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# Panbela Therapeutics Clinical Hold Lifted
- URL: https://www.fdaweb.com/panbela-therapeutics-clinical-hold-lifted/
- Published: 2021-04-15T12:00:00.000Z
- Updated: 2026-09-14T16:55:03.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5149124

FDA has lifted a partial clinical hold against a Panbela Therapeutics Phase 1 first-line study of SBP-101 when used in combination with standard of care agents gemcitabine and nab-paclitaxel for treating patients with metastatic pancreatic ductal adenocarcinoma.

Panbela says that due to recently observed serious visual adverse events that are being evaluated, patients with a history of retinopathy or at risk of retinal detachment are excluded from SBP-101 studies. It has agreed to design of all future studies with an exclusion of such patients and it will also add scheduled ophthalmologic monitoring for all patients. Additionally, in future dose-finding studies screening for retinal toxicity will be included, it says.

  
The company describes SBP-101 as a polyamine metabolic inhibitor designed to induce polyamine metabolic inhibition 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 in pancreatic cancer patients, suggesting potential complementary activity with an existing FDA-approved standard chemotherapy regimen, it says.