Pasithea
Therapeutics Announces Results of Preclinical Study Demonstrating
Tolerizing Vaccine Efficacy in Relapsing-Remitting Model of
Multiple Sclerosis
-- PAS002 is a proprietary DNA
tolerizing vaccine construct encoding GlialCAM --
-- PAS002 effectively reduces
disease severity, delays onset of illness, while also reducing
relapse severity --
-- GlialCAM fragment is present
in MonkeyPox virus, supporting a potential role in current vaccine
development --
Miami Beach, FL -- August 11,
2022 -- InvestorsHub NewsWire -- Pasithea Therapeutics Corp. (Nasdaq:
KTTA) ("Pasithea" or the "Company"), a biotechnology company
focused on the discovery, research and development of new and
effective treatments for psychiatric and neurological disorders,
today announced positive results from a preliminary preclinical
proof of concept study of PAS002, its tolerizing vaccine program in
multiple sclerosis ("MS").
Earlier this
year, a
study in Nature, the world's
leading science journal, showed that a molecule called GlialCAM
found in the brain's white matter is attacked in MS. GlialCAM
shares a component of its protein structure that mimics an
identical component of the Epstein Barr Virus ("EBV") Nuclear
Antigen-1, which plays a critical role in triggering MS.
In this study, relapsing
paralysis was established in a mouse model of relapsing-remitting
experimental autoimmune encephalomyelitis ("EAE"), the standard
animal model of MS. In three groups, a proprietary DNA cassette was
engineered to encode GlialCAM and injected to potentially block
acute disease and its relapse. These DNA molecules were designed to
protect against paralytic disease by tolerizing the immune system
so it would not attack myelin in the brain and spinal cord. The
engineered DNA molecule creates tolerance, working like an 'inverse
vaccine', and was administered intra-muscularly at days 0, 3, 7,
10, and 14. The study had a standard duration of 32
days.
The data showed that the
engineered DNA plasmids provide a high level of efficacy in
reducing disease severity and incidence of relapse when
administered prophylactically in the EAE model, a widely used
relapsing-remitting model of MS.
Key findings from the study
include:
-
treatment with a DNA tolerizing
'inverse vaccine' delayed the onset of paralysis when compared to
vehicle (p<0.001);
-
a statistically significant
reduction in disease severity, when compared to vehicle
(p=0.002);
-
a statistically significant
reduction in relapse severity, when compared to vehicle
(p<0.001);
-
treatment with a DNA vaccine
prevented disease in approximately 50% of the mice, when compared
to vehicle (p=0.004);
The study was conducted at
Hooke Laboratories, an independent full-service Contract Research
Organization with deep experience in EAE animal model of
MS.
"The results of this study show
that this technology has the potential to tolerize to GlialCAM, a
myelin molecule that has molecular similarity to the Epstein Barr
Virus that triggers MS." stated Pasithea's Chairman, National
Academy of Sciences Professor Lawrence Steinman, a world recognized
leading authority in MS. Prof. Steinman's research led to the
development of the drug Tysabri, which is approved to treat
patients with MS and Crohn's disease. "Remarkably the piece of
GlialCAM protein shared between EBV and white matter in the brain,
is also found in the pox viruses, including
monkeypox.
Monkeypox is rarely associated
with brain inflammation, and this new technology may prove useful
for brain inflammation caused in certain viral
infections."
Dr. Tiago Reis Marques, Chief
Executive Officer of Pasithea, stated "We're thrilled with the
strong preclinical efficacy data shown in this study. Although
early-stage, we believe these results demonstrate the promise and
validity of our tolerizing approach, which is built on recent data
on the biological mechanism linking infection with EBV with the
development of MS. We have filed a provisional patent application
and we will continue to rapidly pursue the PAS002 drug development
program."
The Company plans to present
data from this study, including histology data and plasma
inflammatory markers, in future major international conferences,
and also to submit full data for peer-review
publication.
About
Multiple Sclerosis
Multiple
Sclerosis ("MS") is a chronic and potentially disabling autoimmune
disease, and the most common neurodegenerative disease of the
central nervous system in young adults. The pathological hallmark
of MS is the formation of demyelinating lesions in the brain and
spinal cord, with the immune system attacking the myelin sheath
that normally protects nerve fibers in the brain, spinal cord, and
optic nerve. There are now 2.8 million people worldwide who have
MS, and every five minutes, someone, somewhere in the world is
diagnosed with this disorder. While there is no way to predict with
any certainty how an individual's disease will progress, four basic
MS disease courses (also called types or phenotypes) have been
defined: clinically isolated syndrome, relapsing remitting,
secondary progressive and primary progressive. The most common
affecting around 85 per cent of everyone diagnosed with MS is
relapsing remitting MS (RRMS). It means that symptoms appear (a
relapse), and then fade away, either partially or completely
(remitting).
ABOUT
PAS002
PAS002 is an
engineered DNA plasmid designed to tolerize the immune system to
GlialCAM.
About
Pasithea Therapeutics Corp.
Pasithea Therapeutics
Corporation is a U.S. biotechnology company focused on the
discovery, research and development of new and effective treatments
for psychiatric and neurological disorders. With an experienced
team of experts in the fields of neuroscience and
psychopharmacology, Pasithea is developing new molecular entities
for the treatment of psychiatric and neurological disorders.
Pasithea is also focused on addressing the needs of patients
currently suffering with mental illness by providing access to IV
ketamine infusions both in clinics and in-home settings.
Forward
Looking Statements
This press release contains
statements that constitute "forward-looking statements."
Forward-looking statements are subject to numerous conditions, many
of which are beyond the control of the Company. While the Company
believes these forward-looking statements are reasonable, undue
reliance should not be placed on any such forward-looking
statements, which are based on information available to the Company
on the date of this release. These forward-looking statements are
based upon current estimates and assumptions and are subject to
various risks and uncertainties, including, without limitation,
those set forth in the Company's filings with the SEC. Thus, actual
results could be materially different. The Company undertakes no
obligation to update these statements whether as a result of new
information, future events or otherwise, after the date of this
release, except as required by law.
Pasithea
Therapeutics Corp. Company Contact
Dr. Tiago Reis
Marques
Chief Executive
Officer
E:
tiago@pasithea.com
Pasithea
Therapeutics Corp. Investor Relations
Lisa M. Wilson
In-Site Communications,
Inc.
T: 212-452-2793
E:
lwilson@insitecony.com