Posted on

MindMed Included in FTSE Russell 3000® Index

MindMed (NASDAQ: MNMD) (NEO: MMED) (DE: MMQ), a leading psychedelic-inspired medicine company announced that effective Friday, June 25th, 2021, MindMed has been added to the FTSE Russell 3000® index which measures the performance of the largest 3,000 US companies.

The annual Russell indexes reconstitution process captures the 4,000 largest US stocks in May of every year, ranking them by total market capitalization. Membership in the US all-cap Russell 3000® Index, which remains in place for one year, means automatic inclusion in the large-cap Russell 1000 Index or small-cap Russell 2000 Index, as well as the appropriate growth and value style indexes. FTSE Russell determines membership for its Russell indexes primarily by objective, market-capitalization rankings and style attributes.

Robert Barrow, Chief Executive Officer of MindMed said, “Being included in mature and credible indexes like the FTSE Russell 3000® is a true honor. As we continue building MindMed and continue to achieve our important capital market and development milestones, our entire team remains dedicated and motivated to deliver on the potential positive change we can bring to the treatment of mental health and addiction in the years ahead.”

Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $10.6 trillion in assets are benchmarked against Russell’s US indexes. Russell indexes are part of FTSE Russell, a leading global index provider.

For more information on the Russell 3000® Index and the Russell indexes reconstitution, go to the “Russell Reconstitution” section on the FTSE Russell website.

About MindMed

MindMed is a clinical-stage biotech company that discovers, develops and deploys psychedelic inspired medicines and therapies to address addiction and mental illness. The company is assembling a compelling drug development pipeline of innovative treatments based on psychedelic substances including psilocybin, LSD, MDMA, DMT and an ibogaine derivative, 18-MC. The MindMed executive team brings extensive biopharmaceutical experience to MindMed’s approach to developing the next generation of psychedelic inspired medicines and therapies.

MindMed trades on the NASDAQ under the symbol MNMD and on the Canadian NEO Exchange under the symbol MMED. MindMed is also traded in Germany under the symbol MMQ. For more information: www.mindmed.co

About FTSE Russell

FTSE Russell is a leading global index provider creating and managing a wide range of indexes, data and analytic solutions to meet client needs across asset classes, style and strategies. Covering 98% of the investable market, FTSE Russell indexes offer a true picture of global markets, combined with the specialist knowledge gained from developing local benchmarks around the world.

FTSE Russell index expertise and products are used extensively by institutional and retail investors globally. For over 30 years, leading asset owners, asset managers, ETF providers and investment banks have chosen FTSE Russell indexes to benchmark their investment performance and create investment funds, ETFs, structured products and index-based derivatives. FTSE Russell indexes also provide clients with tools for asset allocation, investment strategy analysis and risk management.

A core set of universal principles guides FTSE Russell index design and management: a transparent rules-based methodology, informed by independent committees of leading market participants. FTSE Russell is focused on index innovation and customer partnership applying the highest industry standards and embracing the IOSCO Principles. FTSE Russell is wholly owned by the London Stock Exchange Group.

For more information, visit ftserussell.com

Forward-Looking Statements

Certain statements in this news release related to the Company constitute “forward-looking information” within the meaning of applicable securities laws and are prospective in nature. Forward-looking information is not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as “will”, “may”, “should”, “could”, “intend”, “estimate”, “plan”, “anticipate”, “expect”, “believe”, “potential” or “continue”, or the negative thereof or similar variations. Forward-looking information in this news release include, but are not limited to, statements regarding the performance of MindMed’s shares, ability to maintain its status and the inclusion of its shares in FTSE Russell indexes, index funds and investment strategies.  Although the Company believes that the expectations reflected in such forward-looking information are reasonable, such information involves risks and uncertainties, and undue reliance should not be placed on such information, as unknown or unpredictable factors could have material adverse effects on future results, performance or achievements of the Company. There are numerous risks and uncertainties that could cause actual results and the Company’s plans and objectives to differ materially from those expressed in the forward-looking information, including history of negative cash flows; limited operating history; incurrence of future losses; availability of additional capital; lack of product revenue; compliance with laws and regulations; difficulty associated with research and development; risks associated with clinical trials or studies; heightened regulatory scrutiny; early stage product development; clinical trial risks; regulatory approval processes; novelty of the psychedelic inspired medicines industry; as well as those risk factors discussed or referred to herein and the risks described under the headings “Risk Factors” in the Company’s filings with the securities regulatory authorities in all provinces and territories of Canada which are  available under the Company’s profile on SEDAR at www.sedar.com and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov. Should one or more of these risks or uncertainties materialize, or should assumptions underlying the forward-looking information prove incorrect, actual results and future events could differ materially from those anticipated in such information. Although the Company has attempted to identify important risks, uncertainties and factors that could cause actual results to differ materially, there may be others that cause results not to be as anticipated, estimated or intended. These and all subsequent written and oral forward-looking information are based on estimates and opinions of management on the dates they are made and are expressly qualified in their entirety by this notice. Except as required by law, the Company does not intend and does not assume any obligation to update this forward-looking information.

arrow

Posted on

New Psychedelic Drug Formula Believed to Work to Mitigate Neurological Damage Due to Stroke, Provisional Patent Application Filed

Vancouver, British Columbia, Canada – June 19, 2021 – Core One Labs Inc. (CSE: COOL), (OTC: CLABF), (Frankfurt: LD62, WKN: A2P8K3) (the “Company”) is pleased to announce that its wholly owned subsidiary Akome Biotech Ltd. (“Akome”) has commenced the development of a next-generation psychedelic drug formulation for the purpose of mitigating neurological damage that results from ischemic strokes.

Akome’s next generation psychedelic drug formulation for the mitigation of neurological damage resulting from ischemic strokes, also known as AKO001, is comprised of the psychedelic compound N,N-dimethyltryptamine (DMT) and a specific plant bioactive which, when combined together, are believed to work in a complementary and mitigating manner when provided  to individuals immediately following their ischemic stroke.  A provisional matter of composition patent application for AKO001 has been filed with the United States Patent and Trademark Office (USPTO) under application 63147343.

Ischemia is a condition in which the blood vessels become blocked, and blood flow is stopped or reduced. When blood flow is diminished to a body part, that body part also does not receive adequate oxygen. Most strokes are ischemic by nature, and blood flow through the artery that supplies oxygen-rich blood to the brain becomes blocked, and brain cells begin to die. Ischemic stroke is the 3rd most common cause of death and the leading cause of disability worldwide in adults. [1]The World Health Organization estimates that 17.9 million people die from stroke worldwide each year.

Akome’s specifically chosen plant bioactive and DMT are an ideal combination of compounds for mitigating the neurological damage caused by ischemic strokes.  The bioactive shows evidence of promoting positive apoptotic processes (biological processes that occur in multicellular organisms, where a cell intentionally “decides” to die, or remove itself from an organism), and the DMT induces the formation of glial cells (a type of supportive cell in the central nervous system involved in regulating homeostasis and providing protection to the functioning of the nervous system). These complimentary functions could theoretically optimize in vivo replacement of neurons after neural injury, such as a stroke.

Akome is in process of identifying Contract Research Organizations (CROs) to work with as it sets the development process of its novel AKO001 psychedelic drug formulation and its advancement for the treatment of stroke.

“Our goal with the development of AKO001 is to reduce the damage from the number of life long disabling symptoms that can occur after experiencing a stroke.  We look forward to continued development on this front and providing updates to the medical community on our progress.” stated Joel Shacker CEO of the Company.

About Core One Labs Inc.

Core One is a biotechnology research and technology life sciences enterprise focused on bringing psychedelic medicines to market through novel delivery systems and psychedelic assisted psychotherapy. Core One has developed a patent pending thin film oral strip (the “technology”) which dissolves instantly when placed in the mouth and delivers organic molecules in precise quantities to the bloodstream, maintaining excellent bioavailability. The Company intends to further develop and apply the technology to psychedelic compounds, such as psilocybin. Core One also holds an interest in medical clinics which maintain a combined database of over 275,000 patients. Through these clinics, the integration of its intellectual property, R&D related to psychedelic treatments and novel drug therapies, the Company intends to obtain regulatory research approval for the advancement of psychedelic-derived treatments for mental health disorders.

Core One Labs Inc.

Joel Shacker

Chief Executive Officer

FOR MORE INFORMATION, PLEASE CONTACT:

info@core1labs.com

1-866-347-5058

Cautionary Disclaimer Statement:

The Canadian Securities Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.

Information set forth in this news release contains forward-looking statements that are based on assumptions as of the date of this news release. These statements reflect management’s current estimates, beliefs, intentions, and expectations. They are not guarantees of future performance. The Company cautions that all forward-looking statements are inherently uncertain, and that actual performance may be affected by a number of material factors, many of which are beyond the Company’s control. Such factors include, among other things: risks and uncertainties relating to the Company’s limited operating history and the need to comply with strict regulatory regulations.  Accordingly, actual and future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. Except as required under applicable securities legislation, the Company undertakes no obligation to publicly update or revise forward-looking information.

In addition, psilocybin is currently a Schedule III drug under the Controlled Drugs and Substances Act (Canada) and it is a criminal offence to possess substances under the Controlled Drugs and Substances Act (Canada) without a prescription or authorization. Health Canada has not approved psilocybin as a drug for any indication. Core One does not have any direct or indirect involvement with illegal selling, production, or distribution of psychedelic substances in jurisdictions in which it operates. While Core One believes psychedelic substances can be used to treat certain medical conditions, it does not advocate for the legalization of psychedelics substances for recreational use. Core One does not deal with psychedelic substances, except within laboratory and clinical trial settings conducted within approved regulatory frameworks.

[1] https://www.who.int/health-topics/cardiovascular-diseases/#tab=tab_1

Posted on

CORE ONE LABS RETAINS CANADA’S HIGHEST-RANKED IP LAW FIRM TO ASSIST WITH PATENT FILINGS

Vancouver, British Columbia, Canada – June 18, 2021 – Core One Labs Inc. (CSE: COOL), (OTC: CLABF), (Frankfurt: LD62, WKN: A2P8K3) (the “Company”) is pleased to announce it has retained Smart & Biggar LLP (“Smart and Biggar”) to handle all IP filings for Akome Biotech Ltd. (“Akome”) and Vocan Biotechnologies Inc. (“Vocan”).

Smart & Biggar is Canada’s largest and highest-ranked intellectual property law firm.  Smart and Biggar’s award-wining IP team has helped the most successful companies in Canada and around the world protect, enforce and leverage their IP rights to grow their business.  For innovative pharmaceutical and life sciences companies, they offer specialized expertise for enforcement of IP rights in Canada through combined strengths in prosecution, regulatory and litigation. With over 100 lawyers, patent agents and trademark agents, Smart and Biggar offer legal expertise and technological knowledge across a wide range of industries and scientific and engineering disciplines, with leaders in every field.

“We are very excited to be working with the top IP firm in Canada, who will be assisting us in all of our PCT filings which will protect and strengthen our IP.  The psychedelic medicine arena is in its infancy, with many different companies working toward commercially viable psychedelic drugs solutions.  At Core One we believe we are at the forefront on some breakthrough psychedelic solutions that will be highly valuable in the future.  Engaging the top IP firm in Canada is the first step in creating and protecting the value we intend to create for all shareholders.” stated Joel Shacker CEO of the Company.

About Core One Labs Inc.

Core One is a biotechnology research and technology life sciences enterprise focused on bringing psychedelic medicines to market through novel delivery systems and psychedelic assisted psychotherapy. Core One has developed a patent pending thin film oral strip (the “technology”) which dissolves instantly when placed in the mouth and delivers organic molecules in precise quantities to the bloodstream, maintaining excellent bioavailability. The Company intends to further develop and apply the technology to psychedelic compounds, such as psilocybin. Core One also holds an interest in medical clinics which maintain a combined database of over 275,000 patients. Through these clinics, the integration of its intellectual property, R&D related to psychedelic treatments and novel drug therapies, the Company intends to obtain regulatory research approval for the advancement of psychedelic-derived treatments for mental health disorders.

Core One Labs Inc.

Joel Shacker

Chief Executive Officer

FOR MORE INFORMATION, PLEASE CONTACT:

info@core1labs.com

1-866-347-5058

Cautionary Disclaimer Statement:

The Canadian Securities Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.

Information set forth in this news release contains forward-looking statements that are based on assumptions as of the date of this news release. These statements reflect management’s current estimates, beliefs, intentions, and expectations. They are not guarantees of future performance. The Company cautions that all forward-looking statements are inherently uncertain, and that actual performance may be affected by a number of material factors, many of which are beyond the Company’s control. Such factors include, among other things: risks and uncertainties relating to the Company’s limited operating history and the need to comply with strict regulatory regulations.  Accordingly, actual and future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. Except as required under applicable securities legislation, the Company undertakes no obligation to publicly update or revise forward-looking information.

In addition, psilocybin is currently a Schedule III drug under the Controlled Drugs and Substances Act (Canada) and it is a criminal offence to possess substances under the Controlled Drugs and Substances Act (Canada) without a prescription or authorization. Health Canada has not approved psilocybin as a drug for any indication. Core One does not have any direct or indirect involvement with illegal selling, production, or distribution of psychedelic substances in jurisdictions in which it operates. While Core One believes psychedelic substances can be used to treat certain medical conditions, it does not advocate for the legalization of psychedelics substances for recreational use. Core One does not deal with psychedelic substances, except within laboratory and clinical trial settings conducted within approved regulatory frameworks.

Posted on

Core One Labs Plans Share Consolidation in Preparation of Listing its Common Shares on Nasdaq

Vancouver, British Columbia, Canada – June 16, 2021 – Core One Labs Inc. (CSE: COOL), (OTC: CLABF), (Frankfurt: LD62, WKN: A2P8K3) (the “Company” or “Core One”) advises that in preparation of a potential listing of its common shares on the Capital Market tier of The Nasdaq Stock Market LLC (“Nasdaq” or the “Exchange”), the Company is planning a share consolidation of its outstanding common share capital on the basis of eight (8) pre-Consolidation shares for every one (1) post-Consolidation share (the “Planned Consolidation”). As of the date of this news release, the Company has 114,600,611 common shares issued and outstanding. The exercise price and number of common shares issuable upon the exercise of the Company’s outstanding options and warrants would also be proportionally adjusted upon completion of the Planned Consolidation in accordance with the terms thereof.

The Company is pursuing a Nasdaq listing to enhance its investor profile and increase value for its shareholders.   The Company currently has a presence in the United States (“US”) through its recent acquisition of Ketamine Infusions Centers of Texas Inc., and believes a Nasdaq listing will allow the Company to further US business development, both in terms of attracting institutional and retail investors, as well as through possible M & A opportunities that complement the Company’s existing business divisions, with a particular focus on the advancement of the safe medical use of psychedelics for the treatment of mental health and neurological disorders.

The listing of Core One on Nasdaq will be subject to a number of regulatory requirements, including having a minimum share price of US$3.00.  The registration of its common shares with the SEC and a determination by the Nasdaq that Core One has satisfied all applicable listing requirements.  Subject to approval for listing, the common shares will continue to trade on the Canadian Securities Exchange (CSE) under the ticker symbol “COOL” and in the United States on the OTC-Pink Sheets under the ticker symbol “CLABF.”

Nasdaq is ranked the second-largest exchange by market capitalization worldwide behind the New York Stock Exchange. To qualify for listing on the exchange, a company must be registered with the U.S. Securities and Exchange Commission, must have at least three market-makers, and must meet minimum requirements for assets, capital, public shares and shareholders.

“We are very excited about the prospect of listing the Company on a major exchange in the US.  Our recent acquisitions have provided the Company with increased exposure to the growing US psychedelic market, and we feel that the strong interest in psychedelic stocks presents a real opportunity for the Company to capitalize on.  We believe that listing on the Nasdaq will allow the Company to expand its shareholder base, enhance shareholder value and accelerate M & A initiatives in the US,” stated Joel Shacker CEO of the Company.

Readers are cautioned that while the Company has submitted an application for listing on Nasdaq, completion of a listing is subject to regulatory approvals and the satisfaction of applicable listing requirements.  The Company expects that listing will ultimately require the consolidation of the outstanding share capital of the company to meet minimum market value requirements.  There can be no assurance that a listing will be completed, and in the event a listing is completed it is contemplated that the common shares of the Company would continue to trade in Canada on the Canadian Securities Exchange.  The Company has not made a final decision to proceed with the Planned Consolidation, and will issue a further news release once a decision has been made.

About Core One Labs Inc.

Core One is a biotechnology research and technology life sciences enterprise focused on bringing psychedelic medicines to market through novel delivery systems and psychedelic assisted psychotherapy. Core One has developed a patent pending thin film oral strip (the “technology”) which dissolves instantly when placed in the mouth and delivers organic molecules in precise quantities to the bloodstream, maintaining excellent bioavailability. The Company intends to further develop and apply the technology to psychedelic compounds, such as psilocybin. Core One also holds an interest in medical clinics which maintain a combined database of over 275,000 patients. Through these clinics, the integration of its intellectual property, R&D related to psychedelic treatments and novel drug therapies, the Company intends to obtain regulatory research approval for the advancement of psychedelic-derived treatments for mental health disorders.

Core One Labs Inc.

Joel Shacker

Chief Executive Officer

FOR MORE INFORMATION, PLEASE CONTACT:

info@core1labs.com

1-866-347-5058

Cautionary Disclaimer Statement:

The Canadian Securities Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.

Information set forth in this news release contains forward-looking statements that are based on assumptions as of the date of this news release. These statements reflect management’s current estimates, beliefs, intentions, and expectations. They are not guarantees of future performance. The Company cautions that all forward-looking statements are inherently uncertain, and that actual performance may be affected by a number of material factors, many of which are beyond the Company’s control. Such factors include, among other things: risks and uncertainties relating to the Company’s limited operating history and the need to comply with strict regulatory regulations.  Accordingly, actual and future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. Except as required under applicable securities legislation, the Company undertakes no obligation to publicly update or revise forward-looking information.

In addition, psilocybin is currently a Schedule III drug under the Controlled Drugs and Substances Act (Canada) and it is a criminal offence to possess substances under the Controlled Drugs and Substances Act (Canada) without a prescription or authorization. Health Canada has not approved psilocybin as a drug for any indication. Core One does not have any direct or indirect involvement with illegal selling, production, or distribution of psychedelic substances in jurisdictions in which it operates. While Core One believes psychedelic substances can be used to treat certain medical conditions, it does not advocate for the legalization of psychedelics substances for recreational use. Core One does not deal with psychedelic substances, except within laboratory and clinical trial settings conducted within approved regulatory frameworks.

Posted on

PharmaTher Files FDA Pre-IND Meeting Request and Briefing Package For KETABET™ To Treat Depression

  • Potential for FDA 505(b)(2) regulatory pathway approval and FDA Fast Track designation
  • Advancing Ketamine and KETABET™ alone or in a microneedle patch for intradermal administration
  • Potential next generation treatment for mental health, neurological and pain disorders
TORONTO, June 15, 2021 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, is pleased to announce that it has filed a pre-Investigational New Drug (“pre-IND”) meeting request and complete pre-IND briefing package with the U.S. Food and Drug Administration (“FDA”) to support the clinical development of KETABET™ and the proposed Phase 2 clinical study as a potential next-generation treatment for depression, and to discuss the product development plan for the Company’s patented hydrogel-forming microneedle patch delivery technology.

KETABET™ has the potential to receive FDA approval under the 505(b)(2) regulatory pathway and Fast Track designation by the FDA for treatment in patients with major depressive disorder.  The hydrogel-forming microneedle patch offers a novel way to deliver ketamine and other psychedelics such as psilocybin, DMT, MDMA and LSD, and has the potential to improve on the safety (i.e. fewer side effects), efficacy (i.e. bioavailability, optimized dosing regimen including continuous system delivery) and compliance (i.e. storage, distribution and self-administration) of these psychedelics that currently must be taken orally, inhaled, injected and intravenously.

Fabio Chianelli, Chief Executive Officer of PharmaTher, commented:  “We have an insatiable focus on developing and commercializing novel uses, formulations and delivery forms of ketamine.  We are committed to solving the ketamine puzzle and unlocking its true potential to treat depression by leveraging our robust intellectual property portfolio, clinical and regulatory experience, and our recently approved IND by the FDA to evaluate ketamine to treat Parkinson’s disease in a Phase 2 study.  We are now in a position to lead the way in reviving ketamine and KETABET™ as a potential FDA-approved prescription-based therapy for mental health, neurological and pain disorders.”
​
The Company has assembled a prolific scientific and clinical team experienced in depression, including Dr. Maurizio Fava, MD, Psychiatrist-in-Chief of the Massachusetts General Hospital and Professor Matthew Macaluso, D.O., Clinical Director of the University of Alabama at Birmingham Depression and Suicide Center.

The Potential of KETABET™

KETABET™, a patented combination formulation of FDA-approved ketamine and betaine anhydrous, has been shown in research to enhance the antidepressant effect while having the potential to reduce the known negative side effects of ketamine significantly.1  Side effects such as hallucinations, confusion, memory loss and abuse liability compromise the compliance and potential therapeutic value of ketamine.2  The combination of ketamine and betaine anhydrous produced more robust antidepressant-like responses than their individual effects and that the combination blocked the psychotomimetic effects of ketamine.1  This suggests that betaine anhydrous can be considered as an add-on therapy to ketamine or as a fixed-dose combination therapy for treatment-resistant depression, treatment-resistant bipolar disorder, post-traumatic stress disorder, obsessive-compulsive disorder and chronic pain.

More than 300 million people suffer from major depressive disorder and 100 million people are resistant to available treatments worldwide.  Ketamine is emerging as a viable treatment option for depression. Recent clinical studies have shown that low dose ketamine produces a rapid-acting and sustained antidepressant effect in major depressive disorder,3 bipolar depression,4 depression with suicidal ideation5 and post-traumatic stress disorder.6  Despite this, the potential for abuse and misuse of ketamine and the adverse mental effects of ketamine leads to its limited clinical use and discontinuation.

Betaine anhydrous (CYSTADANE®) was approved by the FDA in 1996 to treat homocystinuria to decrease elevated homocysteine blood concentrations.  There is growing evidence that betaine plays a critical role in regulating brain functions and has an antidepressant-like effect.7  Betaine has been reported to prevent seizures in rodents,8 to improve symptoms of Rett syndrome,9 and to delay the onset of neurologic impairment due to vitamin B12 deficiency10 clinically.  Furthermore, betaine attenuates memory deficits induced by homocysteine.11

The Potential of the Hydrogel-forming Microneedle Patch

The pre-IND briefing package includes a discussion of the product development plan for the patented hydrogel-forming microneedle (“MN”) patch to deliver ketamine and KETABET™ for intradermal administration to treat various mental health, neurological and pain disorders.  The MN patch consists of hydrogel-forming microneedle arrays and an accompanying reservoir that will overcome limitations by the quantity of drug loaded into the needles or onto the needle surfaces. As such, the MN patch can significantly increase the amount of drug that can permeate through the microneedle array and into the skin.12  The MN patch is specifically tailored for ketamine and KETABET™ due to the volume of drug that is required to maximize their therapeutic utility and increase potential market opportunities.

The Company’s proposed MN patch was successfully validated in a proof-of-concept study in delivering esketamine, the S(+) enantiomer of ketamine, which may overcome the drawbacks of ketamine administration in an intravenous or nasal spray format.  Results of this study can be found in a published paper titled “Hydrogel-forming microneedle arrays as a therapeutic option for transdermal esketamine delivery”.13

The KETABET™ MN patch aims to empower patients to dose their medication remotely, safely and conveniently rather than being supervised by a healthcare provider at a certified medical office.  KETABET™ MN patch has the potential for enabling continuous delivery of KETABET™ (without pain) with minimal formulation manipulation into systemic circulation while maintaining constant plasma levels for more than 24 hours that will improve efficacy and compliance for patients.12-13  Also, PharmaTher’s KETABET™ MN patch will incorporate anti-tampering and anti-abuse features that parallel the approach used by commercially available tamper-resistant transdermal fentanyl patches.

Ketamine was approved by the FDA in 1970 and is clinically used for analgesia, sedation, and anesthetic induction.  The FDA granted Fast Track and Breakthrough Therapy designations for SPRAVATO® (esketamine) nasal spray and in March 2019 approved SPRAVATO®, in conjunction with an oral antidepressant, for treatment-resistant depression to Janssen Pharmaceuticals, Inc.  SPRAVATO® requires numerous administration sessions in a certified medical office under medical supervision by a health care provider.14  An equity analyst predicted that SPRAVATO® could generate $3 billion in peak sales.15

About PharmaTher Holdings Ltd.

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

For more information about PharmaTher, please contact:

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

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

Cautionary Statement

This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated”, “potential”, “aim” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on PharmaTher Holdings Ltd. (the “Company”) current belief or assumptions as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by the Company at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Company is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption “Risk Factors” in Company’s management’s discussion and analysis for the period of February 28, 2021 (“MD&A”), dated April 28, 2021, which is available on the Company’s profile at www.sedar.com.

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

Sources:

  1. J.-C. Lin, M.-Y. Lee, M.-H. Chan, Y.-C. Chen, H.-H. Chen, Betaine enhances antidepressant-like, but blocks psychotomimetic effects of ketamine in mice, Psychopharmacology (Berl). 233 (2016) 3223–32
  2. Krystal et al. 1994; Perry et al. 2007
  3. Murrough et al. 2013; Wan et al. 2014
  4. Ionescu et al. 2015; Nugent et al. 2014; Rybakowski et al. 2013
  5. Aligeti et al. 2014; Thakurta et al. 2012; Zigman and Blier 2013
  6. Feder et al. 2020
  7. ​Freed 1984; 1985
  8. Kim et al. 2013; Di Pierro et al. 2015
  9. Percy and Lane 2005
  10. van der Westhuyzen and Metz 1984
  11. ​Chai et al. 2013
  12. Donnelly R.F. Hydrogel-forming microneedles prepared from “super swelling” polymers combined with lyophilised wafers for transdermal drug delivery. PLoSONE. 2014 doi: 10.1371/journal.pone.0111547.
  13. Courtenay, et al. Hydrogel-forming microneedle arrays as a therapeutic option for transdermal esketamine delivery, Journal of Controlled Release, Volume 322, 2020, Pages 177-186.
  14. https://www.fda.gov/news-events/press-announcements/fda-approves-new-nasal-spray-medication-treatment-resistant-depression-available-only-certified
  15. https://www.fiercepharma.com/pharma/j-j-s-depression-nasal-spray-spravato-carrying-big-expectations-and-restrictions-scores-fda
Posted on

CORE ONE LABS INC. ANNOUNCES EXPECTED DELAY AND PROVIDES UPDATE RELATED TO FILING OF ANNUAL REPORT PURSUANT TO NATIONAL POLICY 12-203 – MANAGEMENT CEASE TRADE ORDERS

Vancouver, British Columbia, Canada – June 14, 2021 – Core One Labs Inc. (CSE: COOL), (OTC: CLABF), (Frankfurt: LD62, WKN: A2P8K3) (the “Company” or ”Core One”). The Company is providing this update on the status of the management cease trade order granted on May 3, 2021 (the “MCTO”) by its principal regulator, the British Columbia Securities Commission under National Policy 12-203 – Management Cease Trade Orders (“NP 12-203”), following the Company’s announcement on April 29, 2021 (the “Default Announcement”) that it was unable to file its audited annual financial statements for the year ended December 31, 2020, and accompanying management’s discussion and analysis, annual information form and related certifications (collectively, the “Documents”) on or before April 30, 2021, as required under applicable securities laws. The MCTO does not affect the ability of investors who are not insiders to trade in the securities of the Company.

In follow up to the Update on Default Announcement, issued by the Company on May 31, 2021, the Company reports that the annual audit is ongoing and that, due to the Company’s auditors requiring additional time to complete their audit, the Company now expects to file the Documents on or before June 30, 2021. The Company continues to work closely with its auditor to remedy the default status and file the Documents as soon as possible.

Except as noted, the Company further reports that: (i) there are no changes to the information contained in the bi-weekly status updated dated May 31, 2021, that would reasonably be expected to be material to an investor; (ii) the Company is satisfying and confirms that it intends to continue to satisfy the provisions of the alternative information guidelines under NP 12-203 and issue bi- weekly default status reports for so long as the delay in filing the Documents is continuing, each of which will be issued in the form of a press release; (iii) there has not been any other specified default by the Company under NP 12-203, and, except as set forth below, no such other default is anticipated; (iv) the Company is not subject to any insolvency proceedings; and (v) there is no material information concerning the affairs of the Company that has not been generally disclosed.

In connection with the delay in filing the Documents, the Company wasl not be able to complete and file its interim financial statements, CEO and CFO certifications, and management’s discussion and analysis (the “Interim Filings”) for the three-month period ended March 31, 2021, by the filing deadline of May 31, 2021. The Company anticipates filing the Interim Filings after filing the Documents. The MCTO will stay in effect until the Documents and, if applicable, the Interim Filings are completed, and the Company will continue to issue bi-weekly default status reports as required.

About Core One Labs Inc. 

Core One is a biotechnology research and technology life sciences enterprise focused on bringing psychedelic medicines to market through novel delivery systems and psychedelic assisted psychotherapy. Core One has developed a patent pending thin film oral strip (the “technology”) which dissolves instantly when placed in the mouth and delivers organic molecules in precise

quantities to the bloodstream, maintaining excellent bioavailability. The Company intends to further develop and apply the technology to psychedelic compounds, such as psilocybin. Core One also holds an interest in medical clinics which maintain a combined database of over 275,000 patients. Through these clinics, the integration of its intellectual property, R&D related to psychedelic treatments and novel drug therapies, the Company intends to obtain regulatory research approval for the advancement of psychedelic-derived treatments for mental health disorders.

Core One Labs Inc.

Joel Shacker

Chief Executive Officer

FOR MORE INFORMATION, PLEASE CONTACT:

info@core1labs.com 1-866-347-5058

Cautionary Disclaimer Statement: 

The Canadian Securities Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.

Information set forth in this news release contains forward-looking statements that are based on assumptions as of the date of this news release. These statements reflect management’s current estimates, beliefs, intentions, and expectations. They are not guarantees of future performance. The Company cautions that all forward-looking statements are inherently uncertain, and that actual performance may be affected by a number of material factors, many of which are beyond the Company’s control. Such factors include, among other things: risks and uncertainties relating to the Company’s limited operating history and the need to comply with strict regulatory regulations. Accordingly, actual and future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward- looking information. Except as required under applicable securities legislation, the Company undertakes no obligation to publicly update or revise forward-looking information.

In addition, psilocybin is currently a Schedule III drug under the Controlled Drugs and Substances Act (Canada) and it is a criminal offence to possess substances under the Controlled Drugs and Substances Act (Canada) without a prescription or authorization. Health Canada has not approved psilocybin as a drug for any indication. Core One does not have any direct or indirect involvement with illegal selling, production, or distribution of psychedelic substances in jurisdictions in which it operates. While Core One believes psychedelic substances can be used to treat certain medical conditions, it does not advocate for the legalization of psychedelics substances for recreational use. Core One does not deal with psychedelic substances, except within laboratory and clinical trial settings conducted within approved regulatory frameworks.

Posted on

Core One Labs’ Biosynthesized Psilocybin Provisional Patent Imminent

Vancouver, British Columbia, Canada – June 12, 2021 – Core One Labs Inc. (CSE: COOL), (OTC: CLABF), (Frankfurt: LD62, WKN: A2P8K3) (the “Company”) is pleased to announce that its wholly-owned subsidiary Vocan Biotechnologies Inc. (“Vocan”), a company operating under one of few Health Canada Controlled Drugs and Substances Dealer’s labs, is pleased to announce that it is in the final stages of completing its provisional patent application for the protection of its proprietary biosynthetic psilocybin production system.  Completion of the application is expected in the coming days at which time the provisional application will be made to the United States Patent and Trademark Office.

Over the last four months Vocan has made great strides in further developing its biosynthetic psilocybin production method and has started collecting data to substantiate our drafted provisional patent. As such, we anticipate a forthcoming filing of our provisional patent application.

The process of extracting natural occurring psilocybin from a host plant is inefficient and very expensive, as are synthetic processing techniques. Vocan’s provisional patent application for the biosynthetic processing of psilocybin addresses the many inefficiencies and cost prohibitions of current psilocybin production methods.  The established partnership with the University of British Columbia (UBC) and the collaborative approach employed by UBC and Vocan for producing biosynthetic psilocybin will crystallize the possibility of creating a product that is consistent in quality and concentration, and stereochemically comparable to its natural occurring compound. Core One firmly believes that this collaboration will be able to provide the reliability required for empirical, clinical, and medical psychedelic research.

As innovative businesses entering the medical psychedelic market continue to grow and, as more researchers and organizations rush to further develop the therapeutic and medical benefits of psilocybin, the need for a steady and consistent supply chain will also increase. Core One believes that its biosynthetic production of psilocybin holds a wide appeal for developing psychedelics medicines and clinical industries worldwide, and has significant cost reductions and meaningful efficacy enhancements.

“Core One Labs submitting its patent for its revolutionary biosynthetic psilocybin production system is imminent as we are just days away. This could position the Company as the leader in provision of pharmaceutical API grade psilocybin which could ultimately drive value for shareholders and stakeholders alike.,   We have assembled a world class team to promote and sell our biosynthesized psilocybin to other major companies that are working on therapeutic psychedelic solutions. With current prices of psilocybin being over $7000 USD per gram, we view this space as being highly profitable .” stated Joel Shacker CEO of the Company.

About Core One Labs Inc.

Core One is a biotechnology research and technology life sciences enterprise focused on bringing psychedelic medicines to market through novel delivery systems and psychedelic assisted psychotherapy. Core One has developed a patent pending thin film oral strip (the “technology”) which dissolves instantly when placed in the mouth and delivers organic molecules in precise quantities to the bloodstream, maintaining excellent bioavailability. The Company intends to further develop and apply the technology to psychedelic compounds, such as psilocybin. Core One also holds an interest in medical clinics which maintain a combined database of over 275,000 patients. Through these clinics, the integration of its intellectual property, R&D related to psychedelic treatments and novel drug therapies, the Company intends to obtain regulatory research approval for the advancement of psychedelic-derived treatments for mental health disorders.

Core One Labs Inc.

Joel Shacker

Chief Executive Officer

FOR MORE INFORMATION, PLEASE CONTACT:

info@core1labs.com

1-866-347-5058

Cautionary Disclaimer Statement:

The Canadian Securities Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.

Information set forth in this news release contains forward-looking statements that are based on assumptions as of the date of this news release. These statements reflect management’s current estimates, beliefs, intentions, and expectations. They are not guarantees of future performance. The Company cautions that all forward-looking statements are inherently uncertain, and that actual performance may be affected by a number of material factors, many of which are beyond the Company’s control. Such factors include, among other things: risks and uncertainties relating to the Company’s limited operating history and the need to comply with strict regulatory regulations.  Accordingly, actual and future events, conditions and results may differ materially from the estimates, beliefs, intentions and expectations expressed or implied in the forward-looking information. Except as required under applicable securities legislation, the Company undertakes no obligation to publicly update or revise forward-looking information.

In addition, psilocybin is currently a Schedule III drug under the Controlled Drugs and Substances Act (Canada) and it is a criminal offence to possess substances under the Controlled Drugs and Substances Act (Canada) without a prescription or authorization. Health Canada has not approved psilocybin as a drug for any indication. Core One does not have any direct or indirect involvement with illegal selling, production, or distribution of psychedelic substances in jurisdictions in which it operates. While Core One believes psychedelic substances can be used to treat certain medical conditions, it does not advocate for the legalization of psychedelics substances for recreational use. Core One does not deal with psychedelic substances, except within laboratory and clinical trial settings conducted within approved regulatory frameworks.

Posted on

Core One Labs awaits patent for cost-effective biosynthetic psilocybin production system

Core One Labs’ Biosynthesized Psilocybin Provisional Patent Imminent

Vocan Biotechnologies Inc., a subsidiary of Core One Labs Inc. (COOL) is days away from receiving a patent for its biosynthetic psilocybin production system, which is more efficient and significantly cheaper than conventional methods of extracting psilocybin. The proprietary system aims to produce a reliable product that is consistent in quality and concentration while remaining comparable to naturally occurring psilocybin. Core One believes that there is a wide appeal for biosynthetic production as the psychedelics market grows, as “the need for a steady and consistent supply chain will also increase”.

PDF of article

Posted on

Mydecine Discovers Over 40 Groundbreaking Potential Pharmacologically Active Novel Compounds in Mushrooms

Published at Yahoo! Finance

‍

DENVER, June 08, 2021 (GLOBE NEWSWIRE) — Mydecine Innovations Group (NEO: MYCO) (OTC: MYCOF) (FSE: 0NFA) (“Mydecine” or the “Company’), an emerging biopharma and life sciences company committed to the research, development, and acceptance of alternative nature-sourced medicine for mainstream use, announces that the Mydecine R&D team has made groundbreaking advances in psilocybin research with the discovery of over 40 compounds with pharmacological potential in mushrooms.

Over the past months, Mydecine’s research and development teams have screened over 25 mushroom species, including various varieties of p. cubensis, and has selected and analyzed over 40 unique compounds found throughout the various species. Of these compounds, a large majority appear to have never been reported before and could be vital to the critical effects of naturally-sourced mushrooms on human health and wellbeing as well as synergistic effects with pure psilocybin.

“Most mushrooms, especially the noxious species, have not been investigated for their chemical components,” says Senior Scientist, Duff Sloley. “Most of these compounds are evolved to protect the mushroom’s fruiting body from predation by insects, nematodes and bacteria and are complex and metabolically expensive to produce. Since these compounds are evolved to affect biological systems and aspects of metabolic pathways, they stand a higher chance of proving to be useful pharmaceuticals,” he continued. “As a consequence, studies of the structural, chemical, and possibly fortuitous pharmacological properties of these unknown compounds may lead to the development of beneficial pharmacological treatments for a number of disease states.”

Dr. Sloley holds a PhD in Biology from the University of Waterloo and has over 35 years of experience in analytical research and product development including positions at the University of Saskatchewan’s Neuropsychiatric Research Unit, Novokin Biotech, Sinoveda, and Radient Technologies. Dr. Sloley’s specialties include comparative neurobiology with a focus on neurotransmitter identification, metabolism and disruption as well as botanical composition. Dr. Sloley has extensive experience working in analytical biochemistry in a GLP setting including HPLC, LCMS/MS, UV absorbance and fluorescent detection. Additionally, Dr. Sloley is an active member of the Alberta Mycological Society and will be instrumental in characterizing and discovering new potent compounds as well as working with Society to source novel fungi.

“We have seen accelerated progress through Mydecine’s fully integrated research and cultivation facilities,” stated Josh Bartch, CEO of Mydecine. “These tremendous advances in our treatment development could not have been possible without our state-of-the-art R&D center and world-class research team. We not only have the ability to discover new compounds, but test them for efficacy, manufacture them for clinical research through a scientific rigor. This end-to-end capability is a critical to successful drug development and sets Mydecine apart.”

About Mydecine Innovations Group
Mydecine Innovations Group™ (NEO: MYCO) (OTC:MYCOF) (FSE:0NFA) is an emerging biotech and life sciences company dedicated to developing and commercializing innovative solutions for treating mental health problems and enhancing vitality. The company’s world-renowned medical and scientific advisory board is building out a robust R&D pipeline of nature-sourced psychedelic-assisted therapeutics, novel compounds, therapy protocols, and unique delivery systems. Mydecine has exclusive access to a full cGMP certified pharmaceutical manufacturing facility with the ability to import/export, cultivate, extract/isolate, and analyze active mushroom compounds with full government approval through Health Canada. Mydecine also operates out of a state-of-the-art mycology lab in Denver, CO to focus on genetic research for scaling commercial cultivation of rare (non-psychedelic) medicinal mushrooms.

At the heart of Mydecine’s core philosophy is that psychedelic-assisted psychotherapy will continue to gain acceptance in the medical community with many of the world’s best accredited research organizations demonstrating its remarkable clinical effectiveness. Mydecine recognizes the responsibility associated with psychedelic-assisted therapy and will continue to position itself as a long-term leader across the spectrum of clinical trials, research, technology, and global supply. Mydecine has also successfully completed multiple acquisitions since its inception.

Learn more at: https://www.mydecine.com and follow us on Facebook, Twitter, and Instagram.

On behalf of the Board of Directors:
Joshua Bartch, Chief Executive Officer
contact@mydecineinc.com

For further information about Mydecine Innovations Group, Inc., please visit the Company’s profile on SEDAR at www.sedar.com or visit the Company’s website at www.mydecine.com.

This news release contains forward-looking information within the meaning of Canadian securities laws regarding the Company and its business, which relate to future events or future performance and reflect management’s current expectations and assumptions. Often but not always, forward-looking information can be identified by the use of words such as “expect”, “intends”, “anticipated”, “believes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would” or “will” be taken, occur or be achieved. Such forward-looking statements reflect management’s current beliefs and are based on assumptions made by and information currently available to the Company. Readers are cautioned that these forward-looking statements are neither promises nor guarantees, and are subject to risks and uncertainties that may cause future results to differ materially from those expected including, without limitation, risks regarding the COVID-19 pandemic, the availability and continuity of financing, the ability of the Company to adequately protect and enforce its intellectual property, the Company’s ability to bring its products to commercial production, continued growth of the global adaptive pathway medicine, natural health products and digital health industries, and the risks presented by the highly regulated and competitive market concerning the development, production, sale and use of the Company’s products. 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. There can be no assurance that such information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such information. These forward-looking statements are made as of the date hereof and the Company does not assume any obligation to update or revise them to reflect new events or circumstances save as required under applicable securities legislation.

Posted on

Health Canada Approves AbbVie’s RINVOQ® (upadacitinib) for the Treatment of Adults with Active Psoriatic Arthritis

  • Approval supported by efficacy and safety data of two pivotal Phase 3 studies in which RINVOQ demonstrated improved joint outcomes, physical function and skin symptoms, with a greater proportion of patients achieving minimal disease activity versus placebo*

1,2

  • Significantly more patients taking RINVOQ achieved an ACR20 response than patients receiving placebo 1,2

 

MONTREAL, QC, June 7, 2021 – AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that Health Canada has approved RINVOQ® (upadacitinib, 15 mg), an oral, once-daily selective and reversible JAK inhibitor for the treatment of adults with active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to methotrexate or other Disease-Modifying Anti-Rheumatic Drugs (DMARDs).3

 

“Psoriatic arthritis is a debilitating disease that can cause severe pain, restricted mobility, and lasting structural damage.4, 5 The immune system creates inflammation that can lead to skin lesions associated with psoriasis, as well as pain, fatigue and stiffness in the joints,” 6,7 said Dr. Proton Rahman, FRCPC, Clinical Rheumatologist at Eastern Health and University Research Professor at Memorial University. “Despite treatment advances, some people living with PsA do not achieve their treatment goals, which is why access to new therapies is so critical. The approval of RINVOQ offers Canadian physicians and their patients an important new therapeutic option.”

 

“I have had psoriatic arthritis and psoriasis for more than 30 years. At one point, most of my body was covered in psoriasis, and I was using arm and leg braces to help me walk. These diseases have had a huge impact on my life, which is why I am so pleased that Canadians with psoriatic arthritis now have a new treatment option available to them,” said Marilyn Porth, of Winnipeg, Manitoba.

 

This approval is supported by data from two Phase 3 studies across a broad range of more than 2,000 patients with active psoriatic arthritis.1,2 In both studies, RINVOQ met the primary endpoint of ACR20 response at week 12 versus placebo.1,2 RINVOQ 15 mg also achieved non- inferiority versus adalimumab in terms of ACR20 response at week 12.1 Patients receiving RINVOQ also experienced greater improvements in physical function (HAQ-DI*) and skin symptoms (PASI 75*), and a greater proportion achieved minimal disease activity.1,2 Overall, the safety profile of RINVOQ in psoriatic arthritis was consistent with previously reported results across the Phase 3 rheumatoid arthritis clinical trial program, with no new significant safety risks detected.1,2,8

 

 

 

“The approval of RINVOQ is wonderful news for Canadians living with psoriatic arthritis, and an important step forward for the psoriatic arthritis community,” says Wendy Gerhart, Executive Director, Canadian Spondylitis Association. “From our recent member surveys, we know this devastating disease has a profound impact on people’s quality of life including their physical and mental health. This approval provides a new treatment option to Canadian patients. It is a hopeful time for people living with psoriatic arthritis.”

 

“For more than 20 years, AbbVie has been dedicated to discovering and delivering innovative therapies for people living with rheumatic diseases,” added Tracey Ramsay, Vice President and General Manager, AbbVie Canada. “We are proud of our deep heritage in rheumatology and pleased to expand our portfolio of treatment options for Canadians living with psoriatic arthritis, particularly by offering people the convenience of a once-daily oral medication.”

 

*Physical function was measured by the Health Assessment Questionnaire Disability Index (HAQ-DI). Skin symptoms were measured by a 75 percent improvement in the Psoriasis Area and Severity Index (PASI 75). Minimal disease activity is defined as the fulfillment of five of seven outcome measures: Tender joint count ≤1; swollen joint count ≤1; PASI ≤1 or body surface area-psoriasis ≤3 percent; Patient’s Assessment of Pain Numerical Rating Scale (NRS)

≤1.5; Patient Global Assessment-Disease Activity NRS ≤2.0; HAQ-DI score ≤0.5; and Leeds Enthesitis Index ≤1.

 

About SELECT-PsA 1 1,3

 

SELECT-PsA 1 is a Phase 3, multicenter, randomized, double-blind, parallel-group, active and placebo-controlled study designed to evaluate the safety and efficacy of upadacitinib compared to placebo and adalimumab in adult patients with active psoriatic arthritis who have a history of inadequate response to at least one non-biologic DMARD.

 

Top-line results from SELECT-PsA 1 were previously announced in February 2020. More information on this trial can be found at www.clinicaltrials.gov (NCT03104400).

 

About SELECT-PsA 2 2,3

 

SELECT-PsA 2 is a Phase 3, multicenter, randomized, double-blind, parallel-group, placebo- controlled study designed to evaluate the safety and efficacy of RINVOQ in adult patients with active psoriatic arthritis who have a history of inadequate response to at least one biologic DMARD.

 

Top-line results from SELECT-PsA 2 were previously announced in October 2019. More information on this trial can be found at www.clinicaltrials.gov (NCT03104374).

 

About RINVOQ® (upadacitinib)

 

RINVOQ is a 15 mg, once-daily oral medication in an extended-release tablet. It is a Janus kinase (JAK) inhibitor that interferes with the JAK-STAT signaling pathway, which is thought to play a role in inflammatory response.

 

RINVOQ is indicated for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate, as well as for adults with active psoriatic arthritis who have had an inadequate response or intolerance to

 

 

 

methotrexate or other DMARDs. In RA, RINVOQ may be used as a monotherapy or in combination with methotrexate or other nonbiologic DMARDs. In PsA, RINVOQ may be used as a monotherapy or in combination with methotrexate.

 

For important safety information, please consult the RINVOQ Product Monograph at www.abbvie.ca.

 

About AbbVie in Rheumatology

 

For more than 20 years, AbbVie has been dedicated to improving care for people living with rheumatic diseases. Our longstanding commitment to discovering and delivering innovative therapies is underscored by our pursuit of cutting-edge science that improves our understanding of promising new pathways and targets in order to help more people living with rheumatic diseases reach their treatment goals.

 

About AbbVie

 

AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.ca. Follow @abbviecanada on Twitter or find us on Facebook, Instagram, YouTube and LinkedIn.

 

-30-

 

Media Inquiries: Julie Lepsetz AbbVie Canada (514) 451-9427

julie.lepsetz@abbvie.com

 

 

References

 

  1. McInnes I, et Efficacy and Safety of Upadacitinib Versus Placebo and Adalimumab in Patients With Active Psoriatic Arthritis and Inadequate Response to Non-Biologic Disease-Modifying Anti- Rheumatic Drugs (SELECT-PsA-1): a Double-Blind, Randomized Controlled Phase 3 Trial. 2020 EULAR E-Congress; LB0001.
  2. Genovese MC, et Efficacy and Safety of Upadacitinib in Patients With Active Psoriatic Arthritis and Inadequate Response to Biologic Disease-Modifying Anti-Rheumatic Drugs (SELECT-PsA- 2): a Double-Blind, Randomized Controlled Phase 3 Trial. 2020 EULAR E-Congress; OP0223.
  3. RINVOQ (upadacitinib) product monograph. AbbVie Corporation. Available at: https://abbvie.ca/content/dam/abbvie-dotcom/ca/en/documents/products/RINVOQ_PM.pdf. Accessed June 7, 2021.

 

 

  1. Diseases & Conditions: Psoriatic 2019. American College of Rheumatology. Available at: https://www.rheumatology.org/I-Am-A/Patient-Caregiver/Diseases-Conditions/Psoriatic-Arthritis. Accessed on: May 13, 2021.
  2. Schett G, et al. Structural damage in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis: traditional views, novel insights gained from TNF blockade, and concepts for the Arthritis Res & Ther.2011; 13(Suppl1) :s4(1-9)
  3. Duarte GV, et al. Psoriatic arthritis. Best Pract Res Clin Rheumatol. 2012 Feb;26(1):147-56. doi: 1016/j.berh.2012.01.003.
  4. Diseases & Conditions: Psoriatic 2019. American College of Rheumatology. Available at: https://www.rheumatology.org/I-Am-A/Patient-Caregiver/Diseases-Conditions/Psoriatic-Arthritis. Accessed: December 2020
  5. Cohen , et al. Safety profile of upadacitinib in Rheumatoid Arthritis: Integrated analysis from the SELECT Phase 3 Clinical Program. EULAR 2019; THU0167.