Peyote has the longest documented use of any psychedelic, yet we don’t see many companies researching its properties.
That’s because the psychedelic cactus is endangered – the 13-year growth cycle can’t keep up with the rate of harvesting.
Lophos Pharmaceuticals is developing a sustainable cultivation technique that could reduce the long growth cycle to just 3 years, preserving the species and accelerating research.
The CEO of Lophos says that peyote could help treat obesity, addiction, anxiety, and depression, with a strong potential for microdosing.
A study published yesterday suggests that microdosing LSD reduces stress-induced anxiety and promotes neuroplasticity.
McGill University researchers found that giving rats a microdose 7 days in a row was able to prevent anxiety-like behaviour when exposed to chronic stress conditions, but a single dose had no behavioural effect.
They also found that repeated microdoses prevented two neurobiological changes that occur with stress: the loss of dendritic spines (the branches on neurons that conduct electrical signals) and the decrease in serotonin transmission.
“We have shown that LSD can rebuild these branches that are ‘dismantled’ due to stress. This is a sign of brain plasticity,” explains one of the researchers.
Interestingly, a single microdose actually decreased serotonin neurotransmission – it was only the repeated regimen that increased the firing of serotonin neurons. So if you’re going to microdose, you may want to try it multiple days in a row 😉
Novamind (NM) announced that it will host MindMed’s (MMED) Phase IIb study on LSD for generalized anxiety disorder later this year. The trial will assess 200 patients for 12 weeks following a single dose of MindMed’ LSD formualtion.
About 60% of patients with chronic pain also suffer from a second condition like depression or anxiety.
A University of Tasmania researcher predicts that ketamine therapy will have a “dual beneficial effect” on both pain and mental health.
Other chronic pain experts share this belief. “The domains of pain, anxiety and depression are all connected. If you treat one, another often gets better,” according to researcher Dr. David Borsook.
The hypothesis will be put to the test in an upcoming study of 30 chronic pain patients, which received a $80K grant from the Clifford Craig Foundation.
Exposure therapy has been a common treatment for anxiety disorders (especially OCD) since the 70’s. It involves gradually exposing patients to triggering situations in a safe environment so they can work through their irrational response.
Now imagine being exposed to your triggers through immersive virtual reality… while on psychedelics.
It may sound scary, but psychedelics could actually provide feelings of safety and allow patients to change their perspective and response to the stimuli.
This is how Incannex Healthcare (IXL) plans to treat patients with severe anxiety disorders in upcoming trials in collaboration with Monash University.
MELBOURNE, Australia, March 3, 2022 /PRNewswire/ — Incannex Healthcare Limited (Nasdaq: IXHL) (ASX: IHL), (‘Incannex’ or the ‘Company’) a clinical-stage pharmaceutical company developing unique medicinal cannabis pharmaceutical products and psychedelic medicine therapies for unmet medical needs, today announced it has executed a license agreement with Monash University (‘Monash University’ or ‘Monash’) to develop a novel treatment that combines Virtual Reality (‘VR’) and psychedelics. This marks the initiation of a second clinical psychedelic therapy program.
Incannex has executed an exclusive, global license in perpetuity over an immersive therapeutic VR environment that has been developed by BrainPark, a state-of-the-art clinical research platform at Monash University’s Turner Institute for Brain and Mental Health. The license allows Incannex to investigate the use of the VR therapy tool in combination with a psychedelic drug to develop a new treatment for severe forms of one or more anxiety disorders.
The established VR treatment uses an exposure-based approach, providing triggering stimuli in a graded and controlled manner (Exposure and Response Prevention or ERP). Alongside specialised clinical support and the administration of a psychedelic drug, this approach may allow for the development of new skills, changes in mental and biological responses to triggering stimuli, and reductions in pathological symptoms and behaviours.
The associated research and development project will be funded by Incannex and undertaken by Monash, led by Dr Paul Liknaitzky (Head, The Clinical Psychedelic Research Lab, Turner Institute and Department of Psychiatry, Monash) and Professor Murat Yücel (Director, BrainPark, Turner Institute, Monash), in collaboration with Professor Suresh Sundram (Head, Department of Psychiatry, Monash) and Dr Rebecca Segrave (Deputy Director, BrainPark, Monash).
Three license fees are outlined in the agreement and payable upon the decision by Incannex to proceed to subsequent phases of the research program. The parties are working towards a research agreement for the first of these trials, which will assess optimal dose, safety, and tolerability of the combination treatment method. Commercial aspects of the license agreement are detailed in Appendix A.
CEO and Managing Director of Incannex, Mr. Joel Latham, said; “We’re delighted to have commenced this exciting project and to have expanded our partnership with Monash. The combination of psychedelic compounds with an evidence-based VR therapy is a leading edge in the field of mental health treatments. We look forward to providing more detail about the project in due course when clinical trial planning has been finalised.”
About Incannex Healthcare Limited Incannex is a clinical stage pharmaceutical development company that is developing unique medicinal cannabis pharmaceutical products and psychedelic medicine therapies for the treatment of generalised anxiety disorder (GAD), obstructive sleep apnoea (OSA), traumatic brain injury (TBI)/concussion, lung inflammation (ARDS, COPD, asthma, bronchitis), rheumatoid arthritis and inflammatory bowel disease. U.S. FDA approval and registration, subject to ongoing clinical success, is being pursued for each drug and therapy under development. Each indication represents major global markets and currently have no, or limited, existing registered pharmacotherapy (drug) treatments available to the public. IHL has a strong patent filing strategy in place as it develops its products and therapies in conjunction with its medical and scientific advisory board and partners. Website: www.incannex.com.au Investors: investors@incannex.com.au
Forward-looking statements This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements are made as of the date they were first issued and were based on current expectations and estimates, as well as the beliefs and assumptions of management. The forward-looking statements included in this press release represent Incannex’s views as of the date of this press release. Incannex anticipates that subsequent events and developments may cause its views to change. Incannex undertakes no intention or obligation to update or revise any forward-looking statements, whether as of a result of new information, future events or otherwise. These forward-looking statements should not be relied upon as representing Incannex’s views as of any date after the date of this press release.
Contact Information
Incannex Healthcare Limited Mr Joel Latham Managing Director and Chief Executive Officer +61 409 840 786 joel@incannex.com.au
US IR Contact Rx Communications Group Michael Miller +1-917-633-6086 mmiller@rxir.com
Appendix A
Licence Fees and Royalties
The grant of the license is conditional on the payment of licence fees and royalties that Incannex will pay to Monash as follows:
A$300,000 on execution of the license agreement,
A$250,000 on execution of a research agreement between Incannex and Monash concerning a second clinical trial,
A$250,000 on execution of a research agreement between Incannex and Monash concerning a third clinical trial, and
a royalty of 7.5% of net sales, subject to successful commercialisation of a therapy.
Tripping on ibogaine can last over 24 hours, and it’s not always pleasant. But the wide range of benefits could make it worthwhile.
MINDCURE (MCUR) hopes so at least. The company filed a provisional patent for synthetic ibogaine mixtures to treat various central nervous system disorders like:
Addiction
Traumatic brain injury
Anxiety disorders
Chronic pain such as migraines and cluster headaches
The company aims to be a global supplier of synthetic ibogaine for research purposes and expects to have supply available by the end of Q2 this year.
Vancouver, Canada, and Uttenweiler, Germany (February 22, 2022) – XPhyto Therapeutics Corp. (CSE:XPHY / OTC:XPHYF / FSE:4XT) (“XPhyto” or the “Company”) is pleased to provide an update on its wholly owned subsidiary XPhyto Laboratories Inc. (“XPhyto Labs”). XPhyto Labs’ psychedelic medicine programs based in Edmonton, Canada, are focused on a multi-pronged approach to psychedelic medicine including GMP drug synthesis, proprietary drug delivery systems, novel psychedelic analogue engineering, and clinical validation.
Psychedelic Medicine – Canada
Through its exclusive contract R&D collaboration with Applied Pharmaceutical Innovation (“Applied”), first announced on February 3, 2021, XPhyto Labs is pursuing the application of psychedelic compounds as impactful solutions to mental health-related conditions.
Based on a systematic literature review, the Company identified mescaline (3,4,5-trimethoxyphenethylamine) as a promising candidate for the treatment of a broad range of mental disease states such as depression, anxiety, PTSD, and addiction, as well as cluster headaches. XPhyto and Applied developed a repeatable two-step reaction process with a yield greater than 60% and purity exceeding 99%, which is ideal for clinical use. Analytical methods were developed and validated and to date approximately 60 g of GMP grade mescaline has been manufactured for clinical trial evaluation.
With respect to mescaline drug delivery, XPhyto is focused on formulations designed to avoid common negative side-effects and provide precise and predictable dosage forms for clinical use. Mescaline is a naturally occurring psychedelic compound found in certain cacti, most notably peyote, San Pedro, and Peruvian Torch. These cacti are typically consumed via ingestion which has been associated with gastro-intestinal discomfort, nausea, and a lack of dosing predictability. The Company is pursuing a novel drug delivery system designed to prevent these common negative side-effects and complications; however, due to sensitivity related to intellectual property, further details cannot be disclosed at this time. The Company will announce further details in due course.
In addition to GMP mescaline synthesis and drug delivery, the Canadian operations are also focused on the design and synthesis of novel “2nd generation” psychedelic analogues. The Company has successfully developed and manufactured two promising novel compounds with properties designed to increase bioavailability. Intellectual property related information will be disclosed in due course.
XPhyto and Applied are developing a mescaline clinical trial strategy and are currently in the planning process for a robust Phase I clinical trial to commence in late 2022 to evaluate the safety and dosing parameters for mescaline-based treatment employing a proprietary drug delivery system. Details will be provided as decisions are finalized over the coming months.
“We see a lot of potential therapeutic value in psychedelic compounds for their ability to positively influence neural networks through growth and reorganization,” said Prof. Dr. Löbenberg, XPhyto director and founder and director of the Drug Development and Innovation Centre, University of Alberta. “Our focus is to develop production methodology for GMP manufacturing, proprietary drug formulations with precise, predictable and efficient API delivery for clinical investigation and therapeutic use of novel next-generation psychedelic compounds.”
Psychedelic Medicine – Germany
In addition to operations in Canada and in collaboration with a major German university, the Company is pursuing the development of industrial scale production methodology for GMP psilocybin through an advanced biosynthesis process focused on the insertion of genes from the psilocybin mushroom into certain bio-organisms. Gene insertion is complete and the micro-organisms are now producing psilocybin. The Company will announce further details in due course.
A wild DMT trip that blasts you off to a different dimension has potential to be therapeutic, but also very anxiety-inducing.
That’s why Cybin (CYBN) developed a version of the molecule that breaks down slowly in the body. So instead of a 10-minute rocket ride to outer space, patients have a smoother, more pleasant experience with a larger therapeutic window.
The company received a patent for the formulation this week and will study it as a treatment for anxiety disorders in Q3 of this year.
New research suggests that microdosing doesn’t cause withdrawal symptoms. But can it ease withdrawals from other substances?
MacEwan University researchers found that zebrafish showed increased anxiety behaviour during withdrawal from alcohol, consistent with symptoms that humans experience.
However, when the zebrafish were given microdoses of LSD for 10 days (by putting them in a “dosing tank” for a precise period of time), there were no observed behavioural changes. This indicates that microdosing is not addictive and does not cause withdrawal symptoms.
A study that’s currently underway will examine LSD microdoses on alcohol withdrawal symptoms.
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