AIM ImmunoTech Inc (NYSE:AIM) has welcomed positive data from a study using Ampligen to treat advanced and metastatic pancreatic cancer patients, which improved their median survival rates.
In the single-center named 42 patient program, the immuno-pharma company said patients with locally advanced pancreatic cancer (LAPC) or metastatic disease were treated with Ampligen for six weeks at two doses per week with 400 miligrams (mg) per infusion.
David Strayer, the company's chief medical officer and chief scientific officer, explained how this was the first study investigating the immunomodulatory effect of the TLR-3 agonist Ampligen in patients with such cancer following FOLFIRINOX therapy (chemotherapy) and said the results were "compelling".
"We remain encouraged by the data demonstrating patients who were treated with Ampligen had a longer median PFS (progression-free survival) and overall survival compared to matched controls of patients who did not receive Ampligen.
"We look forward to further evaluation of Ampligen as a treatment for pancreatic cancer in our upcoming Phase 2 study," he added.
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The median overall survival in the Ampligen group was 19 months, compared to a historical control group and subgroup (7.5 and 12.5, respectively) that did not receive Ampligen.
Ampligen is being evaluated to treat pancreatic cancer patients in an Early Access Program (EAP) approved by the Inspectorate of Healthcare in the Netherlands at Erasmus Medical Center.
The data was published in a manuscript in the peer-reviewed journal 'Cancers Special Issue: Combination and Innovative Therapies for Pancreatic Cancer'.
Based on the data, AIM ImmunoTech believes that Ampligen could be a potential effective maintenance therapy after systemic chemotherapy in patients with advanced pancreatic cancer and plans to conduct a Phase 2 study.
This planned trial of around 90 subjects, expected to begin in Q2/Q3 2022, will be a randomized, open-label, controlled, parallel-arm study with the primary objective of comparing the efficacy of Ampligen versus a no treatment control group following FOLFIRINOX for patients with locally advanced pancreatic carcinoma.
AIM ImmunoTech is focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including coronavirus.
Contact the writer at giles@proactiveinvestors.com