AIM ImmunoTech Inc (NYSE:AIM) reported promising follow-on data from its previously published single-center named patient program evaluating its flagship drug candidate Ampligen (rintatolimod) as maintenance therapy for pancreatic cancer.
For the study, patients with locally advanced pancreatic cancer or metastatic disease were treated following FOLFIRINOX (a chemotherapy combination used to treat pancreatic cancer), said the company. The enrollment of additional patients in the Early Access Program (EAP) was approved by the Inspectorate of Healthcare in the Netherlands and new patients have been treated at Erasmus M.C.
The Overall and Progression-Free Survival was presented by lead investigator Professor CHJ van Eijck of Erasmus Medical Center at the fifth Dutch Multidisciplinary Gastrointestinal Oncology Congress, in Ermelo, Netherlands.
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In a statement, Professor CHJ van Eijck said: “We have learned quite a lot from the original study data we published in March and the new data provides further hope for treating late-stage patients. Multi-year survival rates for locally advanced pancreatic cancer (LAPC) and metastatic pancreatic cancer patients are historically low, with 5-year survival typically less than 3%.”
He added: “These additional data, indicating major improvements to survival at 24 months and beyond, point to the potential value of Ampligen as a therapy for pancreatic cancer patients. The data bolster our confidence in the potential of Ampligen for the treatment of late-stage pancreatic cancer and represents a big step forward in Ampligen’s therapeutic development program.”
In addition, AIM has evaluated the initial data reported from Erasmus for both metastatic and LAPC patient populations, analyzing the subset of patients with LAPC. While the predominance of the data collected by Erasmus is in metastatic cancer and that data shows high statistical significance, a small cohort of five LAPC patients also exhibited marked improvement with the Ampligen maintenance therapy.
The overall survival from the start of FOLFIRINOX therapy of two of the patients was 34 and 43 months, and one patient was still surviving at the last reported checkup in April 2022 at 54 months, noted the company.
AIM CEO Thomas K. Equels said that as the company advances in the immuno-oncology development of Ampligen, there has been a lot of interest in the company’s selection of LAPC as its primary indication target.
“We believe that the LAPC standard of care, FOLFIRINOX or gemcitabine + nab-paclitaxel, followed by simple observation with no additional therapy until progression, allows for a much clearer comparison to the randomized control, in contrast to a multi-faceted primary standard of care for metastatic pancreatic cancer patients,” noted Equels. “This provides an opportunity to investigate Ampligen’s effect more accurately on pancreatic cancer in the LAPC patients in the United States.”
Based on the data, AIM said it is advancing the development of Ampligen in a Phase 2 study to evaluate its potential as a therapy for locally advanced pancreatic cancer (AMP-270). AMP-270 is planned to 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 subjects with locally advanced pancreatic adenocarcinoma. Secondary objectives include comparing safety and tolerability.
The firm said AMP-270 is expected to enroll 90 subjects in 30 centers across the US and Europe with 60 subjects in the Ampligen group and 30 subjects in the control group. The Buffett Cancer Center at the University of Nebraska Medical Center (UNMC) and Erasmus MC in the Netherlands are expected to be the primary study sites.
In April this year, AIM engaged contract research organization Amarex Clinical Research LLC to manage the AIM-sponsored Phase 2 study, which is on track to start clinical trials in the third quarter of 2022.
Contact the author Uttara Choudhury at uttara@proactiveinvestors.com
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