Drug Development – MJ Shareholders https://mjshareholders.com The Ultimate Marijuana Business Directory Mon, 14 Mar 2022 16:46:33 +0000 en-US hourly 1 https://wordpress.org/?v=6.5.4 Bright Minds Biosciences Announces Successful Completion of 28-Day Toxicology Studies and Advancement to First-in-Human Clinical Trial https://mjshareholders.com/bright-minds-biosciences-announces-successful-completion-of-28-day-toxicology-studies-and-advancement-to-first-in-human-clinical-trial/ Mon, 14 Mar 2022 16:46:33 +0000 https://www.cannabisfn.com/?p=2940625

Ryan Allway

March 14th, 2022

Psychedelics, Top News


VANCOUVER, British Columbia, March 14, 2022 (GLOBE NEWSWIRE) — Bright Minds Biosciences (“Bright Minds,” “BMB” or the “Company”) (Nasdaq: DRUG) (CSE: DRUG), a biotechnology company focused on developing novel drugs for the targeted treatment of neuropsychiatric disorders, epilepsy, and pain, today announced the successful completion of 28-day repeat-dose toxicity studies for its lead product, BMB-101. Importantly, there were no major toxicological findings after twice daily oral administration of BMB-101 throughout the study period. The studies were conducted by the Company’s contract research partner, ITR Laboratories Canada in Baie d’Urfé, Québec, Canada.

Dr. Revati Shreeniwas, Bright Minds’ Chief Medical Officer, stated, “Dravet Syndrome, a severe form of epilepsy characterized by frequent, prolonged seizures, is a terribly debilitating disease and, unfortunately, remains an area of high unmet medical need. We’re encouraged and hopeful that BMB-101 will provide a new and effective approach to its treatment. These data, generated in our 28-day toxicology studies, provide further support for advancing our clinical program,” concluded Dr. Shreeniwas.

Repeat-dose oral toxicity studies were conducted in mice and dogs. These Good Laboratory Practice (GLP) compliant studies found that BMB-101, at doses up to 40 and 30 mg/kg/day in mice and dogs, respectively, were well tolerated at all dose levels. These data provide new information on a lack of major toxic effects after 28 days, including a lack of any effect to target organs. A no-observed-adverse-effect level (NOAEL) was identified in both species, which will be used in selecting starting dose levels and for establishing safety criteria for human exposure.

“We are delighted to have completed this important milestone, which is pivotal for supporting our forthcoming first-in-human clinical trial, currently expected to begin in 2Q22,” said Ian McDonald, Bright Minds’ Chief Executive Officer. “We have now officially entered the clinical development stage for our lead product, BMB-101, which represents an exciting new chapter for the Company and, hopefully, therapeutic alternative for patients suffering from Dravet Syndrome.”

About BMB-101

BMB-101, a 5-HT2C selective and biased agonist, has demonstrated compelling activity in a host of in-vitro and in-vivo non-clinical tests. Compared to Locaserin, BMB-101 exhibits strong Gq signaling coupled with minimal beta arrestin recruitment. Mechanistically, Serotonin (5- Hydroxytryptamine, 5-HT) is a monoamine neurotransmitter widely expressed in the central nervous system, and drugs modulating 5-HT have made a major impact in mental health disorders. Central 5-HT systems have long been associated with the control of ingestive behavior and the modulation of behavioral effects of psychostimulants, opioids, alcohol and nicotine. Over the past decade, the various 5-HT receptor subtypes have been cloned and characterized. Results of clinical trials and animal studies indicate that 5-HT2C up receptor agonists may have therapeutic potential in the treatment of addiction by decreasing the intake of opioids as well as impulsive behavior that can escalate compulsive drug use.

About Dravet Syndrome

Dravet syndrome is an epilepsy syndrome that begins in infancy or early childhood and can include a spectrum of symptoms ranging from mild to severe. Children with Dravet initially show focal (confined to one area) or generalized (throughout the brain) convulsive seizures that start before 15 months of age (often before age one). These initial seizures are often prolonged and involve half of the body, with subsequent seizures that may switch to the other side of the body. These initial seizures are frequently provoked by exposure to increased temperatures or temperature changes, such as getting out of a bath. Other seizure types emerge after 12 months of age and can be quite varied. Status epilepticus – a state of continuous seizure requiring emergency medical care – may occur frequently in these children, particularly in the first five years of life. Dravet syndrome affects an estimated 1:15,700 individuals in the U.S., or 0.0064% of the population (Wu 2015). Approximately 80-90% of those, or 1:20,900 individuals, have both an SCN1A mutation and a clinical diagnosis of DS. This represents an estimated 0.17% of all epilepsies. As an area of high, unmet medical need, there currently exist only three FDA-approved medications for the treatment of DS: (1) Fintepla® (fenfluramine), which has a black-box label; (2) Diacomit® (stiripentol) and (3) Epidolex® (cannabidiol).

About Bright Minds

Bright Minds is focused on developing novel transformative treatments for neuropsychiatric disorders, epilepsy, and pain. Bright Minds has a portfolio of next-generation serotonin agonists designed to target neurocircuit abnormalities that are responsible for difficult to treat disorders such as resistant epilepsy, treatment resistant depression, PTSD, and pain. The Company leverages its world-class scientific and drug development expertise to bring forward the next generation of safe and efficacious drugs. Bright Minds’ drugs have been designed to potentially retain the powerful therapeutic aspects of psychedelic and other serotonergic compounds, while minimizing the side effects, thereby creating superior drugs to first-generation compounds, such as psilocybin.

Investor Contacts:
Lisa Wilson
In-Site Communications, Inc.
489 Fifth Avenue, 29th Floor
New York, NY 10017
E: [email protected]

Josh Blacher
Bright Minds Biosciences, Inc.
19 Vestry Street
New York, NY 10013
E: [email protected]

This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.

About Ryan Allway

Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.


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Zollaris Laboratories Corp. Receives Health Canada authorization to investigate PSILOCYBIN (PSYCHEDELIC MUSHROOMS) for potential new therapeutics https://mjshareholders.com/zollaris-laboratories-corp-receives-health-canada-authorization-to-investigate-psilocybin-psychedelic-mushrooms-for-potential-new-therapeutics/ Thu, 17 Feb 2022 04:40:13 +0000 https://www.cannabisfn.com/?p=2937917

Ryan Allway

February 16th, 2022

Psychedelics, Top News


Psilocybin therapy is being investigated by Zollaris for the treatment of mental health and other unmet medical needs

HAWKESBURY PROVIDENCEOntarioFeb. 16, 2022 /PRNewswire-PRWeb/ — Zollaris Laboratories Corporation. (hereafter, “Zollaris”) receives authorization from the Health Canada, Office of Controlled Substances for analytical investigation of several psilocybin powders currently permitted under license and available in Canada. The Health Canada license permits Zollaris to proceed to screen suitable candidates and drug preparations to be used in clinical trials to be initiated in 2022. Health Canada has recognized the importance of Zollaris’ analytical research infrastructure, drug development and manufacturing programs aimed at producing a molecular standardization of psilocybin form factors.

Psilocybin therapy is an approach being investigated for the treatment of mental health challenges where current drug therapies have known and unwanted adverse effects and present high potential to addiction. Psilocybin is a psychoactive ingredient found in some species of mushrooms, often referred to as “magic mushrooms” and which have been the focus of renewed interest for medical use in mental health where current therapeutics are not ideal. With this license, Zollaris can enter the pharmaceutical drug development arena to develop future therapeutics.

Under the title of “Drug Development Pathways to Bring Psilocybin (and Psilocin) to the Pharmaceutical Market”, Zollaris Labs will complete the necessary steps in order to produce the first standard of Psilocybin to be sold under USP certification.

Zollaris investigational program is a pivotal passage to get pharmaceutical grade Psilocybin powders with a Made in Canada stamp, in our fully licensed GMP Facility.

ABOUT ZOLLARIS

Zollaris Corporation is a 30,000 state-of-the-art facility located in Hawkesbury, ON. The facility was commissioned in 2019 and founded by experience pharmaceuticals leaders. Zollaris has several categories of licenses which enable it to contract manufacture, perform technical analysis of natural products (“NPNs”), cannabinoids and psychedelic’s for customers and its own brands to be sold in the appropriate medical and recreational channels.

Forward-looking statements

Some statements in this release may contain forward-looking information. All statements, other than statements of historical fact, that address activities, events or developments that the Company believes, expects or anticipates will or may occur in the future (including, without limitation, statements regarding potential acquisitions and financings) are forward-looking statements. Forward-looking statements are generally identifiable by the use of the words “may”, “will”, “should”, “continue”, “expect”, “anticipate”, “estimate”, “believe”, “intend”, “plan” or “project” or the negative of these words or other variations on these words or comparable terminology. Forward-looking statements are subject to a number of risks and uncertainties, many of which are beyond the Company’s ability to control or predict, that may cause the actual results of the Company to differ materially from those discussed in the forward-looking statements. Factors that could cause actual results or events to differ materially from current expectations include the Company’s inability to obtain sufficient financing to execute its business plan; competition; regulation; anticipated and unanticipated costs and delays; the success of the Company’s research and development strategies; the ability to obtain orphan drug status; the applicability of the discoveries made; the successful and timely completion and uncertainties related to the regulatory approval process; the timing of future clinical trials; the timing and outcomes of regulatory or intellectual property decisions; and other risks disclosed in the Company’s public disclosure record on file with the relevant regulatory authorities. Although the Company has attempted to identify important factors that could cause actual results or events to differ materially from those described in forward-looking statements, there may be other factors that cause results or events not to be as anticipated, estimated or intended. Readers should not place undue reliance on forward-looking statements. The forward-looking statements in this news release are made as of the date of this news release, and the Company does not undertake any obligation to publicly update them to reflect new information or subsequent events or otherwise except as required by applicable securities legislation.

Media Contact

Pascal Houde, Zollaris laboratories Corporation, 1 4168554545, [email protected]

SOURCE Zollaris laboratories Corporation

This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.

About Ryan Allway

Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.


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AIkido Pharma Announces Third Quarter Highlights and Corporate Update https://mjshareholders.com/aikido-pharma-announces-third-quarter-highlights-and-corporate-update/ Thu, 11 Nov 2021 23:36:00 +0000 https://www.cannabisfn.com/?p=2935891

Ryan Allway

November 11th, 2021


Highlights recent investments in Electric Vehicles, Cannabis, Tele-health & Innovative Sports Businesses with near term monetization and liquidity events forthcoming

NEW YORKNov. 11, 2021 /PRNewswire/ — AIkido Pharma Inc. (Nasdaq: AIKI) (“AIkido” or the “Company”) today announced its third quarter ending September 30, 2021, financial highlights and provided a corporate update.

(PRNewsfoto/AIkido Pharma Incorporated)
(PRNewsfoto/AIkido Pharma Incorporated)

Highlights

  • Cash and investments exceeding $104 million reflecting very low cash burn over Q2
  • Monetization and liquidity event in DatChat representing over 600% ROI
  • Investment in Tevva Motors electric truck producer, a space with recent Rivian Automotive IPO, ticker symbol RIVN.
  • Investment in Kerna Health, fast growth tele-health business with recurring revenue and large contract backlog with possible liquidity event in 2022
  • New investment in Slinger Bag, displaying strong progress and potential near-term monetization
  • New investment in Kaya Holdings, first U.S. publicly traded company to hold and operate state-issued “touch-the-plant” licenses for the retail, cultivation, and production of cannabis

Anthony Hayes, CEO of AIkido, noted, “We are excited about our current pipeline portfolio, upcoming milestones and pending catalysts. This past quarter showcased our monetization strategy exemplified by a 600% ROI liquidity event in DatChat which went public over the summer. Additionally, we actively invested in several exciting high growth industries such as Electric Vehicles and Tele-health and we continue to actively pursue additional high growth interests with near term monetization events to help enhance shareholder value. We are pleased to also announce today our recent investments in the Cannabis and innovative sports industries that have strong growth potential. We are also working diligently to grow our drug platform through additional licensing efforts and are currently working on partnerships with academic institutions and private enterprise to find, fund and advance new drug compounds that can be brought to commercialization. We continue to maintain an extremely low cash burn and note that our valuation does not currently reflect the value of our assets. With our strong balance sheet, we have pulled our registration statement and we look forward to continued shareholder value creation.”

Third Quarter Highlights

DatChat
On August 17, 2021, DatChat closed its initial public offering at an initial offering price to the public of $4.15 per share under the ticker DATS. On September 22, 2021, the Company sold 167,084 shares of DatChat common stock for net proceeds of approximately $0.9 million. As of September 30, 2021, the Company continued to hold 357,916 shares of DatChat valued at approximately $4.9 million.

Tevva Motors
On September 22, 2021, the Company agreed to purchase 29,004 Interests of Tevva Motors for approximately $1.0 million. Subsequently, on September 30, 2021, the Company entered into a second securities purchase agreement to purchase an additional 29,004 Interests of Tevva Motors for approximately $1.0 million. Tevva Motors Ltd is a UK-based, leading developer of modular electrification systems for medium duty commercial vehicles. This is an exciting space, with companies such as Rivian Automotive recently going public with very high valuations.

Kerna Health,
On September 15, 2021, the Company entered into a securities purchase agreement with Kerna Health Inc. Under Agreement, the Company agreed to purchase 1,333,334 shares of common stock of Kerna for $1.0 million. Kerna health is a fast-growing tele-health business with recurring revenue and large contract backlog and has the potential to lead to a liquidity event in 2022.

Slinger Bag
On August 6, 2021, the Company entered into a securities purchase agreement with Slinger Bag Inc. Under the Agreement, the Company agreed to pay $1.4 million to Slinger Bag for the issuance of a convertible promissory note in the principal amount of $1.4 million and a common stock purchase warrant. Slinger Bag which is currently listed on the OTC market under symbol SLBG, is a fast-growing leading connected sports company focused on delivering innovative, game improvement technologies and equipment across tennis and other ball sports.

Kaya Holding Corp
On September 29, 2021, the Company entered into a securities purchase agreement with Kaya Holding Corp. Under the Agreement, the Company agreed to purchase 8,325,000 shares of common stock of Kaya for approximately $0.7 million. Kaya Holding Corp is currently listed on the OTC market under the symbol KAYS and is the first U.S. publicly traded company to hold and operate state-issued “touch-the-plant” licenses for the retail, cultivation and production of cannabis.

Drug Development Pipeline Update
The Company’s pipeline consists of patented technology from leading universities and researchers and is currently in the process of developing its innovative therapeutic drug pipeline through strong partnerships with world renowned educational institutions, including the University of Texas at Austin, the University of Maryland, Baltimore and Wake Forest University.

  • The Company is also developing a broad-spectrum antiviral platform, in which the lead compounds have activity in cell-based assays against multiple viruses including Influenza virus, Ebolavirus and Marburg virus, SARS-CoV, MERS-CoV, and SARS-CoV-2, the cause of COVID-19.

Convergent Therapeutics
In January 2021, the Company invested in Convergent Therapeutics, which has exclusive rights to technology related to next-generation dual-action peptide receptor radionuclide therapy (“PRRT”) for prostate cancer covered by multiple issued U.S. and foreign patents. Convergent is currently conducting advanced human trials relating to prostate cancer treatments utilizing PRRT that targets the prostate-specific membrane antigen (“PSMA”) present on prostate cancer cells. The technology was developed under the direction of Dr. Neil Bander, Professor of Urologic Oncology at Weill Cornell Medicine.

Silo Pharma
In January 2021, the Company entered into an exclusive patent license agreement with Silo Pharma where Silo Pharma granted the Company a worldwide exclusive, sublicensable, royalty-bearing license to certain Silo Pharma owned provisional patent applications directed to the use of psilocybin in cancer treatment. The license is for “Field of Use” of “treatment of cancer and symptoms caused by cancer, including but not limited to pain, nausea, neuroinflammation, brain and neural dysfunction, depression, seizures, confusion, dizziness, numbness/tingling, dysfunction of the senses and all other symptoms that are caused by cancer of any type.”

About AIkido Pharma Inc.

AIkido Pharma Inc. was initially formed in 1967 and is a biotechnology Company with a diverse portfolio of small-molecule anti-cancer therapeutics. The Company’s platform consists of patented technology from leading universities and researchers, and we are currently in the process of developing an innovative therapeutic drug platform through strong partnerships with world renowned educational institutions, including The University of Texas at Austin and University of Maryland at Baltimore. Our diverse pipeline of therapeutics includes therapies for pancreatic cancer and prostate cancer. We are constantly seeking to grow our pipeline to treat unmet medical needs in oncology. The Company is also developing a broad-spectrum antiviral platform that may potentially inhibit replication of multiple viruses including Influenza virus, SARS-CoV (coronavirus), MERS-CoV, Ebolavirus and Marburg virus.

Forward-Looking Statements

Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in the Company’s filings with the SEC, not limited to Risk Factors relating to its business contained therein. Thus, actual results could be materially different. The Company expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.

Contact:

Investor Relations:

Hayden IR
Brett Maas, Managing Partner
Phone: (646) 536-7331
Email: [email protected]
www.haydenir.com

AIkido Pharma Inc.
Phone: 212-745-1373
Email: [email protected]
www.aikidopharma.com

This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.

About Ryan Allway

Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.


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