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Psychedelic Special Task Force – Report on Psychedelics

Numinus and MAPS reach trial milestone

In a first-of-its-kind trial in Canada, Numinus Wellness (CSE: NUMI) has partnered with MAPS Public Benefit Corporation to collaborate for research on MDMA-assisted therapy. The “single-arm, open-label, compassionate access 1” trial has met several key milestones to enter a pre-implementation stage.

Aiming to expand access and treatment options to patients with PTSD, these significant developments will help gain better understanding of psychedelic-assisted psychotherapies as viable, safe, and necessary.

Who’s who?

  • Eight Numinus therapists working on this trial graduated in November 2020 from Part B of the MAPS-standardized MDMA therapist training program.
  • Dr. Devon Christie, Medical & Therapeutic Services Director at Numinus, was trained in this program and will serve as both the trial’s Principal Investigator and as a therapist.
  • MAPS Public Benefit Corporation, a subsidiary of MAPS, was formed to develop healing and well-being through psychedelic drug development, therapist training programs, and sales of prescription psychedelics.

Neither the FDA or Health Canada have approved this therapy just yet. The safety and efficacy of MDMA-assisted psychotherapy are still under investigation.

NYU Langone and MindMed launch psychedelic center

Operating with an endorsement by NYU Langone’s Department of Psychiatry, the one-of-a-kind health center continues to advance progress in psychedelic medicine through their Psychedelic Medicine Research Training Program.

The program will support development of early-career faculty members and post-doctoral fellows to become independent investigators in the field of psychedelic medicine. Treatment models & training programs developed at the center will scale psychedelic medicines into mainstream adoption by psychiatrists & therapists in America.

They have a lot going on.

Research at the center has and still focuses on the treatment of advanced cancer-related psychiatric and existential distress, addiction, major depression and PTSD.

  • Phase II clinical trial nearing completion to examine the use of psilocybin in treating alcohol use disorder, and developing a Phase II/III trial.
  • Phase II study from 2016 is now in Phase III development, with a funding proposal under review with the National Cancer Institute.
  • Recruitment underway for Phase II study to evaluate the efficacy of psilocybin in the context of “set and setting” therapy for individuals with major depressive disorder.
  • Recently completed a Phase III study on the safety and efficacy of psychotherapy utilizing MDMA for treatment of severe PTSD, and began recruitment for a second Phase III study.
  • Other studies are examining the use of psychedelics for disorders including chronic pain, end-of-life psychotherapy, opioid & tobacco addiction, and more.

Philanthropic efforts have kept the momentum going.

Major philanthropic support from donors have enabled medical breakthroughs and totaled over $10 million in support for studies at NYU Langone.

  • MindMed (OTCM: MMEDF) leads the way with $5 million contribution.
  • Scientist & philanthropist Carey Turnbull: $1 million
  • Private investor Alan Fournier: $2 million
  • President of the Usona Institute, Bill Linton: $1 million
  • Other significant donors include the George Sarlo Foundation, Cody Swift of the Riverstyx Foundation and Dr. Bronner’s Soaps.

Massachusetts is looking to decriminalize all drugs

It’s clear that current drug enforcement regulations are creating an unjust number of arrests and prosecutions in fragile communities. That’s why lawmakers introduced legislation in Massachusetts aiming to end the state’s war on drugs, which has disproportionately targeted racial minorities.

The statewide bill HD.3439 was introduced on Friday to challenge current criminal penalties for the possession of controlled substances in Section 34. These efforts come alongside bills SD.2248 and HD.3829 that aim to solve racial injustice and evaluate the impact of these new regulations.

What are they trying to pass?

  • Remove criminal penalties for possession of all drugs.
  • Legalize and regulate psychedelic substances, including possession, consumption, transportation, and sale of entheogenic plants and fungi.
  • Establish a 21-person task force to conduct studies on entheogenics.
  • Civil fine of up to $50, or submitting to screening for health and economic evaluation in order to provide services to the individual rather than an economic punishment.
  • Completion of this screening won’t be deemed as an admission of criminal charges.
  • Failure to pay the fine won’t incur penalties or incarceration.

What’s up with this “task force”?

  • They will develop recommendations:
    • On how to legalize psychedelic substances “in a manner that maximizes equitable access and sustainable manufacture of these plants.”
    • Regarding “pardons, parole, diversion, expungement, and equity measures” for people with prior criminal records due to possession, or distribution of these substances.

These recommendations will be used to draft legislation to be put into effect no later than June 2022.

UC San Diego researchers are exploring psychedelics to treat phantom limb pain

Imagine losing a limb yet still experiencing chronic pain out of thin air. The phenomena, known as ‘phantom limb’ is a commonly debilitating sensation that a limb is still physically there, because the brain interprets it as such.

The result is lingering pain with no effective solution for up to 80% of the world’s 40 million amputees (according to WHO).

Study Details

Timothy Furnish, MD, clinical professor of anesthesiology at UC San Diego School of Medicine had this to say:

  • The clinical trial will enroll 30 amputees suffering from phantom pain to receive 25 milligrams of psilocybin; another 30 will receive a placebo (niacin).

The trial will assess pain and psychological functioning, including magnetic resonance imaging.

Awakn announces AUD study results

The world’s first MDMA clinical trial addressing alcohol use disorder (AUD) has now provided definitive, promising results. The outcome of the study conducted by Awakn Life Sciences: all patients tolerated the treatment well, and with no adverse reactions. Further trials will now ensue.

  • Dr. Ben Sessa, Chief Medical Officer at Awakn, conducted the Bristol Imperial MDMA in Alcoholism (BIMA) trial.
  • The study evaluated patients’ drinking behavior, quality of life and psycho-social functioning.
  • Phase IIb study in the UK will now proceed. It will be a double-blind, placebo-controlled clinical trial to further investigate safety and efficacy of MDMA.

This is a really big deal.

  • The first clinical research study using MDMA-assisted psychotherapy to treat any addiction, and it was totally successful! Improvements by all measures were clinically observed.
  • Currently available treatments are greatly ineffective, with a high rate of relapse.
  • Alcohol abuse is the most prevalent substance disorder in the world, and one of the top 5 causes of disease and disability in Europe.
  • In the UK, alcohol is the leading cause of diseases for over 20% of the adult population.
  • It’s expected that the COVID-19 pandemic will make matters worse.

Report Readout

Frontier Acquisition Corp, a special purpose acquisition company (SPAC) sponsored by German investor Christian Angermayer, a major backer of COMPASS, will launch biotech SPAC in the U.S.

Mindset landed an international contract to develop and manufacture synthetic psilocybin.

Mind Cure adds global technology leader Robert C. Hill to Board of Directors.

Edmonton psychiatry professor founding new company by studying psychedelic effects on mental health.

Columbia professor turns heads with bold statements on his recreational use of drugs.

Psychedelic drug therapy now offered at Calgary clinic to treat depression, anxiety, PTSD.

Universal Ibogaine Inc. announces appointment of Dr. Rami Batal as Chief Executive Officer.

PharmaTher to collaborate with Terasaki Institute for Novel Microneedle Delivery of Psychedelic Pharmaceuticals.

Therapists could be influencing mystic, spiritual experiences and meaning while patients are on psychedelics.

Entheon Biomedical and Science in Action received ethics approval for in vivo non-GLP toxicology study of DMT.

Hawaii bill dies in session, opposed by the state Department of Health as well as county police departments.

Field Trip Health secures $50 million offering of common shares with Bloom Burton Securities Inc.

DEA gives green light for Psilera’s mission to study new DMT and psilocybin treatments for central nervous system disorders.

Optimi Health Corp goes public, completing a $20.7 million IPO.

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PharmaTher Announces Research Collaboration with Terasaki Institute for Novel Microneedle Delivery of Psychedelic Pharmaceuticals

TORONTO, Feb. 23, 2021 (GLOBE NEWSWIRE) — Newscope Capital Corporation (CSE: PHRM) (OTCQB: PHRRF), who through its wholly-owned subsidiary, PharmaTher Inc. (“PharmaTher”), is a specialty life sciences company focused on the research and development of psychedelic pharmaceuticals, is pleased to announce that PharmaTher has entered into a sponsored research agreement with the Terasaki Institute to develop a novel microneedle patch that aims to deliver psychedelic pharmaceuticals such as psilocybin, 3,4-methylenedioxy-methamphetamine (“MDMA”), lysergic acid diethylamide (“LSD”) and N, N-dimethyltryptamine (“DMT”) through microdosing for unmet medical needs.
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PharmaTher’s microneedle delivery technology, based on novel biocompatible and biodegradable gelatin methacryloyl material (“GelMA”), was invented and developed by the members of the Khademhosseini Lab at the University of California, Los Angeles (“UCLA”), and the Terasaki Institute continues to utilize and expand upon its capabilities.

PharmaTher will focus on developing a microneedle patch for microdosing of psychedelics that may overcome the potential drawbacks of oral administration, subcutaneous injections, topical and nasal delivery systems. The product and clinical development plan will seek to obtain FDA approval in delivering various psychedelics for various mental health, neurological and pain disorders.

The Terasaki Institute for Biomedical Innovation is a biotechnology institute which develops medical devices and cutting-edge protocols for a variety of diagnostic, monitoring and treatment applications. Their research platforms include work in biomaterials, cellular and tissue engineering, wearable biosensors and organs-on-a-chip.

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GelMA Microneedle Patch Prototype
“We are excited to work with the Terasaki Institute and the inventors of the GelMA delivery technology as it enables a solid foundation to expedite the product and clinical development for a first-of-a-kind microdosing delivery system for psilocybin, MDMA, LSD and DMT to treat serious unmet medical needs,” said Fabio Chianelli, CEO of PharmaTher. “Our focus is pursuing prescription-based psychedelic pharmaceuticals for FDA and international regulatory approvals, and unlocking the potential therapeutic value of these compounds via a proprietary microneedle patch. We look forward to working with the Terasaki team lead by the Director and CEO of the Terasaki Institute, Dr. Ali Khademhosseini, in delivering next generation psychedelic pharmaceuticals with the aim to improve therapeutic and safety outcomes while potentially offering a differentiated product profile, improving patient compliance and enabling out-patient treatment options.”

“Our microneedle technology enables one to deliver medications in a safe, easy, painless and minimally-invasive manner, said Dr. Khademhosseini. “It also allows for controllable drug delivery, using materials that are highly biocompatible and biodegradable.”

The GelMA microneedle (Figure 1) delivery technology is safe and painless and has demonstrated to deliver water-soluble and insoluble drugs with desirable release profiles. GelMA is derived from the natural polymer gelatin with crosslinkable methacrylate making it an ideal candidate for microneedle fabrication and various other biomedical applications. The GelMA microneedle patch can efficiently penetrate the stratum corneum layer (outer layer of the skin), enable flexible drug load capacity and combinations, and control-release delivery. Microneedles are considered as a promising way to achieve systemic effects by transdermal delivery of drugs.

About PharmaTher Inc.
PharmaTher Inc., a wholly-owned subsidiary of Newscope Capital Corporation (CSE: PHRM) (OTCQB: PHRRF), is a specialty life sciences company focused on the research and development of psychedelic pharmaceuticals for FDA approval to treat mental health, neurological and pain disorders.

Learn more at: PharmaTher.com and follow us on Twitter, LinkedIn and Facebook.

For more information, please contact:
Fabio Chianelli
Chief Executive Officer
PharmaTher Inc.
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 the Newscope Capital Corporation’s (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 November 30, 2020 (“MD&A”), dated January 27, 2021, which is available on the Company’s profile at www.sedar.com.

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

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Revive Therapeutics Acquires Unique Psilocybin Assets

TORONTO, Feb. 17, 2021 – Revive Therapeutics Ltd. (“Revive” or the “Company”) (CSE: RVV, USA: RVVTF), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is pleased to announce that, further to its press release dated December 21, 2020, it has entered into an asset purchase agreement (the “Agreement”) with Newscope Capital Corporation (“Newscope”) (CSE: PHRM) (OTCQB: PHRRF) to acquire the full rights to PharmaTher Inc.’s (“PharmaTher”) intellectual property (the “Acquired Assets”) pertaining to psilocybin (the “Acquisition”). PharmaTher, a wholly-owned subsidiary of Newscope, is a specialty life sciences company focused on the research and development of psychedelic pharmaceuticals.

Pursuant to the Agreement, Revive will pay aggregate consideration of up to CAD $10 million (the “Purchase Price”). The Purchase Price will be satisfied as follows: (i) $3 million in cash will be paid on the closing date; (ii) $4 million will be satisfied through the issuance of securities in the capital of Revive and (iii) up to $3 million, in either cash or securities in the capital of Revive, in the event that Revive achieves certain milestones, which include Revive obtaining FDA orphan drug designation for psilocybin in the treatment of stroke, traumatic brain injury, or cancer, the commencement of a Phase 2 clinical trial and the regulatory filing for market authorization, such as U.S. Food and Drug Administration (“FDA”) approval. In addition to the Purchase Price, Revive will also pay Newscope a low single digit royalty on all future net sales of products derived from the Acquired Assets.

The Acquired Assets will include all of the following:

  • All intellectual and work property derived from pre-clinical research activities from the National Health Research Institutes (“NHRI”) in traumatic brain injury and stroke, as it relates to psilocybin with the aim to obtain FDA Orphan Drug Designation.
  • Key provisional patent applications with the U.S. Patent and Trademark Office, which include:
(i) Psilocybin in the Treatment of Neurological Brain Injury – United States Provisional Application Serial No. 63/011,493 – Relates to pharmaceutical compositions comprising psilocybin and their use for the treatment of neurological brain injuries and migraines.
(ii) Use of Psilocybin in the Treatment of Cancer, United States Provisional Application Serial No. 63/113,913 – Psilocybin’s use of significant unmet medical needs for Liver Carcinoma, Melanoma, Breast Neoplasms, Kidney Neoplasms and Acute Myeloid Leukemia.
(iii) Psilocybin Pharmaceutical Combination Therapies, United States Provisional Application Serial No. 63/125,106 – Novel combinations of certain FDA approved drugs with psilocybin as a potential therapeutic option to reduce the side effects and improve the effectiveness of psilocybin to treat neurological disorders.

“With this acquisition, we have solidified our foundation in having a leading psychedelics pharmaceutical platform with a focus on proprietary psilocybin-based therapeutics that includes the development of an oral thin film product in collaboration with the University of Wisconsin-Madison, a novel biosynthetic version of psilocybin based on a natural biosynthesis enzymatic platform developed by Dr. Gavin Williams, Professor and Researcher at North Carolina State University, a clinical study with the University of Wisconsin evaluating psilocybin in the treatment of methamphetamine use disorder, and PharmaTher’s psilocybin research initiatives and intellectual property in stroke, traumatic brain injury, cancer and drug combinations,” said Michael Frank, CEO of Revive. “We are now in a position to advance our psilocybin program for future clinical development in various unmet clinical needs in mental health, cancer and neurological disorders.”

“We are pleased to have partnered PharmaTher’s psilocybin program with Revive as they have positioned themselves as a leader in psilocybin pharmaceutical development with their unique product and delivery technology offerings as well as their commitment in commercializing a biosynthetic form of psilocybin for long-term sustainability,” said Fabio Chianelli, CEO of Newscope.

About Revive Therapeutics Ltd.

Revive is a life sciences company focused on the research and development of therapeutics for infectious diseases and rare disorders, and it is prioritizing drug development efforts to take advantage of several regulatory incentives awarded by the FDA such as Orphan Drug, Fast Track, Breakthrough Therapy and Rare Pediatric Disease designations. Currently, the Company is exploring the use of Bucillamine for the potential treatment of infectious diseases, with an initial focus on severe influenza and COVID-19. With its 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@revivethera.com
Website: www.revivethera.com

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

Cautionary Statement

This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on Revive’s current belief or assumptions as to the outcome and timing of such future events. Forward looking information in this press release includes information with respect to the the Company’s cannabinoids, psychedelics and infectious diseases programs. Forward-looking information is based on reasonable assumptions that have been made by Revive at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Revive is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Reference is made to the risk factors disclosed under the heading “Risk Factors” in the Company’s annual MD&A for the fiscal year ended June 30, 2020, which has been filed on SEDAR and is available under the Company’s profile at www.sedar.com.

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PharmaTher Announces Sale of Psilocybin Program

TORONTO, Feb. 17, 2021 (GLOBE NEWSWIRE) — Newscope Capital Corporation (CSE: PHRM) (OTCQB: PHRRF), who through its wholly-owned subsidiary, PharmaTher Inc. (“PharmaTher” or the “Company”), is a specialty life sciences company focused on the research and development of psychedelic pharmaceuticals, is pleased to announce that, further to its press release dated December 21, 2020, it has entered into an asset purchase agreement (the “Agreement”) with Revive Therapeutics Ltd. (“Revive”) (CSE: RVV, USA: RVVTF) to sell the full rights to PharmaTher’s intellectual property (the “Acquired Assets”) pertaining to psilocybin (the “Acquisition”).

Pursuant to the Agreement, Revive will pay aggregate consideration of up to CAD $10 million (the “Purchase Price”). The Purchase Price will be satisfied as follows: (i) $3 million in cash will be paid on the closing date; (ii) $4 million will be satisfied through the issuance of securities in the capital of Revive and (iii) up to $3 million, in either cash or securities in the capital of Revive, in the event that Revive achieves certain milestones, which include Revive obtaining FDA orphan drug designation for psilocybin in the treatment of stroke, traumatic brain injury, or cancer, the commencement of a Phase 2 clinical trial and the regulatory filing for market authorization, such as U.S. Food and Drug Administration (“FDA”) approval. In addition to the Purchase Price, Revive will also pay Newscope Capital Corporation a low single digit royalty on all future net sales of products derived from the Acquired Assets.

“We are very pleased with the sale of our psilocybin program as it pertains to the intellectual property and research for the use of psilocybin in the treatment of stroke, traumatic brain injury and cancer to Revive as it provides us with non-dilutive funding to advance the clinical development of ketamine in the treatment of Parkinson’s disease, KETABET™ in the treatment of depression and the development of our proprietary microneedle delivery technologies to deliver psychedelic pharmaceuticals including ketamine, esketamine, psilocybin, MDMA, LSD and DMT for various mental health, neurological and pain disorders,” said Fabio Chianelli, CEO of PharmaTher. “We are now in a strong position to unlock the value of our unique psychedelic-based product pipeline and microneedle delivery technologies, and to advance our lead program ketamine to treat Parkinson’s disease towards FDA Phase 2 clinical trials.”

“We are pleased with our purchase of PharmaTher’s psilocybin portfolio as it complements Revive’s current psilocybin-based programs in oral thin film delivery, a clinical study for a drug abuse disorder and the development of a biosynthetic version of psilocybin,” said Michael Frank, CEO of Revive. “Revive is positioned to advance its unique prescription-based psilocybin program for future clinical development with the objective in commercializing its product offerings through the FDA approval pathway.”

The Acquired Assets will include all of the following:        

  • All intellectual and work property derived from pre-clinical research activities from the National Health Research Institutes (“NHRI”) in traumatic brain injury and stroke, as it relates to psilocybin with the aim to obtain FDA Orphan Drug Designation.
  • Key provisional patent applications with the U.S. Patent and Trademark Office, which include:

    (i) Psilocybin in the Treatment of Neurological Brain Injury – United States Provisional Application Serial No. 63/011,493 – Relates to pharmaceutical compositions comprising psilocybin and their use for the treatment of neurological brain injuries and migraines.

    (ii) Use of Psilocybin in the Treatment of Cancer, United States Provisional Application Serial No. 63/113,913 – Psilocybin’s use of significant unmet medical needs for Liver Carcinoma, Melanoma, Breast Neoplasms, Kidney Neoplasms and Acute Myeloid Leukemia.

    (iii) Psilocybin Pharmaceutical Combination Therapies, United States Provisional Application Serial No. 63/125,106 – Novel combinations of certain FDA approved drugs with psilocybin as a potential therapeutic option to reduce the side effects and improve the effectiveness of psilocybin to treat neurological disorders.

The Company cautions that psilocybin is still under early-stage research and development and is not making any express or implied claims as to their success alone and in combination of FDA approved drugs or commercial viability.

About PharmaTher Inc.
PharmaTher Inc., a wholly-owned subsidiary of Newscope Capital Corporation (CSE: PHRM) (OTCQB: PHRRF), is a specialty life sciences company focused on the research and development of psychedelic pharmaceuticals for FDA approval to treat mental health, neurological and pain disorders.

Learn more at:  PharmaTher.com and follow us on Twitter, LinkedIn and Facebook.

For more information, please contact:
Fabio Chianelli
Chief Executive Officer
PharmaTher Inc.
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 the Newscope Capital Corporation’s (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 November 30, 2020 (“MD&A”), dated January 27, 2021, which is available on the Company’s profile at www.sedar.com.
​
This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.

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PharmaTher Announces Successful Completion of Pre-IND Meeting with FDA for the Clinical Development of Ketamine in the Treatment of Parkinson’s Disease

TORONTO, Feb. 04, 2021 (GLOBE NEWSWIRE) — Newscope Capital Corporation (CSE: PHRM) (OTCQB: PHRRF), who through its wholly-owned subsidiary, PharmaTher Inc. (“PharmaTher”), is a specialty life sciences company focused on the research and development of psychedelic pharmaceuticals, announced today the successful completion of a Type B pre-Investigational New Drug (“pre-IND”) meeting with the U.S. Food and Drug Administration (“FDA”) regarding PharmaTher’s clinical development plan and its proposed Phase 2 clinical study for ketamine in the treatment of levodopa-induced dyskinesia in patients with Parkinson’s disease (“LID-PD”). Based on the FDA’s feedback from the written response meeting, the FDA confirmed that a 505(b)(2) regulatory pathway is acceptable, which allows for the potential to accelerate the clinical development for drug approval.

In addition to responses of several aspects of the nonclinical and clinical development plan, the FDA was supportive of the proposed Phase 2 clinical study and the use of the Unified Dyskinesia Rating Scale score at three weeks as the primary efficacy endpoint. The FDA also recommended to include various efficacy and safety parameters and endpoints in the proposed Phase 2 clinical study to support future pivotal clinical trials, also known as ‘registration studies’ used by regulatory authorities to evaluate a drug’s safety and efficacy for commercial approval.

PharmaTher will proceed to file an IND application in Q1-2021 with the aim to initiate the Phase 2 clinical study in Q2-2021.

“We were very pleased with the outcome of our pre-IND meeting with the FDA as it provided positive guidance to support our clinical development program for ketamine to treat Parkinson’s disease patients while also outlining the various safety and efficacy endpoints to be used in the Phase 2 study to support a potential Phase 3 clinical study in the future,” said Fabio Chianelli, CEO of PharmaTher. “We have an exemplary clinical and regulatory team that will focus on completing our IND application with the goal to initiate the Phase 2 clinical study in Q2-2021.”

The Company has assembled a prolific scientific and clinical team experienced in Parkinson’s disease, including Dr. Scott Sherman and Dr. Torsten Falk from the University of Arizona, Dr. Alberto Espay from the University of Cincinnati and Dr. Robert Hauser from the University of South Florida.

Ketamine is an FDA-approved drug with a known safety profile. PharmaTher entered into an exclusive license agreement with the University of Arizona to develop and commercialize ketamine to treat Parkinson’s disease and movement disorders.
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​Study results from preclinical studies and case studies in Parkinson’s disease patients from the University of Arizona have shown that low-dose sub-anesthetic ketamine infusion indicates tolerability, safety and the potential of long-term therapeutic benefit to reduce levodopa-induced dyskinesia, improve on time, and reduce depression.1-5

​Parkinson’s disease is a debilitating disorder that affects over 1 million people in the U.S. and more than 7 million people worldwide. There is currently no cure for Parkinson’s disease, although some drug combinations are used to treat the disease symptoms. The global Parkinson’s disease market is expected to grow from USD $5 billion in 2019 to USD $7.5 billion by the end of 2025 6 and it is estimated that the potential market opportunity for LID-PD to be over USD $3 billion in the U.S. alone.

​About PharmaTher Inc.
PharmaTher Inc., a wholly-owned subsidiary of Newscope Capital Corporation (CSE: PHRM) (OTCQB: PHRRF), is a specialty life sciences company focused on the research and development of psychedelic pharmaceuticals, such as ketamine, for FDA approval to treat mental health, neurological and pain disorders.

​Learn more at:  PharmaTher.com and follow us on Twitter, LinkedIn and Facebook.

​For more information, please contact:

Fabio Chianelli
Chief Executive Officer
PharmaTher Inc.
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 the Newscope Capital Corporation’s (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 November 30, 2020 (“MD&A”), dated January 27, 2021, which is available on the Company’s profile at www.sedar.com.

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

References:

  1. UA Clinical Trial to Repurpose Ketamine for Parkinson’s Patients.
  2. US20190060254A1— Compositions and methods for treating motor disorders.
  3. Bartlett, et al, 2020. Preclinical evidence in support of repurposing sub-anesthetic ketamine as a treatment for L-DOPA-induced dyskinesia. Experimental Neurology. Volume 333.
  4. Bartlett, M.J., Joseph, R.M., LePoidevin, L.M., Parent, K.L., Laude, N.D., Lazarus, L.B., Heien, M.L., Estevez, M., Sherman, S.J., Falk, T., 2016. Long-term effect of sub-anesthetic ketamine in reducing L-DOPA-induced dyskinesias in a preclinical model.
  5. Sherman, S.J., Estevez, M., Magill, A.B., Falk, T., 2016. Case reports showing a long-term effect of subanesthetic ketamine infusion in reducing L-DOPA-induced dyskinesias. Case Rep. Neurol. 8, 53–58.
  6. 360iResearch 2020.
Posted on

PharmaTher Signs Exclusive Worldwide License Agreement for Patented Microneedle Delivery Technology to Deliver Ketamine

TORONTO, Feb. 01, 2021 (GLOBE NEWSWIRE) — Newscope Capital Corporation (CSE: PHRM) (OTCQB: PHRRF), who through its wholly-owned subsidiary, PharmaTher Inc. (“PharmaTher”), is a specialty life sciences company focused on the research and development of psychedelic pharmaceuticals, is pleased to announce that PharmaTher has entered into an Exclusive Worldwide Patent and Know-how License Agreement (the “Agreement”) with The Queen’s University of Belfast (“QUB”) for the development and commercialization of a patented hydrogel-forming microneedle delivery technology developed by Professor Ryan Donnelly to support PharmaTher’s product and clinical development initiatives with ketamine.

PharmaTher will incorporate KETABET™, its licensed patented formulation that combines FDA-approved ketamine and betaine, with Professor Donnelly’s patented hydrogel-forming microneedle (“MN”) patch technology.

The proposed KETABET™ MN patch offers a potential game-changing therapeutic solution to treat mental health disorders, neurological and pain disorders.

Most recently, Professor Donnelly’s lab successfully completed research and published a paper titled “Hydrogel-forming microneedle arrays as a therapeutic option for transdermal esketamine delivery” validating the delivery of esketamine, the S(+) enantiomer of ketamine, in a novel microneedle patch which may overcome the drawbacks associated with ketamine administration in an intravenous or nasal spray format.1

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.3 An equity analyst predicted that SPRAVATO® could generate $3 billion in peak sales.4

PharmaTher’s KETABET™ MN patch aims to empower patients to dose their medication remotely, safely and conveniently rather than being under supervision 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.1-2

Also, PharmaTher’s KETABET™ MN patch will incorporate anti-tampering and anti-abuse features because of the combined presence of ketamine and betaine and the delivery format of the product that would parallel the approach used for the tamper-resistant transdermal fentanyl patch.

PharmaTher has the exclusive worldwide license for KETABET™ which has shown in clinical research to enhance the antidepressant effect while having the potential to significantly reduce the known negative side effects of ketamine.5 Side effects such as hallucinations, confusion, memory loss and abuse liability compromise the compliance and potential therapeutic value of ketamine.

The patented MN technology licensed by PharmaTher consists of hydrogel-forming microneedle arrays and accompanying reservoir which will overcome any limitations by the quantity of drug that can be loaded into the needles or onto the needle surfaces. As such, the MN technology can greatly increase the amount of drug that can permeate through the microneedle array and into the skin.2

“With this exclusive license we have created a solid intellectual property foundation and a development and commercialization path for KETABET™ MN patch that could potentially change the way how mental health, neurological and pain disorders are treated,” said Fabio Chianelli, CEO of PharmaTher. “We are pursuing the clinical development of KETABET™ MN patch to overcome the current limitations of ketamine and to unlock the known potential therapeutic value of ketamine as a prescription for regulatory approval worldwide. We look forward to working with Professor Donnelly in delivering the next generation ketamine solution.”

Professor Ryan Donnelly commented: “Our recent research with esketamine in our patented microneedle technology shows the potential of an alternative delivery method that can overcome the limitations of current ketamine delivery options without comprising the safety and compliance of patients. I am excited to work with PharmaTher in their quest to develop a next generation ketamine solution that could help the millions of people who suffer from mental health worldwide.”

Professor Ryan Donnelly is the Chair of Pharmaceutical Technology at QUB. He is a leading expert and researcher in the field of transdermal delivery with primary focus on microneedle drug delivery and its applications on improving therapeutic outcomes for patients. He has authored over 600 peer-reviewed publications, including several granted patents, 5 textbooks and approximately 250 full papers. His work has attracted numerous awards, including the Academy of Pharmaceutical Sciences Innovative Science Award in 2020, the Controlled Release Society Young Investigator Award in 2016, BBSRC Innovator of the Year in 2013, the GSK Emerging Scientist Award in 2012 and the Royal Pharmaceutical Society Science Award in 2011. He graduated with a B.Sc. degree in pharmacy (1999) and a Ph.D. in pharmaceutics (2003) from QUB.

Under the terms of the Agreement, PharmaTher gained exclusive worldwide development and commercial rights to an intellectual property portfolio consisting of granted patents in the U.S., Europe, Japan, India and China and know-how pursuant to the hydrogel-forming microneedle technology for use in the field of ketamine, esketamine, betaine and combinations thereof.

PharmaTher and QUB agreed to terms consistent with industry standards, including future payments based on clinical trial and revenue milestones.
​

About PharmaTher Inc.
PharmaTher Inc., a wholly-owned subsidiary of Newscope Capital Corporation (CSE: PHRM) (OTCQB: PHRRF), is a specialty life sciences company focused on the research and development of psychedelic pharmaceuticals, such as ketamine and psilocybin, for FDA approval to treat mental health, neurological and pain disorders.
​Learn more at:  PharmaTher.com and follow us on  Twitter, LinkedIn and Facebook.
For more information, please contact:
Fabio Chianelli
Chief Executive Officer
PharmaTher Inc.
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 the Newscope Capital Corporation’s (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 November 30, 2020 (“MD&A”), dated January 27, 2021, which is available on the Company’s profile at www.sedar.com.
​
This news release does not constitute an offer to sell or the solicitation of an offer to buy, and shall not constitute an offer, solicitation or sale in any state, province, territory or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state, province, territory or jurisdiction.

References:

  1. 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.
  2. 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.
  3. https://www.fda.gov/news-events/press-announcements/fda-approves-new-nasal-spray-medication-treatment-resistant-depression-available-only-certified
  4. https://www.fiercepharma.com/pharma/j-j-s-depression-nasal-spray-spravato-carrying-big-expectations-and-restrictions-scores-fda
  5. 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
Posted on

Revive Therapeutics Included in First Psychedelic Exchange Traded Fund

TORONTO, Jan. 22, 2021 – Revive Therapeutics Ltd. (“Revive” or the “Company”) (CSE: RVV, USA: RVVTF), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is pleased to announce that it is one of the seventeen companies in the U.S. and Canada that will be included in the First Psychedelics Exchange Traded Fund, which is managed by Horizons ETF Management.

The Horizons Psychedelic Stock Index ETF index is expected to start trading on Tuesday, January 26, under the ticker PSYK on the NEO exchange.

“We are pleased to be included in the First Psychedelics ETF and being recognized as a leading company in the field of psychedelic pharmaceuticals,” said Michael Frank, CEO of Revive.  “We are advancing novel psilocybin-based therapeutics using a proprietary oral thin film delivery technology and a natural biosynthesis enzymatic platform to support clinical research in mental health and substance abuse disorders.”

Revive is advancing its psychedelic pharmaceuticals pipeline with a focus on proprietary psilocybin-based therapeutics that includes the development of an oral thin film product in collaboration with the University of Wisconsin-Madison, a novel biosynthetic version of psilocybin based on a natural biosynthesis enzymatic platform developed by Dr. Gavin Williams, Professor and Researcher at North Carolina State University, a clinical study with the University of Wisconsin evaluating psilocybin in the treatment of methamphetamine use disorder, and the research with psilocybin being developed by PharmaTher Inc. (CSE: PHRM, OTCQB: PHRRF).

About Revive Therapeutics Ltd.

Revive is a life sciences company focused on the research and development of therapeutics for infectious diseases and rare disorders, and it is prioritizing drug development efforts to take advantage of several regulatory incentives awarded by the FDA such as Orphan Drug, Fast Track, Breakthrough Therapy and Rare Pediatric Disease designations. Currently, the Company is exploring the use of Bucillamine for the potential treatment of infectious diseases, with an initial focus on severe influenza and COVID-19. With its 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@revivethera.com
Website: www.revivethera.com

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

Cautionary Statement

This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on Revive’s current belief or assumptions as to the outcome and timing of such future events. Forward looking information in this press release includes information with respect to the 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, 2020, which has been filed on SEDAR and is available under the Company’s profile at www.sedar.com.

Posted on

PharmaTher Signs Exclusive Worldwide License Agreement for Patented Ketamine Formulation Targeting Mental Health, Neurological and Pain Disorders

TORONTO, Jan. 19, 2021 (GLOBE NEWSWIRE) — Newscope Capital Corporation (CSE: PHRM) (OTCQB: PHRRF), who through its wholly-owned subsidiary, PharmaTher Inc. (“PharmaTher”), is a specialty life sciences company focused on the research and development of psychedelic pharmaceuticals, is pleased to announce that PharmaTher has entered into an Exclusive Worldwide License Agreement (the “Agreement”) with the National Health Research Institutes (“NHRI”) for the development and commercialization of a patented combination formulation of FDA-approved ketamine and betaine (“KETABET™”) as a potential next-generation ketamine treatment for mental health, neurological and pain disorders.

KETABET™ has shown in clinical research to enhance the antidepressant effect while having the potential to significantly reduce the known negative side effects of ketamine.1 Side effects such as hallucinations, confusion, memory loss and abuse liability compromise the compliance and potential therapeutic value of ketamine.

Through a proprietary microneedle (“MN”) patch, KETABET™ aims to empower patients to dose their medication remotely, safely and conveniently rather than being under supervision by a healthcare provider at a certified medical office.   KETABET™ MN patch has the potential to incorporate anti-tampering and anti-abuse features because of the combined presence of ketamine and betaine and the delivery format of the product that would parallel the approach used for the tamper-resistant transdermal fentanyl patch.

PharmaTher will seek FDA approval to conduct a Phase II clinical study for KETABET™ targeting the more than 300 million people who suffer from major depressive disorder and 100 million people who are resistant to available treatments worldwide.

“We believe KETABET™ has the potential to change the way mental health, neurological and pain disorders will be treated for the hundreds of millions of people globally who are suffering from these debilitating conditions,” said Fabio Chianelli, CEO of PharmaTher. “We are pursuing the clinical development of KETABET™ to overcome the current limitations of ketamine and to unlock the known potential therapeutic value of ketamine for FDA approval.”

Currently, pharmaceutical companies are developing new types of antidepressants. Approved antidepressants have significant limitations, including delayed response rates and unwanted side effects causing poor patient compliance and low remission rates.

Ketamine was approved by the FDA in 1970 and is clinically used for analgesia, sedation, and anesthetic induction.

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 disorder2, bipolar depression3, depression with suicidal ideation4 and post-traumatic stress disorder5. Despite this, the potential for abuse and misuse of ketamine and the adverse mental effects of ketamine use such as dissociative, hallucinogenic, and amnesic effects6 leads to its limited clinical use and discontinuation.

The FDA granted Fast Track and Breakthrough Therapy designations for SPRAVATO® (esketamine) nasal spray. In March 2019, the FDA approved SPRAVATO®, in conjunction with an oral antidepressant, for treatment-resistant depression to Janssen Pharmaceuticals, Inc. According to the FDA, “because of the risk of serious adverse outcomes resulting from sedation and dissociation caused by Spravato administration, and the potential for abuse and misuse of the drug, it is only available through a restricted distribution system, under a Risk Evaluation and Mitigation Strategy.”7 The estimated annual cost per patient for SPRAVATO® could cost up to $49 thousand with limited reimbursement, whereas intravenous ketamine could cost up to $5,000 per patient annually without any reimbursement. Both require numerous administration sessions in a certified medical office under medical supervision by a health care provider.

COMPASS Pathways plc is developing COMP360 psilocybin therapy to be administered in conjunction with psychological support for treatment-resistant depression. In 2019, Compass Pathways plc completed a Phase I clinical trial and is currently evaluating COMP360 in a Phase IIb trial. The therapy protocol for COMP360, which would last approximately six to eight hours, includes the presence of a therapist and assisting therapist throughout the treatment session.8

PharmaTher aims to develop KETABET™ in a proprietary microneedle patch for FDA approval in certain mental health, neurological and pain disorders and provide the patient with a potentially convenient, safe and effective ketamine treatment through the combination of two FDA-approved drugs, ketamine and betaine.

Betaine anhydrous (CYSTADANE®) was approved by the FDA in 1996 for the treatment of 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.9   Betaine has been reported to prevent seizures in rodents10, to improve symptoms of Rett syndrome11, and to delay the onset of neurologic impairment due to vitamin B12 deficiency12 clinically. Furthermore, betaine attenuates memory deficits induced by homocysteine.13

Based on preclinical studies that supported the granted patent and patent applications of KETABET™, the combination of ketamine and betaine 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 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.

Under the terms of the Agreement, PharmaTher gained exclusive worldwide development and commercial rights to an intellectual property portfolio consisting of a granted patent (Taiwan patent: I648049) and patent applications (International Publication Number: WO2017205666A1) titled, “Method and composition for decreasing the psychotomimetic side effect and addictive disorder of ketamine” in the U.S., Europe, Japan, Canada, Israel and China.

Consistent with industry standards, PharmaTher paid a one-time fee for entering into the Agreement, and all other future payments will be based on clinical trial and revenue milestones reached by PharmaTher.
​

About The National Health Research Institutes
The National Health Research Institutes (NHRI) is a non-profit foundation established in 1995 by the government of Taiwan. Being an autonomous research organization under the supervision of the Department of Health, the NHRI is dedicated to the enhancement of medical research and the improvement of health care in this country. Scientists at the NHRI conduct mission-oriented medical research and investigate many aspects of the basic biomedical sciences, as well as specific diseases. These range from the common problems such as aging, cancer, infectious diseases, mental disorders, occupational diseases, to health policy. For more information about the NHRI visit www.nhri.edu.tw.

About PharmaTher Inc.
PharmaTher Inc., a wholly-owned subsidiary of Newscope Capital Corporation (CSE: PHRM) (OTCQB: PHRRF), is a specialty life sciences company focused on the research and development of psychedelic pharmaceuticals, such as ketamine and psilocybin, for FDA approval to treat mental health, neurological and pain disorders.

​Learn more at:  PharmaTher.com and follow us on Twitter, LinkedIn and Facebook.

​For more information, please contact:
Fabio Chianelli
Chief Executive Officer
PharmaTher Inc.
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” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on the Newscope Capital Corporation’s (the “Company) 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 development and commercialization of a patented combination formulation of FDA-approved ketamine and betaine (“KETABET™”) as a potential next-generation ketamine treatment for mental health, neurological and pain disorders, KETABET™ aims to empower patients to dose their medication remotely, safely and conveniently rather than being under supervision by a healthcare provider at a certified medical office, KETABET™ MN patch has the potential to incorporate anti-tampering and anti-abuse features, seek FDA approval to conduct a Phase II clinical study, intellectual property portfolio, psychedelic pharmaceuticals, psilocybin and ketamine programs and product developments. Forward-looking information is based on reasonable assumptions that have been made by the Company at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Company is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption “Risk Factors” in Company’s management’s discussion and analysis for the period of August 30, 2020 (“MD&A”), dated October 1, 2020, which is available on the Company’s profile at www.sedar.com.

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

​References:

  1. 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. Murrough et al. 2013; Wan et al. 2014
  3. Ionescu et al. 2015; Nugent et al. 2014; Rybakowski et al. 2013
  4. Aligeti et al. 2014; Thakurta et al. 2012; Zigman and Blier 2013
  5. Feder et al. 2020
  6. Krystal et al. 1994; Perry et al. 2007
  7. https://www.fda.gov/news-events/press-announcements/fda-approves-new-nasal-spray-medication-treatment-resistant-depression-available-only-certified
  8. Compass Pathways pls F-1 Filing dated 2020-08-28
  9. Freed 1984; 1985
  10. Kim et al. 2013; Di Pierro et al. 2015
  11. Percy and Lane 2005
  12. van der Westhuyzen and Metz 1984
  13. Chai et al. 2013
Posted on

Revive Therapeutics Announces Research Collaboration with North Carolina State University for Natural Biosynthesis Enzymatic Platform To Develop Psilocybin

TORONTO, Jan. 14, 2021 – Revive Therapeutics Ltd. (“Revive” or the “Company”) (CSE: RVV, USA: RVVTF), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is pleased to announce it has entered into a sponsored research agreement and an exclusive option to license agreement with North Carolina State University (“NC State”) to develop a novel biosynthetic version of psilocybin based on a natural biosynthesis enzymatic platform developed by Dr. Gavin Williams, Professor and Researcher at NC State.

The biosynthetic platform developed by Dr. Gavin Williams provides a potential simple and efficient method for rapidly producing natural products, such as psilocybin, using an engineered enzymatic pathway in E. coli.

Revive seeks to develop and commercialize its own pharmaceutical-grade psilocybin with this biosynthesis technology at scale to support the Company’s current psilocybin-based product pipeline that includes an oral thin film product currently being developed in collaboration with the University of Wisconsin-Madison and the intellectual property and research with psilocybin being developed by PharmaTher Inc. (CSE: PHRM, OTCQB: PHRRF).

“We are excited to partner with NC State and work with Dr. Williams and his team to develop a proprietary form of psilocybin that can be produced at scale for research and commercial purposes while allowing us to create our own unique product offerings with psilocybin in different delivery methods so as to treat the various mental health conditions and other diseases that psilocybin has shown to be a potential viable treatment option for,” said Michael Frank, CEO of Revive. “We continue to expand our psychedelic pharmaceutical objectives in specializing in novel products and uses of psilocybin for unmet medical needs.”

Dr. Williams and his team recently developed an artificial enzymatic platform called the ‘Alcohol Dependent Hemiterpene’ pathway for construction of alkyl pyrophosphates. Here, the products of the ADH pathway will be used to generate key building blocks for psilocybin and its derivatives. The goal is to engineer E. coli to be a factory for psilocybin production, using a completely artificial biosynthetic logic.

Dr. Gavin Williams is Professor and Associate Head of the Department of Chemistry and named LORD Corporation Distinguished Scholar at NC State. Dr. Williams is a decorated chemist and is well-known for his innovative work in polyketide biosynthesis, the development of enzymatic tools for protein engineering, and the development of novel biosensors to guide metabolic engineering and high-throughput synthetic biology. His research lab has an interest in combining the power of biology and organic chemistry to provide access to new complex organic molecules. More specifically, Williams Lab leverages enzyme engineering, biocatalysis, metabolic engineering, organic chemistry, and synthetic biology to access and diversify the structures of natural products, which forms an innovative and powerful platform for drug development and discovery.

About Revive Therapeutics Ltd.

Revive is a life sciences company focused on the research and development of therapeutics for infectious diseases and rare disorders, and it is prioritizing drug development efforts to take advantage of several regulatory incentives awarded by the FDA such as Orphan Drug, Fast Track, Breakthrough Therapy and Rare Pediatric Disease designations. Currently, the Company is exploring the use of Bucillamine for the potential treatment of infectious diseases, with an initial focus on severe influenza and COVID-19. With its 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@revivethera.com
Website: www.revivethera.com

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

Cautionary Statement

This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on Revive’s current belief or assumptions as to the outcome and timing of such future events. Forward looking information in this press release includes information with respect to the 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, 2020, which has been filed on SEDAR and is available under the Company’s profile at www.sedar.com.

Posted on

PharmaTher Approved to Trade on the OTCQB Venture Market

TORONTO, Jan. 13, 2021 (GLOBE NEWSWIRE) — Newscope Capital Corporation (CSE: PHRM) (OTCQB: PHRRF) (the “Company”), who through its wholly-owned subsidiary, PharmaTher Inc., is a specialty life sciences company focused on the research and development of psychedelic pharmaceuticals, is pleased to announce that its common shares have been approved for trading on the OTCQB® Venture Market (“OTCQB”) effective today.

The Company’s U.S. listing will trade under the symbol “PHRRF” while the Company’s primary Canadian listing will continue to trade on the Canadian Securities Exchange under “PHRM”.

Fabio Chianelli, CEO of the Company commented, “We are focused on developing our clinical-stage product pipeline of novel uses and delivery of ketamine for U.S. FDA approval to treat mental health, neurological and pain disorders, and with our common shares listed on the OTCQB it will help us to broaden our awareness and shareholder base with institutional and retail investors in the U.S.”
​
The Company has also applied to the Depository Trust Company (“DTC”) for DTC eligibility, which would greatly simplify the process of trading the Company’s common shares. The Company expects to receive DTC eligibility approval shortly.

Investors can find real-time quotes and market information on the Company at ​https://www.otcmarkets.com/stock/PHRRF/overview.

​About PharmaTher Inc.
​
PharmaTher Inc., a wholly-owned subsidiary of Newscope Capital Corporation (CSE: PHRM) (OTCQB: PHRRF), is a specialty life sciences company focused on the research and development of psychedelic pharmaceuticals, such as ketamine and psilocybin, for FDA approval to treat mental health, neurological and pain disorders.

​Learn more at:  PharmaTher.com and follow us on Twitter, LinkedIn and Facebook.

​For more information, please contact:        
Fabio Chianelli
Chief Executive Officer
PharmaTher Inc.
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” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on the Newscope Capital Corporation’s (the “Company) 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 approval of OTCQB Venture Market listing, application of DTC eligibility, broadening awareness and shareholder base of U.S. institutional and retail investors, and meeting milestones of FDA-approved ketamine for mental health, neurological and pain disorders, FDA approval, intellectual property portfolio, psychedelic pharmaceuticals, psilocybin and ketamine programs and product developments. Forward-looking information is based on reasonable assumptions that have been made by the Company at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Company is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption “Risk Factors” in Company’s management’s discussion and analysis for the period of August 30, 2020 (“MD&A”), dated October 1, 2020, 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.