Wesana Health Announces Positive Feedback From Pre-IND Meeting With FDA on SANA-013

Wesana Health Announces Positive Feedback From Pre-IND Meeting With FDA on SANA-013

Pre-IND Meeting is a Significant Milestone in the Clinical Development of SANA-013, Defining the Pathway to Initiate in-Human Clinical Trials in Q4 2022

CHICAGO and TORONTO, March 14, 2022 (GLOBE NEWSWIRE) — Wesana Health Holdings Inc.  (“Wesana” or the “Company”) (CSE: WESA; OTCQB: WSNAF), a data-driven life sciences company focused on developing the novel therapies of tomorrow and delivering new care paradigms today, announced that they have received a full written response from the Food and Drug Administration (FDA) regarding their pre-Investigational New Drug (IND) meeting for the novel therapy and proprietary protocol of SANA-013 for the treatment of Traumatic Brain Injury (TBI) related major depressive disorder (MDD).

The Company received positive written responses from the FDA on March 11th outlining the requirements to open the IND and commence with clinical studies for SANA-013. The Company believes the written response provides a path to agreements on IND-enabling studies and validates the team’s effort and accomplishments over the past year. Wesana intends to initiate its in-human clinical study program in late 2022. The FDA response also provided important insights pertaining to advancing SANA-013 as a potential treatment for TBI-related MDD.

Mark A. Wingertzahn, Wesana’s Chief Scientific Officer said, “We are highly appreciative of the clear direction FDA has given us in terms of what will be required to advance SANA-013. We look forward to commencing our clinical development program with their feedback in mind and in full compliance with FDA drug development guidelines.”

SANA-013 is covered under patent applications owned by Wesana and directed to novel composition and novel methods of use. Patent applications detail the use of a loading dose of psilocybin and a maintenance dose of psilocybin given concomitantly with a dose of cannabidiol (“CBD”). This novel combination therapy has demonstrated effectiveness through different and potentially complementary pharmacologic pathways. Unlike therapist assisted, single dose therapy, where a large dose of psilocybin is administered in clinic, which has exhibited poor durability and waning effects beginning as early as a few weeks post administration, SANA-013 is being developed to utilize a loading dose of psilocybin followed by self-administered maintenance doses of psilocybin and CBD to provide more sustained effects and benefit over time.

“We were pleased with the feedback from the FDA regarding SANA-013,” said Wesana founder and CEO, Daniel Carcillo. “This is the most important work of my lifetime, and I’m truly excited about the successful completion of this engagement and the clarity of guidance provided by the FDA as we move toward our next phase of development for SANA-013.”

Please refer to the Company’s management’s discussion and analysis dated November 29, 2021, available on the Company’s profile on www.sedar.com for additional information as to the Company’s drug development program and the steps required to be completed for the Company to be able to commence phase I clinical trials.

About Wesana Health

Wesana Health helps people transcend barriers in mental health and performance. We innovate in care development through our therapies and proprietary protocols, and in care delivery through activating a new multidisciplinary, technology-supported clinical model. Learn more at www.wesanahealth.com.

Cautionary Note Regarding Forward-Looking Information

This press release contains “forward-looking information” within the meaning of applicable securities laws with respect to the Company, including, but not limited to: the initiation of Phase I clinical trials in late 2022, the patentability of the Company’s therapies or protocols and any other statement that may predict, forecast, indicate or imply future plans, intentions, levels of activity, results, financial position, operational or financial performance or achievements. Often, but not always, forward-looking information can be identified by the use of words such as “plans”, “expects”, “is expected”, “budget”, “scheduled”, “estimates”, “forecasts”, “intends”, “anticipates”, “will”, “projects”, or “believes” or variations (including negative variations) of such words and phrases, or statements that certain actions, events, results or conditions “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Except for statements of historical fact, information contained herein constitutes forward-looking information. Forward-looking information is not a guarantee of future performance and is based upon a number of estimates and assumptions of management at the date the statements are made.

Certain factors that influence successfully initiating its clinical development program in late 2022 include: (i) the Company has retained industry leading experts/consultant to assist with strategy, drafting and submission of pre-IND meeting Package; (ii) preparation of materials and internal discussions with consultants have been ongoing, productive and in line with timeline expectations; (iii) the pre-IND meeting was completed and provided the Company with the requisite guidance as to whether the protocols for the IND enabling studies are sufficient.

Certain assumptions that influence successfully initiating its clinical development program in late 2022 include: (i) third parties who assisted the Company with the pre-IND submissions will continue to satisfy deadlines on deliverables within anticipated timeframes; (ii) the pre-IND guidance will continue to support that a drug development plan and future clinical trials are going to be acceptable to the FDA; (iii) the Company and its consultants can efficiently and timely address any additional correspondence, submission of additional materials or information pursuant to any ongoing requests as they may arise during the course of their review following the filing of submissions; (iv) additional pre-clinical studies will be commenced and completed on a timely basis and results will be supportive and as anticipated; (v) the Company’s pre-clinical studies (animal pharmacology and toxicology testing) generate data and analyses to support an FDA decision that it is safe to proceed with human trials of the Company’s formulation; and (vi) the Company is able to maintain a GMP supply source necessary to conduct in-human clinical trials.

Any patent efforts of the Company remain at the application stage and there is no assurance that the Company will file additional patent applications or in what jurisdictions they may be filed, if any. Furthermore, while the PCT application has been filed, there is no assurance that a patent(s) will be granted or will be granted in a form that will be sufficient to protect the Company’s proprietary therapies or protocols or enable it to gain or keep any competitive advantage that it may have.

Although management believes that the anticipated future results, performance or achievements expressed or implied by the forward-looking statements are based upon reasonable assumptions and expectations, the reader should not place undue reliance on forward-looking statements because they involve assumptions, known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company to differ materially from anticipated future results, performance or achievements expressed or implied by such forward-looking statements. Certain risk factors include but are not limited to the ability of the Company to protect its intellectual property, changes to patent law, requirements to share intellectual property with service providers, general economic, market and business conditions and other risk factors including those found in the Company’s annual information form dated September 3, 2021 filed on the Company’s profile on SEDAR at www.sedar.com and discussed in the Company’s other public filings available on SEDAR.

Forward-looking information is provided and made as of the date of this news release and the Company does not undertake any obligation to revise or update any forward-looking information other than as required by applicable law.

Investor Contact:
Keenan Gentry
Email: IR@wesanahealth.com 
Phone: 773-236-7972

Media Contact:
Izzy Forman
Email: media@wesanahealth.com 

Nick Opich / Annie Graf
KCSA Strategic Communications
Email: Wesana@kcsa.com 
Phone: 212-896-1206 / 786-390-2644

On behalf of the Board of Directors:
Daniel Carcillo, Chief Executive Officer
Phone: (773) 236-7972

MindMed to Participate in March Investor Conferences

MindMed to Participate in March Investor Conferences

NEW YORK, March 9, 2022 — Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (NEO: MMED), a clinical-stage biopharmaceutical company developing novel products to treat brain health disorders, today announced that Robert Barrow, Chief Executive Officer and Director, will participate in the following upcoming investor conferences in March:

34th Annual Roth Conference

Format: Panel – Psychedelics: “Immunotherapy” for the Mind

Date: Tuesday, March 15 at 10:00 AM PST / 1:00 PM EST

Webcast Link: Click Here 

Oppenheimer Virtual Annual Healthcare Conference

Format: Corporate Presentation

Date: Thursday, March 17 at 12:40 PM EST

Webcast Link: Click Here 

Maxim Virtual Growth Conference

Format: Corporate Presentation

Date: March 28-30, 2022

Further Info: Click Here

A replay of the webcasts will be available in the “Investors” section of MindMed’s website for 30 days following each of the presentations.

About MindMed

MindMed is a clinical-stage biopharmaceutical company developing novel products to treat brain health disorders, with a particular focus on psychiatry, addiction, pain and neurology. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative drug candidates, with and without acute perceptual effects, targeting the serotonin, dopamine and acetylcholine systems.

MindMed trades on the NASDAQ under the symbol MNMD and on the Canadian NEO Exchange under the symbol MMED.

For Investors: ir@mindmed.co

For Media: media@mindmed.co

NeonMind Reports Business Highlights on Partnership Activities, Clinical Pipeline and Corporate Developments

NeonMind Reports Business Highlights on Partnership Activities, Clinical Pipeline and Corporate Developments

– Completed concrete milestones in its strategy to become a leading psychedelic drug developer and specialty clinics operator.

– Developed clear drug development pathway for NEO-001, the industry’s first psilocybin-based obesity treatment with near-term clinical milestones.

– Partnered with well-established specialty treatment providers, SRx Health Solutions and BioScript Solutions to build out a network of NeonMind-branded specialty mental health clinics across Canada

OAKVILLE, ON / ACCESSWIRE / March 10, 2022 / NeonMind Biosciences Inc. (CSE:NEON)(OTCQB:NMDBF)(FRA:6UF) (“NeonMind” or the “Company“), an integrated drug development and wellness company focused on bringing innovative psychedelic-based treatments to people suffering from obesity and mental health disorders, today provided a summary of business highlights on the Company’s activities and progress across its Pharmaceutical and Medical Services Divisions.

Pharmaceutical Division Highlights

  • Successfully completed a pre-Investigational New Drug (pre-IND) consultation with the U.S. Food and Drug Administration (FDA) regarding proposed clinical trials for NeonMind’s lead obesity drug candidate, NEO-001. The Company expects to file its IND application in the first half of 2022 and initiate a Phase 1/2 clinical study during the course of this year.
  • Filed four new provisional patent applications with the United States Patent and Trademark Office to protect NeonMind’s proprietary data derived from the Company’s initial preclinical trial examining the potential use of psilocybin as a treatment for weight loss.
  • Completed an integrated drug development plan for its lead drug candidate targeting obesity, NEO-001, a high-dose psilocybin treatment coupled with behavioral therapy and lifestyle intervention, aimed to improve the efficacy of chronic weight management in adults.
  • Established a Research and Development Advisory Board and expanded NeonMind’s team with regulatory experts to successfully execute its integrated drug development plan and streamline its corporate structure for capital efficiencies.
  • Appointed drug development executive Philippe Martin as Chairman of the Company’s Research and Development Advisory Board.

Medical Services Division Highlights

“We made significant progress in our corporate transformation to become a psychedelic drug developer and specialty mental health clinics operator,” said Robert Tessarolo, President & CEO of NeonMind. “Our strategic focus provides near-term revenue generation and a proprietary groundbreaking treatment for obesity, both of which provide exposure to exciting and novel treatments for mental health and wellness. We now have a clear drug development pathway to bring NEO-001, the first and only psychedelic-based treatment for obesity, into clinical trials. Additionally, our strategic alliances with SRx and BioScript will enable us to quickly establish a network of NeonMind-branded specialty mental health clinics across Canada. As the psychedelic industry continues to undergo rapid expansion, we are well positioned to execute on our growth strategy and develop innovative therapeutic uses for psychedelic compounds to treat weight management conditions and mental health disorders.”

Corporate Highlights

  • The Company’s common shares, listed on the OTCQB Venture Market, became eligible for electronic clearing and settlement through the Depository Trust Company (“DTC”) in the United States.
  • Completed divestiture of assets related to its consumer division, including e-commerce operations and underlying functional food assets, as well as shares owned in Translational Life Sciences Inc. for a combined consideration of approximately C$1.1 million plus royalty. In connection with the divestiture of the consumer division, Amber Allen has resigned as Vice President of Sales, effective January 17, 2022.
  • Launched a new website at www.neonmindbiosciences.com.
  • As a result of NeonMind’s growing specialty clinic operations, the Company has established its new headquarters in Oakville, Ontario. The full address is 295 Robinson Street, Suite 100, Oakville, ON L6J 1G7.

About NeonMind Biosciences Inc.

NeonMind operates two divisions: (i) a pharmaceutical division engaged in drug development of psychedelic compounds with two lead psilocybin-based drug candidates targeting obesity; and (ii) a medical services division focused on launching specialty mental health clinics that integrate psychedelic therapeutics into traditional psychotherapy settings.

In its pharmaceutical division, NeonMind has two distinct psilocybin drug development programs targeting obesity. NeonMind’s lead candidate, NEO-001, employs psilocybin as an agonist at the serotonin 5- HT2A receptor, which is involved in the hallucinogenic effect of psychedelics. The Company’s second drug candidate, NEO-002, employs low-dose psilocybin as an agonist at the 5-HT2C receptor, which controls appetite.

NeonMind and its strategic partners are building NeonMind-branded specialty mental health clinics in Canada that incorporate evidence-backed innovative treatments to address a variety of mental health needs. For more information on NeonMind, go to www.NeonMindBiosciences.com.

Rob Tessarolo, President & Chief Executive Officer, NeonMind Biosciences Inc.
rob@neonmind.com
Tel: 416-750-3101

Investor Relations:
KCSA Strategic Communications
Scott Eckstein/Tim Regan
neonmind@kcsa.com
Tel: 212-896-1210

The Canadian Securities Exchange has not reviewed, approved nor disapproved the contents of this news release.

Cautionary Statement Regarding Forward-Looking Statements

Certain statements contained in this press release constitute forward-looking information. These statements relate to future events or NeonMind’s future performance. The use of any of the words “could”, “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 NeonMind’s current belief or assumptions as to the outcome and timing of such future events. Actual future results may differ materially. In particular, NeonMind’s drug development plans, its ability to retain key personnel, and its expectation as to the development of its intellectual property and other steps in its preclinical and clinical drug development constitute forward-looking information. Actual results and developments may differ materially from those contemplated by forward-looking information. Readers are cautioned not to place undue reliance on forward-looking information. The statements made in this press release are made as of the date hereof. NeonMind disclaims any intention or obligation to publicly update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as may be expressly required by applicable securities laws.

SOURCE: NeonMind Biosciences Inc.

View source version on accesswire.com:
https://www.accesswire.com/692368/NeonMind-Reports-Business-Highlights-on-Partnership-Activities-Clinical-Pipeline-and-Corporate-Developments

Released March 10, 2022

Pure Extracts Receives Initial Purchase Order From New Brunswick

Pure Extracts Receives Initial Purchase Order From New Brunswick

Vancouver, B.C., March 10, 2022 – Pure Extracts Technologies Corp. (CSE: PULL) (OTC: PRXTF) (XFRA: A2QJAJ) (“Pure Extracts” or the “Company”), a plant-based extraction company focused on cannabis, hemp, functional mushrooms and the rapidly emerging psychedelic sector, is pleased to announce that its wholly owned subsidiary, Pure Extracts Manufacturing Corp., has received an initial purchase order (PO) for its cannabis vape cartridges from Cannabis NB, the sole retailer of nonmedical cannabis in the province of New Brunswick.

The Purchase Order (PO) is for 3 SKUs of 1.0 gram Pure Pulls branded vape cartridges filled with a selection of some of the Company’s 30+ proprietary cannabis full-spectrum oil (FSO) and CBD formulations.

Pure Extracts CEO, Ben Nikolaevsky, remarked, “We are pleased to be expanding our sales and brand awareness outside of British Columbia, Alberta, Saskatchewan and Ontario into Eastern Canada. The New Brunswick PO reflects both the high-quality of our products and the consumer demand for legacy brands.”

ON BEHALF OF THE BOARD

 “Ben Nikolaevsky”

Ben Nikolaevsky
CEO and Director

About Pure Extracts (CSE: PULL) (OTC: PRXTF) (XFRA: A2QJAJ)

Pure Extracts Technology Corp. features an all-new, state-of-the-art processing facility located just 20 minutes north of world-famous Whistler, British Columbia. The bespoke facility has been constructed to European Union GMP standards aiming towards export sales of products and formulations, including those currently restricted in Canada, into European jurisdictions where they are legally available. Pure Extracts was granted its Standard Processing License by Health Canada under the Cannabis Act on September 25, 2020, and its Sales Amendment on July 19, 2021. The Company’s stock began trading on the Canadian Securities Exchange (CSE) on November 5, 2020.

Find out more at https://pureextractscorp.com/

Or contact:
Pure Extracts Investor Relations
Tel: +1 604 493 2052
info@pureextractscorp.com

This news release contains forward-looking statements relating to the future operations of Pure Extracts, and the other statements are not historical facts. Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expects” and similar expressions. All statements other than statements of historical fact, included in this release, including, without limitation, statements regarding the future plans and objectives of Pure Extracts’, are forward-looking statements and involve risks and uncertainties. A number of factors could cause actual events, performance or results to differ materially from what is projected in forward looking statements. Although we believe that the assumptions underlying these statements are reasonable, they may prove to be incorrect, and we cannot assure that actual results will be consistent with these forward-looking statements. Given these risks, uncertainties and assumptions, investors should not place undue reliance on these forward-looking statements. Whether actual results, performance or achievements will conform to the Company’s expectations and predictions is subject to a number of known and unknown risks, uncertainties, assumptions and other factors, including those listed under “Risk Factors” in the Company’s Annual Information Form. The Company does not undertake to update any forward-looking information, except as, and to the extent required by, applicable securities laws.

This news release contains information about potential sales revenue from supply agreements, which may be considered as disclosure of financial outlook under applicable securities laws. Such information is subject to the same assumptions, risk factors, limitations, and qualifications as set forth in the above paragraph. Specifically, estimated sales revenue which may be derived from supply contracts has been calculated based on current wholesale prices and assume, among other things, that the Company will be able to find buyers for its products. The financial outlook contained in this news release was made by management as of the date of this news release and was provided for the purpose of providing readers with an understanding of the potential revenue which may be derived from any agreements recently entered into by the Company and are not an estimate of profitability or any other measure of financial performance. Readers are cautioned that the financial outlook contained in this document should not be used for purposes other than for which it is disclosed herein.

The CSE has neither approved nor disapproved the contents of this press release.

Two approaches to treating depression with DMT

Small Pharma Expands Potential of Commercial Portfolio with DMT-based Psychedelic Assets

After finding its DMT formulation to be well-tolerated, Small Pharma (DMT) is launching two new trials this year. 

One will assess how DMT interacts with SSRIs in patients with depression and the other will compare the drug’s effects when administered through muscles versus veins. 

The company has also developed a form of DMT that lasts longer than the typical 30 minute trip, but is still much shorter than a psilocybin or LSD trip.

Biomind Labs (BMND) is taking the opposite approach. The company reduced a DMT trip to just 10-15 minutes by making a formulation that’s inhalable.

Biomind’s formulation will be assessed in a Phase II trial for treatment-resistant depression, which just received approval by the Brazilian Institutional Review Board.

We’re eager to see if the length of the trip makes a difference!

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Biomind Labs Inc.

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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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Awakn Life Sciences to Participate at Upcoming March 2022 Conferences

Awakn Life Sciences to Participate at Upcoming March 2022 Conferences

TORONTO, CANADA, March 09, 2021 – Awakn Life Sciences Corp. (NEO: AWKN) (OTCQB: AWKNF) (FSE: 954) (‘Awakn’), a biotechnology company, researching, developing, and delivering psychedelic therapeutics to treat addiction, announced today that Anthony Tennyson, Chief Executive Officer, is scheduled to present at the following upcoming March 2022 investor conferences. 

34th Annual ROTH Conference

Presentation: Sunday, March 13th to Tuesday, Match 15th 

Registration: Click here 

Oppenheimer’s 32nd Annual Healthcare Conference

Presentation: Wednesday, March 15th to Thursday, March 17th 

Registration: Please contact your Oppenheimer representation 

Maxim’s 2022 Virtual Growth Conference 

Presentation: Monday, March 28th to Wednesday, March 30th 

Registration: Click here

For more information about each conference, or to schedule a one-on-one meeting with Awakn’s management team, please contact your ROTH, Oppenheimer or Maxim representatives, or alternatively KCSA Strategic Communications at Awakn@kcsa.com.  

About Awakn Life Sciences Corp.

Awakn Life Sciences is a biotechnology company, researching, developing, and delivering psychedelic therapeutics to treat addiction. Awakn’s team consists of renowned research experts and world leading chemists, scientists, psychiatrists, and psychologists. Addiction is one of the biggest unmet medical needs of our time, affecting over 20% of the global population and is an industry valued at over $100bn per annum. Awakn is disrupting this underperforming industry by rapidly advancing the next generation of psychedelic drugs and therapies to be used in combination, through preclinical research and clinical stage trials.

www.awaknlifesciences.com  |  Twitter  |  LinkedIn  |  Facebook

Investor Enquiries:
KCSA Strategic Communications 
Valter Pinto / Tim Regan 
Phone: +1 (212) 896-1254
Awakn@KCSA.com

Media Enquiries:

America and Canada: KCSA Strategic Communications  
Anne Donohoe 
Adonohoe@KCSA.com

Rest of World: ROAD Communications 
Paul Jarman / Nora Popova
Awakn@roadcommunications.co.uk

PharmaDrug Announces Interim Positive Findings for the Combination of Cepharanthine and Frontline Chemotherapy for IND-Enabling Prostate Cancer Study

PharmaDrug Announces Interim Positive Findings for the Combination of Cepharanthine and Frontline Chemotherapy for IND-Enabling Prostate Cancer Study

  • Interim results show that oral cepharanthine plus cabazitaxel (combination therapy) significantly reduced tumor volume and increased tumor growth inhibition at day 21, the final day of dosing
  • Dose range findings demonstrate that oral cepharanthine-alone was well tolerated in the current in vivo study
  • Results for oral cepharanthine plus cabazitaxel will be used to support PharmaDrug’s recently submitted provisional patent application which details a novel treatment combination for primary, metastatic and chemotherapy-resistant prostate cancer

Toronto, Ontario – March 9, 2022 – PharmaDrug Inc. (CSE: PHRX) (OTCQB: LMLLF) (“PharmaDrug” or the “Company“), a specialty pharmaceutical company focused on the research, development and commercialization of controlled-substances and natural medicines such as psychedelics, cannabis and naturally-derived approved drugs, is pleased to announce that interim positive findings from its ongoing prostate efficacy study demonstrate that the Company’s enteric coated, oral formulation of cepharanthine (PD-001), when combined with cabazitaxel, significantly reduces tumor volume and provides improved prostate cancer tumor growth inhibition when administered with cabazitaxel. These interim results, provided to the Company on the final day of study dosing will be used to strengthen claims in its recently submitted provisional patent application which sets forth claims related to the use of cepharanthine plus cabazitaxel and/or other taxane family members used in combination to treat primary, metastatic and chemotherapy-resistant prostate cancer.

In 2021 the Company initiated a series of cancer screening studies aimed at uncovering therapeutic opportunities for cepharanthine when used alone or in combination with standard of care (SoC) chemotherapy drugs. Results from these in vitro studies revealed that the combination of cepharanthine and cabazitaxel, a SoC used for castration-resistant, metastatic prostate cancers, provided unexpectedly synergistic reduction in prostate tumor cell survival. Here the Company is pleased to report that a once-per-day oral regimen of PD-001, in combination with cabazitaxel provided statistically significant benefit at the scheduled end of dosing (day 21) in its ongoing prostate efficacy study. Specifically, PD-001 delivered at doses of 3, 9, or 27 mg/kg/day combined with cabazitaxel (3mg/kg/Q3D) provided up to a 64% tumor growth inhibition compared to 37% noted for treatment with cabazitaxel alone. Based on these results, the addition of PD-001 to the SoC, cabazitaxel was found to improve tumor growth inhibition by 73% compared to cabazitaxel-alone. These interim results were deemed to be highly statistically significant, with a p-value less than 0.001 (day 21). The Company will provide complete details of the study outcome when final results become available.

Daniel Cohen, CEO and Chairman of PharmaDrug commented, “We are extremely excited to continue to broaden the use case for PD-001 as a treatment for prostate cancer. While esophageal cancer continues to be our main focus with a goal to move towards an FDA clinical trial, we believe that cepharanthine will ultimately show a wider potential use in the treatment of cancers, specifically in combination with the current standard of care. We will continue to explore cepharanthine’s potential therapeutic relationship with existing standard of care chemotherapies.”

About PD-001 (Enteric-Coated Oral Cepharanthine)

Cepharanthine is a natural product and an approved drug used for more than 70 years in Japan to successfully treat a variety of acute and chronic diseases. In clinical research, Cepharanthine has been shown to exhibit multiple pharmacological properties including anti-oxidative, anti-inflammatory, immuno-regulatory, anti-cancer, anti-viral and anti-parasitic effects1,2. However, historically cepharanthine’s low oral bioavailability has represented a major obstacle to realizing its full clinical potential.

The Company is focused on advancing the clinical development of an improved and patented enteric-coated oral formulation of cepharanthine (PD-001) to treat responsive cancers and COVID-19. Compared to generic cepharanthine, PD-001 has been shown in rodent and non-rodent models to possess markedly improved oral bioavailability (more easily absorbed). These findings support the development of an orally administered formulation, and in so doing, removes the undesirable requirement for frequent intravenous dosing to maintain therapeutic levels of drug in circulation. Despite enormous research efforts, metastatic prostate cancer has a 5-year survival of only 31%3. Through subsequent rounds of refinement to optimize PD-001 dose and dose interval, the Company endeavours to develop an efficacious, oral therapeutic add-on option to potentially improve outcomes for prostate cancer patients using SoC treatment.

PD-001 for Cancer

PharmaDrug’s cancer program is based on cepharanthine’s known anti-cancer activities. Cepharanthine has been shown in multiple preclinical efficacy models to inhibit cancer cell proliferation, induce cancer cell apoptosis (death) and restore cancer cell sensitivity to multiple unrelated classes of chemotherapy. Multidrug resistance continues to represent a considerable clinical challenge. As such, preclinical cancer studies aimed at elucidating the mechanisms that underly chemoresistance; including the critical role drug efflux pumps play in this phenomenon by reducing the intracellular concentration of chemotherapeutic drugs, are of particular interest to PharmaDrug. Cepharanthine has been shown in preclinical studies to potently reverse chemoresistance by downregulating expression of ABCB1, the transcript of which codes for multidrug resistance protein 1, (MDR1, aka P- glycoprotein). Importantly, several prior in vitro and in vivo studies have shown that cepharanthine-mediated reductions in ABCB1 expression restores cancer cell sensitivity to a range of chemotherapeutics including taxanes, vinca alkaloids and platinum-based drugs47. Collectively the two in vitro screening studies already completed by the Company and the interim in vivo efficacy results provided here, continue to reinforce the potential therapeutic opportunities in oncology for PD-001 when used in combination to provide additive or synergistic benefit to existing SoC treatments. For reference to previous press releases related to PharmaDrug’s ongoing efforts in the oncology space please see previous press releases dated Feb 1, 2022 and Nov 18, Oct 15, July 28, 2021. In addition to its ongoing investigations of PD-001 for prostate cancer, the Company plans to fully leverage the streamlined path to approval which comes by way of a recently granted FDA Orphan Drug Designation PD-001 for the treatment of esophageal cancer.

Potential of PD-001 to Treat Prostate Cancer

According to the American Cancer Society, in 2021 there were approximately 248,530 new cases of prostate cancer and about 34,130 deaths from prostate cancer in the United States, and it is the second leading cause of cancer death in American men. Metastatic prostate cancer is commonly treated using androgen deprivation therapy (ADT), including surgical or medical castration, but metastatic castration-resistant prostate cancer (mCRPC) commonly emerges8. The taxanes docetaxel and cabazitaxel are approved for the treatment of mCRPC, however resistance to taxanes is known to develop over time. Agents such as PD-001 which show synergistic benefit when combined with taxanes for the treatment of prostate cancer are sorely needed. The Company’s forthcoming in vivo studies are specifically designed to address the potential of PD-001 to overcome taxane-based chemoresistance in vivo.

About PharmaDrug Inc.

PharmaDrug is a specialty pharmaceutical company focused on the research, development and commercialization of controlled-substances and natural medicines such as psychedelics, cannabis and naturally-derived approved drugs. PharmaDrug owns 100% of Pharmadrug Production GmbH (“Pharmadrug Production”), a German medical cannabis distributor, with a Schedule I European Union narcotics license and German EuGMP certification allowing for the importation and distribution of medical cannabis to pharmacies in Germany and throughout the European Union. PharmaDrug owns 100% Sairiyo Therapeutics (“Sairiyo”), a biotech company that specializes in researching and reformulating established natural medicines with a goal of bringing them through clinical trials and the associated regulatory approval process in the US and Europe. Sairiyo is currently developing its patented reformulation of cepharanthine, a drug that has shown substantial third party validated potential for the treatment of Covid-19 and rare cancers. Sairiyo is also conducting R&D in the psychedelics space for the treatment of non-neuropsychiatric conditions. The Company also owns 100% of Super Smart, a company building a vertically integrated retail business with the goal to elevate the use of functional mushrooms, and psilocybin mushrooms where federally legal, as natural based medicines.

For further information, please contact:

Daniel Cohen, Chairman and CEO
dcohen@pharmadrug.co
(647) 202-124

Caution Regarding Forward-Looking Information:

THE CANADIAN SECURITIES EXCHANGE HAS NOT REVIEWED NOR DOES IT ACCEPT RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.

This press release contains “forward-looking information” within the meaning of applicable securities legislation. All statements, other than statements of historical fact, included herein are forward-looking information. Generally, forward-looking information may be identified by the use of forward-looking terminology such as “plans”, “expects” or “does not expect”, “proposed”, “is expected”, “budgets”, “scheduled”, “estimates”, “forecasts”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases, or by the use of words or phrases which state that certain actions, events or results may, could, would, or might occur or be achieved. In particular, this press release contains forward-looking information in relation to: the development and commercialization of cepharanthine, the use of study results to strengthen claims the Company’s provisional patent application and moving towards an FDA clinical trial relating to treatment of esophageal cancer . This forward-looking information reflects the Company’s current beliefs and is based on information currently available to the Company and on assumptions the Company believes are reasonable. These assumptions include, but are not limited to the ability to successfully prosecute the above referenced provisional patent application, the ability to complete the steps necessary to proceed with the above referenced FDA clinical trial, the ability of the Company to successfully execute on its plans for the Company and its affiliated entities; the ability to obtain required regulatory approvals and the Company’s continued response and ability to navigate the COVID-19 pandemic being consistent with, or better than, its ability and response to date.

Forward-looking information is subject to known and unknown risks, uncertainties and other factors that may cause the actual results, level of activity, performance or achievements of the Company to be materially different from those expressed or implied by such forward-looking information. Such risks and other factors may include, but are not limited to: general business, economic, competitive, political and social uncertainties; general capital market conditions and market prices for securities; the actual results of the Company’s future operations; competition; changes in legislation affecting the Company; the ability to obtain and maintain required permits and approvals, the timing and availability of external financing on acceptable terms; lack of qualified, skilled labour or loss of key individuals; risks related to the COVID-19 pandemic including various recommendations, orders and measures of governmental authorities to try to limit the pandemic, including travel restrictions, border closures, non-essential business closures, service disruptions, quarantines, self-isolations, shelters-in-place and social distancing, disruptions to markets, economic activity, financing, supply chains and sales channels, and a deterioration of general economic conditions; and a deterioration of financial markets that could limit the Company’s ability to obtain external financing.

A description of additional risk factors that may cause actual results to differ materially from forward-looking information can be found in the Company’s disclosure documents on the SEDAR website at www.sedar.com. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. Accordingly, readers should not place undue reliance on forward-looking information. Readers are cautioned that the foregoing list of factors is not exhaustive. Readers are further cautioned not to place undue reliance on forward-looking information as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated.

The Company’s securities have not been registered under the U.S. Securities Act of 1933, as amended (the “U.S. Securities Act”), or applicable state securities laws, and may not be offered or sold to, or for the account or benefit of, persons in the United States or “U.S. Persons”, as such term is defined in Regulations under the U.S. Securities Act, absent registration or an applicable exemption from such registration requirements. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities in the United States or any jurisdiction in which such offer, solicitation or sale would be unlawful.

Forward-looking information contained in this press release is expressly qualified by this cautionary statement. The forward-looking information contained in this press release represents the expectations of the Company as of the date of this press release and, accordingly, are subject to change after such date. However, the Company expressly disclaims any intention or obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as expressly required by applicable securities law.

References:

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