Panbela Therapeutics has announced the commencement of the Phase II ASPIRE clinical trial of SBP-101 plus gemcitabine and nab-paclitaxel to treat metastatic pancreatic ductal adenocarcinoma patients.
The first study centre was activated at Summit Cancer Centers in Spokane, Washington, US. Nearly 60 further sites are planned to be activated this year.
Screening for eligible subjects for the trial has started and enrolment is anticipated to conclude in nearly one year.
A polyamine analogue, SBP-101 can potentially prompt polyamine metabolic inhibition (PMI) by exploiting an increased affinity of the compound for pancreatic ductal adenocarcinoma and other tumours.
The international, double-blind, randomised, placebo-controlled trial is intended to be carried out by the company at cancer centres in Europe, the US and the Asia-Pacific region.
Overall survival is the primary endpoint of the trial.
The trial will also comprise a futility assessment following 104 progression-free survival events.
Panbela president and CEO Jennifer Simpson said: “Pancreatic cancer is one of the most common causes of cancer deaths in the United States and represents a significant unmet medical need, as is underscored by SBP-101’s Fast Track and Orphan Drug designations.
“We are enthusiastic about having initiated the ASPIRE global randomised Phase II trial. Given the rigour of the trial design, we expect the resulting data to support our registration effort.”
In the trial that included individuals with metastatic pancreatic cancer from the US and Australia, SBP-101 demonstrated possible tumour growth inhibition signals.
This indicates the possibility of a complementary activity of SPB-101 with a current Food and Drug Administration-approved standard chemotherapy regimen, if the former obtains approval in the US.
According to findings from trials analysed so far, SBP-101 showed no exacerbation of bone marrow suppression and peripheral neuropathy, which could be the adverse events linked to chemotherapy.
Furthermore, the safety data and PMI profile noted in the present trial sponsored by the company offer support to analyse SBP-101 in a randomised trial.