Panbela to Present at Digestive Disease Week

MINNEAPOLIS, June 10, 2024 – Panbela Therapeutics, Inc., a clinical-stage biopharmaceutical firm dedicated to developing innovative cancer treatments, has announced the presentation of its recent study at the Digestive Disease Week (DDW) conference held from May 18-21, 2024. In collaboration with Vanderbilt University Medical Center, this study focused on the evaluation of eflornithine (Difluoromethylornithine, DFMO) for patients with gastric premalignant conditions in high-risk areas of Latin America.

Gastric adenocarcinoma ranks as the fifth leading cause of cancer-related deaths globally and is the most common infection-associated cancer. In the United States, incidence rates are disproportionately higher among non-white populations. Dr. Douglas R. Morgan from the University of Alabama at Birmingham and Dr. Keith T. Wilson of Vanderbilt University highlighted the significant need for chemoprevention in patients suffering from gastric premalignant conditions such as intestinal metaplasia and atrophic gastritis.

The study, funded by the National Cancer Institute, was a Phase IIa, placebo-controlled randomized clinical trial conducted between September 2016 and December 2022 in rural regions of Honduras and Puerto Rico. Presented by Dr. Wilson on May 21, 2024, at DDW, the trial examined eflornithine's safety and efficacy in subjects aged 30-60, both positive and negative for H. pylori (Hp). Participants were administered either eflornithine or a placebo for 18 months, followed by endoscopic evaluations at baseline and subsequently at 6, 18, and 24 months.

Initial findings revealed that 80% of participants were Hp positive. Histological analysis showed 46% with atrophy and 54% with intestinal metaplasia. Out of the total participants, 78 reached the primary 6-month outcome, 69 reached the end-of-treatment (EoT) stage at 18 months, and 55 completed the study at 24 months. Eflornithine was found to be safe and well-tolerated, with fewer grade 1-2 and grade 3 adverse events compared to the placebo group.

Notably, eflornithine demonstrated a significant reduction in DNA damage, assessed through pH2AX immunostaining, a marker for DNA damage. Measurements at the 24-month mark showed significantly lower DNA damage compared to the 18-month evaluation in the treatment group, whereas the placebo group exhibited no change.

Jennifer K. Simpson, President and CEO of Panbela, emphasized that the company’s focus on the polyamine pathway is crucial for cancer prevention and treatment. Given that cancer cells rely heavily on polyamines for survival, eflornithine’s ability to reduce DNA damage in gastric epithelial cells holds promise for preventing infection-associated gastric cancer in high-risk patients.

Panbela's Broader Development Pipeline

Panbela’s drug development pipeline spans various cancers, focusing on familial adenomatous polyposis (FAP), metastatic pancreatic cancer, and colorectal cancer prevention among others. Key products include Ivospemin (SBP-101) and Flynpovi.

- Ivospemin (SBP-101): This polyamine analogue aims to inhibit polyamine metabolism in pancreatic ductal adenocarcinoma and other tumors. It has shown promising results in clinical trials, including a median overall survival of 14.6 months and an objective response rate of 48% in metastatic pancreatic cancer patients.

- Flynpovi™: A combination of eflornithine and sulindac, Flynpovi has shown effectiveness in preventing large bowel polyps and delaying surgical events in FAP patients. Its safety profile is comparable to single-agent treatments.

- CPP-1X (eflornithine): Being developed as a single agent tablet or powder, CPP-1X shows potential in gastric cancer prevention, neuroblastoma treatment, and managing recent onset Type 1 diabetes.

Panbela Therapeutics remains committed to advancing these therapeutics to address critical unmet medical needs in oncology.

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