AIM ImmunoTech To Include New Patients In Netherlands Pancreatic Cancer Program

AIM ImmunoTech Inc (NYSE: AIM) shares are rising today after the company announced that the Netherlands regulatory authority had approved treatment for six pancreatic cancer patients as part of a new, follow-up Early Access Program (EAP).
Subject to further authorization, the company plans to treat up to 16 pancreatic cancer patients with rintatolimod (Ampligen) under the EAP.
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.
In September last year, the initial EAP demonstrated statistically significant positive pancreatic cancer survival benefits in its Ampligen arm 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.
AIM's planned next steps in its pancreatic cancer program include filing an Investigational New Drug Application in the U.S. and a Clinical Trial Application in the EU to move forward in the study of Ampligen for treating this disease.
The company is also exploring the possibility of applying for Fast Track status that provides more frequent interaction with the FDA review team and a rolling review of the marketing application.
Price Action: AIM shares gained 7.66% at $2.81 on the last check Wednesday.