DGAP-News: AIM ImmunoTech Inc. / Key word(s): Miscellaneous
Median survival approximately two-fold higher in Ampligen arm compared to historical controls; AIM to seek FDA Fast Track designation and orphan drug status in late stage pancreatic cancer
OCALA, FL / ACCESSWIRE / September 22, 2020 / AIM ImmunoTech Inc. (NYSE American:AIM) today announced receipt of statistically significant positive pancreatic cancer survival results from a multi-year Early Access Program (EAP) conducted at Erasmus University Medical Center in the Netherlands.
Prof. Casper van Eijck, MD, PhD, oncologist and a global leading expert in pancreatic cancer
Prof. Casper van Eijck, MD Ph.D., and his team at Erasmus MC found a statistically significantly positive survival benefit when using Ampligen in patients with locally advanced/metastatic pancreatic cancer after systemic chemotherapy. Prof. van Eijck states, "The overall survival of the experimental group was compared to a large historical control cohort matched for age, gender, stage of disease, and number of cycles of Folfirinox chemotherapy. Median survival was approximately two-fold higher, that is 200%, in the Ampligen arm as compared to the historical controls. These results were obtained with a very high degree of statistical significance. Based on these data, I see the potential for Ampligen as a meaningful extension of the standard of care for advanced pancreatic cancer, which we are planning to investigate further." A detailed clinical report and an article for publication are being prepared by Prof. van Eijck and his team at Erasmus MC.
AIM CEO Thomas K. Equels states: "We started this program in January 2017. These exceptional results from Erasmus exceed even our most optimistic expectations. I am deeply grateful to Prof. Casper van Eijck, his team at Erasmus, and Ronald Brus, MD, the guiding hand at myTomorrows, for their vision and careful diligence in implementing this important analysis of Ampligen as a single-agent therapy for late-stage pancreatic cancer. I extend deep gratitude to the government of the Netherlands for its pioneering support and commitment to advancing a critical medical innovation in a deadly cancer with very limited medical interventions. Medical advances in lethal unmet medical needs depend on this sort of outstanding clinical and governmental cooperation and support. We could not have accomplished this but for the support of the Netherlands."
AIM will work with its Contract Research Organization, Amarex Clinical Research LLC, to seek FDA "fast-track" and possibly even FDA "breakthrough" designations and to obtain IND authorizations to conduct a follow-up pancreatic cancer Phase 2/3 clinical trial with sites in the Netherlands at Erasmus MC under Prof. van Eijck, and also at major cancer research centers in the United States. AIM also plans to file dual orphan drug status applications for use of Ampligen in the treatment of late-stage pancreatic carcinoma with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). If granted, this serves to extend a company's exclusivity rights once a drug reaches market.
About AIM ImmunoTech Inc.
AIM ImmunoTech Inc
SOURCE: AIM ImmunoTech Inc.
News Source: Issuer Direct
|Company:||AIM ImmunoTech Inc.|
|EQS News ID:||1135233|
|End of News||DGAP News Service|