AIM ImmunoTech (NYSE: AIM) said Ampligen following FOLFIRINOX, a chemotherapy combination, showed improved survival rates in patients with pancreatic cancer compared to matched controls of patients who did not receive Ampligen.
Ampligen (rintatolimod) was evaluated as a monotherapy to treat patients with locally advanced pancreatic cancer (LAPC) or metastatic disease in an Early Access Program (EAP) in the Netherlands at Erasmus Medical Center.
The company said the study’s main goals were the Systemic Immune-Inflammation Index (SIII), the Neutrophils to Lymphocyte Ratio (NLR), and absolute counts of 18 different populations of circulating immune cells. Meanwhile, secondary goals were progression-free survival (PFS) and overall survival (OS). Based on OS after Ampligen treatment, 27 patients were divided into 11 long-term survivors and 16 short-term survivors.
The company said that at 6 weeks, SIII and the NLR values from the long-term and short-term patients combined showed no significant difference compared to baseline, the values were found to be significantly lower in 11 long-term survivors versus 16 short- term survivors.
T-cells and myeloid cells were not significantly increased after treatment with Ampligen. The numbers of B-cells were increased in long-term survivors.
The company said median PFS was significantly longer (13 months) with Ampligen compared to matched controls (5 months) and the subset of matched controls (8.6 months).
The median OS was significantly longer (19 months) with Ampligen compared to matched controls (7.5 months) and subset of matched controls (12.5 months)
The company plans to conduct a phase 2 trial of Ampligen for locally advanced pancreatic cancer.