Panbela Therapeutics, a U.S.-based clinical stage company, announced today (August 11) that it has enrolled its first patient in a global trial to evaluate a potential cure for pancreatic cancer.
The trial referred to as ASPIRE will involve studying SBP-101, a treatment for metastatic pancreatic ductal adenocarcinoma.
It is a randomized, double-blind placebo-controlled, trial with a primary endpoint of overall survival.
Jennifer Simpson, president and CEO of Panbela, which has subsidiaries in Australia, said that while initiation was gradual, the company is pleased with the current momentum of the ASPIRE trial.
She said: “We expect that a significant number of global sites will be open by year-end with the full complement of sites open by the first quarter 2023. Australia opened last week with the first site activated within the country, and now they’ve enrolled the first patient into the study.
“Australian study centers have been wonderful to work with and were important contributors to our phase 1 trial, enrolling a heavy preponderance of the 50 patients. We’re excited to reach this milestone of first patient enrolled, as we move forward towards interim analysis which is expected to complete in early 2024.”
Australia marked the second country activated for the ASPIRE trial, and first to enroll, with approximately 90 additional sites expected to be activated across 10 countries by early 2023.
Additionally, in response to European and FDA regulatory feedback, the study was amended to include the total trial sample size (600 subjects) and the design modified to utilize overall survival as the primary endpoint to be examined at an interim analysis. While the trial is expected to take approximately 36 months to fully enroll, the interim analysis is still expected to occur in early 2024.
Panbela’s pipeline consists of assets currently in clinical trials with an initial focus on familial adenomatous polyposis (FAP), first-line metastatic pancreatic cancer, neoadjuvant pancreatic cancer, colorectal cancer prevention and ovarian cancer. The combined development programs have a steady cadence of catalysts with programs ranging from pre-clinical to registration studies.
SBP-101 is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition by exploiting an observed high affinity of the compound for pancreatic ductal adenocarcinoma and other tumors.
Objective response rate
The molecule has shown signals of tumor growth inhibition in clinical studies of U.S. and Australian metastatic pancreatic cancer patients, demonstrating a median overall survival of 14.6 months which is final, and an objective response rate of 48%, both exceeding what is seen typically with the standard of care of gemcitabine + nab-paclitaxel.
This suggests, the company says, the potential complementary activity with the existing FDA-approved standard chemotherapy regimen. In data evaluated from clinical studies to date, SBP-101 has not shown exacerbation of bone marrow suppression and peripheral neuropathy, which can be chemotherapy-related adverse events.
Serious visual adverse events have been evaluated and patients with a history of retinopathy or at risk of retinal detachment will be excluded from future SBP-101 studies. The safety data and polyamine metabolic inhibition profile observed in the current Panbela sponsored clinical trial provides support for continued evaluation of SBP-101 in a randomized clinical trial.