AIM ImmunoTech has gained Netherlands Erasmus Medical Center (Erasmus MC) Ethics Committee authorisation to launch a European site for its Phase II clinical trial of Ampligen (rintatolimod) for locally advanced pancreatic cancer.
Dubbed AMP-270, the open-label, randomised, parallel-arm controlled study trial will analyse the efficacy of the investigational drug versus a no-treatment control group as its primary goal.
Locally advanced pancreatic adenocarcinoma patients who have previously received chemotherapy with FOLFIRINOX are eligible for the treatment.
The trial also aims to evaluate safety and tolerability as the secondary goals, with plans to include nearly 90 participants across Europe and the US.
AIM ImmunoTech is dedicated to researching and developing drugs for a range of cancers, immune disorders and viral ailments such as the Covid-19 infection.
The company’s flagship product, Ampligen acts as a highly selective TLR3 agonist immuno-modulator with a wider spectrum of activity observed in trials targeting cancers, viral diseases and immune system disorders.
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Netherlands Erasmus MC Pancreato-biliary surgeon professor Casper van Eijck said: “Approval from the governing ethics board is an important step toward enrolling subjects in the European arm of the AMP-270 clinical trial for locally advanced pancreatic cancer.
“Erasmus MC is tracking several cancer patients that we are hopeful will be enrolled in AMP-270.”
In November last year, AIM ImmunoTech completed subject dosing in the Phase II trial of Ampligen for individuals experiencing post-Covid fatigue.
The trial, named AMP-518, is a randomised, placebo-controlled, two-arm, double-blind, multicentre study designed to assess the safety and efficacy of Ampligen.
The primary protocol planned outcome measure of the trial is the variation in the PROMIS Fatigue Score from baseline to week 13.