AIM ImmunoTech’s
Subsidiary Receives Orphan Medicinal Product Designation by the European
Medicines Agency for Ampligen to Treat Pancreatic Cancer
| Source:AIM ImmunoTech Inc.
photo-release
Prof. Casper van Eijck, surgeon and a global leading expert in pancreatic cancer
Prof. Casper van Eijck, surgeon and a global leading expert in pancreatic cancer
Kazem Kazempour, Ph.D., CEO and President of Amarex Clinical Research, LLC
Kazem Kazempour, Ph.D., CEO and President of Amarex Clinical Research, LLC
OCALA,
Fla., Feb. 24, 2021 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE
American: AIM) today announced that its subsidiary, NV Hemispherx
Biopharma Europe, has received formal notification from the European
Commission (EC) approving the company’s Orphan Medicinal Product
Application for Ampligen as a treatment for pancreatic cancer.
Medications
that have been designated as Orphan products by the European Medicines
Agency (EMA), once commercially approved in the European Union (EU),
receive benefits including up to ten years of protection from market
competition from similar medicines with similar active component and
indication for use that are not shown to be clinically superior.
AIM announced earlier this month
that the Committee for Orphan Medicinal Products of the EMA had
recommended that Ampligen receive the designation for pancreatic cancer.
The company has now received the official approval of that designation.
Prof.
Casper van Eijck, M.D. Ph.D., the lead investigator for the expanded
access program (EAP) for Ampligen at Erasmus Medical Center, stated, “We
are pleased to report that the EMA has approved Ampligen for orphan
medicinal product designation. Pancreatic cancer is the seventh leading
cause of cancer-related deaths worldwide with over 458,000 worldwide
cases of pancreatic cancer in 2018 alone. Despite advancements in the
detection and management of pancreatic cancer, the 5-year survival rate
is only 5-10%. Due to the positive and statistically significant
survival results, versus historical controls, that we observed when
using Ampligen in patients with locally advanced/metastatic pancreatic
cancer–after systemic chemotherapy–we believe that Ampligen has the
potential to be a meaningful extension of the standard of care for
advanced pancreatic cancer. We are currently writing the manuscript
describing the results of our study and are planning to investigate
Ampligen further in the follow-up pancreatic cancer Phase 2/3 clinical
trial and in a Phase 1 trial in combination with check point inhibitors
at Erasmus Medical Center.”
Kazem Kazempour, Ph.D., at Amarex
Clinical Research, commented, “We are working closely with AIM in the
United States to attain FDA ‘fast-track’ status, as well as possible FDA
‘breakthrough’ designations, and to obtain IND authorizations to
conduct a follow-up pancreatic cancer Phase 2/3 clinical trial with
sites in the Netherlands at Erasmus MC under Prof. van Eijck, and also
at major cancer research centers in the United States.”
“Orphan
medicinal product designation in the EU and in the US is a critical
milestone in AIM’s ongoing efforts to develop Ampligen as a treatment
for pancreatic cancer,” said AIM CEO Thomas K. Equels. “Pancreatic
cancer is one of the deadliest cancers because, far too often, it is not
diagnosed until Stage IV, when the disease is so far along that there
are limited therapeutic options. We at AIM hope that Ampligen can one
day help add precious time to the lives of many people suffering from
pancreatic cancer.”
Orphan medicinal product designations
promote the clinical development of drugs that target rare
life-threatening conditions, and which are expected to provide
significant therapeutic advantage over existing treatments. An estimated
466,000 people died of pancreatic cancer worldwide in 2020, according
to the World Health Organization. The five-year survival rate is only 5-10 percent.
Sponsors
who obtain EMA orphan designation “benefit from protocol assistance, a
type of scientific advice specific for designated orphan medicines, and
market exclusivity once the medicine is on the market,” according to the
EMA. Fee reductions are also available depending on circumstances. The
EMA has a comprehensive explanation of the benefits of Orphan Drug Designation (ODD) on its website.
The FDA orphan designation followed the company’s September 22, 2020 announcement
of statistically significant positive pancreatic cancer survival
benefit in the Ampligen arm as compared to a historical control cohort
seen in a multi-year Early Access Program conducted at Erasmus
University Medical Center in the Netherlands. The use of Ampligen
following the current standard of care for pancreatic cancer
(FOLFIRINOX) yielded an overall survival of 19 months, 7.9 months
greater than FOLFIRINOX treatment alone.
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 (PSLRA) of 1995. 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, we
claim the protection of safe harbor for forward-looking statements
contained in the PSLRA. We do not undertake to update any of these
forward-looking statements to reflect events or circumstances that occur
after the date hereof. Orphan Medicinal Production Designation, while
beneficial, does not assure commercial approval. The statistical
analysis of the Erasmus study was based on comparison of the patient
group treated with Ampligen to a historical control group of patients
with similar characteristics who were previously treated for pancreatic
cancer but who did not receive Ampligen. Because these were not
concurrent controls, the assignment to treatment with Ampligen was
neither randomized nor blinded to the investigators or the patients.
Significant additional testing and trials will be required to determine
whether Ampligen will be effective in the treatment of pancreatic cancer
in humans, and no assurance can be given that it will be the case. No
assurance can be given as to whether future pancreatic immuno-oncology
clinical trials will be successful or yield favorable data, and the
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. Additionally, we recognize that
all cancer centers, like all medical facilities, must make the ongoing
COVID-19 pandemic their priority. Therefore, there is the potential for
delays in clinical trial enrollment and reporting in ongoing and future
studies in cancer patients because of the COVID-19 medical emergency. No
assurance can be given that future studies will not result in findings
that are different from those reported in the studies referenced.
Operating in foreign countries carries with it a number of risks,
including potential difficulties in enforcing intellectual property
rights. We cannot assure that our potential foreign operations will not
be adversely affected by these risks.
BioFlorida is the voice of Florida's life sciences industry, representing 8,600 establishments and research organizations in the BioPharma, MedTech, Digital Health and Health Systems that collectively employ nearly 107,000 Floridians. Source: TEConomy/BIO (released 2022)
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