IMMUNE THERAPEUTICS INC RECEIVED MINUTES FROM FDA MEETING FOR LODONAL FOR THE TREATMENT FOR CROHN'S DISEASE
March 26 2018 - 9:35AM
InvestorsHub NewsWire
IMMUNE
THERAPEUTICS INC RECEIVED MINUTES FROM FDA MEETING FOR
LODONALTM FOR THE TREATMENT FOR CROHN’S
DISEASE
Orlando, FL --
March 26,
2018 --
InvestorsHub NewsWire -- Immune Therapeutics, Inc.
(OTCQB:IMUN) ("Immune"
"IMUN" or the "Company"), a clinical late stage biopharmaceutical
company focused on the development of two immunomodulating
therapies (IRT-103 "LodonalTM"
and IRT-101"MENK") for the treatment of autoimmune diseases,
inflammatory diseases, cancer and HIV/AIDs, today
announces that it has
received minutes from the Type C meeting held on January 16, 2018,
between Immune Therapeutics on behalf of Cytocom,
the
license holder,
and
the US Food and Drug Administration (FDA) to discuss next
steps in the development of IRT-103 a oral
once-a-day an adjunct
therapy to the standard of care for moderate to severe
Crohn's disease
in
adults and mild
to severe in pediatric
patients. .
IMUN CEO Noreen Griffin comments, "We
are thrilled to be
taking next steps in the development of
LodonalTM
with the
FDA.
Based upon the discussion
with the FDA and the minutes received following the
meeting, IMUN
/ Cytocom
intends to
immediately
move
forward with
its IND 067442 submission for the Phase 3
pivotal
clinical program
for moderate to severe
Crohn's disease in patients 12 and
over."
Based on the Company's discussion with the
FDA,
Dr. John Abeles, Cytocom CEO, stated "We have agreed to a number of changes to the trial
protocols
based on the FDA
recommendations. The adult trial will now include
patients 12 and over and our drug therapy
will be used as an adjunct
to the standard of care which will include biologists
with the goal to improve
outcome and safety to the standard of care
existing therapies.
The Division
of Gastroenterology
is moving away from use of
CDAI and PCDAI as stand-alone endpoint measures in clinical trials and
therefore, recommends that we revise our endpoints for our adult and pediatric
trials."
The Company has agreed to modify our endpoints
to use the CDAI/PCDAI
definition of remission as the trial's primary endpoint and
endoscopy and symptoms as the key secondary endpoints.
In addition,
the Company has
agreed to conduct a
52-week study and
will measure
the primary and secondary end points at week 12.
The Company has agreed
to continue
the trial
for another 40 weeks with
periodic CDAI/PCDAI and safety through week 52 and plans to use Lodonal in both adult and pediatric subjects
as an adjunct to the Standard of Care.
The Company
will be looking for
labeling for patients 12 and over for remission at 12 weeks
and long-term maintenance at 52 weeks.
A significant
number of Crohn's disease patients do not
reach remission
with current therapies,
many of which
have serious side effects,
and
are looking for additional options," adds
Dr.
Abeles.
"Lodonal
offers a
completely different mechanism of action that has the potential to
transform the Crohn's treatment landscape and bring
our innovative
immunotherapy
LodonalTM
to
adults
and
children suffering from moderate to
severe Crohn's disease."
The Company will also be filing
with the FDA an
Investigational New Drug (IND) application to LodonalTM
in
pediatric patients age 2 to 11 in the treatment of
mild
to
severe Crohn's disease.
IMUN/Cytocom
expects to
submit final
protocols for
a pivotal
phase 2b/3 rollover
trial based
on the meeting with the FDA shortly
and initiate
Moderate to Severe
Crohn's
Disease in its Phase 3 clinical
trials in the
second half of 2018 for patients 12 and over.
About Immune Therapeutics,
Inc.
Immune
Therapeutics
late stage clinical
stage biopharmaceutical company focused on the development
and commercialization
our highly
innovative immunotherapies for the treatment of
autoimmune/inflammatory diseases, cancer and infectious
diseases. Our drug
discovery and development are
focused in two
areas one is the role of Toll-Like Receptors (TLRs) and
Inflammation signaling in human immunology as well as the opioid
receptors which has been shown to participate in the function of
the cells of the immune system, and evidence suggests that opioids
modulate both innate and acquired immune
responses.
We have
developed LodonalTM
that works to
inhibit TLR2-mediated inflammation, which is now
entering
the final phases of clinical
testing.
While
traditional drug development targets a single drug for a particular
disease such as drug A for disease A, drug B for disease B, etc.,
IMUN and Cytocom are approaching the process by identifying and
targeting survival or activation immunology pathways that cross
over between different diseases. IMUN's lead product Lodonal shows
the success of this model with approval
in Nigeria and the Dominican Republic for HIV/AIDS, Cancer and
other autoimmune disease.
Forward-Looking
Statements
This release
may contain forward-looking statements.
Actual results
may differ from those projected due to a number of risks and
uncertainties, including, but not limited to, the possibility that
some or all the matters and transactions considered by the Company
may not proceed as contemplated, and by all other matters specified
in the Company's filings with the Securities and Exchange
Commission.
These
statements are made based upon current expectations that are
subject to risk and uncertainty.
The Company
does not undertake to update
forward-looking statements in this news release to reflect actual
results, changes in assumptions or changes in other factors
affecting such forward-looking information.
Assumptions
and other information that could cause results to differ from those
set forth in the forward-looking information can be found in the
Company's filings with the Securities and Exchange Commission
(www.sec.gov),
including its recent periodic reports.
CONTACT:
888-613-8802
http://www.immunetherapeutics.com/
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