On December 8, 2020 Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with cancer, reported that it has completed patient enrollment in its Phase 1 trial evaluating the safety and tolerability of SBP-101 when used in combination with standard of care agents gemcitabine and nab-paclitaxel for first-line treatment of patients with metastatic pancreatic ductal adenocarcinoma (PDA) (Press release, Sun BioPharma, DEC 8, 2020, View Source [SID1234572430]).
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The trial, which included a dose escalation phase and an expansion phase, enrolled 50 patients, 30 of whom were treated using the dose and schedule that will advance to a randomized trial of the combination versus gemcitabine and nab-paclitaxel alone planned to begin in the first half of 2021. In total, the safety of SBP-101 has been evaluated in 79 patients in two clinical trials.
"We are pleased to have completed enrollment in our Phase 1b trial and expect to announce data in the first half of next year," commented Jennifer Simpson, PhD., M.S.N., C.R.N.P.-President & Chief Executive Officer. "Completing enrollment for SBP-101 marks an important milestone in our quest to bring new therapeutic options to patients with pancreatic cancer, which is an orphan disease and an area of unmet medical need."
SBP-101 is currently being evaluated in a Phase 1a/1b clinical trial of patients with previously untreated metastatic PDA at sites in the United States and Australia. SBP-101 has received Fast Track and orphan drug designation from FDA. For more information, please visit clinicaltrials.gov.
About SBP-101
SBP-101 is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for pancreatic ductal adenocarcinoma. The molecule has shown signals of tumor growth inhibition in clinical studies of US and Australian metastatic pancreatic cancer patients, suggesting complementary activity with an existing FDA-approved chemotherapy regimen. In clinical studies to date, SBP-101 has not shown exacerbation of the typical chemotherapy-related adverse events of bone marrow suppression and peripheral neuropathy. The safety data and PMI profile observed in the current Panbela sponsored current clinical trial provides support for continued evaluation of the compound in a randomized clinical trial. For more information, please visit View Source