NEW YORK, Dec. 4, 2019 /PRNewswire/ -- Over the past year, demand for cannabidiol, or CBD, has been increasing at an exponential pace. In particular, the U.S. experienced massive growth in CBD sales after it passed the Farm Bill in late 2018, legalizing the commercialization of hemp, which CBD is derived from. CBD is the active chemical found within the hemp plant, which falls under the cannabis family. Similarly, marijuana also falls under the cannabis family, but marijuana and hemp are widely different in their biological makeup, as marijuana's active chemical is THC, which is generally known to induce psychoactive effects. Meanwhile, CBD does not cause mind-altering effects but instead stimulates relaxation. Moreover, extensive clinical trials have also concluded that CBD can be effectively used in healthcare to treat a variety of medical conditions. Consequently, many countries began to move towards legalizing CBD because of its versatile uses. For instance, researchers have boasted that CBD can treat symptoms associated with cancer, chronic pain, Alzheimer's, multiple sclerosis, and epilepsy. However, in the U.S., there is currently only one CBD-based drug approved: Epidiolex. Epidiolex is used to treat Lennox-Gastaut and Dravet syndromes, which are two rare epileptic disorders that occur early in adolescence. And while the U.S. has only approved CBD for epilepsy-related conditions, other countries have legalized CBD-based drugs to treat other serious conditions such as HIV/AIDS, depression, and even withdrawal from opioid drugs. Nevertheless, it is important to remember that the CBD industry is still in its infancy stage due to the lack of research authenticating the benefits of the compound. But researchers around the world are engaged in clinical trials to rectify this and prove the efficacy of CBD while promoting it as a next-generation medical treatment. According to data compiled by Grand View Research, the global cannabidiol market was valued at USD 1.34 Billion in 2018 and is expected to expand at a CAGR of 32.6% over the forecast period from 2019 to 2025. Amarantus Bioscience Holdings, Inc. (OTC: AMBS), Sorrento Therapeutics, Inc. (NASDAQ: SRNE), Emerald Health Therapeutics Inc. (OTC: EMHTF) (TSX-V: EMH), Puration Inc. (OTC: PURA), Medical Marijuana, Inc. (OTC: MJNA).
Overall, there are hundreds of studies being conducted to evaluate the efficacy of CBD. Notably, researchers are advancing studies to further promote the use of the CBD for Parkinson's treatment. Currently, the research on CBD for Parkinson's is very limited and most studies are likely small-scale trials. However, the handful of studies that have been conducted suggest that CBD can have positive effects when dealing with nonmotor symptoms. According to Healthline, several studies have hinted that CBD can be used to treat tremors, psychosis, and improve the overall quality of life for some patients. For example, a small scale study suggested that CBD may help ease muscle movements, while another study discovered that CBD reduced the severity of individuals' suffering from psychotic symptoms. Meanwhile, another study suggested that CBD can help suppress sleep disturbances such as vivid dreams, nightmares, or movement. Additionally, several researchers even believe that CBD can ultimately be used to prevent Parkinson's disease, even as there is currently insufficient data on the use of CBD on humans to prevent Parkinson's. Nevertheless, researchers are actively evaluating the effects of CBD on protecting the human brain. And while research on CBD is limited, the small-scale results are highly promising. As such, CBD clinical trials are anticipated to accelerate in the shortcoming future. "The work to date on marijuana and cannabinoids has given promising but conflicting signals," said Rachel Dolhun, MD, Vice President, Medical Communications at The Michael J. Fox Foundation for Parkinson's Research. "This therapy may represent a future treatment option for PD, but the correct dose and formulation are not clear, full side effects and drug interactions are unknown, and benefits have not been rigorously determined. Future studies should be large and well designed to provide clear data on the safety and efficacy of marijuana and cannabinoids in Parkinson's."
Amarantus Bioscience Holdings, Inc. (OTC: AMBS) today announced breaking CBD news that, "a US-based JLABS-alumnus biotechnology holding company developing proprietary orphan neurologic, regenerative medicine and ophthalmic therapies and diagnostics through its subsidiaries, today announced 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."
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Sorrento Therapeutics, Inc. (NASDAQ: SRNE) is a clinical stage, antibody-centric, biopharmaceutical company developing new therapies to turn malignant cancers into manageable and possibly curable diseases. Sorrento Therapeutics, Inc. recently announced that it had established a new business unit to focus on the market potential for its innovative water-soluble cannabidiol (CBD) formulation technology. Cannabidiol (CBD) has been under consideration within the pharmaceutical side of Sorrento for its interesting pharmacological properties and potential clinical benefits in multiple central nervous system, autoimmune or inflammatory disease and pain related indications. "Without distracting from our pharmaceutical business, we have the ability to leverage another Sorrento innovative technology – this time from our formulation experts – and make it available to the broader consumer market," stated Dr. Henry Ji, Chief Executive Officer and Chairman of Sorrento Therapeutics. "Longer-term, we may consider spinning off our CBD consumer business into an independently operated company if appropriate, while our research and clinical development team continues to explore the potential pharmaceutical applications of cannabidiol (CBD) for the medical markets."
Emerald Health Therapeutics Inc. (OTCQX: EMHTF) (TSX-V: EMH) is a Canadian licensed producer of cannabis products focused on differentiated, value-added product development for medical and adult-use customers supported by novel intellectual property, large-scale cultivation, extraction, and softgel encapsulation, as well as unique marketing and distribution channels. Emerald Health Therapeutics, Inc. recently signed an agreement to become a new supplier to STENOCARE A/S of medical cannabis for Denmark and STENOCARE's international markets. Since early September 2019, Emerald and STENOCARE have worked closely together to pre-qualify Emerald's products and production methods. STENOCARE and Emerald will now commence the work with the Danish Medicines Agency to have Emerald's products ready and approved for the Danish Medical Cannabis Pilot Programme. The companies are aiming for product approval for CBD oil, THC oil and CBD+THC oil. The partnership is also intended to extend to STENOCARE's Irish subsidiary and to additional markets which are being evaluated. "We respect STENOCARE's professionalism and their accomplishment in establishing leading distribution channels for medical cannabis in Denmark. We also appreciate their trust in Emerald's capability's and standards as they transition to new preferred supplier relationships," said Riaz Bandali, Chief Executive Officer of Emerald. "As Emerald ramps up production at its two recently fully-licensed production facilities, we look forward to fulfilling our commitment to STENOCARE and helping them to serve Danish patients."
Puration Inc. (OTC: PURA) has been a water purification company that designs, develops, engineers, produces, markets, and distributes personal and group systems that filter, purify, clean, extract or otherwise improve the quality of water on a cost effective, affordable basis, with a minimum of environmental impact. Puration, Inc. recently confirmed finalizing the acquisition of a German company that will enable PURA to bottle its CBD beverages locally for distribution throughout the European market. The acquisition was driven by PURA recently signing a distribution agreement in Europe for its EVERx CBD Sports Water with other CBD infused beverages to follow. The initial European distribution agreement is estimated to add USD 4 Million in sales next year. Management indicates that the potential of European distribution beyond the initial USD 4 Million projection warrants the establishment of a local bottling capacity. The bottling expansion in Europe is part of a bigger plan to expand bottling in Canada and Latin America. PURA announced a letter of intent for a second potential acquisition in Latin American similar to the acquisition in Germany. It is designed to establish a foothold for local bottling in the Latin American market just as the German acquisition is designed to establish a foothold in Europe.
Medical Marijuana, Inc. (OTC: MJNA) is a cannabis company with three distinct business units in the non-psychoactive cannabinoid space. Medical Marijuana, Inc. recently announced that its subsidiary HempMeds® had partnered with Sezzle, a leading alternative digital payment platform, to offer customers cutting-edge payment alternatives. HempMeds® was the first company to ever bring hemp-based cannabidiol (CBD) oil products to market in the U.S. and was also the first to make CBD products available in bulk for U.S. consumers. HempMeds® was also the first-ever company to receive historic federal government import approvals for its CBD products in the nations of Argentina, Brazil, Mexico, and Paraguay, as well as the first to have its CBD products listed in the Prescribers' Digital Reference and one of the first to be certified by the U.S. Hemp Authority. "The number of people searching for e-commerce outlets to purchase CBD has increased every year since 2017. In a study conducted at the University of California, San Diego, researchers found that online search volume for CBD in the U.S. increased 160.4 percent in 2018 compared with 2017 and is expected to increase by 117.7 percent in 2019 compared to 2018," said Medical Marijuana, Inc. Chief Executive Officer Dr. Stuart Titus. "With the number of new consumers becoming interested in purchasing CBD, we believe that Sezzle is a great opportunity to make our CBD products more accessible to people of all socioeconomic backgrounds."
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