Aim immunotech stock3/15/2023 ![]() Additionally, several subjects are still alive more than three years later, it added. At the same time, we are excited to have submitted our Fast Track application, which would confer a number of important benefits and potentially help accelerate approval.”ĪIM said key support for both the study and the application for Fast Track status includes statistically significant clinical data in an Erasmus MC early-access program of 27 subjects, where the overall survival of the Ampligen-treated cohort was 19.2 months from the start of FOLFIRINOX, compared to 12.5 months in the historical control group, for an increase in survival of 6.7 months. “We could not be more enthusiastic about the outlook for this program given the compelling prior clinical data from Erasmus MC, which demonstrated a significant improvement in median overall survival, compared to a matched historical control group. “Given the extensive work to date, we are well-positioned to move aggressively and launch the Phase 2 trial of Ampligen upon approval of the IND,” AIM chief scientific officer Dr David Strayer said in a statement. READ: AIM ImmunoTech finalizes protocol for planned Phase 2 study of Ampligen in patients with pancreatic cancer The AIM-sponsored study will be managed by Amarex Clinical Research, while the Buffett Cancer Center at the University of Nebraska Medical Center and Erasmus MC in The Netherlands are expected to be the primary study sites, AIM added. ![]() Secondary objectives include comparing safety and tolerability. The company said the planned AMP-270 clinical trial of around 250 subjects will be a randomized, open-label, controlled, parallel-arm study with the primary objective of comparing the efficacy of Ampligen when added to SOC (standard of care) versus SOC alone for subjects with advanced pancreatic carcinoma recently treated with FOLFIRINOX chemotherapy regimen. AIM ImmunoTech Inc ( NYSE:AIM) said it has submitted an Investigational New Drug application (IND) and an accompanying application for Fast Track status with the US Food and Drug Administration (FDA) for a planned Phase 2 study of Ampligen as a therapy for locally advanced or metastatic late-stage pancreatic cancer.
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