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Numinus Advances Phase 1 Trial on Proprietary Psilocybin Product

Numinus Advances Phase 1 Trial on Proprietary Psilocybin Product

Finalized study design and protocol mark major milestone to investigate natural Psilocybin

VANCOUVER, BC, Oct. 20, 2021 /CNW/ – Numinus Wellness Inc. (“Numinus” or the “Company”) (TSXV: NUMI), a leader in psychedelics-focused mental healthcare, is pleased to have finalized the study design and protocol for a Phase 1 clinical trial on a naturally derived Psilocybin extract, previously announced on April 26, 2021. This major milestone advances Numinus’ investigation of its first proprietary psychedelic product, which was developed using a patent-pending technology submitted to the US Patent and Trade Office.

Numinus Bioscience has successfully developed a natural extract, PSYBINA™ from Psilocybe species using IP technology related to the production of extracts and downstream derivatives and formulations from Psychoactive Species Cultured Mycelium. The Phase I clinical trial, “A Healthy Adult Investigation Observing Endpoint Measures of Safety and Relative Bioavailability of Psilocybin in comparison to a Psilocybe extract: a fasting, blinded, crossover study” (HOPE), will ascertain the safety and bioavailability of the subsequent formulation PSYBINA RXTM developed to stably deliver Psilocybin and other synergistic compounds. The trial design compares the innovative formulation, designed to be more bioavailable, with synthetic Psilocybin as a baseline comparator and exploratory brain scans will visualize the potential differences in neuroactivity.

With its licensed capabilities, Numinus’ lab will produce, package and label both PSYBINA RX™ and the Psilocybin comparator for the clinical trial which will be conducted at Numinus’ clinical site in Vancouver, British Columbia on 14 healthy volunteers.

“This is a benchmark trial for Numinus Bioscience as it not only tests our theory of synergies of natural complex matrices but also our product design and patent-pending technology,” says Sharan Sidhu, Science Officer and General Manager at Numinus Bioscience. “Our research team has developed PSYBINA RX™ to be stable and more bioavailable, which, coupled with 75% more efficient production of PSYBINA™ using our technological advancements, aims to reduce our production costs of therapeutic products, further advancing our mission of increasing accessibility in psychedelic medicine.”

“The Phase 1 launch leverages multiple Numinus assets, including our Clinical Research team and Numinus Bioscience team working together to successfully develop and run this clinical trial,” says Payton Nyquvest, Founder & CEO, Numinus. “The majority of the work from discovery, research and development, production, clinical trial application and trial conduct are all happening in house, demonstrating our leadership and capabilities in psychedelic therapeutics.”

About Numinus
Numinus Wellness (TSXV: NUMI) helps people to heal and be well through the development and delivery of innovative mental health care and access to safe, evidence-based psychedelic-assisted therapies. The Numinus model – including psychedelic production, research and clinic care – is at the forefront of a transformation aimed at healing rather than managing symptoms for depression, anxiety, trauma, pain and substance use. At Numinus, we are leading the integration of psychedelic-assisted therapies into mainstream clinical practice and building the foundation for a healthier society.

Learn more at www.numinuswellness.com and follow us on LinkedIn, Facebook, Twitter, and Instagram.

Forward-looking statements
This press release contains forward-looking statements within the meaning of applicable securities laws. All statements that are not historical facts, including without limitation, statements regarding future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations or beliefs regarding future performance are “forward-looking statements”. Forward-looking statements can be identified by the use of words such as “expects”, “does not expect”, “is expected”, , “intends”, “anticipates”, “does not anticipate”, “believes” or variations of these words, expressions or statements, that certain actions, events or results “may”, “could”, “would”, “might” or “will be” taken, will occur or will be realized. Such forward-looking statements involve risks, uncertainties and other known and unknown factors that could cause actual results, events or developments to differ materially from the results, events or developments expected and expressed or implied in such forward-looking statements. These risks and uncertainties include, but are not limited to, dependence on obtaining and maintaining regulatory approvals, including the acquisition and renewal of federal, provincial, municipal, local or other licenses, and any inability to obtain all necessary government authorizations, licenses and permits to operate and expand the Company’s facilities; regulatory or policy changes such as changes in applicable laws and regulations, including federal and provincial legalization, due to fluctuations in public opinion, industry perception of integrative mental health, including the use of psychedelic-assisted therapy, delays or inefficiencies or any other reason; any other factor or development likely to hamper the growth of the market; the Company’s limited operating and profitability track record; dependence on management; the Company’s need for additional financing and the effects of financial market conditions and other factors on the availability of capital; competition, including that of more established and better funded competitors; the continued impact of the COVID-19 pandemic; and the need to build and maintain alliances and partnerships, including with research and development companies, customers and suppliers. These factors should be carefully considered, and readers are cautioned not to place undue reliance on forward-looking statements. Despite the Company’s efforts to identify the main risk factors that could cause actual measures, events or results to differ materially from those described in forward-looking statements, other risk factors may cause measures, events or developments to materially differ from those anticipated, estimated or intended. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in forward-looking statements. The Company does not undertake to revise forward-looking statements, even if new information becomes available as a result of future events, new facts or any other reason, except as required by applicable laws. 

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this news release.

SOURCE Numinus Wellness Inc.

For further information: May Lee, Communications Manager, Numinus, may.lee@numinus.com; For investor inquiries: Jamie Kokoska, VP, Investor Relations, Numinus, jamie.kokoska@numinus.com

Related Links

https://numinus.ca/

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

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

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

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

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

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

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

“Initiation of the Phase 2 clinical trial of ketamine to treat Parkinson’s disease, or the KET-LID trial, is a significant milestone for PharmaTher and we are excited about the opportunity to advance a potential new therapeutic solution for Parkinson’s disease patients,” said Fabio Chianelli, CEO of PharmaTher.  
There can be no assurance that the FDA will support any potential request for an expedited path to approval or further development for ketamine in the treatment of Parkinson’s disease.

Ketamine’s Potential In Parkinson’s Disease       

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

Parkinson’s disease is a debilitating disorder that affects over 1 million people in the U.S. and more than 7 million people worldwide. There is currently no cure for Parkinson’s disease, although some drug combinations are used to treat the disease symptoms. The global Parkinson’s disease market is expected to grow from USD $5 billion in 2019 to USD $7.5 billion by the end of 2025 [360iResearch 2020] and it is estimated that the potential market opportunity for LID Parkinson’s disease to be over USD $3 billion in the U.S. alone.

About Parkinson’s Disease

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

About PharmaTher Holdings Ltd.

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

For more information about PharmaTher, please contact:

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

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

Cautionary Statement

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

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

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Blackhawk Growth’s MindBio Therapeutics Successfully Progressed to the Second Half of their Phase 1 Microdosing Clinical Trial

Blackhawk Growth’s MindBio Therapeutics Successfully Progressed to the Second Half of their Phase 1 Microdosing Clinical Trial

Vancouver, British Columbia – TheNewswire – October  04, 2021 – Blackhawk Growth Corp. (CNSX:BLR.CN) (OTC:BLRZF) (Frankfurt:0JJ) (the “Company” or “Blackhawk”) is pleased to announce that its subsidiary, MindBio Therapeutics, has successfully progressed to the second half of their fully funded Phase 1 clinical trial microdosing LSD to patients – this is the largest and first safety study of its kind anywhere in the world. The progress in its clinical trials makes MindBio a step closer towards commercialization and bringing new therapies to market.

The clinical trials have been approved by the New Zealand Government who also contributed NZ$600,000 in funding to support this important safety study. Furthermore, the Government of New Zealand has provided an import license and approval for the substances to be administered at home. It is the first clinic trial of its kind in the world that tests microdosing of 80 participants with psychedelics in a community setting.

MindBio is developing into a multi-disciplinary psychedelics platform conducting clinical trials and drug formulation, and technology development through its agreement with Digital Mind Technology and psychedelic assisted therapies with LeichtMind clinics that is also owned by Blackhawk.

“These clinical trials are a first of their kind, anywhere in the world and are unique because of the fact that the New Zealand Government has given approval for LSD to be imported, experimented with in a laboratory and for a doctor to prescribe LSD in microdoses for patients to take at home as they would any other medication” says Frederick Pels, CEO of Blackhawk Growth Corp.  “We are very pleased that the clinical trials have completed their first half and are progressing towards the finish line within budget and timeframes. We look forward to updating our shareholders in the coming weeks.”

About Blackhawk Growth

Blackhawk is an investment holding company looking to create substantial value for its shareholders through the acquisition and development of high growth companies. It has focused its investments in the health, cannabis and cannabidiol industries in both Canada and the United States. Its portfolio of companies includes Sac Pharma, LeichtMind Clinics, Noble Hemp, Spaced Food, NuWave Foods, and MindBio Therapeutics. Blackhawk continues to bring its investments to cash flow and is growing at an exceeding pace.

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

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

For further information please contact:

Frederick Pels, Chief Executive Officer

(403)-991-7737

fred@blackhawkgrowth.com

Cautionary Note Regarding Forward-Looking Statement

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

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Blackhawk Growth Subsidiary, MindBio Therapeutics, Accelerates Phase 1 & Phase 2 Microdosing Clinical Trials

Blackhawk Growth Subsidiary, MindBio Therapeutics, Accelerates Phase 1 & Phase 2 Microdosing Clinical Trials

Vancouver, British Columbia – TheNewswire – September 07, 2021 – Blackhawk Growth Corp. (CNSX:BLR.CN) (OTC:BLRZF) (Frankfurt:0JJ) (the “Company” or “Blackhawk”) is pleased to provide an update on its most recent investment, MindBio Therapeutics Pty Ltd. (“MindBio Therapeutics”), a clinical stage drug development company conducting research into microdosing and medicinal use of psychedelic medicines to treat a range of debilitating mental health conditions.

MindBio Therapeutics reports that in September 2021, 50% of the phase 1 safety trial in healthy patients will be completed and they will have collected complete safety data on the study participants.  Within the next 6 months, MindBio Therapeutics will complete the remainder of phase 1 trials microdosing LSD.

In the first clinical trial of its kind, participants are prescribed microdoses of LSD to take home in much the same way they would take any other over the counter medicine.  This unique clinical trial aims to demonstrate safety and efficacy of use of microdoses of psychedelic drugs for a medicinal purpose in a community setting.  It is expected that these “community” safety features demonstrated during the clinical trials will be used to support the commercial advancement of the medicines as they move through the regulatory and approvals process.

MindBio Therapeutics has numerous additional trials approved or planned.

  • —Phase 2 Clinical Trials have also just been approved with microdosing of LSD in late stage cancer patients.
  • —MindBio Therapeutics has also three phase 2 clinical trials in planning where microdoses of LSD will be tested against depression, chronic pain and mild cognitive impairment.

A recent peer review has shown that MindBio Therapeutics is one of very few publicly reported psychedelic companies involved in both Phase 1 and Phase 2 clinical trials. MindBio Therapeutics is pioneering the development of micro-dose formulations and a range of technology and artificial intelligence applications to ensure the safe dosage, use and administration of psychedelic medicines in the community. Early indications show that LSD is tolerated well in micro-doses and has a lower side effect profile than the currently prescribed anti-depressant drugs.

Blackhawk Grants Incentive Stock Options and Restricted Shares Units

Blackhawk’s board of directors has granted 4,500,000 incentive stock options to purchase common shares of the Company to certain employees and consultants of MindBio Therapeutics as well as 2,000,000 restricted share units. The options vest on the date of issuance and are exercisable until September 7, 2023 at an exercise price of $0.55 per option share.  The restricted share units vest and will convert into common shares on January 8, 2022, provided the holder remains involved with the Company at the time.

About Blackhawk Growth

Blackhawk is an investment holding looking to create substantial value for its shareholders through the acquisition and development of high growth companies. It has focused its investments in the health, cannabis and cannabidiol industries in both Canada and the United States. Its portfolio of companies includes Sac Pharma, LeichtMind Clinics, Noble Hemp, Spaced Food, NuWave Foods, and MindBio Therapeutics. Blackhawk continues to bring its investments to cash flow and is growing at an exceeding pace.

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

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

For further information please contact:

Frederick Pels, Chief Executive Officer

(403)-991-7737

fred@blackhawkgrowth.com

Cautionary Note Regarding Forward-Looking Statement

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