This section highlights FDA-related milestones and regulatory updates for drugs developed by Panbela Therapeutics (PBLA).
Over the past two years, Panbela Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
eflornithine, ivospemin, and SBP-101. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
eflornithine - FDA Regulatory Timeline and Events
eflornithine is a drug developed by Panbela Therapeutics for the following indication: in Patients with Gastric Premalignant Conditions.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- eflornithine
- Announced Date:
- April 30, 2024
- Indication:
- in Patients with Gastric Premalignant Conditions
Announcement
Panbela Therapeutics, Inc announced that an abstract for eflornithine, an inhibitor of polyamine synthesis, has been accepted for an oral presentation at the Digestive Disease Week (DDW) conference, which will be held May 18-21, 2024.
AI Summary
Panbela Therapeutics, Inc. announced that an abstract on eflornithine, an inhibitor of polyamine synthesis, has been accepted for an oral presentation at the Digestive Disease Week (DDW) conference, scheduled for May 18–21, 2024. The abstract will be presented on May 21, 2024, from 2:00 PM to 3:30 PM EDT in the Research Forum session titled “Chemoprevention for GI Cancers: Drugs and/or Bugs.”
The presentation will evaluate the safety and efficacy of eflornithine (Difluoromethylornithine, DFMO) in patients with gastric premalignant conditions, with a focus on high-incidence areas in Latin America. This work is part of Panbela’s ongoing collaboration with Vanderbilt University Medical Center. Detailed information about the abstract and presentation will be available on Panbela’s website once released by DDW.
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ivospemin - FDA Regulatory Timeline and Events
ivospemin is a drug developed by Panbela Therapeutics for the following indication: Pancreatic Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ivospemin
- Announced Date:
- June 24, 2024
- Indication:
- Pancreatic Cancer
Announcement
Panbela Therapeutics, Inc announced that the independent Data Safety Monitoring Board (DSMB) has completed its third pre-specified safety review of the ongoing Phase 3 ASPIRE clinical trial evaluating ivospemin in combination with gemcitabine and nab-Paclitaxel for the first-line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC)..
AI Summary
Panbela Therapeutics announced that the independent Data Safety Monitoring Board (DSMB) has completed its third pre-specified safety review of the ongoing Phase 3 ASPIRE clinical trial. This trial is studying ivospemin in combination with gemcitabine and nab-Paclitaxel as a first-line treatment for metastatic pancreatic ductal adenocarcinoma (mPDAC). The DSMB recommended that the trial continue without any modifications, marking a third consecutive positive safety review. The current safety database now includes 395 patients, and the lower-than-expected event rate suggests that patients may experience longer survival.
Panbela looks forward to an interim survival analysis expected as early as the first quarter of 2025, which could provide valuable insights into the treatment’s potential. The rapid enrollment progress also positions the study for earlier than expected complete enrollment, offering hope for improving outcomes in mPDAC.
Read Announcement- Drug:
- ivospemin
- Announced Date:
- June 24, 2024
- Estimated Event Date Range:
- January 1, 2025 - March 31, 2025
- Target Action Date:
- Q1 - 2025
- Indication:
- Pancreatic Cancer
Announcement
Panbela Therapeutics, Inc. announced that Rapid Enrollment Positions Company for Enrollment Completion by Q1 2025; Earlier Than Expected
AI Summary
Panbela Therapeutics recently announced encouraging progress in its Phase 3 ASPIRE clinical trial for metastatic pancreatic ductal adenocarcinoma (mPDAC). The independent Data Safety Monitoring Board (DSMB) has now recommended for the third time that the study continue without any modifications. With the safety database growing to include 395 patients, the trial has demonstrated a lower-than-expected event rate, which may indicate that patients are experiencing prolonged survival.
Additionally, the company highlighted that rapid enrollment is positioning it to complete patient enrollment by the first quarter of 2025, which is earlier than anticipated. This swift progress not only underscores the trial’s strong recruitment efforts but also reinforces the potential of ivospemin to improve treatment outcomes for patients facing this challenging cancer. Panbela looks forward to releasing the interim survival analysis in early 2025.
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SBP-101 - FDA Regulatory Timeline and Events
SBP-101 is a drug developed by Panbela Therapeutics for the following indication: Pancreatic Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- SBP-101
- Announced Date:
- April 22, 2024
- Estimated Event Date Range:
- January 1, 2025 - March 31, 2025
- Target Action Date:
- Q1 - 2025
- Indication:
- Pancreatic Cancer
Announcement
Panbela Therapeutics, Inc. announced that the interim data analysis for its ongoing ASPIRE trial is now expected to be available as soon as Q1 2025.
AI Summary
Panbela Therapeutics, Inc. announced that the interim analysis for its ongoing ASPIRE trial is now expected to be available as soon as Q1 2025. This shift from the originally projected mid-2024 timeline is due to a lower-than-expected event rate, indicating that patients in the trial are experiencing longer survival times. The ASPIRE trial is studying the efficacy and safety of ivospemin (SBP-101) when combined with gemcitabine and nab-paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC). The trial requires 33% of the expected total events to take place before the interim analysis can occur, but fewer than half of the anticipated events have happened. Panbela views the outcome as a positive sign for patient survival and anticipates sharing more detailed results in the upcoming Q1 2025 report.
Read Announcement- Drug:
- SBP-101
- Announced Date:
- April 18, 2024
- Indication:
- Pancreatic Cancer
Announcement
Panbela Therapeutics, Inc. announces a poster presentation highlighting the results for ivospemin (SBP-101) as a polyamine metabolism modulator in ovarian cancer at the American Association for Cancer Research (AACR), which took place April 10, 2024.
AI Summary
Panbela Therapeutics, Inc. recently presented a poster at the American Association for Cancer Research (AACR) meeting on April 10, 2024, showcasing promising results for ivospemin (SBP-101) in ovarian cancer treatment. The research, conducted in collaboration with Johns Hopkins University School of Medicine, demonstrated that ivospemin, which functions as a polyamine metabolism modulator, significantly reduces the viability of human ovarian adenocarcinoma cells. Importantly, the study found that when ivospemin is combined with doxorubicin, there is an increase in median survival, delayed tumor onset, and a reduction in overall tumor burden in preclinical models.
The findings suggest that this combination therapy could help address the challenges of platinum-resistant ovarian cancer, a group for whom few treatment options exist. The poster presentation highlighted the potential of moving forward into clinical trials aimed at developing effective novel therapeutics for patients with unmet medical needs in this difficult-to-treat population.
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