AIM ImmunoTech Inc (NYSEAMERICAN:AIM) announced Wednesday that the Dutch Health and Youth Care Inspectorate (IGJ) has approved use of its treatment for six pancreatic cancer patients as part of a new, follow-up Early Access Program (EAP) at Erasmus Medical Center in the Netherlands.
Subject to further authorization, AIM ImmunoTech said it plans to treat up to 16 pancreatic cancer patients with rintatolimod (Ampligen) under the EAP, which follows the success of a previous multi-year Ampligen EAP for pancreatic cancer patients at Erasmus.
The new approval was designed to include several patients treated under the previous EAP, who are still alive despite their diagnoses several years ago of locally advanced or metastatic pancreatic cancer, the company noted.
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AIM ImmunoTech announced on September 22, 2020, that the initial EAP had demonstrated statistically significant positive pancreatic cancer survival benefits in its Ampligen arm, as compared to a historical control cohort. The use of Ampligen, following the current standard of care for pancreatic cancer (FOLFIRINOX), yielded an overall survival of 19 months, or 7.9 months greater than FOLFIRINOX treatment alone. This new group will help focus on immunological markers which will aid in identifying high-level Ampligen responders.
“We are extremely pleased to continue our study in pancreatic cancer patients with Ampligen, given the hopeful previous results,” said Dr Casper van Eijck, the lead investigator for the EAP at Erasmus in a statement.
“By more selectively including patients for this treatment, we hope to better define the ultimate application area. We are grateful to AIM ImmunoTech Inc. for their constructive contribution to enabling this treatment in this aggressive cancer.”
AIM ImmunoTech said its announcement is an important step in its ongoing efforts to expand its pancreatic cancer treatment program, as data gathered in the new study may assist in the company’s plans to transition into a clinical trial with clinical sites in the EU and the US. Both Erasmus and the Buffett Cancer Center at the University of Nebraska Medical Center have tentatively agreed to serve as clinical trial sites.
FDA moves
Additionally, AIM ImmunoTech announced in December 2020 that the US Food and Drug Administration had granted Orphan Drug Designation to Ampligen as a treatment for pancreatic cancer. Also, the European Medicines Agency (EMA) recently recommended to the European Commission (EC) that AIM ImmunoTech’s wholly-owned subsidiary – Hemispherx Biopharma Europe – receive a similar designation in the EU for Ampligen in pancreatic cancer, and the company awaits a final EC decision.
AIM ImmunoTech said its planned next steps in its pancreatic cancer program include filing an Investigational New Drug (IND) application in the US and a Clinical Trial Application (CTA) in the EU to move forward the study of Ampligen for treating this disease.
The company is also exploring the possibility of applying for Fast Track status to assist in the swift advance of Ampligen as a potential treatment for this unmet medical need. Fast Track designation would give AIM ImmunoTech the opportunity to meet more often with the FDA to quickly advance Ampligen through the different phases of the IND, potentially accelerating approval.
The benefits of having an orphan-designated medication with commercial approval in the EU include up to 10 years of protection from market competition from similar medicines with similar active components, and indication for use that are not shown to be clinically superior.
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