Shifting Regulations Open New Doors for the CBD Industry

NEW YORK, Dec. 5, 2019 /PRNewswire/ -- The U.S. cannabidiol market burgeoned after the passage of the Farm Bill in 2018. The Farm Bill legalized the commercialization of CBD-based products as long as they do not contain any more than 0.3% THC levels. Federal regulators decided to legalize the use of CBD after researchers undermined misconceptions that the cannabinoid causes psychotropic effects. Extensive research ultimately proved that CBD offers a plethora of health and therapeutic benefits for consumers, with none of the hallucinogenic properties associated with THC. Notably, most people are using CBD as more of an over-the-counter treatment to alleviate minor medical conditions such as headaches or pain. Moreover, CBD is also known to provide consumers with many beneficial nutrients such as protein, fiber, and essential fatty acids. Additionally, CBD provides consumers with amino acids, vitamins A, C, E, and B complex. Furthermore, studies have also indicated that CBD can be used to treat serious life-threatening conditions such as cancer, multiple sclerosis, HIV/AIDS, Alzheimer's, and Parkinson's. However, to note, there is no evidence that CBD cures or prevents diseases, even as researchers have boasted that CBD can help relieve some symptoms associated with some medical conditions. For instance, many conditions such as cancer or Parkinson's can lead to chronic pain, which can affect daily life activities such as movement or even sleep. CBD is known to relieve inflammation and pain as well as stimulate relaxation. Over the past year, CBD products have rapidly emerged throughout the U.S. and now consumers can easily find CBD products such as tinctures, topicals, oils, and even vapes at their local convenience store, pharmacy, and online. The widespread availability of CBD also highlights the massive expansion of the industry despite it being an underdeveloped market. Nevertheless, research and clinical trials are continuing to promote the benefits of CBD. And as a result, the U.S. CBD market is anticipated to deliver total sales of over USD 20 Billion by 2024 while expanding at a CAGR of 49%, according to data compiled by BDS Analytics and Arcview Market Research. Amarantus Bioscience Holdings, Inc. (OTC: AMBS), Auxly Cannabis Group Inc. (OTC: CBWTF) (TSX-V: XLY), United Cannabis Corporation (OTC: CNAB), GB Sciences, Inc. (OTC: GBLX), iAnthus Capital Holdings, Inc. (OTC: ITHUF) (CSE: IAN)

CBD has been touted for its wide range of health uses, but so far, it has only been approved to treat childhood epilepsy syndromes, such as Dravet syndrome and Lennox-Gastaut syndrome. Last year, the U.S. Food and Drug Administration approved Epidiolex, marking the first approved cannabis-based drug. However, the FDA has made clear that additional research is required in order to advance with more approvals. Notably, the FDA has since held numerous public hearings in order to further understand the efficacy of CBD. And while only one cannabis-based drug has been approved, the efforts of the FDA highlight that CBD is having a profound medical progression. Currently, most consumers are using CBD to predominantly treat their insomnia or anxiety, but as clinical trials continue to develop, more approved CBD-based drugs could emerge. And according to WebMD, there is a long list of conditions in which there is insufficient evidence on the benefits of CBD. For example, WebMD says there is a lack of evidence for bipolar disorder, Crohn's disease, diabetes, dystonia, Huntington's disease, schizophrenia, and Parkinson's disease. Nevertheless, researchers are actively conducting studies to better understand the effects of the compound. Additionally, many industry experts believe that CBD could potentially become a medical breakthrough that could replace dozens of different traditional drugs on the market. "While those in the industry, medical professionals and the public all seem to be in favour of CBD as a medical product, the stringent regulatory barriers in place before any product can be fully licensed require, quite rightly, extensive testing and trials," said Dr. David Dawit, Chief Scientific Officer at Eos Scientific. "The future of CBD looks incredibly promising."

Amarantus Bioscience Holdings, Inc. (OTC: AMBS) announced yesterday that, "subsidiary Elto Pharma, Inc. has received a notice of allowance from the European Patent Office (EPO) covering the use of eltoprazine and eltoprazine in combination with a number of chemical compounds, including cannabidiol (CBD) in the treatment of Parkinson's disease and Parkinson's disease levodopa-induced dyskinesia (PD-LID). Once issued, the patent will protect the use of eltoprazine in the treatment of Parkinson's and PD-LID through 2034. Elto Pharma is focused on the development of eltoprazine as an oral formulation for the treatment of PD-LID, Adult ADHD and Agitation in Alzheimer's disease.

'The notice of allowance from the EPO underscores the potential for eltoprazine in combination with CBD, or chemical compounds, to treat Parkinson's disease,' said Gerald E. Commissiong, President & CEO of Amarantus and interim-CEO of Elto Pharma. 'The potential for cannabinoid pharmaceuticals is rooted in their potentially synergistic effects with other traditional pharmaceutical compounds, such as eltoprazine. We are very pleased with this first notice of allowance that we've received from this international patent family, and we expect to receive many more in the months from jurisdictions around the world, including the United States.'

Clinical data for Eltoprazine in PD-LID

The Eltoprazine study in 22 subjects with long standing PD-LID was a randomized, four-way crossover design in which patients received a single dose of placebo and eltoprazine, at 2.5, 5 and 7.5 mg, in combination with a challenge dose of levodopa (1.5 times usual dose), on four different days, separated by an interval of a week. Data from the study demonstrated that eltoprazine significantly reduced peak dose dyskinesia at both the 5 (p<0.05) and 7.5 mg (p<0.05) doses using the Combined Dyskinesia Rating Scale. The 5 mg dose also showed a significant anti-dyskinetic effect on other measures of dyskinesia, including the Rush dyskinesia rating scale. Importantly, there were no adverse effects on levodopa efficacy at any dose level as evidenced by United Parkinson's Disease Rating Scale (UPDRS Part III) observation. Additionally, all dose levels of eltoprazine were well tolerated with no major adverse effects reported. A link to the publication of the PD LID clinical data is provided here:

Amarantus has entered into a binding term sheet for Elto Pharma to license eltoprazine to Emerald Organic Products. The transaction is expected to close in the fourth quarter of 2019.

About Elto Pharma, Inc: Elto Pharma, Inc. is developing eltoprazine, an oral small molecule 5HT1A/1B partial agonist in clinical development for the treatment of Parkinson's disease levodopa-induced dyskinesia (PD-LID), aggression in Alzheimer's disease and adult attention deficit hyperactivity disorder (adult ADHD). Eltoprazine has been evaluated in over 680 human subjects to date, was well-tolerated and showed promising efficacy results in both cognitive and movement disorders. Eltoprazine has received orphan drug designation (ODD) from the US FDA for the treatment of PD-LID. Eltoprazine was originally developed by Solvay (now Abbvie) for aggression-related indications. The eltoprazine program was out-licensed to PsychoGenics, Inc. (PGI). PGI licensed eltoprazine to Amarantus in 2014 after a successful proof-of-concept trial in PD-LID.

In April 2017, Amarantus incorporated the wholly-owned subsidiary Elto Pharma, Inc. for the purpose of raising capital to finance the further clinical development of eltoprazine.

About Amarantus Bioscience Holdings, Inc: Amarantus Bioscience Holdings (AMBS) is a JLABS alumnus biotechnology company developing treatments and diagnostics for diseases in the areas of neurology, regenerative medicine and orphan diseases through its subsidiaries. The Company's 80.01%-owned subsidiary Breakthrough Diagnostics, Inc., currently a joint venture with Todos Medical, Ltd. has licensed intellectual property rights to the Alzheimer's blood diagnostic LymPro Test ® from Leipzig University that was originally developed by Dr. Thomas Arendt, as well as certain rights to multiple sclerosis diagnostic MSPrecise™ and Parkinson's diagnostic NuroPro. Amarantus entered into a joint venture agreement with Todos Medical, Ltd. to advance diagnostic screening assets, and Todos has exercised its exclusive option to acquire Amarantus' remaining ownership in Breakthrough in exchange for approximately 50% ownership of Todos. The transaction is expected close before the end of the first quarter of 2020. Amarantus also owns approximately 30% of the common shares of Avant Diagnostics, Inc., a healthcare data-generating technology company that specializes in biomarker assay services that target multiple areas of oncology.  Avant provides precision oncology data through its TheraLink® assays to assist the biopharmaceutical industry and clinical oncologists in identifying likely responders, initially for breast cancer, to over 70 FDA-approved drug treatments.

AMBS 50%-owned subsidiary Elto Pharma, Inc. has development rights to eltoprazine, a Phase 2b-ready small molecule indicated for Parkinson's disease levodopa-induced dyskinesia, Alzheimer's aggression and adult attention deficit hyperactivity disorder, commonly known as ADHD. AMBS acquired Cutanogen Corporation from Lonza Group in 2015. Cutanogen is preparing for pivotal studies with Engineered Skin Substitute (ESS) for the treatment of pediatric life-threatening severe burns. ESS is a regenerative medicine-based, autologous full-thickness skin graft technology originally developed by the Shriner's Hospital that can be used to treat severe burns, as well as several other catastrophic and cosmetic dermatological indications. AMBS' wholly-owned subsidiary, MANF Therapeutics Inc. owns key intellectual property rights and licenses from a number of prominent universities related to the development of the therapeutic protein known as mesencephalic astrocyte-derived neurotrophic factor ("MANF"). MANF Therapeutics is developing MANF-based products as treatments for ophthalmological disorders such as Wolfram Syndrome, retinitis pigmentosa and glaucoma, as well as neurodegenerative diseases such as Parkinson's disease. MANF was discovered by the Company's Chief Scientific Officer John Commissiong, PhD. Dr. Commissiong discovered MANF from AMBS' proprietary discovery engine PhenoGuard, from which other neurotrophic activities remain to be characterized. Amarantus has entered into a binding letter of intent to license the therapeutic assets from Elto Pharma, Cutanogen and MANF Therapeutics to Emerald Organic Products."

For our latest "Buzz on the Street" Show featuring Amarantus Bioscience Holdings, Inc. recent corporate news, please head over to:

Auxly Cannabis Group Inc. (OTCQX: CBWTF) (TSX-V: XLY) is an international cannabis company dedicated to bringing innovative, effective, and high-quality cannabis products to the medical, wellness and adult-use markets. Auxly Cannabis Group Inc., together with its wholly-owned subsidiary Robinsons Cannabis Inc., recently announced Robinsons Outdoor Grow, a large scale, high-quality outdoor cultivation project located in the heart of Nova Scotia's award-winning wine region of Annapolis Valley. Robinsons OG is uniquely located in a region that is ideal for outdoor cannabis cultivation given its diverse soil types and microclimates; the same soil on which the Acadians grew hemp over 250 years ago. Located within 25 kilometers of Robinsons' 27,700 sq. ft. indoor facility, Robinsons OG is comprised of over 158 acres of land in Hortonville, Nova Scotia and offers road frontage and highway access, allowing for the potential future development of tourism and point of sale opportunities. Hugo Alves, Chief Executive Officer of Auxly, commented: "We are thrilled to announce our Robinsons OG project. As you know, we are very excited to introduce Andrew's incredible dried cannabis flower to discerning Canadian consumers and Robinsons OG provides us with the perfect platform from which to expand our Robinsons branded product offering. Under Andrew's supervision, Robinsons OG will give us the ability to grow a broader range of Robinsons' genetics, using Robinsons' cultivation methodologies, and take advantage of the unique terroir of the Annapolis Valley to bring Canadian consumers Robinsons branded cannabis products, all produced with an unwavering commitment to quality and craftsmanship."

United Cannabis Corporation (OTCQB: CNAB) is a biotechnology company dedicated to the advancement of cannabinoids for medical applications and is building a platform for designing targeted therapies to increase the quality of life for patients around the world. United Cannabis Corporation recently announced that it had initiated extraction services at its majority-owned processing plant in McMinnville, Tennessee. The Company established the 20-acre, 23,000 square foot Facility to provide contract manufacturing to farmers working in accord with the 2018 Federal Farm Bill and Tennessee's Department of Agriculture's (TDA) Hemp Program. Located in central Tennessee, the McMinnville operation is currently processing industrial hemp for CBD-rich distillates, oils and isolates for further processing. Fibrous bi-products generated during processing will also be collected for sale to a wide range of industrial manufacturing customers. Longer term, the Facility will also offer purification, testing and processing services, as well as packaging, fulfillment, and secure storage capabilities. Clifton Lambreth, the Company's Chief Marketing Officer, commented on the announcement, "This is an important addition to the United Cannabis production network as we gear up to hit 50,000 pounds of daily hemp processing in the first quarter. Tennessee is not only one of the fastest growing hemp farming markets in the country, it's also my home state, so I'm very familiar with the needs of the stakeholders in the region. Their response to our launch has been very enthusiastic and I look forward to working together to establish Tennessee and Untied Cannabis as leaders in the hemp sector.

GB Sciences, Inc. (OTCQB: GBLX) is a diverse cannabis company, focused on standardized cultivation and production methods; as well as biopharmaceutical research and development. GB Sciences, Inc. recently announced it had obtained an exclusive license to formulate, manufacture, and sell cannabis-infused oral thin films through its MME-licensed subsidiaries and affiliates GB Sciences Louisiana, LLC, GB Sciences Nevada, LLC, and GB Sciences Las Vegas, LLC, under US Patent Number 10,265,362 B2 issued April 2019. GB Sciences' new oral thin films will be sold in Louisiana and Nevada, reflecting the company's commitment to providing advanced medical cannabis products. Oral thin films are rapidly gaining popularity due to their efficacy, convenience, and discreteness, and sales are increasing rapidly in major cannabis markets including California and Colorado. "Securing this patented technology will allow us to get our patent-pending active pharmaceutical ingredients into the hands of patients in Louisiana and Nevada right away. This is great for patients, who have access to an entirely new way to consume precisely-dosed cannabis without the potential drawbacks of other delivery systems. And nobody else has this technology - making it a good mechanism for GB Sciences to further monetize its considerable intellectual property portfolio," explained John Poss, Chief Executive Officer and Chairman of GB Sciences, Inc.

iAnthus Capital Holdings, Inc. (OTCQX: ITHUF) (CSE: IAN) owns and operates best-in-class licensed cannabis cultivation, processing and dispensary facilities throughout the United States, providing investors diversified exposure to the U.S. regulated cannabis industry. CBD For Life (the "Company"), a subsidiary of iAnthus Capital Holdings, Inc., recently announced that it is continuing to expand its retail presence with a partnership with Dillard's, Inc. "We're excited for our products to be featured on the shelves of one of the largest and most well-regarded fashion retailers in the United States," said Beth Stavola, Co-Founder of CBD For Life and Chief Strategy Officer of iAnthus. "The ability to reach an even broader audience via the well-established customer base of a great partner like Dillard's brings us another step closer to achieving our end goal of establishing CBD For Life as a household name in beauty and wellness."

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