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PharmaTher Announces Positive Results from Study For Ketamine Microneedle Patch

PharmaTher Announces Positive Results from Study For Ketamine Microneedle Patch

Successfully delivered ketamine and KETABET™ (ketamine and betaine) via microneedle patch, unlocking the potential for desired dosage forms and pharmacokinetic profiles

Pursuing Phase 2 clinical studies in treatment-resistant depression and pain indications in Q4-2022

TORONTO, June 29, 2022 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a leader in specialty ketamine pharmaceuticals, is pleased to announce that it has successfully completed its research study evaluating the Company’s patented hydrogel-forming microneedle patch, PHARMAPATCH™, to deliver ketamine and KETABET™ (ketamine and betaine anhydrous), which aims to prevent the potential side effects of repeated ketamine treatment for depression and other indications, including suicidal ideation, substance abuse, post-traumatic stress disorder, neurological disorders, and chronic pain.

PHARMAPATCH™ has been shown to successfully deliver esketamine, the S(+) enantiomer of ketamine, which may overcome the drawbacks associated with ketamine administration in an intravenous or nasal spray format. Research results were published in a paper titled “Hydrogel-forming microneedle arrays as a therapeutic option for transdermal esketamine delivery”1.

The aim of the research program led by Prof Ryan Donnelly at Queens University Belfast (“QUB”) was to develop and characterize PHARMAPATCH™ for the transdermal delivery of ketamine and KETABET™ in a sustained manner and finalize production scale-up processes for clinical studies. Characterization of drug recovery and stability before drug permeation from films via hydrogel-forming microneedle array patches (“MAP”) was assessed in vitro using the Franz cell apparatus. Based on the findings from in vitro permeation investigations, lead candidate MAP formulations were selected and brought forward for in vivo testing using Sprague-Dawley rats to assess the ability to achieve sustained plasma concentrations of ketamine and betaine within the therapeutic range for potential antidepressant therapy over the course of 48 hours.

PHARMAPATCH™ is an alternative platform that allows ketamine to be delivered transdermally in a sustained and de-risked manner. The results from this study represent the first time that multiple formulations of PHARMAPATCH™ for the delivery of ketamine and betaine have been developed, characterized and tested in an animal model. Extensive characterisation of each drug-containing polymeric film and hydrogel-forming MAP combination in terms of swelling capacity, insertion capabilities, drug recovery, stability, and ultimately in vitro drug permeation using the Franz cell apparatus allowed the selection of the most promising candidate formulations for in vivo testing. Hydrogel-forming MAP-mediated delivery of ketamine and betaine were compared with intramuscular injection and orally administered solution, respectively. At regular time intervals during the 48-hour rat study, blood sample results demonstrated that PHARMAPATCH™ was able to deliver plasma levels of ketamine (between 70-200 ng/mL) in a controlled manner throughout the study.

The findings of this work support PHARMAPATCH™ as a promising drug delivery platform through which effective, de-risked, and safe ketamine therapies can be delivered. Considering the high degree of flexibility possessed by this delivery system in terms of formulation, the potential for effective treatment regimens extending beyond 48 hours could be developed through further alterations in surface area, application time, and drug loading of these polymeric patches. 

The Company is preparing for a planned Phase 2 clinical study to allow for ketamine and KETABET™ microneedle patch evaluation in treatment-resistant depression and chronic pain under the FDA 505(b)(2) regulatory pathway. The Company is manufacturing its ketamine microneedle patches at LTS LOHMANN Therapie-Systeme AG for upcoming GLP pre-clinical pig studies to demonstrate the delivery, dosing and safety profile of ketamine in a comparable animal model to support regulatory filings to conduct human clinical studies in Q4-2022. In addition, scale up of the manufacturing process to support GMP and commercial production is currently underway.

About PHARMAPATCH™    

Microneedle-enhanced intradermal delivery is an elegant, efficient and painless method for increasing the skin permeation of many drugs, including ketamine. Transdermal delivery systems offer several advantages over inhalation and intravenous administration. PharmaTher‘s approach with ketamine consists of a 2-part system comprised of a drug-loaded reservoir placed on top of the hydrogel microneedle array. After administration into the skin (i.e. intradermal delivery), the microneedles become hydrated and swell, creating pores for the reservoir to release the drug content into the tissue over the treatment course. Upon removal, the needles are intact, yet rounded, and do not need to be disposed of as sharps. The drug enters the systemic circulation circumventing absorption and first-pass barriers typical for oral delivery. Studies have shown that systemic drug concentrations are reached minutes after administration and maintained over multiple days with transdermal delivery. This system addresses a major unmet need by offering greater ease of administration and including patients with pre-existing conditions that exempt them from oral or inhalation dosing. In addition, it avoids syringe needles, eliminating pain and patient visits to a clinician.

Potential of the Ketamine Microneedle Patch

The Company’s patented hydrogel-forming microneedle (“MN”) patch aims to deliver ketamine for intradermal administration to treat various mental health, neurological and pain disorders. The MN patch consists of hydrogel-forming microneedle arrays and an accompanying reservoir that will overcome limitations by the quantity of drug loaded into the needles or onto the needle surfaces. As such, the MN patch can significantly increase the amount of drug that can permeate through the microneedle array and into the skin.2 The MN patch is tailored for ketamine due to the required drug volume to maximize their therapeutic utility and increase potential market opportunities.

The ketamine MN patch aims to empower patients to dose their medication remotely, safely and conveniently rather than being supervised by a healthcare provider at a certified medical office. The ketamine MN patch has the potential for enabling continuous delivery of ketamine (without pain) with minimal formulation manipulation into systemic circulation while maintaining constant plasma levels for more than 24 hours, which will improve efficacy and compliance for patients.1-2 Also, the ketamine MN patch will incorporate anti-tampering and anti-abuse features that parallel the approach used by commercially available tamper-resistant transdermal fentanyl patches.

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.

Sources:
1.Courtenay, et al. Hydrogel-forming microneedle arrays as a therapeutic option for transdermal esketamine delivery, Journal of Controlled Release, Volume 322, 2020, Pages 177-186.

2.     Donnelly R.F. Hydrogel-forming microneedles prepared from “super swelling” polymers combined with lyophilised wafers for transdermal drug delivery. PLoSONE. 2014 doi: 10.1371/journal.pone.0111547.

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Managing pain with MDMA

Global Wellness Readies for First Clinical Trial

Could your next surgery involve MDMA?

Shanti Therapeutics of Global Wellness Strategies (GWS) is preparing for a study to see if MDMA has an impact on pain tolerance in healthy volunteers.

The goal is to treat and prevent perioperative pain, or pain associated with surgery.

Managing pain immediately after surgery can help prevent chronic pain and the mental health issues that often follow.

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Wellbeing Digital Sciences Subsidiary IRP Health Approved as Part of Coveted Chronic Pain Centre of Excellence for Canadian Veterans Network

Wellbeing Digital Sciences Subsidiary IRP Health Approved as Part of Coveted Chronic Pain Centre of Excellence for Canadian Veterans Network

The Company’s Ottawa-Based IRP Health Clinic has Also Been Approved by Veterans Affairs Canada for its Reactivation Program  

Vancouver, British Columbia, April 28, 2022 / Globe Newswire / – Wellbeing Digital Sciences Inc.  (“Wellbeing” or the “Company”) (NEO: MEDI) (OTC: KONEF) (FRA: SQ2), an evidence-based  mental healthcare company focused on the development and implementation of innovative clinical  solutions such as psychedelic medicine and digital therapeutics supported by clinical research, is pleased to  announce that its subsidiary, IRP Health Ltd. (“IRP Health” or the “Subsidiary”), has been approved as  part of the Chronic Pain Centre of Excellence for Canadian veterans (“CPCoE”). Additionally, IRP  Health’s clinic in Ottawa, Ontario (the “Ottawa Clinic”) has been approved by Veterans Affair Canada  (“VAC”) for its multidisciplinary Reactivation-branded therapy program (“Reactivation”).  

CPCoE  

After meeting strict criteria, IRP Health’s four Canadian locations will now be listed and recommended as  part of the national network of clinics. The clinics will contribute towards the national collection of data to  help further research and innovation with respect to the treatment of military veterans. The CPCoE provides  national leadership for research co-designed with veterans and their families and supports the  implementation of this research with a national network of clinics to help veterans and their families manage  their pain and reconnect with life.  

Thanks to CAD 20 million in funding from VAC over five years, the CPCoE strives to be a leader in  veteran-first chronic pain research and improving care.. The CPCoE is already the national leader in  researching chronic pain inveterans. Its guiding principles for research include national and international  collaborations, building upon its existing strengths in Canada, and capitalizing on the investments made by  VAC. With the goal of improving veterans’ wellbeing, the CPCoE’s research findings will be used to  promote evidence-based best practices to inform a network of pain clinics, researchers, case managers and  the public. More information can be found by visiting the following website:  https://www.veteranschronicpain.ca/  

Ottawa Clinic 

IRP Health’s Ottawa Clinic has been approved by VAC to begin offering the Reactivation therapy program  at the location. Reactivation is a 12-week, physician-supervised, interdisciplinary pain management  program that assists veterans with chronic musculoskeletal injuries and pain. It aims to help veterans return  to behaviours that are consistent with being well, rather than behaviours that are consistent with suffering.  The goals of Reactivation are to decrease distressing symptoms, increase engagement in the community  and increase the ability to complete daily tasks and also strives to reduce patient disability in both the short  and long term, while giving veterans better control and understanding of their pain and health challenges.  The therapy program combines psychiatry, psychology, occupational therapy, physiotherapy, kinesiology,  and dietetics to provide an interdisciplinary approach and a cutting-edge treatment.  

VAC is a government organization for current and former members of the Canadian Armed Forces, Royal  Canadian Mounted Police and their family members which strives to provide services and benefits intended  to improve the well-being of the veterans and their kin. The approval of the Reactivation program in the  Ottawa Clinic has the potential to make a difference in the lives of many veterans who are coping with  mental and physical illnesses. More information about VAC can be found on its website:  https://www.veterans.gc.ca/eng 

Management Commentary  

“Being recognised by Canada’s leader in chronic pain research and services for military veterans is both a  privilege and an honour. The support and guidance we have received through the CPCoE to this point has  been integral in developing our foundation for growth and we look forward to supporting them through  furthering their national data collection,” said Steven Inglefield, Chief Executive Officer of IRP Health and  Chief Operating Officer of Wellbeing.  

“We are pleased that IRP Health continues to make strides toward improving the lives of veterans and first  responders through the Reactivation program. To be recognized as being a national network of clinics that  works with Canadian veterans, IRP Health is evolving in positive ways. We are proud of the Subsidiary for  becoming part of the CPCoE and helping veterans and their families. As part of Wellbeing, IRP Health is  focused on enriching the lives of its patients and raising the bar for outstanding mental healthcare,” said  Najla Guthrie, Chief Executive Officer of Wellbeing.  

ABOUT IRP HEALTH  

Founded in 2016, IRP began as a rehabilitation and performance centre offering exercise therapy and  rehabilitation programs in Victoria, British Columbia. IRP builds safe and supportive environments while  demonstrating modern, evidence-based physical rehabilitation programs designed specifically for the needs  of veterans and first responders. Building on the success of over 15,000 treatments in the flagship Victoria  location. IRP is adding new locations and programs to improve access to much needed treatments. More  information about IRP Health can be found on its website: https://www.irphealth.ca 

ABOUT WELLBEING DIGITAL SCIENCES  

Wellbeing Digital Sciences Inc. is an evidence-based mental healthcare company focused on the  development and implementation of innovative clinical solutions, including psychedelic medicine and  digital therapeutics, as supported by clinical research. Its mission is supported by a network of North  American clinics that provide forward-thinking therapies and other types of treatment to patients as well as  through a contract research organization that offers clinical trials services to clients pursuing drug  development. In essence, the Company exists to make breakthrough treatments more accessible and to offer  patients transformational experiences. 

On behalf of:  

WELLBEING DIGITAL SCIENCES INC. 

“Najla Guthrie” 

Najla Guthrie, CEO  

For further information, please contact:  

Nick Kuzyk, Investor Relations  

Tel: 1-844-746-6351  

Email: ir@wellbeingdigital.co  

Web: www.wellbeingdigital.co 

Twitter: @Wellbeing_IR  

Notice Regarding Forward-Looking Information: 

This news release contains forward-looking statements including but not limited to statements regarding  the Company’s business, assets or investments, as well other statements that are not historical facts. Readers  are cautioned not to place undue reliance on forward-looking statements, as there can be no assurance that  the plans, intentions or expectations upon which they are based will occur. By their nature, forward-looking  statements involve numerous assumptions, known and unknown risks and uncertainties, both general and  specific, that contribute to the possibility that the predictions, forecasts, projections and other forward 

looking statements will not occur, which may cause actual performance and results in future periods to  differ materially from any estimates or projections of future performance or results expressed or implied by  such forward-looking statements. These assumptions, risks and uncertainties include, among other things,  the state of the economy in general and capital markets in particular, investor interest in the business and  prospects of the Company.  

The forward-looking statements contained in this news release are made as of the date of this news release.  Except as required by law, the Company disclaims any intention and assumes no obligation to update or  revise any forward-looking statements, whether as a result of new information, future events or otherwise,  except as required by applicable securities law. Additionally, the Company undertakes no obligation to  comment on the expectations of, or statements made, by third parties in respect of the matters discussed  above.  

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Treat pain and mental health simultaneously

Tasmanian ketamine study to treat chronic pain patients

About 60% of patients with chronic pain also suffer from a second condition like depression or anxiety.

A University of Tasmania researcher predicts that ketamine therapy will have a “dual beneficial effect” on both pain and mental health.

Other chronic pain experts share this belief. “The domains of pain, anxiety and depression are all connected. If you treat one, another often gets better,” according to researcher Dr. David Borsook.

The hypothesis will be put to the test in an upcoming study of 30 chronic pain patients, which received a $80K grant from the Clifford Craig Foundation.

The Examiner

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24 hour trip anyone?

MINDCURE Achieves Key Development Milestone for Novel Ibogaine Program

Tripping on ibogaine can last over 24 hours, and it’s not always pleasant. But the wide range of benefits could make it worthwhile. 

MINDCURE (MCUR) hopes so at least. The company filed a provisional patent for synthetic ibogaine mixtures to treat various central nervous system disorders like:

  • Addiction
  • Traumatic brain injury
  • Anxiety disorders
  • Chronic pain such as migraines and cluster headaches

The company aims to be a global supplier of synthetic ibogaine for research purposes and expects to have supply available by the end of Q2 this year.

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Blackhawk Subsidiary Digital Mind Technology Starts Phase 1 Development of Digital Therapeutic Platform and is on Track for Completion in Q2, 2022

Blackhawk Subsidiary Digital Mind Technology Starts Phase 1 Development of Digital Therapeutic Platform and is on Track for Completion in Q2, 2022

  • Phase 1 development of new digital therapeutic platform underway 
  • Pilot study in 69 patients completed 
  • Helping cancer patients live better with pain 
  • Improved mental health outcomes in pain management 

Vancouver, British Columbia – TheNewswire – February 17, 2022 – Blackhawk Growth Corp. (CSE:BLR); (CNSX:BLR.CN); (OTC:BLRZF); (Frankfurt:0JJ) (the “Corporation” or “Blackhawk”), is pleased to announce that its subsidiary, Digital Mind Technology Pty. Ltd. (“DMT”) has started its phase 1 development of a digital therapeutic application designed for treating cancer patients experiencing pain and at risk of mental health disorders. DMT expects to complete phase 1 in Q2, 2022,

DMT’s clinical trials in cancer patients aim to develop a mindfulness intervention that is useful in pain management.  Pain, endured for any length of time unsustainably can result in low mood and lead to depression, anxiety and other related mental health disorders.  The mindfulness intervention will be designed to manage negative patterns of thoughts and behaviours.

With pain being one of the most common symptoms reported by nearly 70% of cancer patients1, DMT is creating a digital therapeutic application and web platform between patients and clinicians that can be used by patients to more effectively deal with pain.

Cancer pain remains a challenging symptom occurring long after treatment completion, with a prevalence of 20-50% in cancer survivors.2  The burden of mental health disorders appearing as a co-morbidity in cancer patients is high with around a quarter of cancer patients experiencing depression 3-5.  A cancer diagnosis is life changing and in itself is a source of considerable psychological and emotional distress.

Dr Russell says: “In our pilot clinical trial in 69 patients, we saw that a digital therapeutic was helpful in treating cancer patients cope with fear of cancer recurrence. We are progressing well with our digital therapeutics platform to help cancer patients cope with pain that will have substantial benefit to mental health and wellbeing”.

  1. Van Den Beuken-Van MH, Hochstenbach LM, Joosten EA, Tjan-Heijnen VC, Janssen DJ. Update on prevalence of pain in patients with cancer: systematic review and meta-analysis. Journal of pain and symptom management. 2016;51(6):1070-1090. e1079. 
  2. Gallaway MS, Townsend JS, Shelby D, Puckett MC. Peer Reviewed: Pain Among Cancer Survivors. Preventing Chronic Disease. 2020;17. 
  3. Naser AY, Hameed AN, Mustafa N, et al. Depression and Anxiety in Patients With Cancer: A Cross-Sectional Study. Frontiers in Psychology. 2021;12(1067). 
  4. Pitman A, Suleman S, Hyde N, Hodgkiss A. Depression and anxiety in patients with cancer. BMJ. 2018;361:k1415. 
  5. Hartung TJ, Brähler E, Faller H, et al. The risk of being depressed is significantly higher in cancer patients than in the general population: Prevalence and severity of depressive symptoms across major cancer types. European Journal of Cancer. 2017;72:46-53. 

About Blackhawk Growth

Blackhawk is an investment holding company looking to create substantial value for its shareholders through the acquisition and development of high growth companies. It has focused its investments in the health, cannabis and cannabidiol industries in both Canada and the United States. Its portfolio of companies includes Sac Pharma, TERP Wholesale LLC, LeichtMind Clinics, Noble Hemp, Spaced Food, NuWave Foods, Digital Mind Therapeutics and MindBio Therapeutics, as well as a share position in Gaia Grow Corp. (CSE:GAIA).

The Company diligently posts updates through videos from the official company YouTube channel https://www.youtube.com/channel/UCs4f2tt3yAvOGhNLjgNOy-A  

Please join the conversation on our Blackhawk group supporter’s telegram group at https://t.me/Blackhawkgrowthcorp and visit us online at https://www.blackhawkgrowth.com.

For further information please contact:

Frederick Pels, Chief Executive Officer

(403)-991-7737

fred@blackhawkgrowth.com

Cautionary Note Regarding Forward-Looking Statement

All statements in this press release, other than statements of historical fact, are “forward-looking information” with respect to the Company within the meaning of applicable securities laws, including with respect to the development of a digital therapeutic application by Digital Mind Technology Pty. Ltd. The Company provides forward-looking statements for the purpose of conveying information about current expectations and plans relating to the future and readers are cautioned that such statements may not be appropriate for other purposes. By its nature, this information is subject to inherent risks and uncertainties that may be general or specific and which give rise to the possibility that expectations, forecasts, predictions, projections or conclusions will not prove to be accurate, that assumptions may not be correct and that objectives, strategic goals and priorities will not be achieved. These risks and uncertainties include but are not limited those identified and reported in the Company’s public filings under the Company’s SEDAR profile at www.sedar.com. Although the Company has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking information, there may be other factors that cause actions, events or results not to be as anticipated, estimated or intended. There can be no assurance that such information will prove to be accurate as actual results and future events could differ materially from those anticipated in such statements. The Company disclaims any intention or obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise unless required by law.

Copyright (c) 2022 TheNewswire – All rights reserved.

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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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Healing veterans with DMT

DMT and PTSD

In honour of Veteran’s Day, we’re sharing the story of how a Special Ops veteran changed his life with DMT.

Asher Gibson was diagnosed with PTSD and traumatic brain injury after countless combats across the world. Prescription medications began to dominate his life, so he turned to psychedelic healing.

After smoking DMT, the powerful compound found in ayahuasca, Asher was blasted out of his body and traveled through different dimensions to the beginning of time.

“I remember my whole head being ecstatic and numb, like the most wonderful electrical massage on my brain. The feeling moved down my neck and shoulders and eventually filled my entire body.”

After the trip, Asher’s debilitating neck and shoulder pain was almost non-existent and his mental state subsided to manageable levels. He is no longer dependent on prescription drugs.

“While DMT isn’t the magic button that fixes everything, I believe it’s a powerful guide to help you do the work yourself,” he explains.

To bring this kind of relief to other veterans, consider supporting the Heroic Hearts Project – a non-profit organization that provides ayahuasca retreats for veterans with combat experience or military sexual trauma.

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