Acid trip ends pandemic: issue 38

Hello and welcome back.

After two years of Covid ruling our lives, it seems like we can finally see the light at the end of the tunnel. That might not be the case if it weren’t for psychedelics. Keep reading to discover how LSD lead to the invention of a tool that’s been essential for detecting Covid! 

Here’s what’s in store for you in today’s issue:

🍄 What a DMT trip actually feels like

🍄 The legal psychedelic that’s replacing alcohol

🍄 World’s first DMT trial for depression

🍄 How psychedelics could treat eye disease 👀

🍄 And more.

Be sure to check out this week’s Daily Mushroom podcast:

Michael Kydd opens up about the impact of losing his mother at a young age

On this episode of the Daily Mushroom Podcast, we have Michael Kydd, an independent consultant helping psychedelic companies navigate the complex world of government relations. in this emotional episode, Michael talks about his experience with the passing of his mother, and how he believes psychedelics could have strongly benefited his mothers and his family in that difficult time. 

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World’s first DMT trial for depression

Small Pharma (DMT) successfully completed a phase I trial on the safety of DMT in preparation for a phase II trial on depression. Researchers discovered that:

  • Most of the 24 patients described the experience as pleasurable and not too challenging (even though no one had tried psychedelics before)
  • Although there were 20 adverse events (85% mild, 15% moderate, and 0% severe), no patient regretted participating
  • The trip lasted 20 minutes, and DMT was nearly undetectable in the blood after 60 minutes
  • For three months following the dose, there were no significant negative effects on anxiety or well-being

Phase II results are expected in the first half of this year, which will reveal how one dose compares to two doses in treating depression.

Discovering self-worth with ketamine

Despite having a supportive family and a healthy lifestyle, Sarah had crippling self doubt and suicidal ideation. It wasn’t until she tried ketamine therapy that she realized why she felt these emotions.

The experience revealed that she never healed the scars of feeling unloved during her parents’ divorce. Her dream-like visions on ketamine showed her that separation is a natural part of life, and that she doesn’t need to be perfect to deserve love.

Sarah finally believes “I’m worth being here,’ she says. 

How psychedelics treat eye disease

Glaucoma can cause irreversible vision loss and blindness. Current medications require multiple daily applications and have side effects like redness and stinging of the eyes.

PharmaDrug (PHRX) wants to develop a superior treatment using analogues of DMT.

The company discovered that the compounds can “activate protective pathways within critical cellular compartments of the eye” to reduce pressure inside the eye. 

PharmaDrug will collaborate with the Terasaki Institute for Biomedical Innovation (TIBI) to produce a device that can deliver low doses of the drug to the front of the eye. 

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What a DMT trip actually feels like

Researchers interviewed 36 people immediately after a DMT trip. Here’s what they discovered:

  • All 36 people reported “entering other worlds”
  • 94% encountered some sort of otherworldly being or entity 
  • Entity encounters were overwhelmingly positive and often provided personal and cosmic insights (like self love or the game-like nature of reality)
  • 81% described the trip as “hyperreal” 

DMT increases theta brain waves, which are associated with dreaming, but it’s unclear why people have such similar “dreams” 🤔

Acid-inspired invention earns Nobel Prize

LSD led to the invention of a technology that has slowed the spread of Covid and even earned a Nobel Prize – the PCR test.

Chemist Kary Mullis experimented with lots of synthetic psychedelics, which is no surprise considering he was friends with Albert Hofmann, the creator of LSD. 

He believes psychedelics made him think more creatively and gave him visions of sitting on DNA molecules. When asked if he would have invented PCR technology without LSD, he responded, “I doubt it. I seriously doubt it.”

So this pandemic would likely be a lot longer if it weren’t for LSD!

Replace alcohol with this legal psychedelic drink

Psychedelic Water is a mildly psychoactive drink made with kava root, a herb used by Pacific Islanders in ceremonies for relaxation. The mood-boosting effect makes it the ideal replacement for alcohol. 

Psychedelic Water is having a buy one get one free sale to celebrate the launch of a new flavour – Prickly Pear!

Even multi-platinum producer Murda Beatz is a fan. “I want something that will make me feel good & expand my creativity; Psychedelic Water does exactly that,” he says.

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COMPASS Pathways (CMPS) reported 2021 financial result including a net loss of  $71.7 million ($1.79 loss per share) and $273.2M in cash. The company had a $60.3M loss ($3.55 loss per share) and $190.3M in cash in 2020.

Optimi Health (OPTI) and Doseology Sciences (MOOD) both launched functional mushroom product lines in Canada. The global market for functional mushrooms is expected to grow at a 7.23% compound annual growth rate through 2027.

Filament Health (FH) will license its natural psilocybin to ATMA Journey Centers for use in clinical trials, including an upcoming phase I trial on healthy subjects, which has already received Health Canada approval.

Biomind Labs (BMND), a company researching DMT, 5-MeO-DMT, and mescaline, began trading on the OTCQB market under the symbol “CRSWF” and received DTC eligibility in the US.

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Help patients and clinicians fight for their right to psilocybin

Our friends at TheraPsil helped 86 clinicians apply for Section 56 exemptions so they could participate in a psilocybin therapy training program.

Unfortunately, Health Canada denied the clinicians access to psilocybin, which will impact over 1500 patients who are desperately awaiting psilocybin treatments. Many Canadians will die before they have the chance to try psilocybin therapy.

TheraPsil needs our help to raise $100K to take the Canadian government to court to achieve lasting policy change so that Canadians can access the treatment before it’s too late. 

Plus:

  • The DEA proposed adding 5 more psychedelics to the list of Schedule I substances, which would impede research on the substances. After receiving pushback from the research community, the DEA’s administrative court agreed to hold hearings on the issue. Read more…
  • A bill to form a psychedelic research task force was passed by a Utah Senate committee after passing in the House. The task force will advise regulations surrounding dosage, training, licensing, and safety requirements if therapeutic use is legalized. Read more..
  • Senate committee in Oregon unanimously approved a bill to create a psilocybin equity task force that will guide the state’s psilocybin therapy program. Read more…

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Ai creates new state of consciousness for crime prevention: issue 37

Hello and welcome back.

Happy Fungi Friday 🎉 Whether you swear by the benefits of microdosing or you’re convinced it’s a placebo, get ready for research to confirm your beliefs 🙃

Here’s what’s in store for you in today’s issue:

🍄 The company that’s designing brand new states of consciousness

🍄 Can psilocybin treat the deadliest mental health disorder?

🍄 The effects of different microdosing regimens

🍄 How patients feel 1 year after psilocybin therapy

🍄 And more.

Be sure to check out this week’s Daily Mushroom podcast:

Michael Kydd opens up about the impact of losing his mother at a young age

On this episode of the Daily Mushroom Podcast, we have Michael Kydd, an independent consultant helping psychedelic companies navigate the complex world of government relations. in this emotional episode, Michael talks about his experience with the passing of his mother, and how he believes psychedelics could have strongly benefited his mothers and his family in that difficult time. 

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Can psilocybin treat the deadliest mental health disorder?

Anorexia has a higher mortality rate than any other psychiatric condition, as patients have a high risk of death by both suicide and organ failure.

Current treatments work for less than half of patients, which is why Imperial College London is preparing to study psilocybin therapy as an alternative. 

The school is recruiting female patients who have had a diagnosis for at least 3 years and have tried other forms of treatment without success. They’ll each receive 3 doses of psilocybin, and researchers will use several MRIs and EEG scans to understand the effects of the treatment.

Is microdosing a placebo? 💊

This week, Nova Mentis (NOVA) announced that rats with cognitive impairments saw improvements in memory when given a microdose of psilocybin every other day for just two weeks.

However, a new University of Chicago study found no effect on mood or task performance after giving healthy volunteer 4 LSD microdoses 3-4 days apart in a placebo-controlled study.

Could it be that a more frequent dose is needed to see benefits? Or is psilocybin faster acting than LSD? Or maybe microdosing is a placebo after all.

Stay tuned as we follow along with the latest research. 

Depression free for 1 year

Johns Hopkins researchers found that one year after receiving psilocybin therapy, 75% of patients sustained significant reductions in depression scores and 58% no longer qualified for a diagnosis. 

However, about a third of patients also used traditional antidepressants and 42% received additional psychotherapy at some point during the year.

So although psilocybin therapy can have rapid results, multiple treatment options can help sustain the benefits.

Making microdoses even safer

One of the few concerns that experts have about microdosing is the long term impact on heart health. Psilocybin binds to 5-HT2B receptors, which could increase risk of heart valve disease with frequent use. 

Mydecine (MYCO) developed a group of patent-pending molecules that bind only to 5-HT2A receptors, making them safer for microdosing. The company aims to administer these compounds through a microdosing patch to eliminate another side effect: nausea. 

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Shroom use →  less crime

People who use shrooms are less likely to commit crimes, according to new research.

An analysis of The National Survey on Drug Use and Health found that psilocybin use is linked to significantly reduced odds of arrest for:

  • Larceny
  • Burglary & robbery
  • Simple assault & battery
  • Serious violence
  • DUI
  • And other miscellaneous crimes

LSD appeared to have no impact on crime rates 🤔

Brand new states of consciousness

Mindstate Design Labs raised $11.5M in seed funding to create “new novel states of consciousness that just don’t exist yet.”

The company is taking a reverse approach to drug discovery. Researchers will design a unique state of mind first and then create a compound that can get you there. 

How? Using predictive AI technology, subjective data from 7,000+ trip reports, and biochemical data on how different molecules interact with receptors in the body. 

Who’s brave enough to test out a brand new state of mind?

Introducing Houston, your new microdosing companion

Houston is an app that helps you set intentions, track doses and moods, dose with community, and more, on your journey through inner space.

“Took a dive into Houston just now and WOW, absolutely phenomenal. User friendly, knocks out everything I journal while I’m microdosing, love intention section and the playlists. Wow. I am beyond elated you found me,” says one user.

Download Houston on the App Store and follow their Instagram to see when they launch on Android.

Get a Master’s in mushrooms

Vancouver Island University is launching a psychedelic-assisted therapy graduate certificate program this September, becoming the first accredited school in Canada to offer such a program.

A company called Fluence will also be scaling psychedelic training for therapists in Oregon after completing a $3M seed funding round this week.

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Entheon Biomedical (ENBI) initiated a ketamine study on depression in partnership with Wavepaths. It will monitor brain activity with EEG while assessing the impact of Wavepaths’ personalized music technology. 

Field Trip Health (FTRP) reported Q3 financial highlights including $74.5M in cash and patient services revenues of $1.36M, up more than 50% from Q2 and 330% year over year.

PharmaTher (PHRM) was granted a US patent for its formulation of ketamine and betaine anhydrous, a chemical that occurs naturally in the human body and may increase ketamine’s antidepressant effect. The formulation is already patented in Japan and Taiwan, and the company expects to receive patents in Europe, Canada, Israel and China in the near future.

Enveric Biosciences (ENVB) will partner with the University of Calgary to study oral psilocybin for cancer-related distress. Patient enrollment will begin by the end of this year or early next year.

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Here’s what you missed:

  • Hawaii senators unanimously passed a bill to create a psilocybin research task force and develop a long-term strategy to make treatments accessible and affordable. Read more…
  • With a 7-2 vote, Oklahoma legislators approved a bill in committee to decriminalize low-level possession of psilocybin and promote therapeutic research. Read more…

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PharmaTher Announces Grant of U.S. Patent on Ketamine Formulation

PharmaTher Announces Grant of U.S. Patent on Ketamine Formulation

PharmaTher (PHRM) was granted a US patent for its formulation of ketamine and betaine anhydrous, a chemical that occurs naturally in the human body and may increase ketamine’s antidepressant effect. The formulation is already patented in Japan and Taiwan, and the company expects to receive patents in Europe, Canada, Israel and China in the near future.

PharmaTher Holdings Ltd. Ketamine

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Swimming in acid to cure rare diseases: issue 35

Hello and welcome back.

We loved connecting with you all at the Daily Mushroom + Entheon Biomedical Mental Health Town Hall last night 😍 If you couldn’t make it, no worries, we got you. Check out the recording below.

Here’s what’s in store for you in today’s issue:

🍄 A cure for the most annoying Covid symptom?

🍄 Reducing suicidality for 6 months

🍄 Microdosing for withdrawals

🍄 How to prevent bad trips

🍄 And more.

Be sure to check out this week’s Daily Mushroom podcast:

Mental Health Townhall

On this very special episode of the Daily Mushroom Podcast, we were lucky enough to be joined by some pretty amazing guests. We had Andy Greenshaw, David Mayoh, Timmothy Ko, Valorie Masuda, Marsha Bennett, and of course our host Brett Higson. We asked our readers to submit questions they had about psychedelics for our knowledgeable board to answer and they did not disappoint! This episode is full of all kinds of insight into the expanding world of psychedelic therapy and what the future may hold.

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Swimming in acid 🐠

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.

Did you know we share 70% of our genes with zebrafish? Plus, they are extremely social, making them ideal for behavioural studies. 

Treating rare disorders with ketamine

PharmaTher (PHRM) is developing a treatment for a rare, seizure-inducing disorder called Status Epilepticus using ketamine. This week, it was granted a designation that will save them millions of dollars in the process. 

It’s called an Orphan Drug Designation and it gives the company potential tax credits, grant eligibility, and marketing exclusivity, and waives a $2.4M New Drug Application fee. It’s designed to incentivize R&D of treatments for rare conditions.

PharmaTher previously received the designation for ketamine to treat ALS and complex regional pain syndrome too!

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A cure for the most annoying Covid symptom?

Even months or years after recovering from Covid, many people have no sense of taste or smell – or worse, everything tastes and smells disgusting. 

People are rushing to Reddit and Twitter to share that they’ve finally found a cure: shrooms!

Some report that their senses returned to normal after one dose while others say they were restored gradually over a handful of trips.

Here’s one Reddit user’s experience: “I was shocked and elated.. ran around to find a candle, picked it up, lavender! Began to cry. Began smelling everything in sight. You don’t realize how beautiful it is to smell things, until you can’t smell for almost a year.”

Reducing suicidality for 6 months

A meta-analysis of 7 clinical trials (5 psilocybin + 2 ayahuasca) found that psychedelic therapy significantly reduced suicidality in as little as 80 minutes.

The significant reductions were sustained for 3-4 months, and patients still had a moderate reduction in suicidality after 6 months.

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Entheon Biomedical (ENBI) received approval for a phase I DMT trial and will begin screening patients this month. The trial, which will be conducted in the Netherlands, will gather essential safety and dosing data needed for a phase II study on DMT for nicotine addiction.

Awakn Life Sciences (AWKNF) received a buy rating and a $10 price target from H.C. Wainwright – that’s a 530% increase from its current share price of $1.58 🤑

Lexston Life Sciences (LEXT) received a Section 56 exemption to research psilocybin. It is developing a tool that can rapidly identify and quantify different mushroom compounds such as psilocin, psilocybin, baeocystin, norbaeocystin and aeruginascin.

Tryp Therapeutics (TRYP) announced Q1 financial results including $2.1M in cash and a $3.0M loss for the three months ended November 30, 2021. The company also secured a $2M private placement this week. 

An individual in Oregon was issued a patent for a vape pen for “ayahuasca-like substances” including DMT, 5-MeO-DMT, and 2CB. The decision is receiving backlash from many who claim that the technology is not novel and has been around for years.

How to prevent bad trips

Tripping can be scary. You never really know how hard a dose will hit you or how long the effects will last — especially if it’s your first time.

What if there was a way to get some insight? Well, there is – HaluGen’s Psychedelic Genetic Test.

With a simple cheek swab, the test tells you:

  • How sensitive you are to classical psychedelics like psilocybin, LSD, and DMT
  • How quickly your body metabolizes MDMA, LSD, ayahuasca, and ketamine
  • If your genetics put you at risk of developing psychosis, bipolar disorder, or schizophrenia
  • If you’re prone to adverse reactions from SSRIs

Use the results to find the dose that’s right for you so you can have the best experience possible!

 

Get 10% off when you use promo code ‘dailymushroom

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The good

  • Oregon legislators filed a bill to form a 15-member task force to ensure that access to legal psilocybin services is equitable for all. It will focus on removing barriers for minorities and people with low income. Read more…
  • A second ballot initiative has been filed in Colorado to decriminalize the possession, cultivation, and gifting of psilocybin, psilocyn, ibogaine, mescaline and DMT. The first measure would create legal psilocybin healing centers. Read more…
  • A ballot measure was filed in Michigan to legalize possession, cultivation, and sharing of a range of psychedelics and implement a system for therapeutic and spiritual use. Read more…

The bad

  • A measure that would have decriminalized therapeutic psilocybin in Virginia was defeated by the Senate Judiciary Committee. The bill’s sponsor plans to bring the bill back next year. Read more…
  • Washington’s initiative to legalize guided psilocybin sessions will not pass, according to the bill’s sponsor, Sen. Jesse Salomon. He explains that there are concerns of facilities losing federal revenue for offering the services, and that the Department of Health is too busy with Covid to implement new regulatory framework. Read more…
  • A lawsuit filed by a physician and his cancer patients against the DEA for denying access to psilocybin therapy was rejected by the Court of Appeals. Read more…

And the ugly

  • Health Canada denied dozens of healthcare practitioners access to psilocybin therapy training by rejecting their section 56 exemption applications. Now, clinical trials will likely be the only way to get experience with the psychedelic. TheraPsil, the non-profit that helped with the applications, says that this will impact over one thousand practitioners on their waitlist for psilocybin training and several thousand patients seeking care 💔 Read more…

Video of the Week

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Treating rare disorders with ketamine

PharmaTher Granted FDA Orphan Drug Designation for Ketamine to Treat Status Epilepticus

PharmaTher (PHRM) is developing a treatment for a rare, seizure-inducing disorder called Status Epilepticus using ketamine. This week, it was granted a designation that will save them millions of dollars in the process. 

It’s called an Orphan Drug Designation and it gives the company potential tax credits, grant eligibility, and marketing exclusivity, and waives a $2.4M New Drug Application fee. It’s designed to incentivize R&D of treatments for rare conditions.

PharmaTher previously received the designation for ketamine to treat ALS and complex regional pain syndrome too!

PharmaTher Inc.

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Revive Therapeutics Provides Update of Psilocybin Pharmaceutical Programs

Revive Therapeutics Provides Update of Psilocybin Pharmaceutical Programs

IRB approval to initiate Phase 2 study for methamphetamine abuse disorders

Advancing psilocybin oral thin film, microneedle patch and biosynthesis programs

TORONTO, Jan. 17, 2022 – Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT:31R), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is pleased to provide an update on the Company’s psilocybin pharmaceutical development programs.

“Revive is building a specialty psilocybin-based product pipeline to treat mental illness, substance abuse and neurological disorders. We are embarking on our first clinical study evaluating psilocybin in the treatment of methamphetamine use disorder and advancing the development of an oral psilocybin thin file strip and psilocybin microneedle patch, which will offer flexible therapeutic solutions of psilocybin for unmet medical needs.”

Psilocybin for Methamphetamine Use Disorder

The Company is evaluating psilocybin as a potential treatment for methamphetamine use disorder with the University of Wisconsin-Madison through a clinical trial agreement. Under an investigator-initiated IND, led by Dr.’s Christopher Nicholas and Paul Hutson, the Phase I/II clinical study to evaluate the safety and feasibility of psilocybin in adults with methamphetamine use disorder received Institutional Review Board (“IRB”) approval. As a result of the study, clinical data will provide proprietary and valuable information on the safety, efficacy and dosing of psilocybin to support future pivotal FDA clinical studies in the Company’s proposed oral psilocybin thin film strip. The clinical study will be conducted at the University of Wisconsin-Madison, School of Medicine and Public Health and School of Pharmacy. In addition, the Company will have exclusive access to key intellectual property from this study to support development, regulatory and commercial initiatives.

Psilocybin for Stroke

The Company is evaluating psilocybin as a potential treatment for stroke with the University of Wisconsin-Madison. Under the same investigator-initiated IND, led by Dr.’s Christopher Nicholas and Paul Hutson, the proposed Phase I/II clinical study protocol to evaluate the safety and feasibility of psilocybin for stroke is expected to be submitted to the IRB in February. As a result of the study, clinical data will provide proprietary and valuable information on the safety, efficacy and dosing of psilocybin to support future pivotal FDA clinical studies in the Company’s proposed oral psilocybin thin film strip. The clinical study will be conducted at the University of Wisconsin-Madison, School of Medicine and Public Health and School of Pharmacy. In addition, the Company will have exclusive access to key intellectual property from this study to support development, regulatory and commercial initiatives.

Psilocybin Oral Thin Film Strip        

The Company has initiated the product development program under a feasibility agreement with LTS Lohmann Therapie-Systeme AG, a leader in pharmaceutical oral thin films, to develop and manufacture a proprietary psilocybin oral thin film strip for mental illness, substance abuse and neurological disorders. Research prototype development is underway to support IND-enabling studies with the expectation to conduct a clinical study in Q4-2022.

Psilocybin Microneedle Patch        

The Company entered into a research collaboration agreement with PharmaTher Holdings Ltd. (“PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM) to evaluate the delivery of psilocybin with PharmaTher’s proprietary microneedle patch technology for neuropsychiatric disorders. The project plan has been finalized and the Company will initiate IND-enabling studies with the expectation to conduct a clinical study in Q4-2022.

Psilocybin Biosynthesis        

The Company is developing a novel biosynthetic version of psilocybin based on a natural biosynthesis enzymatic platform under its research collaboration with North Carolina State University developed by Dr. Gavin Williams, Professor and Researcher at NC State. The biosynthetic platform provides a potentially simple and efficient method for rapidly producing natural products, such as psilocybin, using an engineered enzymatic pathway in E. coli. Certain technical milestones have been achieved to date, offering a clear path towards completing validation methods to demonstrate a novel yet simple production process of biosynthetic psilocybin that can be used at a critical scale for clinical and commercial use. The Company expects to complete a research-grade batch of psilocybin for research in Q2-2022 with the aim to conduct clinical studies in 2023.

Psilocybin International Research        

The Company entered into an agreement with the University of Health Sciences Antigua to utilize Revive’s novel psychedelic-assisted therapies, including its tannin-chitosan delivery system and to pioneer the clinical research and development of psychedelics in Antigua and Barbuda. Clinical research is expected to begin shortly with the aim for commercialization in 2022 in Antigua and Barbuda. Once approved for sale, the Company will seek commercial partnerships with specialty pharmaceutical companies in the Caribbean and Latin America.

About Revive Therapeutics Ltd.

Revive is a life sciences company focused on the research and development of therapeutics for infectious diseases and rare disorders, and it is prioritizing drug development efforts to take advantage of several regulatory incentives awarded by the FDA such as Orphan Drug, Fast Track, Breakthrough Therapy and Rare Pediatric Disease designations. Currently, the Company is exploring the use of Bucillamine for the potential treatment of infectious diseases, with an initial focus on severe influenza and COVID-19. With its acquisition of Psilocin Pharma Corp., Revive is advancing the development of Psilocybin-based therapeutics in various diseases and disorders. Revive’s cannabinoid pharmaceutical portfolio focuses on rare inflammatory diseases and the company was granted FDA orphan drug status designation for the use of Cannabidiol (CBD) to treat autoimmune hepatitis (liver disease) and to treat ischemia and reperfusion injury from organ transplantation. For more information, visit www.ReviveThera.com.

For more information, please contact:

Michael Frank
Chief Executive Officer
Revive Therapeutics Ltd.
Tel: 1 888 901 0036
Email: mfrank@revivethera.com
Website: www.revivethera.com

Neither the Canadian Securities Exchange nor its Regulation Services Provider has reviewed or accepts 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” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on Revive’s current belief or assumptions as to the outcome and timing of such future events. Forward looking information in this press release includes information with respect to the the Company’s cannabinoids, psychedelics and infectious diseases programs. Forward-looking information is based on reasonable assumptions that have been made by Revive 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 Revive 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. Reference is made to the risk factors disclosed under the heading “Risk Factors” in the Company’s annual MD&A for the fiscal year ended June 30, 2021, which has been filed on SEDAR and is available under the Company’s profile at www.sedar.com.

Docs on Mushrooms: issue 32

Hello and welcome back.

We’re excited to announce that we’ll be bringing you a FREE virtual event on February 3rd to discuss all things psychedelic and mental health. If your New Year’s resolution is to work on your mental health, you won’t want to miss it! Keep reading for details 😊

Here’s what’s in store for you in today’s issue:

🍄 The most intense psychedelic?

🍄 Impressive findings from a ketamine study on addiction

🍄 A promising treatment for ALS

🍄 Rescheduling psilocybin GLOBALLY

🍄 And more.

Be sure to check out this week’s Daily Mushroom podcast:

What physicians really think about psilocybin

On this episode of the Daily Mushroom Podcast, we have Dr. Lyle Oberg, co-founder, and CEO of MYND life sciences. Dr. Oberg has been had an extensive career across many sectors, including working as a family physician and a Chief Policy and Medical Officer at a cannabis company. He was also part of the Alberta government for 15 years as Minister of Finance, Social Services, Learning, and more. Stick around to hear what Dr. Oberg has to say, we are sure it will give a new insight into the world of psychedelics!

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86% abstinent after ketamine therapy

Six months after receiving three ketamine infusions and Awakn Life Sciences’ proprietary therapy, 86% of patients with severe alcohol use disorder remained abstinent from alcohol. 

Awakn’s study also showed that:

  • The treatment was 2.7x more effective than placebo infusions and alcohol education
  • Risk of mortality within one year dropped from 1 in 8 patients to 1 in 80
  • Liver function improved (shocker)
  • Depression scores were significantly reduced
  • Ability to experience pleasure increased

The downside? There isn’t one. There were no serious adverse reactions either 👏

Slowing the progression of ALS

When diagnosed with ALS, patients are typically given 2 to 6 years to live and experience rapid decline in muscle function. Even after the ice bucket challenge took the internet by storm, a cure has yet to be found. 

Luckily, ketamine is showing potential to slow the progression of the disease to improve both the quality and length of patients’ lives.

In a mouse model of ALS, PharmaTher (PHRM) found that ketamine preserved muscle function and increased life expectancy if administered in the early stages of the disease. 

The company received FDA approval for a Phase II trial that will assess a biomarker of neurodegeneration, functional abilities, muscle strength, and depression scores among ALS patients undergoing ketamine treatments.

Psilocybin + CBD 🧠

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.

Can ketamine enhance addiction medication?

Novamind (NM) is hosting a first-of-its-kind study to find out.

The trial will see if ketamine-assisted therapy can enhance the effectiveness of buprenorphine, a first-line addiction medication, in treating opioid use disorder. 

Will the two drugs finally be able to conquer this treatment-resistant condition?

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Join our virtual Mental Health Town Hall

We’re collaborating with experts at Entheon Biomedical (ENBI) to bring you a special virtual event on February 3rd. 

Here’s what you can expect to learn:

  • The latest psychedelic research on mental health and addiction
  • How psychedelics can be used for personal development
  • All things microdosing
  • Where the industry is headed
  • Answers to all your burning questions

You’ll hear insights and stories from:

  • Timothy Ko, CEO and Founder of Entheon
  • Dr. Andrew Greenshaw, Scientific Advisor to Entheon and Professor of Psychiatry and Neuroscience at the University of Alberta
  • David Mayoh, Communications Manager at Entheon
  • Thomas Hartle, the first Canadian to receive psilocybin therapy
  • And more

Now is your chance to get your questions answered by industry experts and connect with fellow members of the Daily Mushroom Community. We can’t wait to see you there. Register now 👇

The most intense psychedelic?

“​​I truly doubt that there is another psychedelic drug, anywhere, that can match [4-HO-DiPT] for speed, intensity, brevity, and sensitive to dose, at least one that is active orally.”

Field Trip Health’s (FTRP) first novel compound could produce the most intense experience of any oral psychedelic. 

It’s a more stable and soluble version of 4-HO-DiPT — a drug that induces an extremely powerful experience lasting 2-3 hours, according to Alexander Shulgin, the chemist who created it.

Considering he’s experimented with 55 different psychedelics, which he reviewed in “Tryptamines I Have Known and Loved,” we’ll take his word for it. 

Field Trip expects to receive a patent for the formulation next month. 

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Mydecine (MYCO) is launching a program to sell MDMA and psilocybin, as well as training and support services, to healthcare practitioners through Health Canada’s amended Special Access Program. The company also completed a model that can rapidly screen billions of compounds using AI to find novel psychedelics that bind to serotonin receptors. 

Delic Holdings Corp. (DELC) announced that it plans to more than double its footprint in the next 18 months by opening 15 new ketamine clinics, which will be strategically located in secondary cities to improve patient accessibility.

Ketamine One (MEDI) began trading on the OTCQB marketplace under the symbol ‘KONEF’.

atai Life Sciences (ATAI) received FDA approval for a study to investigate how its R-ketamine compound interacts with other drugs.

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Rescheduling psilocybin GLOBALLY 🌍

“Given today’s scientific understanding of psilocybin’s high potential therapeutic value and low risk of dependence, a change of its status as a Schedule I drug is long overdue,” according to Christopher Koddermann.

That’s why he co-founded The International Therapeutic Psilocybin Rescheduling Initiative (ITPRI) – an initiative that’s pushing for psilocybin to be rescheduled on a global scale.

ITPRI aims to reschedule psilocybin through the United Nations’ Convention on Psychotropic Substances, which was enacted over 50 years ago 😮 This would significantly reduce the regulatory barriers that impede psilocybin research and access to treatment.

So yes, rescheduling is long overdue, but better late than never!

Plus, progress in the US & Italy:

  • A Missouri Rep. filed a bill to expand the state’s right-to-try law to include psilocybin, MDMA, DMT, ibogaine, LSD, mescaline, and peyote. This would grant patients with serious illnesses legal access to the substances. Read more…

  • Senator Scott Wiener announced that he is once again pushing for a psychedelic decriminalization bill in California after halting it last year, and believes it has a 50/50 chance of being passed. To generate support, veterans are meeting with Assembly members and changes may be made to possession limits and types of psychedelics included. Read more…

  • Virginia lawmakers introduced a bill to reduce the penalty for possessing peyote, ibogaine, psilocybin, or psilocin from a Class 5 felony to a $100 fine. A separate bill focused on just psilocybin and psilocin was also filed. Read more…
  • Italian officials verified 630,000 signatures collected in support of a measure to decriminalize cultivation of marijuana and psilocybin mushrooms. If the measure is approved by the Constitutional Court, which will be announced on February 15, it will appear on a ballot this spring. Read more…

Turning mushrooms into mush houses

Architect David Benjamin wants to make the construction industry more sustainable using (you guessed it) mushrooms!

He constructed a 40-foot-tall structure using bricks grown from mushroom mycelium. 

The bricks are lightweight yet durable and can be grown in five days without emitting carbon or producing waste.

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Slowing the progression of ALS

PharmaTher Announces FDA Approval of Investigational New Drug (IND) Application for Ketamine to Treat ALS

When diagnosed with ALS, patients are typically given 2 to 6 years to live and experience rapid decline in muscle function. Even after the ice bucket challenge took the internet by storm, a cure has yet to be found. 

Luckily, ketamine is showing potential to slow the progression of the disease to improve both the quality and length of patients’ lives.

In a mouse model of ALS, PharmaTher (PHRM) found that ketamine preserved muscle function and increased life expectancy if administered in the early stages of the disease. 

The company received FDA approval for a Phase II trial that will assess a biomarker of neurodegeneration, functional abilities, muscle strength, and depression scores among ALS patients undergoing ketamine treatments.

PharmaTher Inc.

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PharmaTher Announces Publication of Research Data for KETABET™

PharmaTher Announces Publication of Research Data for KETABET™

Second published study to demonstrate the potential therapeutic utility and mechanism of action of KETABET™ (patented combination of ketamine and betaine) in models of depression

Repeated use of KETABET™ exhibits potential protective and reversing effects on ketamine-elicited psychotomimetic behaviors and cognitive impairments

Supports clinical initiatives as a potential next generation ketamine treatment for mental health and pain disorders with patent protection into 2036
TORONTO, January 4, 2022 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a life sciences company focused on the development and commercialization of specialty ketamine prescription-based products, today announced the publication of a scientific article demonstrating the potential of KETABET™, a patented combination formulation of FDA-approved ketamine and betaine anhydrous, to prevent the potential adverse psychiatric effects of repeated ketamine treatment for depression and other indications including suicidal ideation, substance abuse, post-traumatic stress disorder, and chronic pain. The article titled, “Betaine prevents and reverses the behavioral deficits and synaptic dysfunction induced by repeated ketamine exposure in mice”, is published in Biomedicine & Pharmacotherapy and can be found here.

The newly published study further validates the potential of KETABET™ and support the Company’s ongoing investigator-led observational studies evaluating the impact of betaine on the unwanted ketamine side effects seen post ketamine treatment for subjects with either depression or pain. Based on the outcome from the ongoing observational studies, the Company will advance the KETABET™ program with its microneedle patch technology in Phase 2 clinical studies in H2-2022.

Modulation of glutamatergic NMDA receptor by betaine might be the underlying mechanisms accounting for cognitive dysfunction, behavioral deficits, and synaptic neurotransmission induced by chronic ketamine use. The present published study aimed to assess whether repeated co-treatment with betaine and ketamine improved behavioral impairments and hippocampal synaptic plasticity. The experimental results showed that both co-treatment and post-treatment with betaine could exhibit the protective and reversing effects on subchronic ketamine-elicited psychotomimetic behaviors, cognitive impairments, and decreases in synaptic function, LTP, and PSD-95 protein expression. Therefore, betaine may enhance the therapeutic effect when  combined or post-treated with ketamine for treatment-resistant depression or other mood disorders, and benefit substance abuse disorders.1   

A previously published study revealed that betaine could promote the antidepressant-like effects, yet abolish the psychotomimetic action as well as motor- and cognitive-impairing effects of acute ketamine treatment in mice,2 indicating that betaine might potentially enhance the antidepressant efficacy of ketamine and reduce the acute psychotic symptoms in patients when receive ketamine to treat depression. However, it remained unknown if repeated co-treatment with betaine could minimize the adverse psychiatric effects observed after repeated ketamine use, either medically or recreationally.  The present published study supported the repeated use of betaine with ketamine.1

Fabio Chianelli, Chief Executive Officer of PharmaTher, said, “The published data demonstrates the potential of KETABET™’s ability to eliminate the unwanted psychomimetic effects and limitations of ketamine, and aims to be a safe and effective at-home treatment option for mental health, neurological and pain disorders.  As such, we remain focused on expanding our clinical programs with KETABET™ for FDA approval.”

PharmaTher has an exclusive license agreement with the National Health Research Institutes to develop and commercialize the intellectual portfolio protecting KETABET™, the patent titled “Method and Composition for Decreasing the Psychotomimetic Side Effect and Addictive Disorder of Ketamine”. Granted patents are issued in Japan (Patent no. 6967532) and Taiwan (Patent no. I648049). In addition, the Company expects to convert the current patent applications in the U.S., Europe, Canada, Israel and China into granted patents.  Patent protection is expected to expire in 2036.

About PharmaTher Holdings Ltd.

​PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is focused on the development and commercialization of specialty ketamine prescription-based products such as KETAPATCH™, a  ketamine microneedle patch for mental health and pain disorders, and KETARX™, a ketamine hydrochloride injection USP product for anesthesia, procedural sedation and neurological disorders including Parkinson’s disease and Amyotrophic Lateral Sclerosis. Learn more at PharmaTher.comTwitter and LinkedIn.

For more 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.

References:

  1. Chen, Shao-Tsu et al. “Betaine prevents and reverses the behavioral deficits and synaptic dysfunction induced by repeated ketamine exposure in mice.” Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie vol. 144 (2021): 112369. doi:10.1016/j.bio
  2. J.-C. Lin, M.-Y. Lee, M.-H. Chan, Y.-C. Chen, H.-H. Chen, Betaine enhances antidepressant-like, but blocks psychotomimetic effects of ketamine in mice, Psychopharmacology (Berl). 233 (2016) 3223–32

PharmaTher Provides Update on Product Pipeline and Expected Milestones for 2022

PharmaTher Provides Update on Product Pipeline and Expected Milestones for 2022

Focused on becoming a leader in the development and commercialization of specialty ketamine prescription-based products
Expected milestones for 2022 include initiating Phase 3 clinical study for ketamine to treat Parkinson’s disease (KETLID); completing Phase 2 clinical study for ketamine to treat ALS (KETALS); completing observational study with ketamine and betaine for depression and pain (KETABET); initiating Phase 2 clinical study for ketamine microneedle patch (KETAPATCH); and seeking FDA approval for Ketamine Hydrochloride Injection USPproduct (KETARX)

​TORONTO, December 21, 2021 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a company focused on the development and commercialization of specialty ketamine prescription-based products, is pleased to provide a product pipeline update and expected milestones for 2022.

Fabio Chianelli, Chief Executive Officer of PharmaTher, said, “2021 proved to be a foundational year for PharmaTher as we achieved a number of milestones which have paved the way for an exciting 2022 in unlocking ketamine’s therapeutic potential for treating Parkinson’s disease and ALS, the development of our ketamine hydrochloride injection USP product and our ketamine microneedle patch as a potential next-generation therapeutic solution for mental health, neurological and pain disorders.  We are now in a position both operationally and financially to seek FDA approval for KETARX, our ketamine prescription product, and to enter clinical studies for KETAPATCH, our ketamine patch product, in 2022.”

Project KETLID:  Ketamine for Levodopa-Induced Dyskinesia in Parkinson’s Disease

The Company’s Phase 2 clinical trial (ClinicalTrials.gov Identifier: NCT04912115)  to evaluate the safety, efficacy and pharmacokinetics of ketamine in the treatment of levodopa-induced dyskinesia (“LID”) in patients with Parkinson’s disease is currently ongoing and the Company now expects topline results in Q1-2022. Positive Phase 2 clinical results will allow the Company to request a meeting with the FDA to discuss its plan and obtain an agreement to move to a Phase 3 clinical study under the 505(b)2 regulatory pathway by Q3-2022.

PharmaTher has an exclusive license agreement with the University of Arizona for the intellectual property protecting the potential use of ketamine to treat movement disorders.  The possible therapeutic effect of low-dose ketamine on LID was noted in a retrospective analysis of Parkinson’s disease patients who received ketamine for pain relief. During this analysis, it was observed that the patients experienced an improvement in LID lasting several weeks beyond treatment [Sherman et al, 2016]. These results were corroborated in a test of low-dose ketamine in a rodent LID model, and this possible effect has also been examined in a controlled study [Bartlett et al, 2016].

Project KETALS:  Ketamine for Amyotrophic Lateral Sclerosis (ALS or Lou Gehrig’s Disease)       

An Investigator-initiated IND application has been submitted and it is expected the FDA will accept the IND to proceed to a clinical study for ketamine to treat ALS patients within the next 30 days.  Patient enrollment is targeted for Q1-2022.  On August 3rd, 2021, the Company was granted orphan drug designation by the FDA for ketamine to treat ALS.

PharmaTher has an exclusive license agreement with the University of Kansas for the intellectual property protecting the potential use of ketamine to treat ALS. Ketamine has the potential to effectively increase the life expectancy of those with ALS at any stage and slow the progressive loss of muscle associated with poor outcomes of the disease. The University of Kansas Medical Center researchers and inventors of the potential use of ketamine to treat ALS, Dr. Richard J. Barohn, M.D., John A. Stanford, Ph.D., and Dr. Matthew Macaluso, D.O., have made the promising discovery that ketamine can be administered as an effective treatment for ALS. In addition, unpublished and patent-pending preclinical research has shown that the administration of ketamine preserves muscle function in advancing ALS and increases life expectancy when given in the early stages of muscle decline.

Project KETABET: Ketamine and Betaine Combination Formulation

The Company is supporting an Investigator-lead observational study to evaluate the impact of betaine anhydrous on the unwanted ketamine side effects seen post ketamine treatment for subjects with depression.  The Company now expects results to be reported in early Q1-2022.  Based on the results, the Company will advance the KETABET program with its microneedle patch for clinical studies in the H2-2022.

PharmaTher has an exclusive license agreement with the National Health Research Institutes for the development and commercialization of a patented combination formulation of FDA-approved ketamine and betaine. KETABET has been shown in research to enhance the antidepressant effect while having the potential to reduce the known negative side effects of ketamine significantly.  The combination of ketamine and betaine anhydrous produced more robust antidepressant-like responses than their individual effects and that the combination blocked the psychotomimetic effects of ketamine [Lin, Jen-Cheng et al., 2016].

Project KETAPATCH: Ketamine Microneedle Patch

In collaboration with The Queen’s University of Belfast (“QUB”), led by Professor Ryan Donnelly, the Company has successfully completed the evaluation of a patented hydrogel-forming microneedle patch to deliver Ketamine and KETABET as a potential next-generation treatment for neuropsychiatric, neurodegenerative and pain disorders.  This de-risking milestone supports the Company’s expansion in finalizing IND-enabling studies and the clinical manufacturing scale up with LTS Lohmann, a leader in transdermal delivery systems, to support FDA and international regulatory submissions.  Validation and tech transfer activities to support clinical studies are in progress and the Company expects to conduct clinical studies in H2-2022.

PharmaTher has an exclusive license agreement with QUB for the development and commercialization of a patented hydrogel-forming microneedle delivery technology developed by Professor Ryan Donnelly to support PharmaTher’s product and clinical development initiatives with ketamine and psychedelics.  Professor Donnelly’s lab successfully completed research and published a paper titled “Hydrogel-forming microneedle arrays as a therapeutic option for transdermal esketamine delivery” validating the delivery of esketamine, the S(+) enantiomer of ketamine, in a novel microneedle patch which may overcome the drawbacks associated with ketamine administration in an intravenous or nasal spray format [Courtenay, Aaron J et al., 2020].

Project KETARX: Ketamine Prescription (Rx) Product

The Company is developing its own Ketamine Hydrochloride Injection USP product as part of its plans to support the Company’s future Phase 3 clinical studies and its commercialization plans in the U.S. via a supplemental Abbreviated New Drug Application (“sANDA”) with the FDA for use in anesthesia and procedural sedation.  The Company expects to file for its sANDA in Q4-2022 for commercialization in the U.S. and international markets thereafter.

PharmaTher has entered into an agreement with Alcami Corporation, a global pharmaceutical contract development and manufacturing organization with extensive experience in cGMP sterile fill-finish products and handling of controlled substances, for the clinical and commercial manufacturing for the Company’s KETARX project. The Company expects to form partnerships with research labs, ketamine clinics and pharmaceutical companies that are: seeking a secure supply of cGMP ketamine and ketamine products for current portfolios; exploring alternative dose forms for multiple existing indications; and requiring support to develop and eventually commercialize specific ketamine products for new indications.  In addition, the Company will enter the market with KETARX targeting ketamine’s FDA approved label for anesthesia and procedural sedation.

About PharmaTher Holdings Ltd.

​PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is focused on the research, development and commercialization of specialty ketamine prescription-based products including KETAPATCH, a  ketamine microneedle patch for mental health, neurological and pain disorders, and KETARX, a ketamine hydrochloride injection USP product for anesthesia and procedural sedation. Learn more at PharmaTher.comTwitter and LinkedIn.

For more 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.