Prescient Therapeutics begins recruiting for expanded trial of PTX-100 in blood cancer
An initial phase 1b study evaluating PTX-100 in patients with T-cell lymphomas has produced “encouraging preliminary evidence”.
Prescient Therapeutics (ASX: PTX) has begun recruiting for an expanded clinical trial evaluating its drug PTX-100 in treating aggressive rare blood cancers where the company says there is a “significant unmet clinical need”.
The company announced this morning it has begun recruiting for the expansion cohort of the phase 1b trial in treating T-cell lymphomas.
Under the expansion cohort, between eight and 12 patients will be enrolled with relapsed and refractory T-cell lymphoma.
The study will be open-label, non-randomised and led by world-renowned haematologist Prof H Miles Prince at Melbourne’s Epworth Hospital.
Prescient noted that “excellent safety data” and “encouraging preliminary evidence” of clinical efficacy in the initial phase 1b study led to the expanded cohort, which will focus on patients with peripheral T-cell lymphomas (PTCL).
Patients with cutaneous T-cell lymphoma (CTCL) will be included in the trial to boost insight in drug activity in any T-cell lymphomas.
A shipment of PTX-100 has arrived in Australia to support the trial.
Prescient plans to complete recruitment of the expansion cohort by the end of the year.
PTCL blood cancers
PTCL refers to a group of uncommon and aggressive cancers that generally affect people aged 60 and over.
It occurs when a patient’s T-cells, which are an important part of the immune system, grow too quickly and out of control – turning cancerous.
Current treatments comprise combination chemotherapy regimens, radiotherapy, stem cell transplants and steroid therapy.
‘Encouraging preliminary evidence’
Under the initial phase 1b study, one PTCL patient has undergone 37 therapy cycles and is on PTX-100.
Prescient said this patient has “particularly aggressive disease” that failed five prior therapies, which were unable to control the disease for more than a few months before the disease progressed.
“When treated with PTX-100, this patient experienced a partial response (reduction in cancer burden), and this response has endured for 24 months so far,” the company stated.
Another patient with CTCL had failed three prior treatments and also had aggressive disease.
When treated with PTX-100, this patient also had a partial response, with reduced cancerous lesions and symptomatic relief.
This patient was on PTX-100 for 12 months.
Unmet need
According to Prescient, standard treatments for patients with this type of disease would expect to have disease progression within four months.
Prescient chief executive officer and managing director Steven Yatomi-Clarke said there was a lack of effective treatment options for PTCL blood cancers.
He said the unmet clinical need for treatments may provide a shorter regulatory path and the fastest route to market for PTX-100.
“Subject to efficacy observed in this expansion cohort, it may be possible to conduct a subsequent registration study that is smaller and shorter than large phase III studies typically seen in other cancer trials.”