AIM ImmunoTech Inc (NYSEAMERICAN: AIM) is running for the top in the market this morning, and for good reason. The company announced statistically significant positive data from a key Early Access Program (EAP). Here’s what’s going on:
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AIM Stock Rockets On EAP Data
In a press release issued this morning, AIM ImmunoTech announced that it received statistically significant positive pancreatic cancer results from an Early Access Program. The EAP spanned multiple years and was conducted at Erasmus University Medical Center in the Netherlands.
The data show that the flagship drug product at AIM, Ampligen, effectively increased survival rates in patients with pancreatic cancer. As a result of the positive data, the company plans to seek Fast Track and Breakthrough designations for Ampligen from the FDA.
Moreover, AIM intends on obtaining IND authorizations to conduct a follow-up pancreatic cancer Phase 2/3 clinical trial both in the Netherlands and the United States. The company also said that it plans on filing dual orphan drug status applications for the use of Ampligen as a treatment of late-stage pancreatic carcinoma in the United states and Europe.
In a statement, Professor Casper van Eijck, MD Ph.D, had the following to offer:
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.
The above statement was followed up by Thomas K. Equels, CEO at AIM. Here’s what he had to offer:
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.
This Is Huge News
The news released by AIM ImmunoTech this morning proved to be overwhelmingly positive. Pancreatic cancer is very difficult to treat, and the patients included in the EAP have already undergone standard of care therapy.
With significant positive data surrounding the survival of this pretreated population of patients in hand, the company is well on its way to potential approval of Ampligen as a treatment for pancreatic cancer. That would be a massive move.
By 2025, the pancreatic cancer market is expected to grow to be worth well over $4 billion annually. With a market cap of around $80 million, tapping into even a small percentage of this market would be a massive move for the company, aking AIM stock one to watch closely.
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