AIM ImmunoTech Inc (NYSEAMERICAN:AIM) announced positive results Tuesday from a pancreatic cancer Early Access Program (EAP) evaluating its drug Ampligen in the Netherlands.
Professor Casper van Eijck and his team at Erasmus University Medical Center found a statistically significantly positive survival benefit when using Ampligen in patients with locally advanced/metastatic pancreatic cancer after systemic chemotherapy.
"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,” van Eijck said in a statement. “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."
READ: AIM ImmunoTech says enrollment for Ampligen study of cancer patients with coronavirus underway
A detailed clinical report and an article for publication are being prepared by van Eijck and his team, the company said.
"These exceptional results from Erasmus exceed even our most optimistic expectations,” AIM CEO Thomas Equels said. “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.”
myTomorrows is an international leader in providing physicians access to experimental medicines, the company said.
Equels also credited the Netherlands for creating an environment conducive to success.
“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,” Equels said. “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 said it will work with its contract research organization, Amarex Clinical Research LLC, to seek FDA fast-track and possibly breakthrough designations and to obtain investigational new drug authorizations to conduct a follow-up pancreatic cancer Phase 2/3 clinical trial. Such a trial would have sites in the Netherlands led by van Eijck, as well as, at major cancer research centers in the US.
AIM also plans to file dual orphan drug status applications for use of Ampligen in the treatment of late-stage pancreatic carcinoma with the FDA and the European Medicines Agency (EMA). If granted, this extends a company's exclusivity rights once a drug reaches the market.
Contact Andrew Kessel at [email protected]
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