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.
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. Secondary objectives include comparing safety and tolerability.
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.
READ: AIM ImmunoTech finalizes protocol for planned Phase 2 study of Ampligen in patients with pancreatic cancer
“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.
“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. 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.”
AIM 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. Additionally, several subjects are still alive more than three years later, it added.
The company said it believed that the clinical significance of these data as a treatment for pancreatic cancer provides Ampligen with a strong case for FDA Fast Track designation, which is designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill unmet medical needs.
A drug that has been granted FDA Fast Track status is eligible for some or all of the following:
- More frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval;
- More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers;
- Eligibility for Accelerated Approval and Priority Review if relevant criteria are met; and
- Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by the FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA.
Submission of its IND and Fast Track applications are very significant milestones for the company, AIM CEO Thomas Equals said.
“The rapid progress we have made is especially important given the devastating nature of pancreatic cancer,” he said.
“Further, both the FDA and the EMA have granted Ampligen orphan drug status in pancreatic cancer. This creates the potential for several years of market exclusivity. There is a significant unmet need for a safe and effective therapy for these patients, and we believe Ampligen holds enormous promise.”
AIM ImmunoTech is focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders, and viral diseases, including coronavirus.
Contact the author at stephen.gunnion@proactiveinvestors.com