AIM ImmunoTech Submits IND and Accompanying Fast Track Application for Phase 2 Trial of Ampligen in Patients with Locally Advanced or Metastatic Late-Stage Pancreatic Cancer
October 19 2021 - 7:25AM
AIM ImmunoTech Submits IND and Accompanying Fast Track Application
for Phase 2 Trial of Ampligen in Patients with Locally Advanced or
Metastatic Late-Stage Pancreatic Cancer
AIM ImmunoTech Inc. (NYSE American: AIM) today announced that it
has submitted an Investigational New Drug application (IND) and an
accompanying application for Fast Track status with the U.S. Food
and Drug Administration (FDA) for a planned Phase 2 study of the
company’s drug Ampligen as a therapy for locally advanced or
metastatic late-stage pancreatic cancer.
The planned AMP-270 clinical trial of approximately 250 subjects
will be a Phase 2, 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.
Amarex Clinical Research will manage the AIM-sponsored study.
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
anticipated.
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.
AIM believes that the clinical significance of these data as a
treatment for pancreatic cancer provide 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
- 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 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
AIM Chief Scientific Officer David Strayer, MD, commented,
“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. 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. Ampligen
has also demonstrated a strong safety profile in numerous trials.
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 CEO Thomas K. Equels further commented, “Submission of our
IND and Fast Track application are very significant milestones for
the company and I would like to thank our entire team, as well as
our clinical and regulatory advisors, for their tremendous efforts
in preparing these carefully planned submissions. The rapid
progress we have made is especially important given the devastating
nature of pancreatic cancer. 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.”
See:
- AIM ImmunoTech Inc.’s Drug Ampligen
Awarded FDA’s Orphan Drug Designation Status for the Treatment of
Pancreatic Cancer
- AIM ImmunoTech’s Subsidiary
Receives Orphan Medicinal Product Designation by the European
Medicines Agency for Ampligen to Treat Pancreatic Cancer
About AIM ImmunoTech Inc.
AIM ImmunoTech Inc. is an immuno-pharma company focused on the
research and development of therapeutics to treat multiple types of
cancers, immune disorders, and viral diseases, including COVID-19,
the disease caused by the SARS-CoV-2 virus.
Cautionary Statement
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
(the “PSLRA”). Words such as “may,” “will,” “expect,” “plan,”
“anticipate” and similar expressions (as well as other words or
expressions referencing future events or circumstances) are
intended to identify forward-looking statements. Many of these
forward-looking statements involve a number of risks and
uncertainties. Among other things, for those statements, the
Company claims the protection of safe harbor for forward-looking
statements contained in the PSLRA. No assurances can be given as to
whether the FDA will promptly authorize the Company’s IND or
require significant changes or grant Fast Track status. If the IND
is authorized, no assurance can be given that any studies will be
successful or yield favorable data. Studies and trials are subject
to many factors including lack of regulatory approval(s), lack of
study drug, or a change in priorities at the institutions
sponsoring other trials. Significant additional testing and trials
will be required to determine whether Ampligen will be an effective
therapy for locally advanced or metastatic late-stage pancreatic
cancer or otherwise, and no assurance can be given that this will
be the case. There is the potential for delays in clinical trial
enrollment and reporting because of the COVID-19 medical emergency.
We do not undertake to update any of these forward-looking
statements to reflect events or circumstances that occur after the
date hereof.
Contacts:
Crescendo Communications, LLCPhone:
212-671-1021Email: aim@crescendo-ir.com
AIM ImmunoTech IncPhone:
800-778-4042Email: IR@aimimmuno.com
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