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, Fla., Aug. 11, 2022 (GLOBE 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 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.