A Phase 2 Study to Evaluate the Efficacy and Safety of Ampligen® Compared to Control Group / No Treatment Following FOLFIRINOX in Subjects with Locally Advanced Pancreatic Adenocarcinoma

You may be able to join if

• Subjects will be eligible for enrollment in the study only if they meet ALL the following criteria at time of Screening: 1. Histological diagnosis of pancreatic adenocarcinoma confirmed pathologically: Unresectable pancreatic cancer; locally advanced pancreatic cancer. 2. Measurable disease per RECIST v.1.1. 3. Completion of at least four (4) months of first line FOLFIRINOX treatment and no disease progression per RECIST v.1.1 as confirmed by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) scan 4 to 12 weeks after last FOLFIRINOX treatment. 4. Male or non-pregnant, non-lactating female, ≥18 years or age. 5. Negative pregnancy test for female subjects. Women of child-bearing potential (WOCBP) and Women not of child-bearing potential are eligible to participate. Both women of child-bearing potential and women of non child-bearing potential should use an approved method of birth control and agrees to continue to use this method for the duration of the study and for 90 days after last treatment. Acceptable methods of contraception include abstinence, female subject/partner's use of hormonal contraceptive (oral, implanted, or injected) in conjunction with a barrier method (WOCBP only), female subject/partner's use of an intrauterine device (IUD), or if the female subject/partner is surgically sterile or two years post-menopausal. All male subjects/partners must agree to use a condom consistently and correctly for the duration of the study and for 90 days after last treatment. In addition, subjects may not donate sperm for the duration of the study and for 90 days after last treatment. Females who are less than two (2) years post-menopausal, those with tubal ligations and those using contraception must have a negative serum pregnancy test at baseline within the one (1) week prior to the first study medication infusion. Every six weeks, and at study termination a pregnancy test should be performed, either serum or urine stick test. However, if the urine result is positive, a serum pregnancy test will be performed. Any pregnancy that occurs while taking Ampligen® should be recorded using a Pregnancy Report Form and reported immediately to AIM ImmunoTech Inc. 6. Provide signed written informed consent and willingness, ability to comply with study requirements. 7. Minimum weight of 40kg at baseline. 8. Karnofsky Performance Status of 80 or higher at baseline. 9. Subject must have a projected life expectancy of ≥ 3 months in the opinion of the Investigator. 10. Subject has adequate organ function by the following laboratory assessments at baseline (obtained ≤ 21 days prior to Randomization): Hematologic: Platelets ≥ 100×109/L Hemoglobin ≥ 9.0 g/dL Absolute Neutrophil Count (ANC) ≥ 1.5×109/L Absolute lymphocyte count ≥ 3 x 109/L Hepatic: AST/ALT ≤ 3×ULN (if liver metastases are present, ≤ 5×ULN) Alkaline phosphatase ≤ 2.0×ULN (if liver metastases are present, ≤ 5×ULN) Total bilirubin ≤ 1.5×ULN Albumin ≥ 3.0 g/dL Renal: Creatinine clearance ≥ 60 mL/min using the Cockcroft-Gault formula. Coagulation PT-INR and APTT within normal limits