Personalised cancer medicine developer Prescient Therapeutics (ASX: PTX) is proceeding with the Phase 1b study of its PTX-100 agent will proceed to the next dose level following successful completion of the second cohort of patients and demonstrating acceptable safety.
CEO and Managing Director, Steven Yatomi-Clarke, said follow-up analyses on patients in the first cohort at 500 mg/m2 has revealed two patients with partial response and stable disease.
The Phase 1b basket study will seeks to determine the safety, dose regimen and treatment schedule of PTX100 as a single agent, in several cancers where Ras and RhoA mutations are prevalent. These mutations are present in many cancer types, but there are still no approved therapies against either Ras or RhoA mutant cancers.
The study is being conducted at Melbourne’s Epworth Healthcare and Peninsula & South Eastern Haematology and Oncology Group.
The three patients enrolled and treated in the second study cohort were heavily pre-treated patients suffering from advanced pancreatic cancer; peripheral T cell lymphoma (PTCL) and Angioimmunoblastic T-cell lymphoma (AITL).
The patients in this cohort received 1,000 mg/m2 doses of PTX100 with no drug-related safety issues observed.
Mr Yatomi-Clarke said that based on these safety observations, the study’s safety monitoring committee approved the trial to proceed to the next dose of 2,000 mg/m2 of PTX-100.
In addition, two patients from the first 500 mg/m2 cohort had reported with stable disease or better at the end of 4 cycles of PTX-100 and meet criteria for continued treatment under the protocol.
One patient in 500mg/m2 cohort has multi-chemorefractory PTCL and is stable while and the other patient, who has cutaneous T cell lymphoma (CTCL) and achieved a partial response (PR). Both of these patients have received 9 cycles of PTX-100 treatment.
“We are very pleased to progress this unique study to the next dose level. We thank the patients involved and the dedication of the researcher teams for their work given the challenges and disruptions faced by everyone working in our healthcare system,” Mr Yatomi-Clarke said.
The PTX-100 basket study is an open-label, non-randomized trial that will enrol up to 24 participants to evaluate the pharmacokinetics and pharmacodynamics of PTX-100, as well as safety and efficacy of up to three different doses in patients with advanced malignancies.
