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and its subsidiaries are an immuno-pharma company headquartered in Ocala, Florida, and focused on the research and development of therapeutics to treat multiple types of cancers, viral diseases and immune-deficiency disorders for which there are inadequate or unmet therapies.
The Company s research and development of Ampligen has included a variety of diseases and health matters: Conducting clinical trials to evaluate the efficacy and safety of Ampligen for the treatment of pancreatic cancer.
Based on clinical success as to safety and efficacy in our pancreatic cancer Early Access Program and an ongoing Phase 2 trial, AIM has made the business decision to focus its efforts on the development of Ampligen for the treatment of late-stage pancreatic cancer, as we believe that of all the opportunities a wide-spectrum therapeutic such as Ampligen has pancreatic cancer treatment is the path that will potentially lead to the most lucrative outcome.
While Ampligen showed positive safety and efficacy in trials involving other solid tumor types, we believe that pancreatic cancer presents the best business opportunity.
Pancreatic cancer killed more than 100,000 people in the American and European Union markets and more than 450,000 people worldwide as recently as 2022.
When AIM looks at the global health problem of pancreatic cancer, we see a large market in an unmet medical need and with relatively little clinical competition.
This large unmet market is enhanced by our intellectual property program.
We have a well-developed pancreatic cancer program with broad combination therapy patents in the United States, Japan and Europe, as well as market exclusivity provided by orphan drug designations in the United States and the European Union.
Oncology is an area of biotech which can produce multibillion-dollar mergers and acquisitions deals large-market Phase 3 oncology clinical trials with positive data are a focus for acquisition.
AIM strongly believes that such a Phase 3 study will be possible following the ongoing Phase 2 clinical study evaluating Ampligen in combination with AstraZeneca s anti-PD-L1 immune checkpoint inhibitor Imfinzi (durvalumab) in the treatment of metastatic pancreatic cancer patients with stable disease post-FOLFIRINOX standard of care (the DURIPANC study).
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and its subsidiaries (collectively, AIM , Company , we or us ) are an immuno-pharma company headquartered in Ocala, Florida, and focused on the research and development of therapeutics to treat multiple types of cancers, viral diseases and immune-deficiency disorders and to treat cancers for which there are currently inadequate or unmet therapies.
The Company is currently proceeding primarily in four areas: Conducting clinical trials to evaluate the efficacy and safety of Ampligen for the treatment of pancreatic cancer.
The Company is prioritizing activities in an order related to the stage of development, with those clinical activities such as pancreatic cancer, ME/CFS and Post-COVID conditions having priority over antiviral experimentation.
The Company intends that priority clinical work be conducted in trials authorized by the FDA or European Medicines Agency ( EMA ), which trials support a potential future NDA.
However, AIM s antiviral experimentation is designed to accumulate additional preliminary data supporting their hypothesis that Ampligen is a powerful, broad-spectrum prophylaxis and early-onset therapeutic that may confer enhanced immunity and cross-protection.
Accordingly, AIM will conduct antiviral programs in those venues most readily available and able to generate valid proof-of-concept data, including foreign venues.
We have recently announced that we have engaged Amarex Clinical Research ( Amarex ), our Clinical Research Organization, with the application and eventual management of a follow-up Investigational New Drug ( IND ) application for the study of a potential avian influenza combination therapy of our Ampligen and AstraZeneca s FluMist, a nasal spray vaccine that helps prevent seasonal influenza.
In addition, we recently announced that the Erasmus Medical Center Safety Committee grants approval to proceed with a Phase 2 Study of Ampligen and Imfinzi as a potential combination therapy for late-stage pancreatic cancer.
In fact, in March 2022 we announced interim data from an investigator-initiated, Phase 2, single-arm, efficacy/safety trial to evaluate the effectiveness of combining intensive locoregional intraperitoneal (IP) chemoimmunotherapy of cisplatin with IP Ampligen (TLR-3 agonist) and IV infusion of the checkpoint inhibitor pembrolizumab for patients with recurrent platinum-sensitive ovarian cancer.
To do this, among other things, we need a population infected with a virus.