Psycheceutical Inc., a private Florida company, is developing a unique way to deliver psychedelics – through a cream or patch applied to the back of the neck. This method allows psychedelics to enter the brain in just 5-10 minutes without entering the bloodstream, which reduces negative side effects.
– New SLS-003 Program Extends Seelos’ Ketamine Franchise into Additional Indications Including Chronic Neuropathic Pain and Additional Psychiatric Disorders
– Program has been Granted Orphan Drug Designation in the US for the Treatment of Complex Regional Pain Syndrome
NEW YORK, Nov. 24, 2021 /PRNewswire/ — Seelos Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today announced it has entered into an exclusive license agreement (License Agreement), whereby it acquired a worldwide license (excluding China, Taiwan, Macau and Hong Kong) from iX Biopharma Ltd (iX Biopharma) for Wafermine™, a sublingual racemic ketamine wafer, and a worldwide license for other sublingual ketamine wafers, delivered using a proprietary fast-dissolving wafer-based drug delivery platform technology known as WaferiX™.
Seelos plans to evaluate sublingual ketamine, now named SLS-003, in pain indications such as chronic neuropathic pain and Complex Regional Pain Syndrome (CRPS) and in additional psychiatric disorders, including post-traumatic stress disorder (PTSD).
The US Food and Drug Administration (FDA) has granted Wafermine™ Orphan Drug designation for the treatment of CRPS.
“Our licensing of this new program broadens Seelos’ ketamine franchise with a formulation that we believe will be more suitable for chronic dosing in indications like CRPS and PTSD, which are both very difficult indications to treat effectively,” said Raj Mehra, Ph.D., Chairman and CEO of Seelos. “The pharmacokinetic, pharmacodynamic and safety profiles of SLS-003 that have been demonstrated to date suggest a formulation with the potential of being prescribed with less restrictions than current formulations. Our team is very excited to be developing both acute, in SLS-002, and a potentially chronic, in SLS-003, ketamine-based therapy programs. We look forward to initiating studies with SLS-003 in 2022 and our recent capital raises have accounted for the expected development costs for initiating studies.”
“We are delighted to collaborate with Seelos Therapeutics, whose deep insights in ketamine drug development make them an ideal partner to further the development of Wafermine™ and the other sublingual ketamine products,” said Eddy Lee, Chairman and CEO of iX Biopharma. “Licensing our WaferiX™-based pharmaceutical drugs to suitable third parties for development and commercialization is a core strategy to unlock the value of our assets. We are therefore excited that this commercially significant agreement with Seelos is a validation of our ability to deliver on this strategy.”
Pursuant to the License Agreement, Seelos will pay iX Biopharma a one-time, upfront fee of $9,000,000, comprised of $3,500,000 in cash and $5,500,000 in restricted shares of Seelos’ common stock for the worldwide license for Wafermine™ (excluding China, Taiwan, Macau and Hong Kong), the worldwide license for WaferiX™ in other ketamine formulations, and clinical supplies. Seelos will also pay iX Biopharma certain milestone payments contingent on achievement by Seelos of certain development, regulatory and commercial milestones and a low double-digit royalty on future net sales of certain licensed products.
About iX Biopharma LTD
iX Biopharma is a specialty pharmaceutical and nutraceutical company listed on the Catalist board of the Singapore Exchange Securities Trading Limited (SGX-ST), operating a fully integrated business model from drug development to manufacturing and supply, with facilities in Australia. The Group is focused on the development and commercialization of therapies for diseases of the central nervous system using novel, patent-protected formulations for sublingual delivery.
For more information about iX Biopharma LTD, please visit their website: https://www.ixbiopharma.com/.
About WaferiX™
The licensed products utilize iX Biopharma’s patented sublingual wafer technology, known as WaferiX™, to disintegrate under the tongue rapidly for faster therapeutic action and predictable dosing. In pharmacokinetic studies, sublingual delivery using WaferiX™ increased bioavailability of active compounds when compared to oral administration, while avoiding excessively high peak plasma concentrations typical of IV bolus dosing.
About Seelos Therapeutics
Seelos Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and advancement of novel therapeutics to address unmet medical needs for the benefit of patients with central nervous system (CNS) disorders and other rare disorders. The Company’s robust portfolio includes several late-stage clinical assets targeting psychiatric and movement disorders, including orphan diseases. Seelos is based in New York, New York.
For more information, please visit our website: http://seelostherapeutics.com, the content of which is not incorporated herein by reference.
Forward Looking Statements
Statements made in this press release, which are not historical in nature, constitute forward-looking statements for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, among others, those related to the efficacy and potential applications for the Licensed Products and associated Wafermine technology; the satisfaction of the conditions related to any contingent milestone or royalty payments; and the funding of all future development, manufacturing and commercialization of the Licensed Products. These statements are based on Seelos’ current expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Risks associated with Seelos’ business and plans described herein include, but are not limited to, the risks that Seelos will not realize the expected benefits from the license with iX Biopharma, risks associated with the implementation of Seelos’ business strategy, the risks related to raising capital to fund its development plans and ongoing operations, risks related to Seelos’ current stock price, risks related to the global impact of COVID-19, as well as other factors expressed in Seelos’ periodic filings with the U.S. Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, even if subsequently made available by us on our website or otherwise. We do not undertake any obligation to update, amend or clarify these forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.
Contact Information:
Anthony Marciano
Chief Communications Officer
Seelos Therapeutics, Inc. (Nasdaq: SEEL)
300 Park Avenue, 2nd Floor
New York, NY 10022
(646) 293-2136
anthony.marciano@seelostx.com
https://seelostherapeutics.com/
https://twitter.com/seelostx
https://www.linkedin.com/company/seelos
SOURCE Seelos Therapeutics, Inc.
Englewood Cliffs NJ, Nov. 18, 2021 (GLOBE NEWSWIRE) — Silo Pharma, Inc. (OTCQB: SILO) a development-stage biopharmaceutical company focused on the use of psychedelics as a therapeutic, today announced that their joint venture partner Zylo Therapeutics received its first ketamine shipment and initiated loading ketamine into their Z-Pod® transdermal technology.
Eric Weisblum, CEO of Silo Pharma stated “The commencement of Novel Ketamine loaded Z-Pods is a pivotal advancement for administering Ketamine as a therapeutic with the patented Z-Pod® technology. This important milestone for Silo will help us study the benefits of slow-release transdermal release of Ketamine. The delivery and loading accelerates the development to deliver Ketamine as a therapeutic and potentially Psilocybin in a time-released or dosage-controlled manner.”
About Silo Pharma
Silo Pharma is a developmental stage biopharmaceutical company focused on merging traditional therapeutics with psychedelic research for people suffering from indications such as depression, PTSD, Alzheimer’s, Parkinson’s, and other rare neurological disorders. Silo’s mission is to identify assets to license and fund the research which we believe will be transformative to the well-being of patients and the health care industry. For more information, visit www.silopharma.com .
Safe Harbor and Forward-Looking Statements
This news release contains “forward-looking statements” within the meaning of the “safe-harbor” provisions of the Private Securities Litigation Reform Act of 1995. These statements are identified by the use of words “could”, “believe”, “anticipate”, “intend”, “estimate”, “expect”, “may”, “continue”, “predict”, “potential” and similar expressions that are intended to identify forward-looking statements. Such statements involve known and unknown risks, uncertainties, and other factors that could cause the actual results of Silo Pharma, Inc. (“Silo” or “the Company”) to differ materially from the results expressed or implied by such statements, including changes to anticipated sources of revenues, future economic and competitive conditions, difficulties in developing the Company’s technology platforms, retaining and expanding the Company’s customer base, fluctuations in consumer spending on the Company’s products and other factors. Accordingly, although the Company believes that the expectations reflected in such forward-looking statements are reasonable, there can be no assurance that such expectations will prove to be correct. The Company disclaims any obligations to publicly update or release any revisions to the forward-looking information contained in this presentation, whether as a result of new information, future events, or otherwise, after the date of this presentation or to reflect the occurrence of unanticipated events except as required by law.
Investor Relations Contact:
Hayden IR
Brett Maas 646-536-7331
Email: brett@haydenir.com
Mycotopia Therapies (TPIA) and Agile Pharmaceutical Solutions formed a joint venture to develop an oral psilocybin tablet for depression. The companies may work with HAVN Life Sciences (HAVN) in Jamaica for assistance with development and sourcing materials.
TORONTO, November 11, 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 successfully completed its first research study evaluating MicroDose-MN™, a proprietary microneedle (“MN”) patch for the intradermal delivery of psychedelics, in delivering psilocybin. These results provide support to file for an IND application with the FDA to conduct Phase 2 clinical studies in 2022 with psilocybin for various indications.
The aim of PharmaTher’s research program was to develop a suitable prototype of MicroDose-MN™ patch for transdermal (intradermal) drug delivery to confirm compatibility and suitability to deliver psilocybin. The research program scope included, full characterization of psilocybin conjugated on the microneedle patch backbone, establishment and demonstration of the loading capacity for psilocybin, and release rate evaluations for the psilocybin conjugated materials using appropriate models that will be used to support the Company’s IND application with the FDA.
The Company’s research program with psilocybin conjugated microneedles have been successfully fabricated, optimized, and characterized. Both structural aspects and ex-vivo skin insertion assessments of the psilocybin conjugated microneedles have demonstrated successful fabrication and acceptable performance. The incorporation of psilocybin per microneedle without issue and the ability to demonstrate complete ex vivo skin model release over several days demonstrates potential for larger doses and modified release profiles. With these results, the Company believes it has an acceptable prototype for completing IND-enabling studies with the aim to conduct clinical studies in 2022. Details of the research program will be published in a scientific journal.
The Company previously announced that it has entered into a collaboration agreement with Revive Therapeutics Ltd. (“Revive”) (OTCQB: RVVTF) (CSE: RVV) for the evaluation of the psilocybin MicroDose-MN™ patch and is currently in discussions with Revive in finalizing a definitive agreement to advance the clinical and commercial development. There can be no assurance that a definitive agreement will be entered into between PharmaTher and Revive.
The Company believes that its MicroDose-MN™ patch for delivering psilocybin and other psychedelics may enable flexible drug load capacity and combinations, controlled released delivery, and be able to present desired pharmacokinetic and safety profiles. In addition, the MicroDose-MN™ patch for psychedelics aims to empower patients to dose their medication remotely, safely and conveniently rather than under supervision by a healthcare provider at a certified medical office or hospital. To achieve this, the Company will incorporate anti-tampering and anti-abuse features that would parallel the approach used for the tamper-resistant transdermal fentanyl patch.
The Company is completing its evaluation of MicroDose-MN™ with 3,4-methylenedioxy-methamphetamine (“MDMA”), lysergic acid diethylamide (“LSD”), and N, N-dimethyltryptamine (“DMT”) and expects to provide results before the end of this year and pursue clinical studies in 2022.
The Company is actively engaged in partnering discussions for the use of its microneedle patch system to deliver psychedelics including, but not limited to, MDMA, LSD, DMT, ibogaine and mescaline. As such, PharmaTher offers potential partners a differentiated and validated delivery system for psychedelics, desired pharmacokinetic profiles, intellectual property protection, cGMP microneedle patches for IND-enabling and clinical studies, and a clear clinical pathway towards clinical studies in 2022.
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”, “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.
LOS ANGELES, CA / ACCESSWIRE / November 4, 2021 / Cannabis Global, Inc. (OTC PINK:CBGL), an innovation-oriented company investing in disruptive cannabis technologies, today released information on its research and development programs for psychedelic mushrooms and entheogenic plants, and the process of infusing the active ingredients into foods and beverages.
“Our emphasis is on both direct infusion of the fungus and plant materials, and on extracting the active ingredients,” commented Cannabis Global Inc CEO, Arman Tabatabaei. “We have seen strong success in both methods and have used both to infuse a variety of ingredients”, he continued.
Much of the Company’s development efforts have centered on masking the strong tastes of mushroom extracts and entheogenic plants. Cannabis Global is utilizing dual extraction technologies utilizing water and food grade ethanol, rather than stronger solvents that are both not food grade and require extensive purging in order to meet the expected California testing standards. The dual extractions are then emulsified using the all-natural processes developed by the Company for cannabis edibles.
Mr. Tabatabaei continued, “We are hopeful about the possible passage of Senator Scott Wiener’s (D-San Francisco) Senate Bill 519 in California, which would allow us to move forward with our research and development, and possible commercialization of psychedelics-infused food and beverage products. Once legalized, we foresee possible licensing opportunities for our existing infusion technologies, and the marketing of pre-made psychedelic containing emulsions, and emulsions containing both psychedelics and cannabinoid, with food and beverage brands. We are also especially excited about moving beyond ordinary THC with these combinations through the inclusion of rare cannabinoids, such as Tetrahydrocannabivarin (THC-V) and Cannabinol (CBN).”
About Cannabis Global, Inc.
Cannabis Global, Inc. is a Los Angeles-based, fully audited and reporting Company with the U.S. Securities & Exchange Commission, trading under the stock symbol CBGL. We are an emerging force in the cannabis marketplace with a growing product and proprietary intellectual property portfolio. We are marketing and producing Comply Bag™, an innovative solution for cannabis storage, transport and tracking. Our subsidiary, Natural Plant Extract (NPE), is a Southern California licensed cannabis manufacturer and distributor which licenses our technologies to produce edibles for the cannabis marketplace. Cannabis Global has filed three non-provisional and multiple provisional patents for cannabis infusion and nanoparticle technologies and continues an active research & development program.
Forward-looking Statements
This news release contains “forward-looking statements” which are not purely historical and may include any statements regarding beliefs, plans, expectations or intentions regarding the future. Such forward-looking statements include, among other things, the development, costs and results of new business opportunities and words such as “anticipate,” “seek,” intend,” “believe,” “estimate,” “expect,” “project,” “plan,” or similar phrases may be deemed “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the inherent uncertainties associated with new projects, the future U.S. and global economies, the impact of competition, and the Company’s reliance on existing regulations regarding the use and development of cannabis-based products. These forward-looking statements are made as of the date of this news release, and we assume no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements. Although we believe that any beliefs, plans, expectations and intentions contained in this press release are reasonable, there can be no assurance that any such beliefs, plans, expectations or intentions will prove to be accurate. Investors should consult all of the information set forth herein and should also refer to the risk factors disclosure outlined in our annual report on Form 10-K, our quarterly reports on Form 10-Q and other periodic reports filed from time-to-time with the Securities and Exchange Commission. For more information, please visit www.sec.gov.
Contact:
Arman Tabatabaei
IR@CannabisGlobalInc.com
+1 (310) 986-4929
IR Contact:
John Grosso
http://www.iconiconsulting.com/
+1 (424) 239-9521
References:
https://www.hempgrower.com/article/ab-45-passes-california-legislature-draws-opposition-smokable-hemp-legalize-cbd/
https://leginfo.legislature.ca.gov/faces/billTextClient.xhtml?bill_id=202120220AB45
https://www.jdsupra.com/legalnews/california-finally-breaks-from-fda-on-8133219/
SOURCE: Cannabis Global, Inc.
View source version on accesswire.com:
https://www.accesswire.com/671138/Cannabis-Globals-Research-into-Psychedelic-Mushroom-Focuses-on-Foods-and-Beverage-Infusions
PharmaTher (PHRM) and Revive Therapeutics (RVV) are entering into a research agreement to develop psychedelic patches that could be used at home!
The biodegradable patches will use microneedles to deliver both micro and macrodoses of psilocybin, ketamine, MDMA, LSD, DMT, ibogaine, and mescaline. PharmaTher is currently studying the effects of the psilocybin microdose patch, with results expected by the end of this month.
The companies aim to create a delivery method that’s safe and convenient enough for patients to administer on their own, without supervision.
Building specialty psilocybin-based product pipeline
Evaluating potential for neuropsychiatric indications for clinical studies in 2022
TORONTO, Nov. 03, 2021 – Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (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 research collaboration agreement with PharmaTher Holdings Ltd. (“PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a clinical-stage psychedelics biotech company, to evaluate the delivery of psilocybin with PharmaTher’s proprietary microneedle (“MN”) patch technology for neuropsychiatric disorders.
PharmaTher is currently conducting IND-enabling research studies with MicroDose-MN™, a patent-pending biocompatible and biodegradable gelatin methacryloyl microneedle patch, to deliver psilocybin to support an IND application with the FDA for clinicals studies in 2022. Research results with MicroDose-MN™ for psilocybin will be made available in November 2021 by PharmaTher.
Revive is building a specialty psilocybin-based product pipeline with the aim to treat mental illness, substance abuse and neurological disorders. In addition to the proposed psilocybin MicroDose-MN™ patch, the Company has the following development and commercial programs:
The collaboration agreement will give Revive the ability to evaluate the MicroDose-MN™ for psilocybin program to support upcoming clinical and commercial developments globally.
Michael Frank, CEO of the Company commented, “We are maintaining our focus in building a unique psilocybin-based product portfolio through research collaborations, licensing and commercialization agreements with academic research institutions and specialty pharmaceutical companies. The collaboration with PharmaTher complements our psilocybin product offerings as potential treatments for mental illness, substance abuse and neurological disorders. We believe there is no one fits all product profile solution with psilocybin and that for psilocybin to be a next generation therapeutic, it will require different use and delivery forms to achieve the intended target indications. As such, we aim to become a leader in psilocybin-based solutions for unmet medical needs by collaborating with companies that have intellectual property and experience in their delivery technologies.”
“Revive is a valued partner of PharmaTher and we are pleased to collaborate with them to achieve their objective in building a specialty psilocybin-based product pipeline that encompasses various delivery methods including our proprietary microneedle patch, which can deliver various psychedelics via the skin, enable flexible drug load capacity and combinations, and control-release delivery; overcome the potential drawbacks of oral administration, subcutaneous injections, topical and nasal delivery systems; maintain constant plasma levels for more than 24 hours; and aim to empower patients to dose their medication remotely, safely and conveniently rather than under supervision by a healthcare provider at a certified medical office,” said Fabio Chianelli, CEO of PharmaTher.
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 on Twitter and LinkedIn.
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 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, 2021, which has been filed on SEDAR and is available under the Company’s profile at www.sedar.com.
PharmaTher is currently conducting IND-enabling research studies with MicoDose-MN™, a patent-pending biocompatible and biodegradable gelatin methacryloyl microneedle patch, to deliver psilocybin to support an IND application with the FDA for clinical studies in 2022. Research results with MicroDose-MN™ for psilocybin will be made available in November 2021.
The Company is also conducting research studies with its MicoDose-MN™ and MacroDose-MN™ patch as a next generation delivery system for psychedelics with ketamine, 3,4-methylenedioxy-methamphetamine (“MDMA”), lysergic acid diethylamide (“LSD”), and N, N-dimethyltryptamine (“DMT”). Also, the Company has decided to expand research to include ibogaine and mescaline.
Partnership opportunities currently exist with MDMA, LSD, DMT, ibogaine and mescaline for specialty pharmaceutical companies seeking a differentiated and validated delivery system for psychedelics, desired pharmacokinetic profiles, intellectual property protection, cGMP microneedle patches for IND-enabling and clinical studies, and a clear clinical pathway towards FDA Phase 1 and 2 clinical studies in 2022.
The Company’s MicroDose-MN™ and MacroDose-MN™ patches have the potential to efficiently penetrate the stratum corneum layer (outer layer of the skin), enable flexible drug load capacity and combinations, and control-release delivery, which may overcome the potential drawbacks of oral administration, subcutaneous injections, topical and nasal delivery systems. In addition to the potential of maintaining constant plasma levels for more than 24 hours, the MN patches aim to empower patients to dose their medication remotely, safely and conveniently rather than under supervision by a healthcare provider at a certified medical office. To achieve this, the Company will incorporate anti-tampering and anti-abuse features that would parallel the approach used for the tamper-resistant transdermal fentanyl patch.
“We are pleased to collaborate with Revive in achieving their product portfolio objectives with psilocybin. Our microneedle patch technologies aim to become a next generation delivery system for psychedelics for various indications and healthcare environments. Although our focus remains on building our ketamine-based product pipeline, we will continue to partner with specialty pharmaceutical companies seeking a delivery solution for psychedelics and proprietary drugs to unlock significant value and return on investment for PharmaTher,” said Fabio Chianelli, CEO of PharmaTher.
Michael Frank, CEO of the Company, commented, “Our focus is developing and commercializing a specialty psilocybin-based product portfolio, and the research collaboration with PharmaTher complements our psilocybin product offerings as potential treatments for mental illness, substance abuse and neurological disorders. We believe there is no one-fits-all product profile solution with psilocybin. For psilocybin to be a next-generation therapeutic, different use and delivery forms will be required to achieve the intended target indications. As such, we aim to become a leader in psilocybin-based solutions for unmet medical needs by collaborating with companies that have intellectual property and experience in their delivery technologies, such as PharamTher.”
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 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.
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 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.
Using an AI drug discovery program, Mydecine (MYCO) successfully added a novel psilocin analogue with improved delivery and stability to its pipeline.
The AI technology synthesizes billions of drug candidates and filters them based on psychedelic-related targets such as how they bind to receptors.
Mydecine also filed a patent for nanoemulsion technology that can:
