Shocking data was released on August 11, 2022, that showed an ‘inverse vaccine’ that prevented 50% of mice from getting MS, and for the mice that had MS, the disease was practically stopped in its tracks.
Pasithea Therapeutics Announces Results of Preclinical Study Demonstrating Tolerizing Vaccine Efficacy in Relapsing-Remitting Model of Multiple Sclerosis
On August 11, 2022, Pasithea Therapeutics Corp. (Nasdaq: KTTA), a biotechnology company focused on the discovery, research, and development of new and effective treatments for psychiatric and neurological disorders, 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 part 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 block acute disease and its relapse potentially. 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 on 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 by 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, built on recent data on the biological mechanism linking infection with EBV with the development of MS. We have filed a provisional patent application. 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 submit complete data for peer-review publication.
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 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 percent of everyone diagnosed with MS is relapsing-remitting MS (RRMS). It means that symptoms appear (a relapse) and then fade away, either partially or entirely (remitting).
Pasithea investor group sends letter to stockholders regarding board
On August 5, 2022, Camac Partners, affiliates of Concord Investment Partners and Leonite Capital, who together are one of the largest stockholders of Pasithea Therapeutics, issued the following open letter to their fellow stockholders:
August 5, 2022
Dear Pasithea Stockholders,
We are soliciting your support to call a Special Meeting of Stockholders to remove the incumbent Board of Directors (the “Board”). This board has overseen a massive destruction in the value of your investment. Our reason is simple: we have lost all confidence in the directors’ ability to be effective and prudent stewards of our capital.
The incumbent directors have asked you to support them despite doing their best to disenfranchise stockholders through dilutive, non-arm’s length acquisitions and insider share issuances that have only served to benefit themselves – at the direct expense of all other stockholders. They oversaw a share price decline of more than 80% and then – once our group emerged to advocate for stockholder interests – they proceeded to disenfranchise all stockholders by issuing new shares that could represent nearly 20% of the Company to the Board’s chairman and his business associate in a highly speculative transaction.1 To make matters worse, the transaction was done at a 47.5% discount to net cash per share, effectively giving away your cash to the Company’s insiders.
Consider the following additional facts:
Since its initial public offering (“IPO”) to the day directly preceding our first public letter to Pasithea’s Board, the Company’s stock has fallen from an IPO price of $5.00 (for a unit composed of a share of stock and a warrant) to just $0.86 per share. This equates to a loss of 83% in a period of less than a year. Management has miscommunicated this by pointing to recent share price appreciation, which has only occurred as the result of our public involvement and advocacy.
While you have paid market prices for your shares, the incumbent directors issued the vast majority of their shares at a fraction of a penny less than a year before going public. The remainder they issued to themselves through option grants and dilutive related-party transactions. Pasithea’s directors do not have skin in the game.
The Board has compensated itself more in the last year than the cumulative value of its directors’ investment in the Company. The incumbent directors are more interested in preserving their lucrative positions at Pasithea than in creating value for stockholders.
We urge you to ask yourselves:
Is this the type of behavior that you would expect to see from a steward of your capital?
Is this a Board of Directors that is likely to change the way in which it treats the Company’s stockholders?
Given how the Board has behaved historically, is this a team that is likely to put your interests and your capital on an equal playing field with its own?
We believe that the answers to these questions are self-evident. This is not how a board of directors should treat its stockholders.
SUPPORT US IN IMPROVING PASITHEA FOR THE BENEFIT OF ALL STOCKHOLDERS.
RETURN THE WHITE SPECIAL MEETING REQUEST CARD TODAY.
Sincerely,
David Delaney Avi Geller Eric Shahinian Concord IP2 Ltd. Leonite Capital LLC Camac Capital LLC
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