Pasithea Therapeutics Announces Results of Preclinical Study Demonstrating Tolerizing Vaccine Efficacy in Relapsing-Remitting Model of Multiple Sclerosis
11 August 2022 - 10:00PM
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 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 proof of concept 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 the 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 as a treatment 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
ContactDr. Tiago Reis MarquesChief Executive OfficerE:
tiago@pasithea.com
Pasithea Therapeutics Corp. Investor
RelationsLisa M. WilsonIn-Site Communications, Inc.T:
212-452-2793E: lwilson@insitecony.com
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