AIM ImmunoTech Inc.


AIM ImmunoTech Announces the Expansion of its Pancreatic Cancer Program to Include New Patients in the Netherlands

Early Access Program Will Also Allow Further Treatment of Patients Treated Under the Previous Ampligen Early Access Program

OCALA, Fla., Feb. 10, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) today announced that the Dutch Health and Youth Care Inspectorate (IGJ) has approved 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 we plan 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 MC. 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.

AIM 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 Prof. Casper van Eijck, MD, PhD, the lead investigator for the EAP at Erasmus MC. "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."

This announcement is an important step in AIM’s 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 European Union (EU) and the United States. Both Erasmus MC and the Buffett Cancer Center at the University of Nebraska Medical Center (K. Klute, MD, M.A. Hollingsworth, PhD) have tentatively agreed to serve as clinical trial sites. Additionally, AIM announced in December 2020 that the U.S. Food and Drug Administration had granted Orphan Drug Designation to Ampligen as a treatment for pancreatic cancer; the European Medicines Agency (EMA) recently recommended to the European Commission (EC) that AIM’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’s planned next steps in its pancreatic cancer program include filing an Investigational New Drug (IND) application in the United States and a Clinical Trial Application (CTA) 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 to assist in the swift advance of Ampligen as a potential treatment for this unmet medical need. Fast Track designation would give AIM 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 ten 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.

About AIM ImmunoTech Inc.

AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus.

Cautionary Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act (PSLRA) of 1995. Words such as "may," "will," "expect," "plan," "anticipate," and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. Many of these forward-looking statements involve a number of risks and uncertainties. Among other things, for those statements, we claim the protection of safe harbor for forward-looking statements contained in the PSLRA. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Orphan Medicinal Production Designation, while beneficial, does not assure commercial approval. The statistical analysis of the Erasmus study was based on comparison of the patient group treated with Ampligen to a historical control group of patients with similar characteristics who were previously treated for pancreatic cancer but who did not receive Ampligen. Because these were not concurrent controls, the assignment to treatment with Ampligen was neither randomized nor blinded to the investigators or the patients. Significant additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of pancreatic cancer in humans, and no assurance can be given that it will be the case. No assurance can be given as to whether future pancreatic immuno-oncology clinical trials will be successful or yield favorable data, and the trials are subject to many factors, including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. While the company believes that it is adequately funded for current trials over the next two years, no assurance can be given that additional funding will not be required for future studies or the full anticipated IND and CTA processes. Additionally, we recognize that all cancer centers, like all medical facilities, must make the ongoing COVID-19 pandemic their priority. Therefore, there is the potential for delays in clinical trial enrollment and reporting in ongoing and future studies in cancer patients because of the COVID-19 medical emergency. No assurance can be given that future studies will not result in findings that are different from those reported in the studies referenced. Operating in foreign countries carries with it a number of risks, including potential difficulties in enforcing intellectual property rights. We cannot assure that our potential foreign operations will not be adversely affected by these risks.


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