Prescient Therapeutics advances development of PTX-100

Latest News

Prescient Therapeutics (ASX:PTX) says the Phase 1b study of PTX-100 will proceed to the next dose level following successful completion of the first cohort of patients and demonstrating acceptable safety.

The company said Peninsula and South Eastern Haematology and Oncology Group (PASO) has also been added as a new site to the study to aid recruitment and diversity of cancer types.

The Phase 1b 'basket study' is assessing the safety, dose regimen and treatment schedule of PTX100, a first-in-class drug, against several cancers where Ras and RhoA mutations are prevalent.

The company said three patients in the first study cohort were heavily pre-treated patients suffering from advanced multiple myeloma, cutaneous T cell lymphoma (CTCL) and peripheral T-cell lymphoma (PTCL).

The patients in this cohort received 500mg/m2 doses of PTX100 with no drug-related safety issues observed, it said, adding the study’s safety monitoring committee has endorsed the trial to proceed to the next dose of 1,000 mg/m2 of PTX-100.

"The clinical team at the Epworth Hospital reported that the patient with CTCL experienced symptomatic relief and has requested to continue PTX-100 therapy in line with the protocol. The clinical response status of this patient is yet to be confirmed," said the company in a statement.

Prescient also announced the expansion of the study to include PASO in South-Eastern Victoria under the guidance of Professor Vinod Ganju.

According to the study’s Principal Investigator, Professor Miles Prince AM, "We were able to enrol and treat heavily pre-treated patients in the initial cohort, with the regimen of PTX-100 being well tolerated with no drug related adverse events. We are encouraged and excited to be proceeding into the second cohort of this trial at a higher dose of PTX-100. It is also great to welcome Professor Ganju's centre in the next cohort to further progress this important study."

Prescient CEO and managing director Steven Yatomi-Clarke said, "We are delighted with the safety profile in the first cohort leading to a dose escalation of PTX-100, especially in heavily pre-treated patients with advanced cancers. We are especially pleased at the progress of this trial in the face of substantial global disruptions.

“The Ras pathway has been in focus over the last 12 months, receiving much attention from the medical and pharmaceutical communities, and we believe the outcomes of this PTX-100 study – especially as a unique, first-in-class inhibitor of this pathway - will warrant attention.”