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PharmaTher Announces FDA Approval of Ketamine IND In The Treatment of Parkinson’s Disease

TORONTO, May 17, 2021 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (CSE: PHRM) (OTCQB: PHRRF), a psychedelics biotech company, is pleased to announce that the U.S. Food and Drug Administration (“FDA”) has approved the Company’s Investigational New Drug (“IND”) application to proceed with a Phase 2 clinical trial to evaluate the safety, efficacy and pharmacokinetics of ketamine in the treatment of levodopa-induced dyskinesia in patients with Parkinson’s disease (“LID-PD”).  PharmaTher expects to begin enrolling patients in the Phase 2 clinical trial in Q3-2021.  Assuming the Phase 2 clinical trial is positive, the Company will request a meeting with the FDA to discuss its plan and obtain an agreement to move to a Phase 3 clinical study under the 505(b)(2) regulatory pathway next year.
Fabio Chianelli, Chief Executive Officer of PharmaTher, said, “The FDA’s acceptance of our IND application for ketamine to treat Parkinson’s disease is a significant milestone for us.  The FDA IND is our first of many we will aim to obtain, and we are one of the few psychedelics-focused biotech companies that have an IND approved by the FDA for a recognized psychedelic drug.  The IND paves the way for us to expeditiously evaluate ketamine and other psychedelics via the FDA regulatory pathway in various mental illness, neurological and pain disorders.  We are committed to building a rich product pipeline of novel uses, formulations and delivery methods of psychedelics, and with our FDA IND in place, we now have the foundation in making PharmaTher a global leader in psychedelic-based therapeutics.”

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 [360iResearch 2020] and it is estimated that the potential market opportunity for LID-PD to be over USD $3 billion in the U.S. alone.

About the Phase 2 Clinical Trial

The clinical trial is titled “A Multi-Center, Phase II, Randomized, Double-Blind, Prospective, Active Placebo-Controlled Trial of Sub-Anesthetic Ketamine to Treat Levodopa-Induced Dyskinesia in Subjects with Parkinson’s Disease.” It is anticipated that up to eight clinical sites in the U.S. will randomize a total of up to 36 subjects to the investigational product (ketamine) or active control (midazolam). The primary end-point of the study is the change in the Unified Dyskinesia Rating Scale (“UDysRS”) total score from Baseline to Week 8. Secondary endpoints of the study include the change in Total Objective Scores of the UDysRS, total daily OFF times as assessed by subject-completed 24-hour diaries and change in the UPDRS total and sum scores of motor and dyskinesia from Baseline to Week 8. Because LID can markedly affect a Parkinson patient’s everyday activities, a reduction in LID could improve the patient’s quality of life.

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’s Potential In Parkinson’s Disease

Ketamine is an FDA-approved N-methyl-D-aspartate (“NMDA”) receptor-modulating drug that is widely used as an anesthetic agent either alone or in combination with other anesthetic agents [Smith et al, 1987; Pacheco et al, 2014]. The possible therapeutic effect of low-dose ketamine on LID was noted in a retrospective analysis of PD patients who received ketamine for pain relief. During this analysis, it was observed that the patients experienced an improvement in LID lasting several weeks beyond treatment [Sherman et al, 2016]. These results were corroborated in a test of low-dose ketamine in a rodent LID model, and this possible effect has also been examined in a controlled study [Bartlett et al, 2016]. Ketamine may also have additional benefits in the treatment of pain [Niesters et al, 2014] and depression [Diamond et al, 2014; Murrough et al, 2013], which are frequent comorbidities of Parkinson’s disease.

About Parkinson’s Disease   

There is currently no cure for Parkinson’s disease. Although the etiology of Parkinson’s disease is not fully understood, it is thought to result from loss of pigmented dopaminergic neurons in the Substantia nigra and their striatal projections, leading to dopamine deficiency in the striatum [Schapira and Jenner, 2011]. This ultimately affects the cortico-striatal system that controls movement. As a progressive neurogenerative disorder of the central nervous system that primarily affects the motor nerve system, symptoms of Parkinson’s disease may emerge slowly and include tremors, rigidity, bradykinesia, and postural instability [Paulson and Stern, 2004]. Also, patients may experience non-motor symptoms such as autonomic dysfunction (orthostatic hypotension, constipation, bladder dysfunction), psychiatric (depression), cognitive and sensory symptoms (pain) [Olanow, et al, 2009]. These non-motor symptoms become more common as the disease progresses. Treatments, including levodopa and dopamine agonists, which restore the dopamine deficits in the brain, have been employed for almost 50 years. However, with continued treatment using levodopa, dose-limiting motor side-effects often emerge. This includes the emergence of abnormal involuntary movements termed Levodopa Induced Dyskinesias, which can be identified in about 50% of patients within five years after initiation of levodopa treatment and in almost all patients within ten years post-treatment initiation. These side effects often limit further dose increases in dopaminergic therapy.

There can be no assurance that the FDA will support any potential request for an expedited path to approval or further development for ketamine in the treatment of Parkinson’s disease.

About PharmaTher Holdings Ltd.

PharmaTher Holdings Ltd. (CSE: PHRM) (OTCQB: PHRRF) is a psychedelics biotech company focused on the research, development and commercialization of ketamine and novel microneedle patches for the delivery of psychedelics to treat mental illness, neurological and pain disorders.
​
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.

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Revive Therapeutics Files for FDA Orphan Drug Designation for Psilocybin in Traumatic Brain Injury

TORONTO, April 27, 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 filed an application with the U.S. Food and Drug Administration (“FDA”) to receive Orphan Drug Designation (“ODD”) for Psilocybin to treat moderate to severe traumatic brain injury (“TBI”).

There are no FDA approved treatments for cognitive impairments due to TBI. Moderate to severe TBI is a subset of TBI and can lead to a physical, cognitive, emotional, and behavioral changes over the course of a person’s life. These changes may affect a person’s ability to function in their everyday life. Approximately 50% of people with severe TBI will experience further decline in their daily lives or die within 9 years of their injury. People with TBI are fifty times more likely to die from seizures and six times more likely to die from pneumonia.[1]

Psilocybin offers a potential solution to manage moderate to severe cases of TBI. Psilocybin has the potential with its neuroreparative effect to improve loss of cognitive function after TBI lessening disability. The clinical effect of psilocybin appears to be related to its attenuation of traumatically-induced glutamate excitotoxicity during the early post-injury period. In preclinical studies conducted at the National Health Research Institutes, which was part of the research program acquired from PharmaTher Holdings Ltd. (CSE: PHRM) (OTCQB: PHRRF), characterized the potential neuroreparative effect of psilocybin compared to being treated with a vehicle (saline) using a TBI mouse model. Adult mice were randomly assigned to 4 groups: (1) control, (2) TBI+vehicle, (3) TBI+low dose psilocybin, and (4) high dose psilocybin. Cognitive function was examined by the Morris water maze test after the injury. It was found that psilocybin, given after injury, improved cognitive function in TBI mice. Also, there were no adverse effects observed with psilocybin.

Michael Frank, CEO of Revive commented: “The FDA orphan drug application for psilocybin to treat moderate to severe TBI is an important milestone for Revive as we focus on building a robust product pipeline focused on novel uses and delivery forms of psilocybin to treat significant unmet medical needs. We are currently seeking to evaluate psilocybin in a clinical trial for moderate to severe TBI and advancing our development of a proprietary oral thin film psilocybin product for the potential treatment of certain neurological disorders, such as brain damage caused by all forms of TBI and stroke, and other related mental health and substance abuse disorders.”

The Orphan Drug Act grants special status to a drug or biological product to treat a rare disease or condition upon request of a sponsor. This status is referred to as orphan designation (or sometimes “orphan status”). The FDA grants ODD status to products that treat rare diseases, providing incentives to sponsors developing drugs or biologics. The FDA defines rare diseases as those affecting fewer than 200,000 people in the United States at any given time. ODD would qualify psilocybin for certain benefits and incentives, including seven years of marketing exclusivity if regulatory approval is ultimately received for the designated indication, potential tax credits for certain clinical drug testing costs, activities, eligibility for orphan drug grants, and the waiver of the FDA New Drug Application filing fee of approximately USD $2,400,000.

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.

Source:

  1. https://www.cdc.gov/traumaticbraininjury/pdf/moderate_to_severe_tbi_lifelong-a.pdf
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PharmaTher Expands Patent Portfolio with Filing of U.S. Patent Application for Ketamine and Repurposing of Psychedelics with panaceAI™

TORONTO, April 27, 2021 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (CSE: PHRM) (OTCQB: PHRRF), a specialty psychedelic pharmaceutical company, today announced that it has filed a provisional patent application with the U.S. Patent and Trademark Office outlining the novel use of ketamine as a potential treatment for Type 2 diabetes and obesity, based on the evaluation of the Company’s drug repurposing artificial intelligence (“AI”) platform, panaceAI™.  PharmaTher is also advancing research with panaceAI™ to evaluate repurposing opportunities with N,N-Dimethyltryptamine (“DMT”), 3,4-Methylenedioxy​methamphetamine (“MDMA”) and lysergic acid diethylamide (“LSD”) for future clinical development and partnering opportunities.
The patent application, entitled “Use of Ketamine in the Treatment of Diabetes and Obesity,” identifies protein bindings and interactions with ketamine leading to the discovery of ketamine as a potential treatment for Type 2 diabetes and obesity. The Company has submitted an Investigational New Drug (“IND”) application with the U.S. Food and Drug Administration (“FDA”) for the initiation of a Phase 2 clinical trial to evaluate ketamine in the treatment of Parkinson’s disease.  Upon the FDA accepting the IND, PharmaTher will leverage the IND to expand the clinical development of ketamine in depression, amyotrophic lateral sclerosis (Lou Gehrig’s disease), pain and obesity-related disorders.

PharmaTher uses its drug repurposing AI platform, panaceAI™, to expand on the Company’s patent portfolio of novel uses of DMT, MDMA and LSD. PharmaTher’s objective is to discover novel uses of these psychedelics and incorporate them into the Company’s proprietary microneedle patch delivery system currently being evaluated at the Terasaki Institute. The Company seeks to commercialize the product developments either internally or partner with life sciences companies seeking to expand their product portfolio with psychedelics. PharmaTher recently used panaceAI™ to discover novel uses of psilocybin in the potential treatment of certain cancers, which led to the sale of the Company’s psilocybin intellectual property portfolio to Revive Therapeutics Ltd. (CSE: RVV, OTC: RVVTF) for a consideration of up to CAD $10 million.

Fabio Chianelli, CEO of PharmaTher, commented:  “We continue to focus on building our patent and product portfolio of prescription-based psychedelics through our drug repurposing and delivery methods for unmet medical needs,” Fabio Chianelli, CEO of PharmaTher. “Our strategy is to investigate ketamine in FDA Phase 2 clinical trials for Parkinson’s disease and depression and with panaceAI™, we aim to find new uses of psychedelics, such as ketamine, psilocybin, DMT, MDMA and LSD, and incorporate them into our proprietary microneedle patch delivery system.  We are well-positioned to unlock value in our patent portfolio consisting of novel uses, formulations and delivery systems for psychedelics as a pharmaceutical prescription.”

About PharmaTher Holdings Ltd.

PharmaTher Holdings Ltd. (CSE: PHRM) (OTCQB: PHRRF) is a specialty psychedelic pharmaceutical company focused on the research, development and commercialization of ketamine and novel microneedle patches for the delivery of psychedelics to treat neuropsychiatric, neurodegenerative and pain disorders.
​
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 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 Submission of IND Application with the FDA for Phase 2 Clinical Trial Evaluating Ketamine in the Treatment of Parkinson’s Disease

TORONTO, April 20, 2021 (GLOBE NEWSWIRE) — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (CSE: PHRM) (OTCQB: PHRRF), a specialty psychedelic pharmaceutical company, today announced it submitted an Investigational New Drug (“IND”) application with the U.S. Food and Drug Administration (“FDA”) for the initiation of a Phase 2 clinical trial to evaluate the safety, efficacy and pharmacokinetics of low-dose ketamine in the treatment of levodopa-induced dyskinesia in patients with Parkinson’s disease (“LID-PD”).
“The submission of our IND application with the FDA is an important milestone as it provides us with a solid foundation to advance our ambition in commercializing ketamine and unlocking its therapeutic potential through novel uses, formulations and delivery methods in the treatment of neurodegenerative diseases (ie. Parkinson’s disease and Lou Gehrig’s disease), mental illness (ie. Depression and PTSD) and chronic pain,” said Fabio Chianelli, CEO of PharmaTher.

Ketamine is an FDA-approved N-methyl-D-aspartate (“NMDA”) receptor-modulating drug that is widely used as an anesthetic agent either alone or in combination with other anesthetic agents [Smith et al, 1987; Pacheco et al, 2014]. The possible therapeutic effect of low-dose ketamine on LID was noted in a retrospective analysis of PD patients who received ketamine for pain relief. During this analysis, it was observed that the patients experienced an improvement in LID lasting several weeks beyond treatment [Sherman et al, 2016]. These results were corroborated in a test of low-dose ketamine in a rodent LID model, and this possible effect has also been examined in a controlled study [Bartlett et al, 2016]. Ketamine may also have additional benefits in the treatment of pain [Niesters et al, 2014] and depression [Diamond et al, 2014; Murrough et al, 2013], which are frequent comorbidities of Parkinson’s disease.

The clinical trial is titled “A Multi-Center, Phase IIA, Randomized, Double-Blind, Prospective, Active Placebo-Controlled Trial of Sub-Anesthetic Ketamine to Treat Levodopa-Induced Dyskinesia in Subjects with Parkinson’s Disease.” It is anticipated that up to eight clinical sites in the U.S. will randomize a total of up to 36 subjects to the investigational product (ketamine) or active control (midazolam). The primary end-point of the study is the change in the Unified Dyskinesia Rating Scale (“UDysRS”) total score from Baseline to Week 8. Secondary endpoints of the study include the change in Total Objective Scores of the UDysRS, total daily OFF times as assessed by subject-completed 24-hour diaries and change in the UPDRS total and sum scores of motor and dyskinesia from Baseline to Week 8. Because LID can markedly affect a Parkinson patient’s everyday activities, a reduction in LID could improve the patient’s quality of life.

Assuming the Phase 2 clinical trial is positive, the Company will request a meeting with the FDA to discuss its plan and obtain an agreement to move to a pivotal Phase 3 clinical study under the 505(b)(2) regulatory pathway. However, there can be no assurance that the FDA will support any potential request for an expedited path to approval or further development.

About Parkinson’s Disease

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 the etiology of PD is not fully understood, it is thought to result from loss of pigmented dopaminergic neurons in the Substantia nigra and their striatal projections, leading to dopamine deficiency in the striatum [Schapira and Jenner, 2011]. This ultimately affects the cortico-striatal system that controls movement.

As a progressive neurogenerative disorder of the central nervous system that primarily affects the motor nerve system, symptoms of Parkinson’s disease may emerge slowly and include tremors, rigidity, bradykinesia, and postural instability [Paulson and Stern, 2004]. Also, patients may experience non-motor symptoms such as autonomic dysfunction (orthostatic hypotension, constipation, bladder dysfunction), psychiatric (depression), cognitive and sensory symptoms (pain) [Olanow, et al, 2009]. These non-motor symptoms become more common as the disease progresses.

Treatments, including levodopa and dopamine agonists, which restore the dopamine deficits in the brain, have been employed for almost 50 years. However, with continued treatment using levodopa, dose-limiting motor side-effects often emerge. This includes the emergence of abnormal involuntary movements termed Levodopa Induced Dyskinesias, which can be
identified in about 50% of patients within five years after initiation of levodopa treatment and in almost all patients within ten years post-treatment initiation. These side effects often limit further dose increases in dopaminergic therapy.​

About PharmaTher Holdings Ltd.

PharmaTher Holdings Ltd. (CSE: PHRM) (OTCQB: PHRRF) is a specialty psychedelic pharmaceutical company focused on the research, development and commercialization of ketamine and novel microneedle patches for delivering psychedelics to treat neuropsychiatric, neurodegenerative and pain disorders.

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

For more information, 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 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 Provides Update on Psychedelic Product Programs

TORONTO, April 15, 2021 (GLOBE NEWSWIRE) — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (CSE: PHRM) (OTCQB: PHRRF), a specialty psychedelic pharmaceutical company, is pleased to provide an update on its psychedelic product programs as it relates to the clinical and commercial development of ketamine and the research and development of proprietary microneedle patch delivery systems for psychedelics such as ketamine, psilocybin, N,N-Dimethyltryptamine (“DMT”), 3,4-Methyl​enedioxy​methamphetamine (“MDMA”) and lysergic acid diethylamide (“LSD”)
“Over the last 12 months, we have been focused on building our intellectual property portfolio, which currently consists of 17 granted patent and patent applications, advancing the clinical development of our ketamine product pipeline targeting Parkinson’s disease, depression and Lou Gehrig’s disease, and developing novel microneedle patch delivery systems to unlock the clinical value of psychedelics to treat neuropsychiatric, neurodegenerative and pain disorders,” said Fabio Chianelli, CEO of PharmaTher. “With the recent closing of the sale of our psilocybin program to Revive Therapeutics for up to CAD $10 million, of which we received $3 million in cash and $4 million in Revive common stock upfront, we are in a good financial position to advance our FDA Phase 2 clinical studies with ketamine and to finalize the development of our proprietary microneedle patch delivery systems for clinical trials and to partner with life sciences companies seeking a differentiated, safe and effective delivery option for psychedelics.”

Clinical and Commercial Development Initiatives for Ketamine

Ketamine is a rapid-acting, nonbarbiturate general anesthetic approved by the Food and Drug Administration (“FDA”) in 1970 and is clinically used for analgesia, sedation, and anesthetic induction. Ketamine is a generic drug classified by the Drug Enforcement Agency (“DEA”) as a Schedule III controlled substance. Published studies have demonstrated ketamine’s potential in major depressive disorder, bipolar depression, depression with suicidal ideation, post-traumatic stress disorder, drug addiction, Parkinson’s disease, and pain management.

PharmaTher is planning on developing its own branded ketamine and is advancing the clinical development of ketamine for Parkinson’s disease, depression and Amyotrophic lateral sclerosis (“ALS”), also known as Lou Gehrig’s disease under the FDA 505(b)(2) regulatory pathway. The 505(b)(2) regulatory pathway provides for FDA approval based on data (i.e., preclinical and clinical data) previously reviewed by the FDA for the approval of a separate drug application. PharmaTher seeks to leverage this regulatory pathway to potentially accelerate the development and lower the clinical and regulatory risk of its ketamine-focused product pipeline. The Company plans to have investigational new drug (“IND”) applications with the FDA this year to evaluate ketamine in Phase 2 clinical trials for Parkinson’s disease, depression, and ALS.

Commercialization of Ketamine

PharmaTher plans to commercialize its own branded ketamine product to support its growing ketamine-based product pipeline and meet the increasing demand for ketamine globally. The Company is in discussions with contract development and manufacturing organizations (“CDMOs”) for the development and commercialization of ketamine and to file an Abbreviated New Drug Application (“ANDA”) to obtain FDA approval to market ketamine in the U.S. An ANDA is a request to the FDA to manufacture and market a generic drug in the U.S. The Company will provide details on its commercialization strategy once a CDMO is chosen.

Ketamine for Parkinson’s Disease

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. 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.

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. 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 potential long-term therapeutic benefit to reduce levodopa-induced dyskinesia, improve on time, and reduce depression.
PharmaTher will file its IND application with the FDA this month to evaluate the safety, efficacy and pharmacokinetics of a low dose of ketamine for the treatment of levodopa-induced dyskinesia (“LID”) in individuals with Parkinson disease (“PD”) in a Phase 2 clinical trial. Assuming the Phase 2 clinical trial is positive, the Company will request a meeting with the FDA to discuss its plan and to obtain an agreement to move to a pivotal Phase 3 clinical study under the 505(b)(2) regulatory pathway.

KETABET™ for Major Depressive Disorder

Over 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. Despite this, the potential for abuse and misuse of ketamine and the adverse mental effects of ketamine uses such as dissociative, hallucinogenic, and amnesic effects leads to its limited clinical use and discontinuation.

PharmaTher entered into an exclusive worldwide license agreement with the National Health Research Institutes to develop and commercialize a patented combination formulation of FDA-approved ketamine and betaine (“KETABET™”) as a potential next-generation ketamine product. KETABET™ has shown in research studies to enhance the antidepressant effect while having the potential to significantly reduce the known negative side effects of ketamine.

In Q2-2021, PharmaTher plans to file a pre-Investigational New Drug (“pre-IND”) meeting request with the FDA to support the clinical development of KETABET™ in depression. The pre-IND meeting will provide valuable information for the Company to conduct a Phase 2 clinical study in the U.S. and obtain agreement that a 505(b)(2) regulatory pathway is acceptable, allowing for the potential to accelerate the clinical development for KETABET™ approval. After the pre-IND meeting, PharmaTher will file an IND application to conduct a Phase 2 clinical study.

Ketamine for Amyotrophic Lateral Sclerosis (Lou Gehrig’s disease)

Currently, there is no known cure for Amyotrophic lateral sclerosis (“ALS”). ALS is a progressive neuromuscular disease with a life expectancy of only 2 to 6 years after diagnosis. ALS affects approximately 50,000 people in the U.S. and Europe, with over 5,000 new cases diagnosed annually. As ALS advances, upper and lower motor neurons die, causing the brain to lose its ability to control muscle movement. Peak sales for a new drug to treat ALS can achieve over USD $1 billion.

PharmaTher entered into an exclusive license agreement with The University of Kansas to develop and commercialize the intellectual property of ketamine to treat ALS. Inventors Dr. Richard J. Barohn, M.D., John A. Stanford, Ph.D., and Dr. Matthew Macaluso, D.O., have made the promising discovery that ketamine can be administered as an effective treatment for ALS. Their preclinical research has shown that the administration of ketamine preserves muscle function in advancing ALS and increases life expectancy when given in the early stages of muscle decline.

PharmaTher plans to apply for orphan drug designation with the FDA in Q2-2021 and file its IND with the FDA in Q3-2021 to support the clinical development of ketamine in ALS.

Proprietary Microneedle Patch Delivery Systems

PharmaTher is developing two novel microneedle patch delivery systems to support KETABET™ and microdosing of psychedelics as part of its product lifecycle strategy. PharmaTher believes that the microneedle patch delivery systems for psychedelics may overcome the potential drawbacks of oral administration, subcutaneous injections, topical and nasal delivery systems.
PharmaTher is in discussions with CDMOs to manufacture clinical-grade microneedle patches to evaluate the delivery of psychedelic drugs, such as ketamine, psilocybin, DMT, MDMA and LSD in human clinical trials.

Hydrogel-Forming Microneedle Delivery System for Ketamine

PharmaTher entered into an exclusive worldwide patent and know-how license agreement with The Queen’s University of Belfast (“QUB”) to develop and commercialize a patented hydrogel-forming microneedle patch delivery technology developed by Professor Ryan Donnelly to support PharmaTher’s product and clinical development initiatives involving ketamine. The patented microneedle (“MN”) patch delivery system consists of hydrogel-forming MN arrays and an accompanying reservoir which will overcome any limitations by the quantity of drug that can be loaded into the needles or onto the needle surfaces. The MN patch can significantly increase drug permeating through the microneedle array and into the skin. This MN patch is ideal for KETABET™ due to drug loading capacity and combination.

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.

PharmaTher will continue developing the hydrogel-forming MN patch and evaluate it with KETABET™. PharmaTher’s proposed KETABET™ MN patch aims to empower patients to dose their medication remotely, safely and conveniently rather than 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. Also, the KETABET™ MN patch will incorporate anti-tampering and anti-abuse features and the product’s delivery format that would parallel the approach used for the tamper-resistant transdermal fentanyl patch.

Development of the ketamine hydrogel-forming MN delivery system at QUB is ongoing, and development milestones will be made available as they arise.

GelMA Microneedle Delivery System for Psychedelics

The Company entered into an exclusive license agreement for the development and commercialization of a proprietary microneedle delivery system, comprised of a biocompatible and biodegradable gelatin methacryloy (“GelMA”) composite developed in Khademhosseini Lab at the University of California, Los Angeles (“UCLA”), for use with psychedelic pharmaceuticals, including, but not limited to, psilocybin, LSD, MDMA, DMT, ibogaine and cannabinoids.

The GelMA MN patch delivery system delivers both water-soluble and insoluble drugs with desirable release profiles, efficiently penetrates the stratum corneum layer (outer layer of the skin), and enables flexible drug load capacity and combinations, and control-release delivery. The GelMA patch delivery system focuses on the Company’s psychedelic microdosing program.

PharmaTher entered into a sponsored research agreement with the Terasaki Institute to further develop the GelMA MN patch for microdosing of psychedelics. The results of certain development milestones will be made available as they arise.

About PharmaTher Holdings Ltd.

PharmaTher Holdings Ltd. (CSE: PHRM) (OTCQB: PHRRF) is a specialty psychedelic pharmaceutical company focused on the research, development and commercialization of ketamine and novel microneedle patches for delivering psychedelics to treat neuropsychiatric, neurodegenerative and pain disorders.

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

For more information, 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 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 Advancing Research for Novel Microneedle Delivery of Ketamine

Represents a potential next-generation treatment for neuropsychiatric, neurodegenerative and pain disorders
TORONTO, March 24, 2021 /CNW/ – Newscope Capital Corporation (CSE: PHRM) (OTCQB: PHRRF), today announced that its wholly-owned subsidiary, PharmaTher Inc. (“PharmaTher”), a psychedelics biotech company, has entered into a sponsored research agreement with The Queen’s University of Belfast (“QUB”) for the development of a patented hydrogel-forming microneedle (“MN”) patch to deliver ketamine and the PharmaTher’s proprietary ketamine formulation, KETABET™”. This advance represents a potential next-generation treatment for neuropsychiatric, neurodegenerative and pain disorders.
The research will be led by Professor Ryan Donnelly, a world leader in the research of microneedle delivery technologies. 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. His research validates 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 proposed ketamine and KETABET™ MN patch offer a potential game-changing therapeutic solution for various unmet medical needs. Ketamine is becoming an emerging treatment option for major depressive disorder2, bipolar depression3, depression with suicidal ideation4 and post-traumatic stress disorder5. Despite its potential, ketamine has the potential for abuse and misuse—leading to problems such as dissociative, hallucinogenic and amnesic effects6. These risks have led to its limited clinical use and discontinuation.​

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.7

PharmaTher’s patented MN technology consists of hydrogel-forming microneedle arrays and accompanying reservoir (Figure #1) 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 skin8.

As a result, 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.1,8

Also, PharmaTher’s KETABET™ MN patch will incorporate anti-tampering and anti-abuse features. The combined presence of ketamine and betaine and the delivery format of the product would parallel the approach used by 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.9 An equity analyst predicted that SPRAVATO® could generate $3 billion in peak sales.10

“The potential for ketamine is significant and we are leading the way to develop a better ketamine solution to treat these unmet medical needs,” said Fabio Chianelli, CEO of PharmaTher.  “We believe that ketamine and our proprietary ketamine formulation, KETABET™, delivered in the patented microneedle patch could potentially change the ways that mental health, neurodegenerative and pain disorders are treated.  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 lab has successfully delivered esketamine using our patented microneedle technology, which 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. We are 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.”

PharmaTher will focus on developing a microneedle patch for FDA approval to better deliver psychedelics that may overcome the potential drawbacks of oral administration, subcutaneous injections, topical and nasal delivery systems.

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 neuropsychiatric, neurodegenerative and pain disorders.
​
Learn more at:  PharmaTher.com and follow us on Twitter and LinkedIn.

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. 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. 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.
8. 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.
9.https://www.fda.gov/news-events/press-announcements/fda-approves-new-nasal-spray-medication-treatment-resistant-depression-available-only-certified
10.https://www.fiercepharma.com/pharma/j-j-s-depression-nasal-spray-spravato-carrying-big-expectations-and-restrictions-scores-fda

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Revive Therapeutics Announces Successful Research Results for Psilocybin to Treat Traumatic Brain Injury and Filing of International Patent Application

TORONTO, March 19, 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 positive results of a pre-clinical study evaluating the efficacy of psilocybin in the treatment of mild traumatic brain injury (“TBI”) in a rodent model of TBI. The study was conducted at the National Health Research Institutes (“NHRI”), which was part of the psilocybin program acquired from PharmaTher Inc., a subsidiary of Newscope Capital Corporation (CSE: PHRM, OTCQB: PHRRF).

The study characterized the potential neuroreparative effect of psilocybin compared to being treated with a vehicle (saline) using a TBI mouse model. Adult mice were randomly assigned to 4 groups: (1) control, (2) TBI+vehicle, (3) TBI+low dose psilocybin, and (4) high dose psilocybin. Cognitive function was examined by the Morris water maze test after the injury. It was found that psilocybin, given after injury, improved cognitive function in TBI mice. Also, there were no adverse effects observed with psilocybin.

With the its recent acquisition of the provisional patent application from PharmaTher Inc., titled, “Psilocybin in the Treatment of Neurological Brain Injury”, and the positive research results with psilocybin in a TBI model, Revive has filed an international Patent Cooperation Treaty (“PCT”) application (PCT/CA2021/050360) allowing it to seek protection of this invention in 153 countries, including the U.S., Europe, Canada, Japan and China.

Michael Frank, CEO of Revive commented: “We are pleased with the results from our psilocybin research study in TBI as it strengthens our intellectual property portfolio for novel uses of psilocybin and it complements our robust psilocybin-based portfolio 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, and a clinical study with the University of Wisconsin evaluating psilocybin in the treatment of methamphetamine use disorder. We are focused on advancing psilocybin to treat mild TBI, also commonly known as concussions.”

According to the CDC,  there were about 2.87 million TBI-related emergency department visits and hospitalizations annually in the U.S. A TBI is mostly caused by a bump, blow, or jolt to the head that disrupts the normal function of the brain. Most TBIs that occur each year are mild, also referred to as concussions. According to Stanford Children’s Health, over 3.5 million sports-related injuries are reported annually among children in the U.S. and around 21% of all are traumatic brain injuries. Significant new treatment solutions for TBI are needed.

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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World Leading Depression Researcher Dr. Maurizio Fava Joins PharmaTher as Scientific and Clinical Advisor

TORONTO, March 16, 2021 (GLOBE NEWSWIRE) — Newscope Capital Corporation (the “Company” or “Newscope”) (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 the appointment of Dr. Maurizio Fava, MD, as a scientific and clinical advisor for PharmaTher’s clinical research initiatives with KETABET™”, a patented combination formulation of FDA-approved ketamine and betaine, as a potential next-generation treatment for major depressive disorder.
Dr. Fava is Psychiatrist-in-Chief of the Massachusetts General Hospital (“MGH”), director, Division of Clinical Research of the MGH Research Institute, executive director of the Clinical Trials Network and Institute, (MGH), associate dean for clinical and translational research and the Slater Family Professor of Psychiatry at Harvard Medical School.

KETABET™ is being developed as a novel treatment option for the more than 300 million people who suffer from major depressive disorder and 100 million people who are resistant to available treatments worldwide.   KETABET™ has shown in a research study 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.

“We are very pleased to have Dr. Fava join us as a scientific and clinical advisor and we look forward to his contributions as we advance the clinical development of KETABET™ in the treatment of major depressive disorder,” said Fabio Chianelli, CEO of PharmaTher. “Dr. Fava is a world leader in the field of depression and he brings invaluable guidance and extensive clinical trial experience having served as Principal Investigator on various clinical trials involving ketamine to treat depression.”

Dr. Fava commented: “There is a significant unmet medical need for new therapeutics for depression and ketamine, with its limitations, is an attractive treatment option.  I am particularly interested in PharmaTher’s approach and, should KETABET™ demonstrate its therapeutic potential in a placebo-controlled clinical study, it may be a promising new approach to the treatment of resistant depression. I look forward to working with PharmaTher in their pursuit to evaluate KETABET™ in advanced clinical studies.”

Dr. Fava is a world leader in the field of depression. He has edited eight books and authored or co-authored more than 900 original articles published in medical journals with international circulation, articles which have been cited more than 85,000 times in the literature and with an h index of over 140. Dr. Fava founded and was director of the Massachusetts General Hospital (MGH) Depression Clinical and Research Program from 1990 until 2014. Under Dr. Fava’s direction, the Depression Clinical and Research Program became one of the most highly regarded depression programs in the country, a model for academic programs that link, in a bi-directional fashion, clinical and research work. In 2007, he also founded and is now the executive director of the MGH Psychiatry Clinical Trials Network and Institute, the first academic CRO specialized in the coordination of multi-center clinical trials in psychiatry.  Dr. Fava has been successful in obtaining funding as principal or co-principal investigator from both the National Institutes of Health and other sources for a total of more than $120 million. Dr. Fava’s prominence in the field is reflected in his role as the co-principal investigator of STAR*D, the largest research study ever conducted in the area of depression, and of the RAPID Network, the NIMH-funded series of studies of novel, rapidly-acting antidepressant therapies. Dr. Fava has also developed with Dr. David Schoenfeld a novel design (with over five patents), the sequential parallel comparison design (SPCD), to address the problem of excessive placebo response in drug trials and to markedly reduce sample size requirements for these trials. He is also the former President of the American Society of Clinical Psychopharmacology.

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 neuropsychiatric, neurodegenerative and pain disorders.

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

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. 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

PharmaTher Expands to Neuromuscular Diseases with Exclusive License Agreement for Ketamine in the Treatment of Lou Gehrig’s Disease

TORONTO, March 02, 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 license agreement with The University of Kansas for the development and commercialization for the intellectual property of ketamine in the treatment amyotrophic lateral sclerosis (“ALS”), also known as Lou Gehrig’s disease.
The University of Kansas Medical Center inventors Dr. Richard J. Barohn, M.D., John A. Stanford, Ph.D., and Dr. Matthew Macaluso, D.O., have made the promising discovery that ketamine can be administered as an effective treatment for ALS. Their preclinical research has shown that the administration of ketamine preserves muscle function in advancing ALS and increases life expectancy when given in the early stages of muscle decline.

Currently, there is no known cure for ALS. ALS affects approximately 50,000 people in the U.S. and Europe, with over 5,000 new cases diagnosed annually. Peak sales for a new drug to treat ALS can achieve over USD $1 billion.
ALS is a progressive neuromuscular disease with a life expectancy of only 2 to 6 years after diagnosis. As ALS advances, upper and lower motor neurons die causing the brain to lose its ability to control muscle movement. ALS patients experience progressive loss of voluntary muscle action as an effect of the disease, resulting in the inability to speak, eat, move and, eventually, breathe.

Thus far, only three pharmaceuticals have been approved by the FDA for the treatment of ALS: riluzole, edaravone, and most recently, Nuedexta (dextromethorphan HBr and quinidine sulfate). These drugs are effective against disease mechanisms of ALS but fail to have measurable effects on attenuating disease progression or improve survival.

Therefore, there is an imperative need for new pharmacological therapies that can stop or slow the muscle decline associated with ALS progression and extend life expectancy of the ALS patient.

Ketamine has the potential to effectively increase life expectancy of those with ALS at any stage and slow the progressive loss of muscle associated with poor outcomes of the disease.

Ketamine works by blocking the action of the ionotropic glutamate receptor, the NMDA receptor. Unlike other inhibitors of NMDA receptor function, such as riluzole, ketamine dampens NMDA receptor-related glutamate excitotoxicity indirectly. Further, ketamine can lower D-serine concentrations intracellularly and also partially activates dopamine receptors. Collectively, these mechanisms of ketamine contribute in part to the drug’s neuroprotective effects which may extend to the motor neurons targeted in ALS.
​
PharmaTher will seek FDA approval for orphan drug designation of ketamine in the treatment of ALS and will advance towards an FDA investigational new drug application to conduct a Phase II clinical study this year.

“We are pleased to have added the Lou Gehrig’s disease program to our already impressive development pipeline that focuses on novel uses, formulations and delivery of ketamine in the treatment of neuropsychiatric, neurological and neuromuscular diseases,” said Fabio Chianelli, CEO of PharmaTher.

Under the terms of the Agreement, PharmaTher gained exclusive worldwide development and commercial rights to provisional patent no. 63/025,778 titled Ketamine to Extend Survival after Muscle Wasting in Amyotrophic Lateral Sclerosis. 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 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 neuropsychiatric, neurological and neuromuscular diseases.

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

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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Newscope Announces DTC Eligibility of Its Common Shares in the United States

TORONTO, March 01, 2021 (GLOBE NEWSWIRE) — Newscope Capital Corporation (the “Company” or “Newscope”) (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 today that its common shares are now eligible for electronic clearing and settlement through The Depository Trust Company (“DTC”) in the United States. In addition to trading in the United States on the OTCQB Venture Market under the symbol “PHRRF”, the Company’s common shares continue to trade on the Canadian Securities Exchange under “PHRM”.
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“Following our recent listing on the OTCQB Venture Market, we are pleased to have received DTC eligibility, as it is expected to increase accessibility and visibility of our common shares for U.S investors, and increase liquidity and broaden our shareholder base in the U.S.,” said Fabio Chianelli, CEO of the Company. “We are positioned to communicate our passion in developing novel uses and formulations of ketamine and the delivery via a microneedle patch of psychedelics such as ketamine, psilocybin, MDMA, DMT and LSD for neuropsychiatric, neurological and neuromuscular diseases.”

DTC is a subsidiary of the Depository Trust & Clearing Corporation, a U.S. company that manages the electronic clearing and settlement of publicly traded companies. Securities that are eligible to be electronically cleared and settled through DTC are considered “DTC eligible”. DTC services reduces costs and accelerates the settlement process for investors and brokers trading Canadian securities in the United States.

About Newscope Capital Corporation
Newscope Capital Corporation (CSE: PHRM) (OTCQB: PHRRF), who through its wholly-owned subsidiary, PharmaTher Inc., is a specialty life sciences company focused on the research and development of psychedelic pharmaceuticals for FDA approval to treat neuropsychiatric, neurological and neuromuscular diseases.
Learn more at:  PharmaTher.com and follow us on Twitter and LinkedIn.
For more information, please contact:
Fabio Chianelli
Chief Executive Officer
Newscope Capital Corporation (d/b/a 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.