Pancreatic adenocarcinoma treatment.
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 enrollment 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 tumors.
The international, double-blind, randomized, placebo-controlled trial is intended to be carried out by the company at cancer centres in Europe, the US and the Asia-Pacific region.
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 rigor 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 tumor 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.