Eight patients were enrolled and treated. Stage 4 Metastatic Triple Negative Breast Cancer – Phase 1/2 study of metastatic triple-negative breast cancer using chemokine modulation therapy, including Ampligen and pembrolizumab. Assuming this trial and subsequent planned clinical trials confirm the existing data, AIM expects to then submit a New Drug Application for use of Ampligen in pancreatic cancer patients.įurthermore, AIM continues to advance multiple additional Ampligen clinical trials at university cancer centers testing whether tumor microenvironments can be reprogrammed to increase the effectiveness of cancer immunotherapy, including with checkpoint inhibitors:Īdvanced Recurrent Ovarian Cancer - A follow-up Phase 2 study of advanced recurrent ovarian cancer using cisplatin and pembrolizumab, plus Ampligen up to 45 patients to be enrolled numerous patients have commenced treatment. The Buffett Cancer Center at the University of Nebraska Medical Center (UNMC) and Erasmus MC in The Netherlands are expected to be the primary study sites, although additional sites are expected to participate. Food and Drug Administration for a planned Phase 2 study of Ampligen as a therapy for locally advanced or metastatic late-stage pancreatic cancer. AIM anticipates that these planned trials primarily will be AIM-sponsored and AIM-funded.įollowing statistically significant positive survival data collected from the Early Access Program at Erasmus Medical Center (Erasmus MC) in the Netherlands, AIM and its Contract Research Organization, Amarex Clinical Research LLC, submitted an Investigational New Drug application and an accompanying application for Fast Track status to the U.S. AIM’s strategy is to advance trials and activities that have the shortest path to potential FDA and EMA drug approval, providing opportunities for expedited success. Please refer to the full 10-Q for complete details.ĪIM has established a strong foundation of laboratory, pre-clinical and clinical data with respect to the development of nucleic acids and natural interferon to enhance the natural antiviral defense system of the human body, and to aid the development of therapeutic products for the treatment of certain cancers and chronic diseases.

The net loss from operations for the three months ended Septemwas $3.8 million, or $0.08 per share, compared to $3.3 million, or $0.08 per share, for the three months ended September 30, 2020. General and administrative expenses for the three months ended Septemwere $1.8 million, compared to $2.1 million for the three months ended September 30, 2020. Research and development expenses for the three months ended Septemwere $2.0 million, compared to $1.1 million for the three months ended September 30, 2020.

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