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Silo Pharma Announces Successful Dosing of Patients Suffering from Parkinson’s Disease in Psilocybin Study

Silo Pharma Announces Successful Dosing of Patients Suffering from Parkinson’s Disease in Psilocybin Study

Study is examining effects of Psilocybin on Inflammatory Markers

ENGLEWOOD CLIFFS, N.J., May 19, 2022 (GLOBE NEWSWIRE) —  Silo Pharma, Inc . (OTCQB: SILO), a development-stage biopharmaceutical company focused on the use of psychedelics as a therapeutic, today announces that it in conjunction with the University of California San Francisco (UCSF), researchers have successfully dosed patients suffering from Parkinson’s disease. As part of this study, the researchers are collecting blood samples to determine the effects of psilocybin on inflammatory markers of patients who have exhibited signs of Parkinson’s.

This study is taking place at The Translational Psychedelic Research (TrPR) Program at UCSF.  TrPR brings together scientists and care providers across disciplines to understand how psilocybin, LSD, ketamine, MDMA and related compounds impact the brain and other organ systems. The goal of TrPR is to accelerate progress towards impactful and accessible psychedelic treatments.

Eric Weisblum, CEO of Silo Pharma commented “Successful dosing and collection of blood samples from enrolled patients is an important milestone that demonstrates the progress being made in this study which seeks to examine the effects of Psilocybin as an Anti-inflammatory agent.. We are encouraged by the progress and look forward to the next cohort of patients receiving therapeutic treatment and sharing the analysis of these markers when data has been analyzed and completed.”

About Silo Pharma
Silo Pharma. Inc. is a development-stage biopharmaceutical company focused on merging traditional therapeutics with psychedelic research for people suffering from indications such as PTSD, Parkinson’s, and other rare neurological disorders. Silo’s mission is to identify assets to license and fund the research which we believe will be transformative to the well-being of patients and the health care industry. For more information, visit www.silopharma.com

Safe Harbor and Forward-Looking Statements
This news release contains “forward-looking statements” within the meaning of the “safe-harbor” provisions of the Private Securities Litigation Reform Act of 1995. These statements are identified by the use of words “could”, “believe”, “anticipate”, “intend”, “estimate”, “expect”, “may”, “continue”, “predict”, “potential” and similar expressions that are intended to identify forward-looking statements. Such statements involve known and unknown risks, uncertainties and other factors that could cause the actual results of Silo Pharma, Inc. (“Silo” or “the Company”) to differ materially from the results expressed or implied by such statements, including changes to anticipated sources of revenues, future economic and competitive conditions, difficulties in developing the Company’s technology platforms, retaining and expanding the Company’s customer base, fluctuations in consumer spending on the Company’s products and other factors. Accordingly, although the Company believes that the expectations reflected in such forward-looking statements are reasonable, there can be no assurance that such expectations will prove to be correct. The Company disclaims any obligations to publicly update or release any revisions to the forward-looking information contained in this presentation, whether as a result of new information, future events or otherwise, after the date of this presentation or to reflect the occurrence of unanticipated events except as required by law.

Investor Relations Contact:
Hayden IR
Brett Maas
646-536-7331
Email: brett@haydenir.com

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PharmaTher Announces Grant of U.S. Patent on Formulation and Production Process of Ketamine and Ketamine Analogs

PharmaTher Announces Grant of U.S. Patent on Formulation and Production Process of Ketamine and Ketamine Analogs

TORONTO, May 5, 2022 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a leader in specialty ketamine pharmaceuticals, is pleased to announce that the United States Patent and Trademark Office granted US Patent No: 11,286,230, titled “Ketamine Flow Synthesis” (the “Patent”), which refers to a continuous-flow process technology for the preparation of ketamine and ketamine analogs. The Company gained exclusive worldwide development and commercial rights of the Patent along with Europe patent no. 3700887B1 and patent applications in China and Canada from Gesval S.A., a public limited company incorporated by the University of Liège, Belgium.

Fabio Chianelli, Chief Executive Officer of PharmaTher, commented: “Our goal is to become the leader in specialty ketamine pharmaceuticals.  The recent grant of the U.S. patent strengthens our patent portfolio of novel uses, delivery forms, formulations, and production processes of ketamine and ketamine analogs to serve the unmet medical needs for mental health, neurological and pain disorders, and surgery.”

The Patent strengthens the Company’s global intellectual property portfolio of ketamine, which consists of novel uses (i.e. Parkinson’s disease, Amyotrophic Lateral Sclerosis), delivery forms (i.e. microneedle patch, injection, infusion and wearable pump), formulations (i.e. ketamine and betaine, analogs), production (i.e. process flow synthesis), and the Company’s FDA orphan drug designation portfolio of ketamine for Amyotrophic Lateral Sclerosis, Complex Regional Pain Syndrome and Status Epilepticus.

As part of its short-term product strategy, the Company is developing its own Ketamine Injection and Infusion product to support the Company’s expected pivotal clinical studies for Parkinson’s disease and Amyotrophic Lateral Sclerosis (Lou Gehrig’s disease), future FDA 505(b)(2) regulatory submissions in mental health, neurological and pain disorders, and its commercialization plans in the U.S. via an FDA Abbreviated New Drug Application (“ANDA”) for anesthesia and procedural sedation. The Company expects to file the ANDA in Q4-2022 for commercialization in the U.S. In addition, the Company’s long-term product strategy is to develop novel ketamine formulations and drug delivery systems, including its patented microneedle patch and proposed wearable pump device for the intradermal and subcutaneous delivery of ketamine, respectively.

Ketamine was approved by the FDA in 1970 and is clinically used for analgesia, sedation, and anesthetic induction. Ketamine is also emerging as a viable treatment option for various mental health, neurological and pain disorders. However, the methods generally used for the production of ketamine are time-consuming and typically based on stepwise macroscopic batch processes resulting in low productivity, reproducibility and flexibility due to poor mixing and heat transfer.

Developed at the Center for Integrated Technology and Organic Synthesis (CiTOS, ULiège) headed by Professor Jean-Christophe Monbaliu, the Patent relates to a scalable, safe and efficient continuous-flow process in micro/mesofluidic reactors for the production of ketamine and ketamine analogs, thereby addressing the shortcomings of the ketamine batch processes to improve yield production, reproducibility, purity profile, and requiring smaller footprint for production. In addition to improving the production process of racemic ketamine, the Patent provides various methods for synthesizing ketamine analogs (i.e. arylcycloalkylamine derivatives) by using continuous-flow conditions with a drastically improved efficiency relative to batch procedures, which is of paramount importance for developing next-generation ketamines.

About PharmaTher Holdings Ltd.

​PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is focused on the development and commercialization of specialty ketamine pharmaceuticals for mental health, neurological, and pain disorders. Learn more at PharmaTher.com.

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”, “may” 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 three and nine month periods ended February 28, 2022 and 2021 (“MD&A”), dated April 25, 2022, 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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Core One Labs’ Akome Receives Positive Results from Bioassay Studies Will Look to Advance its Psychedelic Based Formulations

Core One Labs’ Akome Receives Positive Results from Bioassay Studies Will Look to Advance its Psychedelic Based Formulations

Vancouver, British Columbia, Canada – April 2, 2022 – Core One Labs Inc. (CSE: COOL), (OTC: CLABF), (Frankfurt: LD6, WKN: A3CSSU) (the “Company” or “Core One”) is pleased to announce that its wholly owned subsidiary Akome Biotech Ltd. (“Akome”) through a research arrangement with Neuro-Zone Srl, (“Neuro-Zone”) based in Bresso, Italy, has achieved positive results from its in vitro biological assay (“bioassay”) development studies (“bioassay studies”); furthering the Company’s patent pending psychedelic bioactive compounds that could lead to groundbreaking drug formulations for  Alzheimer’s Disease (AD), Parkinson’s Disease (PD), Major Depressive Disorder (Depression) and Stroke, (collectively “targeted diseases” or “neurological indications”).

Bioassay studies are one of the most important tools in new drug discovery and development as they identify whether a compound or, in Akome’s research scenarios, bioactive compounds, have the desired effect on targeted disease pathways.

Neuro-Zone’s bioassay studies have, to date, focused on confirming the relationship between the plant bioactives covered in Akome’s United States Patent and Trademark Office (USPTO) patent submissions, (namely AKO001, AKO002, AKO003 and AKO004 (see Company press releases dated June 19, 2021, May 6, 2021, July 21, 2021, and July 26, 2021, respectively), and the underlying neuropathological mechanisms related to conditions such as AD, PD, Depression and Stroke.

Neuro-Zone’s bioassay studies have allowed researchers to assess the effect of Akome’s plant bioactives on various biological targets associated with the neurological indications in question. Positive results emerging from the bioassay studies indicate that Akome’s plant bioactives possess the desired biological effects against Alzheimer’s Disease neuropathological mechanisms, as well as against other neuroinflammatory processes.

Using these positive results Akome and Neuro-Zone are actively mapping out the next stages in the Company’s drug development process.

“The positive results from these studies have demonstrated that Akome is making significant steps towards developing groundbreaking drug formulations that can be used to treat neurological diseases. This is great news for the tens of millions of people who are affected by Alzheimer’s, Parkinson’s, Depression and Stroke, across the globe” stated Joel Shacker, the Company’s CEO.

About Neuro-Zone

Neuro-Zone is a functional service company supporting drug discovery and research projects in the fields of inflammation and age-related pathologies, including underlying mechanisms of common brain diseases. With their added value deep scientific knowledge and cutting-edge technological platforms, Neuro-Zone studies the cell-cell interactions and biological activity of the Company’s new candidate drugs and provide understanding on the role of the microenvironment in the complex disease scenarios.

About Core One Labs Inc. 

Core One Labs is a life sciences biotechnology research and development company focused on bringing psychedelic medicines to market through the development and production of psychedelic compounds, the advancement of psychedelic assisted treatments, and the integration of novel delivery systems technology.

The Company has a multi-faceted business approach and incorporates several complementary lines of businesses and units in establishing itself as an industry leader in the rapidly growing and emerging psychedelics market space.

Core One, through its wholly owned subsidiary Vocan Biotechnologies Inc., has developed and filed for patent protection of a proprietary psilocybin production system using engineered bacteria. It is also the holder of 4 provisional patents for the development of psychedelic-based pharmaceutical formulations targeting neurological and mental health disorders, under its 100% owned subsidiary Akome Biotech Ltd., and 3 provisional patents under its other 100% owned subsidiary, Awakened Biosciences Inc., for additional synthetic technologies for psilocybin and psilocin production methods.

In addition to the development of psychedelics and psychedelic compounds, Core One holds an interest in four medical clinics which maintain a combined database of more than 275,000 patients. Through its clinics the Company intends to integrate a roll out of its intellectual property related to psychedelic technologies and participate in the advancement of psychedelic-based treatments for mental health disorders.

Core One Labs Inc.

Joel Shacker

Chief Executive Officer

FOR MORE INFORMATION, PLEASE CONTACT:

info@core1labs.com

1-866-347-5058

Cautionary Disclaimer Statement:

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

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

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

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Ketamine + Parkinson’s meds

PharmaTher Announces Positive Topline Results from Clinical Study of Ketamine for Parkinson’s Disease

The most common Parkinson’s medication, Levodopa, causes involuntary muscle movements in most patients who take it long-term.

PharmaTher (PHRM) found that a low dose of ketamine reduces these muscle spams in 100% of Parkinson’s patients — but it’s unclear by how much or for how long…

However, a separate study from 2016 found that low doses of ketamine reduced this side effect for up to one month and also eased depression.

PharmaTher is confident that the results will pave the way for a Phase 3 trial. 

PDF of article

PDF of article 2

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PharmaTher Announces Positive Topline Results from Clinical Study of Ketamine for Parkinson’s Disease

PharmaTher Announces Positive Topline Results from Clinical Study of Ketamine for Parkinson’s Disease

100% of patients treated with ketamine demonstrated reduction in dyskinesias as measured by the Unified Dyskinesia Rating Scale

Ketamine was well tolerated with no serious adverse events reported

Study results are adequate to give an effect size in powering a Phase 3 clinical study

PharmaTher planning a Phase 3 clinical study to allow for FDA approval of KETARX™ (ketamine) for Parkinson’s disease under the 505(b)(2) regulatory pathwayTORONTO, March 23, 2022 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a leader in specialty ketamine pharmaceuticals, is pleased to announce positive topline results from the dose-finding and tolerability clinical study (the “Study”) of ketamine for the treatment of levodopa-induced dyskinesia (“LID”) in patients with Parkinson’s disease. The Study results are adequate to give an effect size in powering a Phase 3 clinical study which is expected to bridge the design with increased treatment duration relative to the Company’s Phase 2 clinical study (NCT04912115).

The Study evaluated the safety, tolerability and efficacy of low-dose ketamine infusion for the treatment of LID in patients with Parkinson’s disease. Efficacy data from the Study demonstrated that 100% of patients treated with ketamine demonstrated a reduction in dyskinesias as measured by the Unified Dyskinesia Rating Scale during the Study period compared to the pre-treatment baseline. Safety data from the Study demonstrated that ketamine was well tolerated with no serious adverse events reported. All adverse events were mild or moderate and reflected the expected side-effects of ketamine administration. This Study further supports the previous findings in the observational study publication, titled “Case Reports Showing a Long-Term Effect of Subanesthetic Ketamine Infusion in Reducing l-DOPA-Induced Dyskinesias,” regarding the positive impact of ketamine in reducing LID.  Full results of the Study are expected to be submitted for presentation at a medical congress by June 2022.

Dr. Scott Sherman, MD, PhD, Principal Investigator of the Study, commented: “The results of this clinical study further support that ketamine is well-tolerated even in an older population of patients with advanced Parkinson’s disease. This opens the door to a fast-track development of a novel non-surgical treatment for levodopa-indued dyskinesia, that will fill a major gap in the existing therapeutic arsenal.” Dr. Scott Sherman is the Associate Professor of Neurology and Director of the Movement Disorders Center at the University of Arizona College of Medicine, Medical Director of the Arizona Chapter of American Parkinson’s Disease Association, and Director of the Parkinson’s Disease Program of the HealthSouth Rehabilitation Institute of Tucson.

Fabio Chianelli, CEO of PharmaTher, commented: “We are very pleased with the results from this clinical study as it gives us further confidence that ketamine can safely and effectively reduce levodopa-induced dyskinesia in patients with Parkinson’s disease and it paves the way for a potential Phase 3 clinical study to support FDA approval via the 505(b)(2) regulatory pathway.”

Based on the Study results, the Company is preparing to engage the FDA to establish the next steps for a planned Phase 3 clinical study to allow for ketamine’s approval for Parkinson’s disease under the 505(b)(2) regulatory pathway. The Company plans to use its proprietary ketamine intravenous product, KETARX™, for the planned Phase 3 clinical study.

Ketamine’s Potential In 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. 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 Parkinson’s disease to be over USD $3 billion in the U.S. alone.

Ketamine is an FDA-approved N-methyl-D-aspartate receptor-modulating (NDMA) 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 levodopa-induced dyskinesia was noted in a retrospective analysis of Parkinson’s disease 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 some drug combinations are used to treat the disease symptoms. 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. (OTCQB: PHRRF) (CSE: PHRM) is focused on the development and commercialization of specialty ketamine pharmaceuticals for mental health, neurological, and pain disorders. Learn more at PharmaTher.com.

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”, “may” 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, 2021 (“MD&A”), dated January 27, 2022, 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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Core One Labs’ Akome Biotech Initiates Neurogenesis Stimulation and Modeling Studies: Advancing its Proprietary Psychedelic-based Pharmaceutical Formulations

Core One Labs’ Akome Biotech Initiates Neurogenesis Stimulation and Modeling Studies: Advancing its Proprietary Psychedelic-based Pharmaceutical Formulations

Vancouver, British Columbia, Canada – March 4, 2022 – Core One Labs Inc. (CSE: COOL), (OTC: CLABF), (Frankfurt: LD6, WKN: A3CSSU) (the “Company” or “Core One”) is pleased to announce that its wholly owned subsidiary Akome Biotech Ltd. (“Akome”), has entered into an agreement with the Universidad Complutense de Madrid (“Universidad Complutense”), officially commencing neurogenesis stimulation and modelling studies research, to advance the development of the Company’s patent pending psychedelic bioactive compounds that target Alzheimer’s Disease, Parkinson’s Disease, Major Depressive Disorder and Ischemic Stroke.

Neurogenesis is the ability of the brain to grow new neurons. Until recently, neuroscientists believed that the central nervous system, including the brain, was incapable of neurogenesis and unable to regenerate. However, research conducted over the last two decades confirms, not only that adult neurogenesis is a normal process that occurs in the healthy brain, but also that it can be enhanced by psychedelics among other potent stimulants. Neurogenesis is considered important in neuroplasticity, the ability of the brain to form new connections and pathways and change how its circuits are wired. Through Akome’s initial data mapping of how psychedelic substances and selected bioactive substances cooperate, there is potential for significant stimulus in adult neurogenesis in the brains of individuals that are afflicted with certain neurological disorders, and Akome’s research with Universidad Complutense seeks to prove that its chosen bioactive-compounds can enhance such processes.

The research, which is currently underway, is being led by Dr. Jose A. Morales-Garcia, PhD, of the Universidad Complutense de Madrid, a leading institution with extensive experience in psychedelics research, and neurodegenerative processes responsible for conditions such as Alzheimer’s disease, Major Depressive disorder, Parkinson’s disease and ischemic stroke. The scope of research is designed to advance the Company’s hypothesis that the selected candidate bioactive compounds included in its patent submissions, are viable candidates and will react positively upon targets in the Central Nervous System, and have the potential to stimulate neurogenesis in the brain of individuals afflicted with neurological disorders, and subsequently result in groundbreaking clinical implications for the indications of Ischemic stroke, Alzheimer’s disease, Major Depressive disorder and Parkinson’s disease.

Dr. Morales is an Assistant Professor and Honorary fellow in the Cellular Biology Department at the Complutense University of Madrid, Medical School, a scientist at the Center for Networked Biomedical Research on Neurodegenerative Diseases, as well as a professor in the Master of Pharmacological Research at the Autonoma University of Madrid. Dr. Morales has over 40 scientific publications in peer-reviewed journals.

Dr. Morales’ has vast research background in the identification and analysis of new cellular targets implicated in neurogenesis and neurodegeneration as well as focused work in the study in vitro and in vivo of the mechanism underlying neurodegenerative disease, mainly Alzheimer´s and Parkinsonism in order to develop new neuroprotective, anti-inflammatory and neurogenic compounds for the treatment of these disorders.

“I believe that the treatment of individuals with neurological disorders through the use of psychedelic based pharmaceuticals, will become a major focus of mental healthcare in the near future. The groundbreaking work that Universidad Complutense is doing for Akome, will contribute significantly to the advancement of our drug formulations as we work to commercialize our patents. By developing unique psychedelic based pharmaceutical formulations that can be used for the treatment of Alzheimer’s, Parkinson’s, Depression and Ischemic Stroke, the Company is positioning itself to serve a larger and more diverse patient base,” stated Joel Shacker, the Company’s CEO.

About Core One Labs Inc.

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

Core One Labs Inc.

Joel Shacker

Chief Executive Officer

FOR MORE INFORMATION, PLEASE CONTACT:

info@core1labs.com

1-866-347-5058

Cautionary Disclaimer Statement:

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

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

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

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Core One Labs’ Akome Biotech Signs Research Agreement with University of Barcelona, Faculty of Pharmacy and Food Sciences

Core One Labs’ Akome Biotech Signs Research Agreement with University of Barcelona, Faculty of Pharmacy and Food Sciences

Vancouver, British Columbia, Canada – January 26, 2022 – Core One Labs Inc. (CSE: COOL), (OTC: CLABF), (Frankfurt: LD6, WKN: A3CSSU) (the “Company” or “Core One”) is pleased to announce that its wholly owned subsidiary Akome Biotech Ltd. (“Akome”) has signed a consulting agreement with the Universitat de Barcelona (the “University of Barcelona” or the “University”), Faculty of Pharmacy and Food Sciences, Laboratory of Medicinal Chemistry, of Barcelona, Spain.

By virtue of this agreement, Professor Maria Carmen Escolano, a full professor at the University’s Unit of Medicinal Chemistry in the Faculty of Pharmacy and Food Sciences, and her team will provide technical guidance for the in vitro development of Akome’s psychedelic based bioactive compounds targeting Major Depressive Order, Stroke, Parkinson’s Disease and Alzheimer’s Disease.

The University of Barcelona, Faculty of Pharmacy and Food Sciences, Laboratory of Medicinal Chemistry, has been selected by Akome as the successful candidate organization to provide technical guidance for the necessary in vitro studies of its proposed pharmaceutical psychedelic drug formulations.

Conducting in vitro studies is essential in the development of any new pharmaceutical drug. In vitro studies determine whether a pharmaceutical candidate produces the desired changes on cell cultures as an early indicator of efficacy. These studies are usually completed quickly and are designed based on information already presented in the provisional patents that have been filed by Akome.

Professor Escolano received her PhD from the University of Barcelona in 1993. Upon completion, she undertook research posts at the University College of London and Kingston University (UK) working in the synthesis of complex molecules with biological interest. Professor Escolano currently serves as a full professor at the Unit of Medicinal Chemistry in the Faculty of Pharmacy and Food Sciences, a post she has occupied for the last 14 years.

Professor Escolano leads the medicinal research group at the Universitat de Barcelona. The focus of this research group is the pharmacology of neurodegenerative diseases. Professor Escolano and her group have conducted in vitro development of multiple candidate substances for the treatment of neurological conditions. Professor Escolano is a renowned authority in the field, with over 95 publications in textbooks and peer-reviewed scientific journals. Akome is looking forward to the advancement of its pipeline of bioactive compounds specifically those targeting the neurodegenerative diseases, Parkinson’s and Alzheimer’s.

“We are excited to announce our contract with the University of Barcelona, Faculty of Pharmacy and Food Sciences, Laboratory of Medicinal Chemistry,” stated Joel Shacker CEO of the Company.  “Professor Escolano and her team have an enormous amount of experience, and knowledge of the targeted diseases, and the research acumen that will allow Core One to efficiently move forward with the more in-depth in vitro and in vivo studies that are necessary in effectively mapping out development of pre-clinical trials.”

About Core One Labs Inc.

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

Core One Labs Inc.

Joel Shacker

Chief Executive Officer

FOR MORE INFORMATION, PLEASE CONTACT:

info@core1labs.com

1-866-347-5058

Cautionary Disclaimer Statement:

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

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

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

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PharmaTher Provides Update on Product Pipeline and Expected Milestones for 2022

PharmaTher Provides Update on Product Pipeline and Expected Milestones for 2022

Focused on becoming a leader in the development and commercialization of specialty ketamine prescription-based products
Expected milestones for 2022 include initiating Phase 3 clinical study for ketamine to treat Parkinson’s disease (KETLID); completing Phase 2 clinical study for ketamine to treat ALS (KETALS); completing observational study with ketamine and betaine for depression and pain (KETABET); initiating Phase 2 clinical study for ketamine microneedle patch (KETAPATCH); and seeking FDA approval for Ketamine Hydrochloride Injection USPproduct (KETARX)

​TORONTO, December 21, 2021 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a company focused on the development and commercialization of specialty ketamine prescription-based products, is pleased to provide a product pipeline update and expected milestones for 2022.

Fabio Chianelli, Chief Executive Officer of PharmaTher, said, “2021 proved to be a foundational year for PharmaTher as we achieved a number of milestones which have paved the way for an exciting 2022 in unlocking ketamine’s therapeutic potential for treating Parkinson’s disease and ALS, the development of our ketamine hydrochloride injection USP product and our ketamine microneedle patch as a potential next-generation therapeutic solution for mental health, neurological and pain disorders.  We are now in a position both operationally and financially to seek FDA approval for KETARX, our ketamine prescription product, and to enter clinical studies for KETAPATCH, our ketamine patch product, in 2022.”

Project KETLID:  Ketamine for Levodopa-Induced Dyskinesia in Parkinson’s Disease

The Company’s Phase 2 clinical trial (ClinicalTrials.gov Identifier: NCT04912115)  to evaluate the safety, efficacy and pharmacokinetics of ketamine in the treatment of levodopa-induced dyskinesia (“LID”) in patients with Parkinson’s disease is currently ongoing and the Company now expects topline results in Q1-2022. Positive Phase 2 clinical results will allow the Company to 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 by Q3-2022.

PharmaTher has an exclusive license agreement with the University of Arizona for the intellectual property protecting the potential use of ketamine to treat movement disorders.  The possible therapeutic effect of low-dose ketamine on LID was noted in a retrospective analysis of Parkinson’s disease 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].

Project KETALS:  Ketamine for Amyotrophic Lateral Sclerosis (ALS or Lou Gehrig’s Disease)       

An Investigator-initiated IND application has been submitted and it is expected the FDA will accept the IND to proceed to a clinical study for ketamine to treat ALS patients within the next 30 days.  Patient enrollment is targeted for Q1-2022.  On August 3rd, 2021, the Company was granted orphan drug designation by the FDA for ketamine to treat ALS.

PharmaTher has an exclusive license agreement with the University of Kansas for the intellectual property protecting the potential use of ketamine to treat ALS. Ketamine has the potential to effectively increase the life expectancy of those with ALS at any stage and slow the progressive loss of muscle associated with poor outcomes of the disease. The University of Kansas Medical Center researchers and inventors of the potential use of ketamine to treat ALS, 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. In addition, unpublished and patent-pending 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.

Project KETABET: Ketamine and Betaine Combination Formulation

The Company is supporting an Investigator-lead observational study to evaluate the impact of betaine anhydrous on the unwanted ketamine side effects seen post ketamine treatment for subjects with depression.  The Company now expects results to be reported in early Q1-2022.  Based on the results, the Company will advance the KETABET program with its microneedle patch for clinical studies in the H2-2022.

PharmaTher has an exclusive license agreement with the National Health Research Institutes for the development and commercialization of a patented combination formulation of FDA-approved ketamine and betaine. KETABET has been shown in research to enhance the antidepressant effect while having the potential to reduce the known negative side effects of ketamine significantly.  The combination of ketamine and betaine anhydrous produced more robust antidepressant-like responses than their individual effects and that the combination blocked the psychotomimetic effects of ketamine [Lin, Jen-Cheng et al., 2016].

Project KETAPATCH: Ketamine Microneedle Patch

In collaboration with The Queen’s University of Belfast (“QUB”), led by Professor Ryan Donnelly, the Company has successfully completed the evaluation of a patented hydrogel-forming microneedle patch to deliver Ketamine and KETABET as a potential next-generation treatment for neuropsychiatric, neurodegenerative and pain disorders.  This de-risking milestone supports the Company’s expansion in finalizing IND-enabling studies and the clinical manufacturing scale up with LTS Lohmann, a leader in transdermal delivery systems, to support FDA and international regulatory submissions.  Validation and tech transfer activities to support clinical studies are in progress and the Company expects to conduct clinical studies in H2-2022.

PharmaTher has an exclusive license agreement with 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 and psychedelics.  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 [Courtenay, Aaron J et al., 2020].

Project KETARX: Ketamine Prescription (Rx) Product

The Company is developing its own Ketamine Hydrochloride Injection USP product as part of its plans to support the Company’s future Phase 3 clinical studies and its commercialization plans in the U.S. via a supplemental Abbreviated New Drug Application (“sANDA”) with the FDA for use in anesthesia and procedural sedation.  The Company expects to file for its sANDA in Q4-2022 for commercialization in the U.S. and international markets thereafter.

PharmaTher has entered into an agreement with Alcami Corporation, a global pharmaceutical contract development and manufacturing organization with extensive experience in cGMP sterile fill-finish products and handling of controlled substances, for the clinical and commercial manufacturing for the Company’s KETARX project. The Company expects to form partnerships with research labs, ketamine clinics and pharmaceutical companies that are: seeking a secure supply of cGMP ketamine and ketamine products for current portfolios; exploring alternative dose forms for multiple existing indications; and requiring support to develop and eventually commercialize specific ketamine products for new indications.  In addition, the Company will enter the market with KETARX targeting ketamine’s FDA approved label for anesthesia and procedural sedation.

About PharmaTher Holdings Ltd.

​PharmaTher Holdings Ltd. (OTCQB: PHRRF) (CSE: PHRM) is focused on the research, development and commercialization of specialty ketamine prescription-based products including KETAPATCH, a  ketamine microneedle patch for mental health, neurological and pain disorders, and KETARX, a ketamine hydrochloride injection USP product for anesthesia and procedural sedation. Learn more at PharmaTher.com, 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”, “may” 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 August 31, 2021 (“MD&A”), dated October 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 Applies for FDA Orphan Drug Designation for Ketamine to Treat Rare Neurological Disorder Status Epilepticus

PharmaTher Applies for FDA Orphan Drug Designation for Ketamine to Treat Rare Neurological Disorder Status Epilepticus

  • Adds to PharmaTher’s existing FDA orphan drug portfolio with amyotrophic lateral sclerosis and complex regional pain syndrome
  • Strengthens commitment to treat rare disorders and life-threatening conditions with ketamine
TORONTO, November 24, 2021 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, is pleased to announce that it has applied with the U.S. Food and Drug Administration (“FDA”) to receive Orphan Drug Designation (“ODD”) for ketamine to treat Status Epilepticus (“SE”), a rare neurological disorder requiring emergency treatment for a seizure.  The Company has received FDA ODD for ketamine to treat amyotrophic lateral sclerosis (“ALS”) and complex regional pain syndrome (“CRPS”).  The addition of SE strengthens the Company’s pharmaceutical strategy in developing novel uses and delivery methods (i.e. microneedle patch) for ketamine to treat rare disorders and life-threatening conditions.

SE is a life-threatening occurrence of a prolonged seizure or recurrent seizures without recovery of consciousness between seizures (Lowenstein 1999) lasting more than five minutes. Epidemiological studies found an annual incidence of SE ranging from 41/100,000-61/100,000 (DeLorenzo 1996). Based on these studies, there are approximately 120,000-180,000 episodes of convulsive SE each year in the U.S. SE affects individuals of all ages and it complicates various neurological and systemic illnesses. If SE is not treated immediately, permanent neuronal damage may occur, contributing to high morbidity and mortality rates. The mortality associated with SE is estimated at 17% and may lead to morbidity, including cognitive defects and neurological injury. SE is initially treated with benzodiazepines, which approximately 35-45% of patients are refractory to benzodiazepines.

Fabio Chianelli, Chief Executive Officer of PharmaTher, said, “Ketamine has the potential to treat various mental health, neurological and pain disorders, and we are focused on expanding ketamine’s therapeutic utility in rare disorders and life-threatening conditions including, but not limited to, Parkinson’s disease, amyotrophic lateral sclerosis, complex regional pain syndrome, and now status epilepticus.  The FDA orphan drug application for ketamine to treat status epilepticus builds on our belief in the potential of ketamine to improve quality of life and to save lives.”

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 orphan 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. Orphan drug designation would qualify ketamine 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 $2.4 million.

About PharmaTher Holdings Ltd.

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

For more business development opportunities or 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 August 31, 2021 (“MD&A”), dated October 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 Initiates Phase 2 Clinical Trial of Ketamine for the Treatment of Parkinson’s Disease

PharmaTher Initiates Phase 2 Clinical Trial of Ketamine for the Treatment of Parkinson’s Disease

“KET-LID” trial to evaluate ketamine’s safety and efficacy in the treatment of levodopa-induced dyskinesia in patients with Parkinson’s disease

TORONTO, October 6, 2021 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, announced today that it has initiated its Phase 2 KET-LID clinical trial of Ketamine for the treatment of Levodopa-Induced Dyskinesia in Subjects with Parkinson’s Disease. Patient screening and enrollment is expected to begin in October 2021 with data anticipated in late-Q4 2021.The Phase 2 KET-LID clinical trial is a randomized, double-blind, active placebo-controlled study evaluating the safety, efficacy and pharmacokinetics of ketamine in the treatment of levodopa-induced dyskinesia in patients with Parkinson’s disease.  The primary and secondary endpoints are the changes in the following: i) total score of the Unified Dyskinesia Rating Scale (UDysRS), ii) total objective score (III, IV) of the UDysRS, iii) total daily OFF times as assessed by subject- completed 24-hour diaries, and iv) Unified Parkinson’s Disease Rating Scale (UPDRS) total score of part III (motor) and sum score of Questions 4.1 and 4.2 (dyskinesia) in part IV.

As previously announced, an IND for the trial has been approved by the FDA.  The Company has completed its clinical trial start-up activities and selection of essential vendors including  project management, central laboratory, clinical supply kits and logistics, data management and biostatistics, and clinical site management and monitoring.  Clinical trial drug product (ketamine) and active placebo (midazolam) have also been obtained.  

For further detail about the KET-LID trial (ClinicalTrials.gov Identifier: NCT04912115), titled “A Multi-Center, Phase II, Randomized, Double-Blind, Prospective, Active Placebo-Controlled Trial of Sub-Anesthetic Intravenous Infusion of Ketamine to Treat Levodopa-Induced Dyskinesia in Subjects with Parkinson’s Disease,” please visit https://clinicaltrials.gov/ct2/show/NCT04912115?term=PharmaTher&draw=2&rank=1.

If the Phase 2 clinical study 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 in the first half of 2022.  

“Initiation of the Phase 2 clinical trial of ketamine to treat Parkinson’s disease, or the KET-LID trial, is a significant milestone for PharmaTher and we are excited about the opportunity to advance a potential new therapeutic solution for Parkinson’s disease patients,” said Fabio Chianelli, CEO of PharmaTher.  
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.

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 levodopa-induced dyskinesia (LID) was noted in a retrospective analysis of Parkinson’s disease 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.

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 Parkinson’s disease to be over USD $3 billion in the U.S. alone.

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.

About PharmaTher Holdings Ltd.

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

For more information about PharmaTher, please contact:

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

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

Cautionary Statement

This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated”, “potential”, “aim” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on PharmaTher Holdings Ltd. (the “Company”) current belief or assumptions as to the outcome and timing of such future events. Forward-looking information is based on reasonable assumptions that have been made by the Company at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Company is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Factors that could cause actual results to differ materially from those anticipated in these forward-looking statements are described under the caption “Risk Factors” in Company’s management’s discussion and analysis for the period of May 31, 2021 (“MD&A”), dated September 7, 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.