AIM ImmunoTech Inc. (AIM:NYSE American), which focuses on research and development of therapeutics to treat immune disorders, viral diseases and multiple types of cancers, 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."
AIM ImmunoTech advised that "Prof. Casper van Eijck, M.D., 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 remarked, "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...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."
The company's CEO Thomas K. Equels commented, "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...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."
The firm stated that it plans to work closely with Amarex Clinical Research LLC, its Contract Research Organization, in order to seek U.S. Food and Drug Administration (FDA) "fast-track" and perhaps even FDA "breakthrough" designations. In addition, AIM ImmunoTech intends to obtain IND authorizations to conduct a Phase 2/3 pancreatic cancer trial in the Netherlands at Erasmus MC under the supervision of Prof. van Eijck and at major cancer research centers in the U.S. to follow-up on the recent positive study results.
The company added that it also has plans to file dual orphan drug status applications for use of Ampligen in the treatment of late-stage pancreatic carcinoma with both the FDA and the European Medicines Agency (EMA).
AIM ImmunoTech is an immuno-pharma company based in Ocala, Fla., that is focused on developing therapeutics to treat immune disorders, viral diseases including COVID-19, the disease caused by the SARS-CoV-2 virus and multiple types of cancers. The company's product offerings include rintatolimod (Ampligen® or Rintamod®) and the FDA-approved drug Alferon N Injection®. The firm believes that its pre-clinical research studies and clinical trials suggest that Ampligen may have broad-spectrum anti-viral and anti-cancer properties. The firm has previously conducted clinical trials of Ampligen in cancer patients in the areas of advanced recurrent ovarian cancer, colorectal cancer, malignant melanoma, renal cell carcinoma and triple negative metastatic breast cancer.
AIM ImmunoTech. began the day with a market capitalization of around $81.0 million with approximately 39.69 million shares outstanding and a short interest of about 6.9%. AIM shares opened nearly 16% higher today at $2.36 (+$0.32, +15.69%) over yesterday's $2.04 closing price. The company's shares have traded today between $2.26 and $2.74 per share and are presently trading at $2.45 (+$0.41, +20.10%).[NLINSERT]
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