastic T-cell lymphoma.
Notably, the patients in this cohort received 1,000 mg/m2 doses of PTX100 without any drug-related safety concerns observed.
On the basis of these safety observations, the safety monitoring committee of the study approved the trial to progress to the next dose of 2,000 mg/m2 of PTX-100.
Additionally, two patients from the first 500 mg/m2 cohort had reported with stable disease or better at the end of four cycles of PTX-100 and meet criteria for constant treatment under the protocol.
One patient in the 500mg/m2 cohort has multi-chemorefractory PTCL and is stable while the other patient, having cutaneous T cell lymphoma attained a partial response. Both of these patients have received nine cycles of PTX-100 treatment.
PTX-100 Basket Study Details
The Phase 1b basket study is led by an internationally renowned oncologist Professor H. Miles Prince AM, who has contributed to the successful development of several innovative breakthrough cancer therapies.
- PTX-100 Phase 1 basket study is an open-label, non-randomized trial.
- This study will enroll up to 24 candidates for evaluating the pharmacokinetics and pharmacodynamics of PTX-100, along with safety & efficacy of up to three different doses in patients with advanced malignancies.
- The objective is to identify the optimal time and dose-dependent effect of multiple doses of PTX-100.
- The study takes a ‘basket’ approach to evaluate the drug on several cancers with a view to addressing specific mutations, instead of the origin of tumor.
Basket studies pioneered by several United States companies have rapidly identified patient populations that could benefit from the investigational drug, sometimes leading to fast track approval.
PTX-100 will be administered to the patients by intravenous infusion (IV) over sixty minutes on days one to five of a 14-day cycle for four cycles unless any toxicity is examined.
Furthermore, the company is looking for identification of the mutational status of malignancies of each patient and, within the restrictions of small sample size, seek to correlate this status with any clinical activity.
Numerous biomarkers of cancer will be examined for the identification of patients that may be most likely to respond to PTX-100 therapy.
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