Panbela Therapeutics Inc. (PBLA) Reports Partial Clinical Hold on SBP-101 Trial
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Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with cancer, in its pursuit to meet the urgent need for new therapeutic options for patients with pancreatic cancer, has been 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).
SBP-101 has received Fast Track and Orphan Drug designation from FDA and Panbela has been working closely with the FDA to advance its development studies of SBP-101 for patients with metastatic PDA.
What We Know Now
Panbela continues to be in communication with the trial investigators regarding the recommendation from the independent data safety monitoring board (DSMB) of the ongoing Phase 1 clinical trial to hold administration of SBP-101 pending further investigation of visual disturbance adverse events.
Some patients in the trial were noted to have complaints of visual changes, although visual changes were not seen in the SBP-101 monotherapy study. We have consulted with the DSMB and SBP-101 will not be administered to ongoing patients in the current trial while additional safety information is analyzed. Patients will continue with the standard drug regimen. All other trial activities continue. Panbela has conferred with FDA regarding the plan to continue the trial but hold dosing of SBP-101 in ongoing patients until we can learn more. Withholding SBP-101 constitutes a “partial clinical hold”. There is no impact on enrollment, as enrollment of the trial completed in December 2020, and the study is ongoing.
Panbela is working to finalize a visual screening program in order to understand the significance of reported visual changes and to inform future studies. We will also seek to evaluate the exact cause of these recent visual reports and to determine whether serial eye exams during treatment can identify potential toxicity or risk before symptoms develop.
While we evaluate supplementary data, we remain confident in the potential benefits of SBP-101 including its potential benefits for patients with pancreatic cancer. We are thankful to the patients who have, or are, participating in our clinical trials. We are committed to objectively evaluating the data from those clinical studies to confirm both the therapeutic benefits and safety profile of our polyamine inhibitor in metastatic pancreatic cancer patients.
Panbela is planning to submit interim results at a major cancer conference and looks forward to publication of final efficacy and safety data, when available.
Additionally, all other research and manufacturing activities related to future SBP-101 indications are continuing, including working with the FDA to initiate a randomized trial mid-year.
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 and other tumors. 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 standard 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 generally provides support for continued evaluation of the compound in a randomized clinical trial subject to Panbela’s submission of a complete response and the FDA’s removal of the partial clinical hold. For more information, please visit https://clinicaltrials.gov/ct2/show/NCT03412799.
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