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PharmaTher Expands Psychedelic Patent Portfolio with Filing of U.S. Patent Application for Novel Ketamine Formulation

  • Strengthens position to become a leader in the intradermal delivery of FDA prescription-based ketamine products
  • Supports commercializing novel uses and delivery methods of psychedelics
TORONTO, July 21, 2021 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, today announced that it has filed a provisional patent application with the U.S. Patent and Trademark Office outlining a novel formulation of ketamine for intradermal administration as potential treatments for mental health, neurological and pain disorders.  The Company’s intellectual property portfolio includes 19 granted patent and patent applications filed in over 150 countries.

Fabio Chianelli, CEO of PharmaTher, commented:  “As we continue to advance our clinical programs with ketamine, we are building a robust intellectual portfolio of potential prescription-based ketamine products and psychedelics through novel uses, formulations and delivery forms to treat various diseases and disorders.  I am pleased with our continued dedication to becoming a leader of novel ketamine products and implementing a patent strategy that would protect our clinical development and commercialization initiatives.”

The patent application, entitled “Methods and Compositions of Ketamine Formulation for Intradermal Administration,” describes the potential improvement and therapeutic value of ketamine by delivering it through the skin.  Intradermal drug delivery, defined as bypassing the outermost layer of the skin (the stratum corneum) by a suitable device (i.e. patch or spray) and depositing the drug in the underlying viable skin layers (the epidermis and dermis), is an attractive alternative drug delivery approach employed to overcome certain drug administration challenges present in oral, subcutaneous and intramuscular injections, intravenous, and intranasal delivery.  Also, intradermal delivery methods and compositions provide the potential for significant reduction of skin irritation, rapid and controlled drug uptake, pharmacodynamics and pharmacokinetics, as well as improved bioavailability and deposition of the drug at a pre-specified volume.

PharmaTher is positioning itself as an innovator of novel uses, formulations and delivery forms of ketamine.  PharmaTher has a robust pharmaceutical pipeline including, an FDA approved IND to conduct a Phase 2 clinical trial evaluating ketamine to treat Parkinson’s disease, and upcoming clinical studies with KETABET™ (ketamine and betaine) for depression and ketamine for amyotrophic lateral sclerosis (Lou Gehrig’s disease).

The Company also focuses on incorporating psychedelics (i.e. ketamine, psilocybin, DMT, MDMA and LSD) in a microneedle patch with the potential to improve on the safety (i.e. fewer side effects), efficacy (i.e. bioavailability, optimized dosing regimen including continuous system delivery) and compliance (i.e. storage, distribution and self-administration) of these compounds.

In addition, the Company continues to evaluate novel uses of ketamine that would follow the FDA 505(b)(2) regulatory pathway targeting rare disorders that could receive orphan drug designation and large market indications that the FDA could grant fast track designation.  As a result, certain PharmaTher current and future programs have the potential to meet the requirements for these FDA designations.

About PharmaTher Holdings Ltd.

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

For more information about PharmaTher, please contact:

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

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

Cautionary Statement

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

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

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PharmaTher To Participate in Grizzle Psychedelics Con

TORONTO, June 28, 2021 (GLOBE NEWSWIRE) — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, today announced that Fabio Chianelli, Chief Executive Officer, will participate in the Grizzle Psychedelics Con today at 12 PM ET.
“I am very excited to participate in this one-of-a-kind virtual investor conference made possible by Grizzle Media, who has built an amazing platform and dedicated following of institutional and retail investors seeking investment ideas in high growth sectors such as psychedelics,” said Fabio Chianelli, CEO of PharmaTher. “I encourage everyone to attend this event and I look forward to discussing PharmaTher’s promising psychedelics product pipeline and strategy including our FDA Phase 2 clinical study with ketamine to treat Parkinson’s disease and our novel microneedle patch to deliver psychedelics for mental health, neurological and pain disorders.”

The details of the Grizzle Psychedelics Con are as follows:

Start Date: Monday, June 28, 2021 at 12 PM ET

Fabio Chianelli, CEO, Presenting Time: 2:15 PM ET

Conference Website: https://grizzle.com/psychedelics-con-2021/

Watch Live: https://www.youtube.com/watch?v=Red-_CXhLmY

The Grizzle Psychedelics Con will also be available thereafter.

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

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

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

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

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PharmaTher To Present At The H.C. Wainwright Psychedelics In Psychiatry And Beyond Virtual Conference

TORONTO, June 16, 2021 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, today announced that Fabio Chianelli, Chief Executive Officer, will be presenting at the H.C. Wainwright Psychedelics in Psychiatry and Beyond Virtual Conference on June 17, 2021.
The corporate presentation will be available on-demand starting at 7:00 am ET.  For more information about this event and to attend, visit: https://hcwevents.com/psychedelics/.

As previously announced, the Company provided an update on its research and development initiatives including the FDA Phase 2 study with ketamine to treat Parkinson’s disease, a Phase 2 study with KETABET™ for treatment-resistant depression, and the development of novel microneedle patches for delivering psychedelics such as ketamine, psilocybin, DMT, MDMA and LSD. 

For more information about PharmaTher’s activities, visit www.PharmaTher.com.

About PharmaTher Holdings Ltd.

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

For more information about PharmaTher, please contact:

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

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

Cautionary Statement

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

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

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

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

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

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

The Potential of KETABET™

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

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

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

The Potential of the Hydrogel-forming Microneedle Patch

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

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

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

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

About PharmaTher Holdings Ltd.

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

For more information about PharmaTher, please contact:

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

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

Cautionary Statement

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

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

Sources:

  1. J.-C. Lin, M.-Y. Lee, M.-H. Chan, Y.-C. Chen, H.-H. Chen, Betaine enhances antidepressant-like, but blocks psychotomimetic effects of ketamine in mice, Psychopharmacology (Berl). 233 (2016) 3223–32
  2. Krystal et al. 1994; Perry et al. 2007
  3. Murrough et al. 2013; Wan et al. 2014
  4. Ionescu et al. 2015; Nugent et al. 2014; Rybakowski et al. 2013
  5. Aligeti et al. 2014; Thakurta et al. 2012; Zigman and Blier 2013
  6. Feder et al. 2020
  7. ​Freed 1984; 1985
  8. Kim et al. 2013; Di Pierro et al. 2015
  9. Percy and Lane 2005
  10. van der Westhuyzen and Metz 1984
  11. ​Chai et al. 2013
  12. Donnelly R.F. Hydrogel-forming microneedles prepared from “super swelling” polymers combined with lyophilised wafers for transdermal drug delivery. PLoSONE. 2014 doi: 10.1371/journal.pone.0111547.
  13. Courtenay, et al. Hydrogel-forming microneedle arrays as a therapeutic option for transdermal esketamine delivery, Journal of Controlled Release, Volume 322, 2020, Pages 177-186.
  14. https://www.fda.gov/news-events/press-announcements/fda-approves-new-nasal-spray-medication-treatment-resistant-depression-available-only-certified
  15. https://www.fiercepharma.com/pharma/j-j-s-depression-nasal-spray-spravato-carrying-big-expectations-and-restrictions-scores-fda
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PharmaTher Provides Research and Development Update and Milestones for 2021

TORONTO, June 10, 2021 (GLOBE NEWSWIRE) — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, is pleased to provide an update on the research and development initiatives of its psychedelic product programs and upcoming milestones for 2021
“We are well-positioned, both financially and operationally, to execute on our remaining milestones for 2021, which includes completing a Phase 2 study with ketamine to treat Parkinson’s disease, a Phase 2 study with KETABET™ for treatment-resistant depression, and the development of our novel microneedle patches for delivering psychedelics such as ketamine, psilocybin, DMT, MDMA and LSD,” said Fabio Chianelli, CEO of PharmaTher.  “The recent FDA acceptance of our IND to proceed to a Phase 2 study in Parkinson’s disease will pave the way for us to confidently submit future IND’s and advance clinical studies evaluating novel uses, formulations and delivery forms of psychedelics to treat various mental health, neurological and pain disorders.”

FDA Phase 2 Clinical Studies

For the rest of 2021, PharmaTher will focus on advancing three promising developments through clinical studies:

Ketamine for Parkinson’s Disease

Following the FDA acceptance of the Company’s investigational new drug application to proceed with a Phase 2 clinical trial to evaluate the safety, efficacy and pharmacokinetics of ketamine in the treatment of levodopa-induced dyskinesia in patients with Parkinson’s disease, the Company has begun clinical trial start-up activities to begin enrolling patients in Q3-2021 and to announce clinical results in Q4-2021.

For those interested in the study (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.

Assuming the Phase 2 clinical trial is positive, the Company will request a meeting with the FDA to discuss its plan and obtain an agreement to move to a Phase 3 clinical study under the 505(b)2 regulatory pathway in 2022.

KETABET™ for Treatment-Resistant Depression

The Company is preparing a pre-IND meeting request and briefing documents to submit to the FDA to support the clinical development of KETABET™ and the Phase 2 study for treatment-resistant depression.  The Company intends to file the pre-IND meeting request this month, obtain FDA feedback on its clinical study design, and file the IND in Q3-2021.

With the overlap of the clinical operations from the Parkinson’s disease study, the Company has already activated start-up activities and identified potential clinical sites to screen and enroll patients for the proposed Phase 2 study in Q3/Q4-2021.  The aim is to share clinical results by the end of this year.

Amyotrophic Lateral Sclerosis (“ALS” or “Lou Gehrig’s Disease”)

Following the Company’s recent submission to receive orphan drug designation for ketamine to treat ALS, the Company is working with its clinical advisors in finalizing a proposed Phase 2 study design. The objective is to request a pre-IND meeting with the FDA in Q3-2021 and submit the IND in Q4-2021.

PharmaTher has an exclusive license agreement with the University of Kansas for the intellectual property protecting the potential use of ketamine to treat ALS, which was discovered by Dr. Richard J. Barohn, M.D., John A. Stanford, Ph.D., and Dr. Matthew Macaluso, D.O.  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.

Microneedle Patch for the Delivery of Psychedelics

For the second half of 2021, PharmaTher will focus on working with its research and development partners to advance next generation microneedle patches for the delivery of psychedelics:

Hydrogel-Forming Microneedle Delivery System for Ketamine

PharmaTher is working with Professor Ryan Donnelly under a research agreement with The Queen’s University of Belfast to finalize the patented hydrogel-forming microneedle patch development to deliver ketamine and KETABET™.

The research leverages the successful proof of concept achieved in delivering esketamine, the S(+) enantiomer of ketamine, via the microneedle patch, which may overcome the drawbacks associated with ketamine administration in an intravenous or nasal spray format.  Details of the research can be found in a published paper titled “Hydrogel-forming microneedle arrays as a therapeutic option for transdermal esketamine delivery.”

Validation and tech transfer to support clinical studies will be completed in Q4-2021.  Interim development results will be made available as they arise throughout 2021.

Microdosing Psychedelics with GelMA Microneedle Delivery System

The Company is working with the Terasaki Institute, led by Dr. Ali Khademhosseini, under a research agreement to finalize the development of a proprietary microneedle delivery system comprised of a biocompatible and biodegradable gelatin methacryloy (“GelMA”) composite for use with psychedelics such as psilocybin, DMT, MDMA and LSD.

The GelMA patch delivery system is the driving force of the Company’s psychedelics microdosing program. It is expected that validation results in delivering these psychedelics will be completed in Q4-2021.  Interim development results will be made available as they arise throughout 2021.

Clinical Manufacturing and Supply

The Company entered into a Co-Development Agreement with TSRL, Inc. to jointly develop a patented hydrogel-forming microneedle patch delivery technology licensed from The Queens University of Belfast, to control the manufacturing and supply of microneedle patches for the Companies respective clinical and commercial drug programs.

PharmaTher is focused on incorporating psychedelics (i.e. ketamine, psilocybin, DMT, MDMA and LSD) and TSRL is focused on incorporating antiviral medications (i.e. Zanamivir, other antiviral therapeutics and vaccines) in a microneedle patch with the potential to improve the safety (i.e. fewer side effects), efficacy (i.e. bioavailability, optimized dosing regimen including continuous system delivery) and compliance (i.e. storage, distribution and self-administration) of these compounds that currently must be taken orally, inhaled, injected and intravenously.

Recent activities included the tech transfer for scale-up and manufacturing of clinical supplies to a GMP contract research lab and a pre-IND meeting with the FDA that achieved agreement with the agency on proposed 505(b)2 product development plans.

The Company aims to validate clinical production of the microneedle patch this year and to enter into clinical studies in 2022 to deliver certain psychedelics such as ketamine, psilocybin, DMT, MDMA and LSD.

About PharmaTher Holdings Ltd.

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

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

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

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

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

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PharmaTher and TSRL Enter into Co-Development Agreement For Microneedle Patch Delivery Technology for Psychedelics and Antivirals

TORONTO, June 1, 2021 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company and TSRL, Inc. (“TSRL”), a company focused on developing microneedle patches for the delivery of antivirals for the treatment of influenza, are pleased to announce that PharmaTher and TSRL (collectively the “Companies”) entered into a Co-Development Agreement to jointly develop a microneedle array patch with the aim to control the manufacturing and supply of microneedle patches for the Companies respective clinical and commercial drug programs.
PharmaTher and TSRL share the commitment to commercialize a patented hydrogel-forming microneedle patch delivery technology licensed from Queens University of Belfast.  PharmaTher is focused on incorporating psychedelics (i.e. ketamine, psilocybin, DMT, MDMA and LSD) and TSRL is focused on incorporating antiviral medications (i.e. Zanamivir, other antiviral therapeutics and vaccines) in a microneedle patch with the potential to improve on the safety (i.e. fewer side effects), efficacy (i.e. bioavailability, optimized dosing regimen including continuous system delivery) and compliance (i.e. storage, distribution and self-administration) of these compounds that currently must be taken orally, inhaled, injected and intravenously.
TSRL is comprised of a team of pharma industry veterans with deep drug development expertise, ranging from discovery and preclinical development to clinical, regulatory, and IP strategy development.  TSRL’s facility is based in Ann Arbor, Michigan, and is positioned as a preclinical accelerator for anti-infective therapeutic product concepts, with an emphasis on improving dosing regimens and outcomes of approved product with suboptimal market uptake. TSRL has performed in-house optimization of the Zanamivir drug-device combination product, and initiated tech transfer for scale-up and manufacturing to toxicology and clinical supplies to a GMP contract research lab. TSRL has successfully conducted a pre-IND meeting with the US FDA and achieved agreement with the agency on their proposed 505(b)2 product development plans.
Fabio Chianelli, CEO of PharmaTher commented:  “We are very excited to collaborate with TSRL as they have de-risked certain technical and manufacturing aspects of the microneedle patch and by sharing our resources it will allow PharmaTher to expedite the clinical and commercial development of the microneedle patch with ketamine and other psychedelics.  Also, the collaboration will ensure control over the manufacturing and supply of microneedle patches for not only both of our respective product programs, but also it may unlock future commercial partnering opportunities with pharmaceutical companies seeking a microneedle patch delivery system.”
Dr. Elke Lipka, CEO of TSRL commented: “We are delighted to join forces with PharmaTher, as this collaboration will allow us to execute our respective lean development strategies for the manufacturing of the microneedle array and ultimately the array/drug reservoir combination product. In addition to increased cost effectiveness, there is substantial strategic overlap between our two organization with respect to the regulatory strategy for our product candidates. Microneedle-enabled drug delivery is at the cusp of becoming one of the most promising approaches to achieve carefully tuned systemic delivery of therapeutics and vaccine.”

Microneedle-enhanced intradermal delivery is an elegant, efficient and painless method for increasing the skin permeation of many drugs, including psychedelics, antiviral therapeutics and vaccines.
Transdermal delivery systems offer a number of advantages over inhalation and IV administration. Our approach consists of a 2-part system comprised of a drug-loaded reservoir that is 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 directly enters the systemic circulation, circumventing absorption and first-pass barriers typical for oral delivery. Our studies show that with transdermal delivery, systemic drug concentrations are reached within minutes after administration and are maintained over multiple days. This system addresses a major unmet need by offering greater ease of administration, inclusion of patients with pre-existing conditions that exempt them from oral or inhalation dosing. It avoids syringe needles, eliminating pain and patient visits to a clinician. We also anticipate that patient compliance will be improved with a self-administered transdermal patch.
About TSRL, Inc.    

TSRL, Inc. collaborates with partners in academia and industry to develop anti-infective therapeutics and drug delivery technologies. In these collaborations, TSRL provides infrastructure, drug development expertise, and access to non-dilutive funding. TSRL’s portfolio holds promising lead-stage anti-infective therapeutics. More information about TSRL and portfolio technologies are available at TSRLinc.com.

About PharmaTher Holdings Ltd.

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

For more information about PharmaTher, please contact:

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

For more information about TSRL, please contact:

Elke Lipka, PhD, MBA
Chief Executive Officer
TSRL, Inc.
Tel:  734-663-4233
Email: elipka@tsrlinc.com
Website: www.tsrlinc.com

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

Cautionary Statement

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

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

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PharmaTher Collaborates with MediSynergics to Develop Patented Ketamine Formulation for Pain Disorders and to Discover Novel Psychedelic Formulations

TORONTO, May 27, 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 entered into a collaboration agreement with MediSynergics, LLC. (“MediSynergics”), a drug discovery company, to develop MediSynergics patented ketamine derivatives for pain and other CNS disorders and to investigate drug discovery and development of next-generation psychedelic derivatives, such as psilocybin, N,N-Dimethyltryptamine (“DMT”), 3,4-Methyl​enedioxy​methamphetamine (“MDMA”) and lysergic acid diethylamide (“LSD”), mescaline, and ibogaine.
PharmaTher and MediSynergics will initially collaborate to advance the research of MediSynergics patented ketamine derivatives as an alternative to opioid medications for pain disorders using predictive preclinical animal models.  Efficacy of the patented ketamine derivatives were demonstrated to be comparable or better than ketamine when tested in a murine capsaicin inflammatory pain model.  The patented ketamine compounds are derivatives discovered by MediSynergics of which the majority were determined in preclinical in vitro binding affinity studies to not bind to the NMDA receptor, suggesting they may have fewer side effects that have limited ketamine’s use as a pain treatment. In parallel, MediSynergics, out of its research and controlled-substance licensed laboratory, is planning to evaluate novel formulations of psychedelics for clinical development to advance through the FDA regulatory pathway.

MediSynergics was founded over eleven years ago by two former Pfizer drug discovery researchers, Mr. Dennis Godek, M.A., CEO and Mr. Harry R. Howard, M.S., CSO, having extensive experience in CNS and infectious disease therapeutic areas.  Since then, MediSynergics has secured 12 patents, two provisional patents in the U.S., and has discovered ketamine derivatives that potentially have changed the pharmacology of ketamine.  Mr. Howard, Chief Scientific Officer of MediSynergics, co-discovered the $1 billion atypical antipsychotic drug ziprasidone (Geodon™, Zeldox™) which is used to treat schizophrenia and mania.  Mr. Howard also developed expertise in the design of novel compounds to treat CNS disorders including depression and ADHD and is listed as an inventor of 58 U.S. patents issued to Pfizer Inc. and named on 71 U.S. and Worldwide patents.

Fabio Chianelli, Chief Executive Officer of PharmaTher, said, “We are excited to work with MediSynergics in the discovery and development of novel psychedelic derivatives and formulations for pain and CNS disorders.  This drug discovery and development collaboration complement our current strategy of finding novel uses and delivery forms of psychedelics by diversifying our product pipeline and building our product lifecycle plans with robust intellectual property and know-how, as well as strengthening our drug discovery and development capabilities with experienced chemists that have FDA drug approvals on their resume. We continue to focus on our core competencies in quickly advancing our ketamine programs to clinical studies and developing our novel microneedle patch for the intradermal delivery of psychedelics. The addition of our drug discovery division focused on novel psychedelic formulations uniquely position us as an up-and-coming player in prescription-based psychedelics for unmet medical needs and partnering opportunities.”

Dennis Godek, Chief Executive of MediSynergics, said, “We are extremely pleased to be working with PharmaTher to help advance the development of ketamine derivatives and the future potential of novel psychedelic derivatives and formulations for treating CNS disorders of unmet medical need.  The benefits of ketamine for treatment resistant depression are already being realized by patients with FDA approval in 2019.  It is hoped that the discovery and development of novel psychedelics and formulations will greatly benefit patients suffering from debilitating neurological illnesses.”

Under the collaboration agreement, PharmaTher and MediSynergics will share the results of the ketamine program and will work toward exclusive licensing of any of the inventions that show potential entering into clinical studies.

About PharmaTher Holdings Ltd.

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

For more information about PharmaTher, please contact:

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

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

Cautionary Statement

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

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

Posted on

PharmaTher Files for FDA Orphan Drug Designation for Ketamine to Treat Lou Gehrig’s Disease

TORONTO, May 25, 2021 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, is pleased to announce that it has filed an application with the U.S. Food and Drug Administration (“FDA”) to receive Orphan Drug Designation (“ODD”) for ketamine to treat amyotrophic lateral sclerosis (“ALS”), also known as Lou Gehrig’s disease.
ALS is a progressive neuromuscular disease with a life expectancy of only two to six years after diagnosis. Currently, there is no known cure for ALS. ALS affects approximately 50,000 people in the U.S. and Europe, with over 5,000 new cases diagnosed annually. As ALS advances, upper and lower motor neurons die, causing the brain to lose its ability to control muscle movement. ALS patients experience progressive loss of voluntary muscle action as an effect of the disease, resulting in the inability to speak, eat, move and, eventually, breathe. The FDA approved only three pharmaceuticals for the treatment of ALS: riluzole, edaravone, and Nuedexta (dextromethorphan HBr and quinidine sulfate). These drugs are effective against disease mechanisms of ALS but fail to have measurable effects on attenuating disease progression or improve survival. Therefore, there is an imperative need for new pharmacological therapies that can stop or slow the muscle decline associated with ALS progression and extend the life expectancy of the ALS patient.  Peak sales for a new drug to treat ALS has the potential to achieve over USD $1 billion.

The rationale for ketamine as a potential treatment for 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. 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.

Ketamine works by blocking the action of the ionotropic glutamate receptor, the NMDA receptor. Unlike other inhibitors of NMDA receptor function, such as riluzole, ketamine dampens NMDA receptor-related glutamate excitotoxicity indirectly. Further, ketamine can lower D-serine concentrations intracellularly and also partially activates dopamine receptors. Collectively, these mechanisms of ketamine contribute in part to the drug’s neuroprotective effects, which may extend to the motor neurons targeted in ALS.
PharmaTher previously announced that it has entered into an exclusive license agreement with The University of Kansas for the development and commercialization of the intellectual property of ketamine in the treatment of ALS.

Fabio Chianelli, Chief Executive Officer of PharmaTher, said, “Ketamine has tremendous potential for not only mental illness and pain disorders but also for neurodegenerative diseases such as ALS.  Our FDA orphan drug application for ketamine to treat this life-threatening disease complements our patent portfolio that aims to protect the proposed method of use and dosage claims of ketamine for ALS.  Although patent protection or market exclusivity could last beyond 2040, our intention to seek orphan drug designation is to leverage the expedited regulatory and clinical development incentives offered by the FDA for repurposed drugs in treating rare diseases.  We are working with our clinical and regulatory advisors in preparing our clinical development plan and study protocol while leveraging our recent investigational new drug application approved by the FDA for Parkinson’s disease to proceed with a potential phase 2 clinical study in ALS patients this year.”

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. The incidence of ALS is well within the limit of 200,000 for orphan indication status. 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 to treat mental illness, neurological and pain disorders.  PharmaTher is currently conducting an FDA approved phase 2 clinical study with ketamine to treat Parkinson’s disease and is developing a novel microneedle patch for the intradermal delivery of psychedelics.
​
Learn more at:  PharmaTher.com and follow us on Twitter and LinkedIn.

For more information about PharmaTher, please contact:

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

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

Cautionary Statement

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

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

Posted on

Accomplished Clinical Researcher Matthew Macaluso Joins as Scientific and Clinical Advisor for PharmaTher’s Ketamine Programs

TORONTO, May 20, 2021 — PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (CSE: PHRM) (OTCQB: PHRRF), a psychedelics biotech company, is pleased to announce the appointment of Professor Matthew Macaluso, D.O. as a scientific and clinical advisor for PharmaTher’s clinical research programs involving ketamine as a potential treatment for major depressive disorders and amyotrophic lateral sclerosis (“ALS” or “Lou Gehrig’s Disease”).
Matthew Macaluso, D.O. is an academic psychiatrist with over ten years of extensive clinical trial research experience involving novel drugs to treat those patients with refractory and often severe forms of depression that are not responsive to currently marketed drugs. He is the Bee McWane Reid Professor for the Department of Psychiatry and Behavioral Neurobiology in the School of Medicine at The University of Alabama at Birmingham (“UAB”).  Professor Macaluso is also the Clinical Director of the UAB Depression and Suicide Center. He has been principal investigator on over 60 trials of novel investigational medications with a focus on treatment resistant major depression, including studies involving ketamine and esketamine.

Fabio Chianelli, CEO of PharmaTher commented: “We are excited to have Matt join us as a scientific and clinical advisor.  Matt has extensive experience in conducting clinical studies involving depression, including being a principal investigator of clinical studies involving esketamine which led to an FDA approval.  He is also a co-inventor for the novel use of ketamine as a potential treatment for ALS.  We look forward to his contributions in guiding us in our clinical development initiatives with ketamine in various neuropsychiatric and neurodegenerative diseases that we are pursuing.”

Professor Macaluso commented: “It is well known in the literature and clinical practice that ketamine has tremendous potential in various CNS and neurological disorders.  I am intrigued by PharmaTher’s passion in pursuing ketamine in clinical trials that could offer hope to those who require a safe and effective treatment option that will ultimately improve their quality of life. I look forward to guiding PharmaTher’s clinical strategy and advancing their clinical programs with the intent to obtain regulatory approvals.”

About PharmaTher Holdings Ltd.

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

For more information about PharmaTher, please contact:

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

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

Cautionary Statement

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

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

Posted on

Revive Therapeutics Enters into Feasibility Agreement with LTS Lohmann to Develop Oral Psilocybin Thin Film Strip

TORONTO, May 17, 2021 – Revive Therapeutics Ltd. (“Revive” or the “Company”) (CSE: RVV, USA: RVVTF, FRANKFURT: 31R), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is pleased to announce it has entered into a feasibility agreement with LTS Lohmann Therapie-Systeme AG (“LTS”), a leader in pharmaceutical oral thin films, to develop and manufacture a proprietary oral psilocybin thin film strip for the Company’s clinical and commercial initiatives to evaluate in mental illness, neurological and substance abuse disorders.

“We are very excited to work with LTS, as one of the world’s largest innovators and suppliers of oral thin films, to develop our proprietary oral psilocybin thin film strip product for pharmaceutical use,” said Michael Frank, CEO of Revive. “Revive positioned itself as an innovator of novel uses and delivery forms of psilocybin, as a potential treatment for unmet medical needs. Revive, with our relationship with LTS, will be able to expedite its clinical and commercial ambitions with psilocybin as a pharmaceutical, globally.”

Over the last twelve months, the Company has been focused on creating relationships and building a robust psilocybin-based product pipeline that includes novel uses, formulations, oral thin film delivery and biosynthetic forms of psilocybin. The Company collaborated with University of Wisconsin-Madison to develop an oral thin film technology and is engaged with North Carolina State University to develop a novel biosynthetic version of psilocybin based on a natural biosynthesis enzymatic platform developed by Dr. Gavin Williams. Also, Revive is working with the University of Wisconsin to evaluate psilocybin as a potential treatment of methamphetamine use disorder and it recently submitted an application with the U.S. Food and Drug Administration (“FDA”) to receive Orphan Drug Designation (“ODD”) for psilocybin to treat traumatic brain injury, based in part of the research program acquired from PharmaTher Holdings Ltd. (CSE: PHRM) (OTCQB: PHRRF).

There are a number of advantages and benefits of an orally dissolvable psilocybin thin film such as the rapid dissolving and onset of action to the bloodstream, the ease and convenience for patients to administer without the need of water, chewing or swallowing, the potential of improved therapeutic outcomes and efficacy for underserved diseases and disorders including the flexibility to create accurate dosing and tasteful options.

“At LTS, we are unrelenting in our commitment to make life better for patients,” comments Bas van Buijtenen, CEO of LTS. “Under this agreement, we will deploy our full expertise and experience to the development of new therapeutic options in an area that fits perfectly with our strategic focus. The cooperation with Revive is an opportunity to demonstrate once again how LTS creates commercial value at every stage of development.”

Under the terms of the Agreement, LTS shall perform certain formulation development of oral psilocybin thin films, to support preclinical studies for the product development, as well as GMP manufacturing of clinical trial supplies.

Revive cautions that psilocybin is still under early-stage research and development and is not making any express or implied claims as to their success in the treatment of mental illness, neurological and substance abuse disorders or commercial viability.

About LTS Lohmann Therapie-Systeme AG

LTS Lohmann Therapie-Systeme AG is a leading pharmaceutical technology company that develops and manufactures innovative drug delivery systems such as Transdermal Patches (“TTS”) and Oral Thin Films (“OTF”) for the pharmaceutical industry. LTS’s commercial offering encompasses more than 20 marketed products and a diverse pipeline of more than 30 development projects targeting multiple disease indications. LTS’s innovation pipeline contains both partner-funded as well as proprietary, LTS-funded projects. LTS maintains its leading position through the continuous refinement of its core TTS and OTF technologies and by advancing emerging drug delivery technologies, including Micro Array Patches for the transdermal delivery of large molecule, biological actives. Founded in 1984, LTS operates today from two sites in Andernach, Germany and West Caldwell, NJ, USA and a representative office in Shanghai, China.

About Revive Therapeutics Ltd.

Revive is a life sciences company focused on the research and development of therapeutics for infectious diseases and rare disorders, and it is prioritizing drug development efforts to take advantage of several regulatory incentives awarded by the FDA such as Orphan Drug, Fast Track, Breakthrough Therapy and Rare Pediatric Disease designations. Currently, the Company is exploring the use of Bucillamine for the potential treatment of infectious diseases, with an initial focus on severe influenza and COVID-19. With its recent acquisition of Psilocin Pharma Corp., Revive is advancing the development of Psilocybin-based therapeutics in various diseases and disorders. Revive’s cannabinoid pharmaceutical portfolio focuses on rare inflammatory diseases and the company was granted FDA orphan drug status designation for the use of Cannabidiol (CBD) to treat autoimmune hepatitis (liver disease) and to treat ischemia and reperfusion injury from organ transplantation. For more information, visit www.ReviveThera.com.

For more information, please contact:

Michael Frank
Chief Executive Officer
Revive Therapeutics Ltd.
Tel: 1 888 901 0036
Email: mfrank@revivethera.com
Website: www.revivethera.com

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

Cautionary Statement

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