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AbbVie Receives Health Canada Approval for the Combination of VENCLEXTA® (venetoclax) with Obinutuzumab for Patients with Previously Untreated Chronic Lymphocytic Leukemia

  • VENCLEXTA® (venetoclax) plus obinutuzumab is the first chemotherapy-free, fixed-duration combination regimen approved by Health Canada for patients with previously untreated chronic lymphocytic leukemia (CLL).
  • Approval is based on data from the Phase 3 CLL14 trial, which showed that patients treated with obinutuzumab plus one year of treatment with VENCLEXTA had clinically meaningful and statistically significant progression-free survival (PFS) and higher rates of undetectable minimal residual disease compared to patients receiving a standard of care chemoimmunotherapy regimen of obinutuzumab and chlorambucil.1

 

Montreal, QC, May 5, 2020 – AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, announced today that Health Canada has approved VENCLEXTA® (venetoclax) in combination with obinutuzumab for the treatment of adult patients with previously untreated chronic lymphocytic leukemia (CLL). The regimen combines six 28-day cycles of obinutuzumab with 12 cycles of VENCLEXTA.

 

“Venetoclax in combination with obinutuzumab is an effective treatment with a finite treatment duration. The approval by Health Canada is good news, especially for patients that prefer not to remain on therapy indefinitely,” explains Dr. Sue Robinson, MD, FRCPC, Professor, Division of

Hematology, Department of Medicine, Dalhousie University, Halifax, Nova Scotia. “Based on my experience on the CLL14 clinical trial, I am looking forward to prescribing this combination regimen for older patients with previously untreated CLL and/or those who have concomitant medical problems”.

 

This is the third indication for VENCLEXTA, a first-in-class B-cell lymphoma-2 (BCL-2) inhibitor. BCL-2 is a protein that prevents cancer cells from undergoing apoptosis, the process that leads to the natural death or self-destruction of cancer cells. VENCLEXTA is also approved in combination with rituximab for the treatment of adult patients with CLL who have received at least one prior therapy, and as a monotherapy for the treatment of CLL in the presence or absence of 17p deletion in adult patients who have received at least one prior therapy and for whom there are no other available treatment options.1

 

“Lymphoma Canada is pleased with the approval of VENCLEXTA in combination with obinutuzumab by Health Canada for the treatment of chronic lymphocytic leukemia. Due to the nature of the disease and its high relapse rate, it is important to offer patients effective treatment options so that they can face their cancer journey with the comfort of knowing that there are always alternatives,” says Antonella Rizza, Chief Executive Officer, Lymphoma Canada.

 

This most recent approval is based on the primary analysis (median follow up of 28 months) of the Phase 3 CLL14 clinical trial, which demonstrated clinically meaningful and statistically significant progression-free survival (PFS; the time during and after treatment without disease progression, relapse, or death) as assessed by investigators in patients treated with VENCLEXTA plus obinutuzumab compared

 

to patients who received a standard of care chemotherapy regimen of chlorambucil plus obinutuzumab (hazard ratio 0.35; 95% CI (0.23,0.53), p<0.0001, medians not yet reached).1

 

“We are extremely proud of the Health Canada approval of VENCLEXTA in combination with obinutuzumab,” said Denis Hello, General Manager, AbbVie Canada. “This third approval for VENCLEXTA underscores our commitment to develop blood cancer treatments.”

 

CLL, which is typically a slow-progressing cancer of the bone marrow and blood2, is one of the most common types of leukemia in adults. In Canada, CLL accounts for approximately 1,745 newly diagnosed cases of leukemia each year and is responsible for more than 600 deaths a year.3

 

VENCLEXTA is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the

U.S. and by AbbVie outside of the U.S.

 

About the CLL14 Trial

The randomized, multicenter, open-label, actively controlled Phase 3 CLL14 trial, which was conducted in close collaboration with the German CLL Study Group (DCLLSG), evaluated the efficacy and safety of a combined regimen of VENCLEXTA and obinutuzumab (n=216) versus obinutuzumab and chlorambucil (n=216) in patients with previously-untreated CLL and coexisting medical conditions (total Cumulative Illness Rating Scale [CIRS] score >6 or creatinine clearance <70 mL/min). The therapies were administered for a fixed duration of 12 cycles for VENCLEXTA in combination with six cycles of obinutuzumab. Cycles were comprised of 28 days. The trial enrolled 432 patients, all of whom were diagnosed according to the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria and were previously untreated. The primary efficacy outcome was PFS as assessed by the investigator.4 Key secondary endpoints included MRD-negativity in peripheral blood and bone marrow, and overall and complete response rates.4,5

 

About AbbVie Care

Canadians prescribed VENCLEXTA can be enrolled in AbbVie Care, AbbVie’s signature care program. The program is designed to provide a wide range of customized services including reimbursement and financial support, pharmacy services, lab work reminders and coordination, personalized education and ongoing disease management support throughout the treatment. For more information, please visit www.abbviecare.ca.

 

About AbbVie in Oncology

At AbbVie, we strive to discover and develop medicines that deliver transformational improvements in cancer treatment by uniquely combining our deep knowledge in core areas of biology with cutting-edge technologies, and by working together with our partners – scientists, clinical experts, industry peers, advocates, and patients. We remain focused on delivering these transformative advances in treatment across some of the most debilitating and widespread cancers. We are also committed to exploring solutions to help patients obtain access to our cancer medicines. AbbVie’s oncology portfolio now consists of marketed medicines and a pipeline containing multiple new molecules being evaluated worldwide in more than 300 clinical trials and more than 20 different tumor types.

 

About AbbVie

AbbVie is a global, research and development-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.ca and www.abbvie.com. Follow @abbvieCanada and @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

 

-30-

Media:

Eileen Murphy AbbVie Canada 514-449-9788

eileen.murphy@abbvie.com

 

 

 

1 Venclexta Product Monograph. AbbVie Corporation, Canada. https://www.abbvie.ca/content/dam/abbvie- dotcom/ca/en/documents/products/VENCLEXTA_PM_EN.pdf. Accessed April 30, 2020.

2 Lymphoma Canada. Chronic lymphocytic leukemia. www.lymphoma.ca/lymphoma/lymphoma-101/types- lymphoma/cll. Accessed May 2020.

3 Canadian Cancer Statistics. Chronic lymphocytic leukemia statistics. www.cancer.ca/en/cancer- information/cancer-type/leukemia-chronic-lymphocytic-cll/statistics/?region=on. Accessed May 2020.

4 Fischer K, et al. Effect of fixed-duration venetoclax plus obinutuzumab (VenG) on progression-free survival (PFS), and rates and duration of minimal residual disease negativity (MRD–) in previously untreated patients (pts) with chronic lymphocytic leukemia (CLL) and comorbidities. Presented at the 2019 American Society of Clinical Oncology Annual Meeting: June 4, 2019; Chicago.

5 N Engl J Med 2019;380:2225-36. DOI: 10.1056/NEJMoa1815281

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CHAMPIGNON FORMS NORTH AMERICAN CLINICAL EXPANSION COMMITTEE

VANCOUVER, British Columbia, May 4, 2020 – Champignon Brands Inc. (“Champignon” or the “Company”) (CSE: SHRM) (FWB: 496) (OTCQB: SHRMF), a human optimization sciences company focused on applying novel and natural treatment protocols to address a broad range of disorders and deficiencies with an emphasis on psychedelic medicine, has advanced its North American new clinical entity (NCE) expansion stratagem via the formation of a dedicated planning committee (the “Committee”).

The Committee has been mandated with accelerating the Company’s entry into the U.S., where it plans to open and/or acquire a minimum of five NCEs during 2020. Champignon continues to conduct discussions with revenue generating clinics located in California, New York, Pennsylvania, Texas, Florida and Missouri.

“We will look to capitalize on the fragmented nature of the U.S. ketamine clinic marketplace with the objective of creating a consortium of integrated mood disorder treatment and research facilities,” commented Gareth Birdsall, CEO of Champignon. “By leveraging existing protocols, data sets and SOPs from our flagship clinic, the Canadian Rapid Treatment Centre of Excellence, arguably the most advanced integrated mood disorder centre in North America, we will improve economics, increase patient enrollment and function as the pre-eminent brick and mortar staging ground for novel molecule discovery initiatives. Champignon remains bullish on the U.S. marketplace due to favourable co-payer infrastructure, as well as a vast addressable patient population.”

About Champignon Brands Inc.

Champignon Brands (CSE: SHRM) is focused on the formulation and manufacturing of novel ketamine, anaesthetics and adaptogenic delivery platforms for the nutraceutical and psychedelic medicine while being supported by a leading psychedelics medicines clinic platform. The Company is pursuing the development and commercialization of rapid onset treatments capable of improving health outcomes, such as depression and post-traumatic stress disorder (PTSD), as well as substance and alcohol use disorders. Under a collaborative research agreement with the University of Miami’s Miller School of Medicine, the Company is conducting preclinical studies and eventual human clinical trials, with the objective of demonstrating safety and efficacy of the combination of psilocybin and cannabidiol in treating mTBI with PTSD or stand-alone PTSD. Champignon continues to be inspired by sustainability, as its medicinal mushroom-infused SKUs are organic, non-GMO and vegan certified. For more information, visit the Company’s website at: https://braxiascientific.com/.

ON BEHALF OF THE BOARD OF DIRECTORS

W. Gareth Birdsall
CEO & Director
E: info@champignonbands.com
T: +1 (778) 549-6714

FOR INVESTOR INQUIRIES:
Tyler Troup
Circadian Group
E: SHRM@braxiascientific.com

FOR CHAMPIGNON BRANDS FRENCH INQUIRIES:
Remy Scalabrini, Maricom Inc.
E: rs@maricom.ca
T: (888) 585-MARI

The CSE and Information Service Provider have not reviewed and does not accept responsibility for the accuracy or adequacy of this release.

Forward-looking Information Cautionary Statement

Except for statements of historic fact, this news release contains certain “forward-looking information” within the meaning of applicable securities law. Forward-looking information is frequently characterized by words such as “plan”, “expect”, “project”, “intend”, “believe”, “anticipate”, “estimate” and other similar words, or statements that certain events or conditions “may” or “will” occur. Forward-looking statements are based on the opinions and estimates at the date the statements are made, and are subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those anticipated in the forward-looking statements including, but not limited to delays or uncertainties with regulatory approvals, including that of the CSE. There are uncertainties inherent in forward-looking information, including factors beyond the Company’s control. There are no assurances that the business plans for Champignon Brands described in this news release will come into effect on the terms or time frame described herein. The Company undertakes no obligation to update forward-looking information if circumstances or management’s estimates or opinions should change except as required by law. The reader is cautioned not to place undue reliance on forward-looking statements. Additional information identifying risks and uncertainties that could affect financial results is contained in the Company’s filings with Canadian securities regulators, which are available at www.sedar.com.

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AIkido Pharma Inc. Provides Update on Anticipated Distribution Date for Hoth Dividend Distribution

NEW YORK, May 4, 2020 /PRNewswire/ — AIkido Pharma Inc. (Nasdaq: AIKI) (“AIkido” or the “Company”) today announced that the distribution date for the previously announced distribution to our stockholders of shares of Hoth Therapeutics, Inc. (“Hoth”) will not be taking place today, May 4, 2020, because of the requirement that the shares be registered prior to distribution. AIkido will provide a distribution date for the distribution of the shares promptly once the registration statement is declared effective. The Company is waiting on (“Hoth”) to seek acceleration of the registration statement, which is a prerequisite for distribution. We hope for this to be done shortly and will update shareholders as soon as possible. The record date has not changed and individuals who were shareholders at 4pm on April 30th, 2020 will be receiving the dividend. No further action is required.

(PRNewsfoto/AIkido Pharma Incorporated)

About AIkido

AIkido was initially formed in 1967 and is a biotechnology company with a diverse portfolio of small-molecule anti-cancer therapeutics.  The Company’s platform consists of patented technology from leading universities and researchers and we are currently in the process of developing an innovative therapeutic drug platform through strong partnerships with world renowned educational institutions, including The University of Texas at Austin and Wake Forest University. Our diverse pipeline of therapeutics includes therapies for pancreatic cancer, acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL). In addition, we are constantly seeking to grow our pipeline to treat unmet medical needs in oncology

Forward-Looking Statements

Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in the Company’s filings with the SEC, not limited to Risk Factors relating to its business contained therein. Thus, actual results could be materially different. The Company expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.

Contact :

Investor Relations:

Hayden IR

Brett Maas, Managing Partner

Phone: (646) 536-7331

Email: brett@haydenir.com

www.haydenir.com

AIkido:

Phone: 212-745-1373

Email: investorrelations@AIkido.com

www.AIkido.com

 

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Rojo Resources Ltd. announces the conditional approval of reverse take-over transaction with Salvation Botanicals Ltd.

Rojo Resources Ltd. (“Rojo” or the “Company”) (TSXV: RJ:H) is pleased to announce that it has received conditional approval from the TSX Venture Exchange (the “Exchange”) for its proposed reverse take-over transaction (the “Transaction”) pursuant to the definitive arrangement agreement dated October 2, 2019, as amended by the amended and restated arrangement agreement dated March 9, 2020 (the “Arrangement Agreement”), entered into with Salvation Botanicals Ltd. (“Salvation”). The Transaction will result in Rojo’s reactivation and graduation from the NEX board of the Exchange to a Tier 2 industrial issuer.

Pursuant to the Arrangement Agreement, Rojo will change its name to “Numinus Wellness Inc.”, or such other name as may be agreed to by Rojo and Salvation, and consolidate its issued and outstanding common shares on the basis of 2:1. Upon completion of the Transaction, Salvation will become a subsidiary of Rojo and continue its business as a public company listed on the Exchange.

Completion of the Transaction is subject to a number of standard closing conditions and final Exchange approval. A copy of the Company’s Filing Statement, which contains detailed information in respect of Rojo, Salvation, and the proposed business of the combined company on completion of the Transaction, has been filed and is available under the Company’s profile at www.sedar.com.

The Transaction cannot close until the required approvals are obtained. There can be no assurance that the Transaction will be completed as proposed or at all. Investors are cautioned that, except as disclosed in the filing statement prepared in connection with the Transaction, any information released or received with respect to the Transaction may not be accurate or complete and should not be relied upon.

Trading in the securities of Rojo should be considered highly speculative. The Exchange has in no way passed upon the merits of the proposed transaction and has neither approved nor disapproved the contents of this press release.

ON BEHALF OF THE BOARD OF ROJO RESOURCES LTD.

Allen Morishita

President and Chief Executive Officer

For further information contact:

Patricia Wilson

Chief Financial Officer
604 803-2201

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

This news release contains forward-looking statements that 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 are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from Rojo’s expectations include the failure to satisfy the conditions of the relevant securities exchange(s) and other risks detailed from time to time in the filings made by Rojo with securities regulations. The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. The reader is cautioned not to place undue reliance on any forward-looking information. 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. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by applicable law.

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Oregon psychedelic startup tests nasal spray for PTSD, depression as legislative momentum builds

Mike Arnold, the founder of Silo Wellness, on a trip to Jamaica. (Photo courtesy Mike Arnold)

If you want to know just how quickly public sentiment around psychedelics is changing, consider this: Gwyneth Paltrow sent her staffers to psilocybin-assisted therapy in the first episode of the Netflix docu-series the Goop Lab. Meanwhile, billionaires attending the World Economic Forum in Davos heard a pitch from a company developing a hallucinogenic drug to treat opioid addiction.

With Oregon activists pushing for state-wide decriminalization of magic mushrooms for therapeutic use this year, one local startup wants to keep the momentum going. Silo Wellness, based in Springfield, Oregon, has developed a nasal spray for microdosing psilocybin meant to aid with anxiety, PTSD and depression. The company now hopes to spread the good word, offering seminars for volunteers who normally wouldn’t try it on the black market to test the device in a controlled setting in Jamaica, where magic mushrooms are legal.

“My hypothesis being that this has the best chance of catalyzing legalization in the United States, when people go back and tell their peers and friends on Facebook that they tried mushrooms,” Mike Arnold, a former trial attorney and the founder of Silo Wellness, said in January before the COVID-19 outbreak.

Arnold says his goal is to “get psychedelics in the hands of as many people as quickly and inexpensively as possible.”

Almost 50 years after President Richard Nixon launched an anti-drug crusade, a growing number of researchers, companies and institutions are betting that the long-shunned hallucinogens could be poised for growth amid rising scientific evidence for their efficacy in treating some of the toughest mental health and addiction challenges.

Over 260 million people of all ages suffer from depression, which is a leading cause of disability worldwide, according to the World Health Organization. With the rise of awareness around mental health and mental illness, more startups are targeting the underserved market than ever before, says Stephen Hays, the founder of What If Ventures, which invests in early-stage mental health and addiction recovery focused companies.

More than 700 startups are building solutions for mental health and emotional well-being, with just over $4.5 billion invested, according to Hays’ estimates. About a dozen are focused on psychedelics, laying the groundwork in the anticipation of their removal from Schedule 1 category, which may happen in the next two years.

“Because the regulation is being crafted from scratch and the laws have to be changed, there are going to be a lot of people who start businesses and then get blindsided by the bureaucracy of the system,” said Hays. “It’s a really hard place to invest early without getting a little bit lucky.”

Earlier this month, the U.K.-based Compass Pathways, which is conducting the world’s first large-scale psilocybin therapy clinical trial, raised $80 million in a Series B round from investors, including ATAI Life Sciences, Founders Fund and Able Partners. The company, which holds a US patent relating to methods of treating drug-resistant depression “with a psilocybin formulation,” is also backed by Silicon Valley billionaire Peter Thiel, who has invested in other companies focused on psychedelics.

Meanwhile, Johns Hopkins University and Imperial College London last year opened new research centers, with more than $20 million in commitments from wealthy private donors, to study compounds like LSD and psilocybin for mental health disorders, depression and addiction.

Psilocybin is officially listed as an “eligible investigation drug” for terminally ill patients under the Right to Try Act passed by President Trump in 2018. According to one study, most cancer patients experienced “significant decreases in depressed mood and anxiety” after a session, while two-thirds said it was among the most meaningful experiences of their lives.

“For the first time in decades, psychiatry has a real shot at having approved treatments that not only alleviate the symptoms, but empower patients, and we simply cannot afford to miss that chance,” Ekaterina Malievskaia, chief innovation officer and co-founder of Compass Pathways wrote on LinkedIn in December.

Clockwise from upper left: Journalist Anastasia Ustinova, entrepreneur and consultant Eric Boone; Dr. Sunil Aggarwal, an affiliate clinical assistant professor at the University of Washington School of Medicine; and Mike Arnold, founder of Silo Wellness, recording an episode of the GeekWire Health Tech Podcast.

Oregon could become one of the first states to decriminalize the psychedelic mushrooms this year, with activists collecting signatures for several 2020 ballot initiatives, including for therapeutic uses. California and Vermont may follow suit.

Silo Wellness’s Arnold says he got involved in the industry for real purpose. After building a lucrative career as an “intimidating cross-examiner, a rugby-playing lawyer” with poor anger management skills, Arnold felt a profound transformation thanks to a guided meditation with a handful of magic mushrooms. That experience sent him on a quest to make the healing opportunities of fungi available to a much wider audience.

Thus was born the “spore to door” psychedelic therapy company, which formulated its product in Jamaica with a team led by pharmacologist Parag Bhatt and Marine combat veteran Scott Slay. Arnold also partnered with Michael Hartman, a former senior scientist at the pharmaceutical giant Novartis and the inventor of a cannabis and hemp inhaler.

The spray allows users to get the effects of a metered sub-psychedelic dose without the complications of an upset stomach. When inhaled, psilocybin goes directly to the bloodstream through the nasal membranes and eventually the liver for metabolizing. The company has no plans for commercial release yet.

Unlike with cannabis, where patients knew about the benefits of marijuana long before the capital market, this time high net worth individuals and institutional investors got on board early, which may create a threat for the industry, making it follow a big-pharma, prescription-only model, says Arnold.

“This is not the type of medicine you should have to go to a pharmacy and pay a lot of money for,” he said.

 Listen to GeekWire’s Health Tech Podcast above or subscribe in any podcast app to hear a discussion with Mike Arnold, founder of Silo Wellness; entrepreneur and consultant Eric Boone of Cannabinovation.com; Dr. Sunil Aggarwal, an affiliate clinical assistant professor at the University of Washington School of Medicine; and journalist Anastasia Ustinova.

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Vireo Health Announces Formation of Resurgent Biosciences Subsidiary

— Non-plant-touching entity to commercialize Vireo’s intellectual property portfolio

MINNEAPOLIS, April 30, 2020 /PRNewswire/ — Vireo Health International, Inc. (“Vireo” or the “Company”) (CNSX: VREO, OTCQX: VREOF), the science-focused multi-state cannabis company with active operations in exclusively medical-only markets and licenses in nine states and the commonwealth of Puerto Rico, today announced the formation of a wholly-owned subsidiary company called Resurgent Biosciences, Inc. (“Resurgent”).

Vireo Logo (PRNewsfoto/Vireo Health, Inc.)

Resurgent Biosciences is a Delaware corporation which has been created with the intent to commercialize Vireo’s portfolio of intellectual property and related initiatives in a non-plant-touching entity which may broaden potential partnership opportunities or other strategic outcomes as Vireo seeks to monetize scientific advancements within the cannabis industry and beyond. Vireo currently has a wide array of patent applications pending approval by the United States Patent and Trademark Office. Its patent for harm reduction in tobacco products was granted earlier this year.

“The formation of Resurgent Biosciences was a necessary progression of our development as we continue working toward identifying the appropriate partners to help us achieve Vireo’s vision for the future of cannabis,” said founder and Chief Executive Officer Kyle Kingsley, M.D. “Much of our intellectual property has been built with partnership in mind, and structuring those valuable assets under Resurgent will enable us to be optimally flexible as it relates to monetization opportunities both in the near- and long-term future. We are looking forward to working with our partners to commercialize scientific advancements in cannabis that may ultimately benefit millions of consumers across the United States and, potentially, the world.”

About Vireo Health International, Inc.

Vireo Health International, Inc. is a physician-led cannabis company focused on building long-term, sustainable value by bringing the best of medicine, science, and engineering to the cannabis industry. With operations strategically located in early-stage, limited-license medical markets, Vireo manufactures pharmaceutical-grade cannabis products in environmentally-friendly greenhouses and distributes its products through its growing network of Green Goods™ retail dispensaries and hundreds of third-party locations. Its current core medical markets of New York, Minnesota, Pennsylvania, Arizona, New Mexico, Maryland, Ohio and Rhode Island all have the potential to enact adult-use legalization in the next three to 24 months, and two additional markets in Puerto Rico and Massachusetts also have potential for commercialization. Combined with its teams’ focus on driving scientific innovation within the industry and securing meaningful intellectual property, Vireo believes it is well positioned to become a global market leader in the cannabis industry. Today, eight of its 10 markets are operational with 13 of its 32 total retail dispensary licenses open for business. For more information about the company, please visit www.vireohealth.com.

Contact Information 

Investor Inquiries
Sam Gibbons
Vice President, Investor Relations
samgibbons@vireohealth.com
(612) 314-8995

Media Inquiries
Albe Zakes
Vice President, Corporate Communications
albezakes@vireohealth.com
(267) 221-4800

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SOURCE Vireo Health International, Inc.

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CHAMPIGNON KETAMINE TREATMENT TO BE DISPENSED BY MAJOR CANADIAN PHARMACY CHAIN; CLOSES ALTMED

VANCOUVER, British Columbia, April 30, 2020 – Champignon Brands Inc. (“Champignon” or the “Company”) (CSE: SHRM) (FWB: 496) (OTCQB: SHRMF), a human optimization sciences company focused on applying novel and natural treatment protocols to address a broad range of disorders and deficiencies with an emphasis on psychedelic medicine, continues to strengthen its vertically integrated psychedelic medicine ecosystem via the acceleration of its ketamine topicals prescription fulfillment capabilities.

The Company is pleased to announce the addition of central fill and compounding infrastructure for its proprietary ketamine formulations via a location at one of Canada’s leading retail pharmacy chains (the “Pharmacy”), as well as the dispensing of its products throughout the Pharmacy’s network.

Champignon will leverage the Pharmacy’s existing infrastructure to distribute or “central fill” ketamine topical prescriptions to a network of Canadian medical and pain/addiction clinics (the “Clinics”). These compounded products will provide Champignon an accretive revenue stream with robust margins.

Champignon and the Pharmacy have also begun to design a custom, Level B clean room (the “Clean Room”), located within the current Pharmacy footprint. The Company will leverage its Clean Room to compound and package its ketamine formulations including, but not limited to, off-market intranasal esketamine and ketamine topicals. Champignon projects that the construction of its Clean Room will be complete by Q3 2020 and will contain all design specifications per new NAPRA guidelines.

“With this arrangement, Champignon boasts complete vertical integration with respect to our rapid onset ketamine treatments and therapies. From novel formulations to product development at a purpose-built GMP and DIN licensed pharmaceutical facility, and now automated prescription fulfillment and on-site compounding infrastructure, we have managed to capture the entire product lifecycle,” commented Gareth Birdsall, CEO of Champignon.

Champignon’s central fill capabilities will optimize the Company’s prescription fulfillment infrastructure, all while simultaneously advancing its ketamine data collation initiatives for the following indications: concussion/traumatic brain injury (TBI), anxiety and treatment resistant depression.

Champignon’s ketamine-based formulations will be used by the Clinics for the purposes of conducting chart reviews and associated patient studies under human ethics approval from Health Canada. Resulting data from the chart reviews/studies will be used by the Company for peer-reviewed publishing mandates, as well as to expedite future Phase 1 human clinical trials.

Birdsall added, “The data collated by our network of clinics as physicians prescribe our ketamine products for a variety of indications will assist with improving the success outcomes of our planned trials for later this calendar year.”

Additionally, Champignon is pleased to announce that it has closed its acquisition of AltMed Capital Corp. (“AltMed”), subject to the submission of the necessary filings to the BC Corporate Registry and including any other necessary exchange approvals.

AltMed is a Canadian ketamine clinic operator, psychedelic medicine IP aggregator and novel drug discoverer. AltMed has a suite of assets that will accelerate Champignon’s multipronged business strategy, enabling the Company to reach the consumer directly through rapid-onset medical treatments, with an anticipated rollout of new clinical entities (NCEs) already identified and to be opened across the United States and Canada.

Furthermore, the Company reports that AltMed has purchased the balance of the shares of the Canadian Rapid Treatment Centre of Excellence Inc. (“CRTCE”), resulting in a 100% ownership of the CTRCE by AltMed and replacing the originally contemplated retained interest in CRTCE to be held by its principals.

The CRTCE is licensed (2018) by the College of Physicians and Surgeons Ontario (CPSO) under OHPP (out-of-hospital premise program) to administer ketamine treatments for indications, including, but not limited to, depression, bipolar disorder, post-traumatic stress disorder and obsessive-compulsive disorder (OCD). The CRTCE is the only vertically integrated rapid-onset treatment centre operating from proof-of-concept to human clinical trials and publication, with study results in peer-reviewed journals by the world’s leading experts in psychopharmacology.

With this acquisition now complete, the Company stands ready to, among other things, to open a minimum of 5 new clinics in key markets, including New York, Florida and California, which are anticipated to be fully operational by Q4 2020.  In consideration of the transaction, 76,034,000 common shares have been issued, of which 17,122,000 will be subject only to applicable hold periods under securities legislation and 58,912,000 will be subject to voluntary resale restrictions and released in five equal tranches every three months and being subject to applicable hold periods under securities legislation. Additionally, 2,100,000 share purchase warrants will be issued in exchange for outstanding AltMed share purchase warrants. A finder’s fee is applicable to this transaction.

About Champignon Brands Inc.

Champignon Brands Inc. (CSE: SHRM) is a research-driven company specializing in the formulation of a suite of medicinal mushrooms health products as well as novel ketamine, anaesthetics and adaptogenic delivery platforms for the nutritional, wellness and alternative medicine industries. Via its vertically integrated alternative medicine product range, Champignon is pursuing the development and commercialization of rapid onset treatments capable of improving health outcomes for patients suffering with conditions like depression and post-traumatic stress disorder (PTSD), as well as substance and alcohol use disorders. Under a collaborative research agreement with the University of Miami’s Miller School of Medicine, the Company is conducting preclinical studies and eventual human clinical trials, with the objective of demonstrating safety and efficacy of the combination of psilocybin and cannabidiol in treating mTBI with PTSD or stand-alone PTSD. Champignon continues to be inspired by sustainability, as its medicinal mushroom-infused SKUs are organic, non-GMO and vegan certified. For more information, visit the Company’s website at: https://braxiascientific.com/.

ON BEHALF OF THE BOARD OF DIRECTORS

W. Gareth Birdsall
CEO & Director
E: info@champignonbands.com
T: +1 (778) 549-6714

FOR INVESTOR INQUIRIES:
Tyler Troup
Circadian Group
E: SHRM@braxiascientific.com

FOR CHAMPIGNON BRANDS FRENCH INQUIRIES:
Remy Scalabrini, Maricom Inc.
E: rs@maricom.ca
T: (888) 585-MARI

The CSE and Information Service Provider have not reviewed and does not accept responsibility for the accuracy or adequacy of this release.

Forward-looking Information Cautionary Statement

Except for statements of historic fact, this news release contains certain “forward-looking information” within the meaning of applicable securities law. Forward-looking information is frequently characterized by words such as “plan”, “expect”, “project”, “intend”, “believe”, “anticipate”, “estimate” and other similar words, or statements that certain events or conditions “may” or “will” occur. Forward-looking statements are based on the opinions and estimates at the date the statements are made, and are subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those anticipated in the forward-looking statements including, but not limited to delays or uncertainties with regulatory approvals, including that of the CSE. There are uncertainties inherent in forward-looking information, including factors beyond the Company’s control. There are no assurances that the business plans for Champignon Brands described in this news release will come into effect on the terms or time frame described herein. The Company undertakes no obligation to update forward-looking information if circumstances or management’s estimates or opinions should change except as required by law. The reader is cautioned not to place undue reliance on forward-looking statements. Additional information identifying risks and uncertainties that could affect financial results is contained in the Company’s filings with Canadian securities regulators, which are available at www.sedar.com.

Posted on

Notice of Record Date of Hoth Distribution

Today, April 30th is Record Date to Own Company Shares to Receive Hoth Dividend

NEW YORK, April 30, 2020 /PRNewswire/ — AIkido Pharma Inc. (Nasdaq: AIKI) (“AIkido” or the “Company”) today announced a reminder to the Company’s stockholders that today, April 30, 2020, is the record date for the previously announced distribution to our stockholders of shares of common stock of Hoth Therapeutics, Inc. (“Hoth”).  Each stockholder of the Company, as of 4:00 p.m. Eastern Time on April 30, 2020, is entitled to receive one (1) share of Hoth common stock for every five hundred (500) shares of AIkido common stock held.  The original ratio of seventy (70) shares was changed to reflect the increase in the number of Company shares issued and outstanding, as of today’s record date.  The Company expects to distribute the shares of Hoth common stock on May 4, 2020.

(PRNewsfoto/AIkido Pharma Incorporated)

The Company will not distribute fractional shares of Hoth common stock, and any fractional shares will be rounded down to the nearest whole share.  Stockholders of the Company do not need to take any action to receive the shares of Hoth common stock, other than be a stockholder of record on April 30, 2020, and stockholders do not need to pay any consideration for, surrender or exchange shares of AIkido common stock.

About AIkido

AIkido was initially formed in 1967 and is a biotechnology company with a diverse portfolio of small-molecule anti-cancer therapeutics.  The Company’s platform consists of patented technology from leading universities and researchers and we are currently in the process of developing an innovative therapeutic drug platform through strong partnerships with world renowned educational institutions, including The University of Texas at Austin and Wake Forest University. Our diverse pipeline of therapeutics includes therapies for pancreatic cancer, acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL). In addition, we are constantly seeking to grow our pipeline to treat unmet medical needs in oncology

Forward-Looking Statements

Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in the Company’s filings with the SEC, not limited to Risk Factors relating to its business contained therein. Thus, actual results could be materially different. The Company expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.

Contact:

Investor Relations:   

Hayden IR

Brett Maas, Managing Partner

Phone: (646) 536-7331

Email: brett@haydenir.com

www.haydenir.com

AIkido:                   

Phone: 212-745-1373

Email: investorrelations@AIkido.com  

www.AIkido.com

 

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SOURCE AIkido Pharma Inc.

News Provided by PR Newswire via QuoteMedia

Posted on

Revive Therapeutics Provides an Update on its Psilocybin-Based Pharmaceutical Program

TORONTO, April 29, 2020 – Revive Therapeutics Ltd. (“Revive” or the “Company”) (CSE: RVV), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is pleased to provide further insight on its plans for its psilocybin-based pharmaceutical program.  The Company will investigate novel oral dosage forms of psilocybin, such as oral dissolvable thin films or tablets, based on the Company’s wholly-owned patent-pending psilocybin formulations and its exclusive licensed drug delivery technology from the Wisconsin Alumni Research Foundation.

“We are expanding our psilocybin-based pharmaceutical portfolio with unique oral dosage and drug delivery forms that will target and have the potential to treat diseases and disorders currently not investigated with psychedelic compounds,” said Michael Frank, Revive’s Chief Executive Officer. “We are combining our robust intellectual property portfolio in both psychedelic formulations and our drug delivery technology which is unique within the industry, and leveraging our research partnership with the University of Wisconsin-Madison to establish a specialty portfolio of psilocybin-based pharmaceuticals that we can advance to clinical trials and partnerships with other life sciences companies.”

Through initial evaluations with the Company’s research team, it has been found there are several unique parallels between the Company’s intellectual property portfolio of psilocybin-based formulations and delivery mechanism and the drug delivery technology, which is comprised of tannin-chitosan composites that have been studied with cannabidiol in the past.  Revive intends to research both delivery mechanisms in parallel as each provides its own unique qualities such as the potential of rapid onset of action and time-release compositions.  The future of psilocybin as a medication will come in many forms.  The Company believes that the most optimal delivery method to pursue and unlock the potential of psilocybin to treat a broad spectrum of diseases and disorders will be in the form of both an oral dissolvable tablet and an oral thin film strip, commonly recognized as a ‘Breath Strip’.  The Company is preparing its formulation development plans intending to pursue clinical studies for indications currently not being evaluated with psilocybin. We believe the combination of psilocybin and our tannin-chitosan delivery platform gives us a unique advantage.

Revive’s psilocybin-based formulations have been engineered to work synergistically with the body’s own natural pathways of absorption while offering a contemporary approach to consumption. The Company has key provisional patent applications with the U.S. Patent and Trademark Office that cover methods of production of psilocybin-based formulations, including sublingual sprays, effervescent tablets, hard-shell capsules, sublingual and transmucosal delivery systems (i.e. gum drops, oral strips, dosing pens). Furthermore, Revive has a patent-pending portfolio that includes Psilocybin extraction and crystallization methodologies.

The drug delivery technology aims to deliver both synthetic and natural extract of psilocybin in a potential number of ways such as topical gels, creams or ointments, oral or transdermal patches, oral dosages and foams. The delivery technology is a natural, non-toxic, biodegradable and biocompatible composite that combines a tannin material, which is derived from a plant group having antibacterial, antifungal, antioxidant and wound healing properties, and a chitosan material, which is derived from the crustacean group having blood-clotting and antimicrobial properties. The delivery technology has a rapid onset of action and controlled or sustained release potential capabilities and may allow combining multiple extracts from mushrooms in one formulation.

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 strains including COVID-19. With its recent 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@fbn.436.myftpupload.com
Website: www.revivethera.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” 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 Offering, including the intended use of proceeds. 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, 2019, which has been filed on SEDAR and is available under the Company’s profile at www.sedar.com.

 

Posted on

CHAMPIGNON SELECTED AS HEADLINE PARTNER FOR PSYCH: THE PSYCHEDELICS SYMPOSIUM AT PROHIBITION PARTNERS LIVE

VANCOUVER, British Columbia, April 28, 2020 – Champignon Brands Inc. (“Champignon” or the “Company”) (CSE: SHRM) (FWB: 496) (OTCQB: SHRMF), a human optimization sciences company focused on applying novel and natural treatment protocols to address a broad range of disorders and deficiencies with an emphasis on psychedelic medicine, is pleased to announce it has been selected as the Headline Partner for Prohibition Partners LIVE’s PSYCH: The Psychedelics Symposium (“PSYCH”), scheduled to take place June 22 – 23, 2020.

PSYCH is architected and moderated by Prohibition Partners LIVE and will be this year’s most significant psychedelics virtual conference, bringing together key stakeholders at the forefront of the industry to share unparalleled insights and intelligence. Thought leaders from the worlds of health care, science and business will present their latest findings and expert analysis on the state of the industry from unique locations across the globe.

While cannabis has paved much of the way for psychedelics in terms of legal progress and changing public perception, psychedelics as medicines are backed by a comparatively more powerful knowledge base. The potential for psychedelics in innovative treatments for numerous high-prevalence health problems has become the next major focus.

Champignon quickly established itself as an industry leader within this emerging arena and boasts an impressive portfolio of accretive assets that target key segments in the psychedelic as medicines for mental health conditions vertical:

  1. Psychedelic medicines clinic platform;
  2. Novel drug discovery; and
  3. Formulations and delivery systems.

PSYCH participants will have the opportunity to attend live-streamed keynotes and panels from over 150 CEOs, policymakers and cultural leaders, and gain unrivalled access to some of the most influential brands and businesses in the world as they discuss how cannabis and psychedelics will affect our future.

Prohibition Partners’ Managing Director Stephen Murphy stated, “The impact of COVID-19 has put greater emphasis on the importance of mental health. Consumers are looking for options to improve their mental health and, as the body of evidence mounts for psychedelics, the healthcare industry is responding with solutions. We’re delighted to partner with Champignon Brands on PSYCH and support their vision of improving mental health via psychedelics.”

Champignon invites all current and prospective shareholders to join PSYCH on June 22 – 23 to discover the latest developments in the psychedelic industry, learn from world-renowned speakers and engage with a network of industry-leading professionals.

About Champignon Brands Inc.

Champignon Brands Inc. (CSE: SHRM) is a research-driven company specializing in the formulation of a suite of medicinal mushrooms health products as well as novel ketamine, anaesthetics and adaptogenic delivery platforms for the nutritional, wellness and alternative medicine industries. Via its vertically integrated alternative medicine product range, Champignon is pursuing the development and commercialization of rapid onset treatments capable of improving health outcomes for patients suffering with conditions like depression and post-traumatic stress disorder (PTSD), as well as substance and alcohol use disorders. Under a collaborative research agreement with the University of Miami’s Miller School of Medicine, the Company is conducting preclinical studies and eventual human clinical trials, with the objective of demonstrating safety and efficacy of the combination of psilocybin and cannabidiol in treating mTBI with PTSD or stand-alone PTSD. Champignon continues to be inspired by sustainability, as its medicinal mushroom-infused SKUs are organic, non-GMO and vegan certified. For more information, visit the Company’s website at: https://braxiascientific.com/.

ON BEHALF OF THE BOARD OF DIRECTORS

W. Gareth Birdsall
CEO & Director
E: info@champignonbands.com
T: +1 (778) 549-6714

FOR INVESTOR INQUIRIES:
Tyler Troup
Circadian Group
E: SHRM@braxiascientific.com

FOR CHAMPIGNON BRANDS FRENCH INQUIRIES:
Remy Scalabrini, Maricom Inc.
E: rs@maricom.ca
T: (888) 585-MARI

The CSE and Information Service Provider have not reviewed and does not accept responsibility for the accuracy or adequacy of this release.

Forward-looking Information Cautionary Statement

Except for statements of historic fact, this news release contains certain “forward-looking information” within the meaning of applicable securities law. Forward-looking information is frequently characterized by words such as “plan”, “expect”, “project”, “intend”, “believe”, “anticipate”, “estimate” and other similar words, or statements that certain events or conditions “may” or “will” occur. Forward-looking statements are based on the opinions and estimates at the date the statements are made, and are subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those anticipated in the forward-looking statements including, but not limited to delays or uncertainties with regulatory approvals, including that of the CSE. There are uncertainties inherent in forward-looking information, including factors beyond the Company’s control. There are no assurances that the business plans for Champignon Brands described in this news release will come into effect on the terms or time frame described herein. The Company undertakes no obligation to update forward-looking information if circumstances or management’s estimates or opinions should change except as required by law. The reader is cautioned not to place undue reliance on forward-looking statements. Additional information identifying risks and uncertainties that could affect financial results is contained in the Company’s filings with Canadian securities regulators, which are available at www.sedar.com.