Psilocybin + CBD 🧠

Wesana Health Granted US FDA Pre-IND Meeting for SANA-013

The majority of patients with traumatic brain injury (TBI) also experience depression, and patients with severe TBI-related depression are 5x more likely to attempt suicide.

Wesana Health (WESA) is planning a study to see if the condition can be treated with one large dose of psilocybin in a clinic, followed by “self-administered maintenance doses” of psilocybin and CBD to sustain the benefits.

Researchers believe the treatment will promote neuroplasticity and neurogenesis while reducing neuroinflammation.

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Fixing brain damage at home

Ixtlan Bioscience Announces the Filing of New Patent for the Psilocybin Treatment of Alzheimer’s Disease and Brain Pathologies

Evidence suggests that microdosing improves cognitive function and memory. This kit could take the benefits up a notch.👇🏽

Ixtlan Bioscience, a private Israeli company, filed a US patent for a microdosing kit that can be used at home to treat Alzheimer’s, brain damage, and neuronal disorders.

The kit includes:

  • Psilocybin capsules
  • Games and exercises to enhance the benefits of microdosing
  • A web application that patients can use to track their progress.

Who knows, maybe this time next year, it’ll be the trending gift to put under the tree. 🎄

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Pasithea Therapeutics Launches In-Home Intravenous Ketamine Therapy in Major U.S. Cities, Expanding its International Footprint

Pasithea Therapeutics Launches In-Home Intravenous Ketamine Therapy in Major U.S. Cities, Expanding its International Footprint

— Pasithea Clinics to offer ketamine infusion therapy for the treatment of mental health disorders —

— First mobile clinics launch in New York City, Los Angeles, San Diego, and San Francisco, with expansion to additional U.S. cities in coming months —

— Treatments conducted by board-certified medical professionals —

MIAMI BEACH, Fla., Nov. 17, 2021 (GLOBE NEWSWIRE) — Pasithea Therapeutics Corp. (Nasdaq: KTTA) (“Pasithea” or the “Company”), a novel biotechnology company focused on the research and discovery of new and effective treatments for psychiatric and neurological disorders, today announced that its wholly owned subsidiary, Pasithea Clinics, commenced clinical operations, offering in-home intravenous (“IV”) ketamine therapy to patients suffering from treatment-resistant mental health issues. Initially, the treatment will be offered in New York City, Los Angeles, San Diego, and San Francisco and will expand nationwide in the coming months.

“The need for more effective treatment options for patients with mental health disorders has never been greater. Ketamine, when used at sub-anesthetic doses, has been shown to be highly effective in treating some psychiatric disorders. Still, we need to broaden access to this treatment to a larger patient population in a safe and convenient way. Through our mobile clinics, patients benefit from receiving the ketamine therapy in the privacy and comfort of their own homes. With patient safety as our top priority, all ketamine treatments will be delivered by board-certified medical professionals. This launch is an important stepping stone in expanding our international footprint in this space,” stated Dr. Tiago Reis Marques, CEO of Pasithea Therapeutics.

Patients with mental health disorders often struggle to complete day-to-day activities, and even small tasks can take extra effort. In disorders such as depression and post-traumatic stress disorder, symptoms such as fatigue, social isolation, lack of motivation, and high levels of anxiety are frequent. The effort to go to a physical clinic can be overwhelming. By providing this treatment at the patient’s home, Pasithea aims to broaden access to this important therapy.

“We are pleased to commence our U.S. rollout in major cities in New York and California, with plans to scale our business in other cities over the coming months. Although ketamine is a very safe drug to administer, there are still some risks. Patient safety is of paramount importance, and we are providing a network of highly trained medical professionals to administer this treatment in the comfort of the patient´s home. Our medical team ensures that our patients receive state-of-the-art support throughout their treatment experience. We believe we can become the best-in-class and largest provider of IV ketamine treatments in the United States. We will use our at-home model to expand our reach in the U.S. in a fast and accessible way,” said Dr. Adam Nadelson, Managing Director of Pasithea Clinics in the United States.

Ketamine is a U.S. Food and Drug Administration (“FDA”) approved drug introduced to the medical community as an anesthetic more than 50 years ago. It has recently been repurposed for the treatment of psychiatric disorders using significantly lower doses than in anesthesia and is now gaining ground as a promising treatment for mental health disorders. In certain psychiatric conditions, such as treatment-resistant depression (“TRD”) and post-traumatic stress disorder (“PTSD”), it has shown remarkable efficacy and a rapid and sustained effect, and up to 70% of those who receive this treatment can eventually show a clinical response. While the number of treatments suggested is done on a case-by-case basis, a typical treatment plan consists of up to six infusions in the interval of two to three weeks.

About Pasithea Therapeutics Corp.

Pasithea Therapeutics Corporation is a U.S. biotechnology company focused on the research and discovery 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

PharmaTher Announces Positive Research Results for Psilocybin Microneedle Patch

PharmaTher Announces Positive Research Results for Psilocybin Microneedle Patch

  • Delivering psilocybin via microneedle patch unlocks potential for desired dosage forms and pharmacokinetic profiles for improved safety and effectiveness.
  • Completing microneedle patch research programs with other psychedelics before year-end.
  • Pursuing Phase 2 clinical studies in 2022 with psilocybin and notable psychedelics.

TORONTO, November 11, 2021 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, is pleased to announce that it has successfully completed its first research study evaluating MicroDose-MN™, a proprietary microneedle (“MN”) patch for the intradermal delivery of psychedelics, in delivering psilocybin. These results provide support to file for an IND application with the FDA to conduct Phase 2 clinical studies in 2022 with psilocybin for various indications.

The aim of PharmaTher’s research program was to develop a suitable prototype of MicroDose-MN™ patch for transdermal (intradermal) drug delivery to confirm compatibility and suitability to deliver psilocybin. The research program scope included, full characterization of psilocybin conjugated on the microneedle patch backbone, establishment and demonstration of the loading capacity for psilocybin, and release rate evaluations for the psilocybin conjugated materials using appropriate models that will be used to support the Company’s IND application with the FDA.

The Company’s research program with psilocybin conjugated microneedles have been successfully fabricated, optimized, and characterized. Both structural aspects and ex-vivo skin insertion assessments of the psilocybin conjugated microneedles have demonstrated successful fabrication and acceptable performance. The incorporation of psilocybin per microneedle without issue and the ability to demonstrate complete ex vivo skin model release over several days demonstrates potential for larger doses and modified release profiles. With these results, the Company believes it has an acceptable prototype for completing IND-enabling studies with the aim to conduct clinical studies in 2022. Details of the research program will be published in a scientific journal.

The Company previously announced that it has entered into a collaboration agreement with Revive Therapeutics Ltd. (“Revive”) (OTCQB: RVVTF) (CSE: RVV) for the evaluation of the psilocybin MicroDose-MN™ patch and is currently in discussions with Revive in finalizing a definitive agreement to advance the clinical and commercial development. There can be no assurance that a definitive agreement will be entered into between PharmaTher and Revive.

The Company believes that its MicroDose-MN™ patch for delivering psilocybin and other psychedelics may enable flexible drug load capacity and combinations, controlled released delivery, and be able to present desired pharmacokinetic and safety profiles. In addition, the MicroDose-MN™ patch for psychedelics aims to empower patients to dose their medication remotely, safely and conveniently rather than under supervision by a healthcare provider at a certified medical office or hospital. To achieve this, the Company will incorporate anti-tampering and anti-abuse features that would parallel the approach used for the tamper-resistant transdermal fentanyl patch.

The Company is completing its evaluation of MicroDose-MN™ with 3,4-methylenedioxy-methamphetamine (“MDMA”), lysergic acid diethylamide (“LSD”), and N, N-dimethyltryptamine (“DMT”) and expects to provide results before the end of this year and pursue clinical studies in 2022.

The Company is actively engaged in partnering discussions for the use of its microneedle patch system to deliver psychedelics including, but not limited to, MDMA, LSD, DMT, ibogaine and mescaline. As such, PharmaTher offers potential partners a differentiated and validated delivery system for psychedelics, desired pharmacokinetic profiles, intellectual property protection, cGMP microneedle patches for IND-enabling and clinical studies, and a clear clinical pathway towards clinical studies in 2022.

About PharmaTher Holdings Ltd.

​PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is a clinical-stage psychedelics biotech company focused on the research, development and commercialization of novel uses, formulations and delivery methods of psychedelics, such as ketamine, to treat mental health, neurological and pain disorders. PharmaTher is currently advancing an FDA approved phase 2 clinical study with ketamine to treat Parkinson’s disease and is developing a novel microneedle patch for the intradermal delivery of psychedelics and infectious disease treatments.

Learn more at: PharmaTher.com and follow us on Twitter and LinkedIn.

For more business development opportunities or information about PharmaTher, please contact:

Fabio Chianelli
Chief Executive Officer
PharmaTher Holdings Ltd.
Tel: 1-888-846-3171
Email: info@pharmather.com
Website: www.pharmather.com

Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.

Cautionary Statement

This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated”, “potential”, “aim”, “may” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on PharmaTher Holdings Ltd. (the “Company”) current belief or assumptions as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by the Company at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Company is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption “Risk Factors” in Company’s management’s discussion and analysis for the period of August 31, 2021 (“MD&A”), dated October 27, 2021, which is available on the Company’s profile at www.sedar.com.

This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.

Try psychedelic therapy at home in these states

Origin Therapeutics Portfolio Company TripSitter Expands to Eight Additional States

TripSitter Clinic Corp. now offers at-home ketamine therapy in 10 states!

The company, which is part of Origin Therapeutics’ portfolio, expanded its services to eight new states: Arizona, Colorado, Michigan, Washington, Florida, New York, Ohio, and Virginia, in addition to California and Illinois.

Patients can receive a prescription for oral ketamine after a virtual consultation a physician. They can then take the medication at home with virtual guidance, followed by therapy sessions.

Another company, My Ketamine Home, offers similar services in Texas, Florida, and California.

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