Widespread Clinical Studies Can Reinvigorate the Legalization Movement for Cannabis
NEW YORK, April 17, 2019 /PRNewswire/ -- Researchers and scientists are constantly developing new, innovative medicines to effectively treat patients. However, the cost to conduct clinical trials and then receive approval to commercialize a drug is absurdly expensive. The Tufts Center for the Study of Drug Development estimated that in 2017, it cost pharmaceutical companies approximately USD 2.7 Billion to bring medicine from invention stages to shelves. And even after pharmaceutical companies are granted approval to commercialize, studies have concluded that many of these drugs negatively harm consumers. Now, the growing concern over the mental and physical health damage caused by traditional medicines have prompted medical institutes to reevaluate, which has, in turn, brought forth medical cannabis into the spotlight. Small-scale research and clinical trials have concluded that medical cannabis can effectively treat medical conditions that common medications such as opioids also treat. Moreover, cannabis is significantly cheaper to cultivate and commercialize, when compared to other drugs that are undergoing trials. Data from the Marijuana Business Factbook suggested that the average cost for a startup wholesale cannabis cultivation businesses is as low as USD 10 per sq. ft. for outdoor grow houses but can go for as much as USD 75 per sq. ft.for indoor facilities. Despite the inexpensive costs to grow medical cannabis, the plant is still not a registered treatment under international regulations. However, as clinical trials continue to progress, more countries could be expected to adopt medical cannabis legalizations. According to data compiled by Verified Market Intelligence, the global marijuana market was valued at USD 42.20 Billion in 2017 and is projected to reach USD 466.81 Billion by 2025. Additionally, the market is expected to register a CAGR of 35.3% from 2018 to 2025. Pressure BioSciences, Inc. (OTC: PBIO), Sorrento Therapeutics, Inc. (NASDAQ: SRNE), Intec Pharma Ltd. (NASDAQ: NTEC), Zynerba Pharmaceuticals, Inc. (NASDAQ: ZYNE), Neptune Wellness Solutions Inc. (NASDAQ: NEPT) (TSX: NEPT)
Another major issue about pharmaceutical companies developing their own medicines is whether or not they will meet their primary endpoints. If a company were to miss its primary endpoint, it will usually pour more funds into its clinical trials or, worst-case scenario, terminate the trial. Furthermore, most drugs developed by large pharmaceutical companies are aimed towards treating one or several other medical applications. On the other hand, cannabis can be used to treat a variety of medical conditions such as chronic pain, cancer, Alzheimer's, Parkinson's, epilepsy, multiple sclerosis, and anxiety. "The opioid problem is lethal and growing. Prescription opioid abuse is actually worse than heroin abuse; it's a bigger problem, and it starts in the doctor's office," said Dr. Dustin Sulak, Founder and Director of Integr8 Health, a network of holistic health clinics, "Cannabis can replace and reduce opioid use. Adding cannabis makes opioids safer by widening the therapeutic index. Cannabis can prevent opioid tolerance-building and the need for dose escalation. And cannabis can treat the symptoms of opioid withdrawal. Finally, cannabis is safer than the other harm reduction options."
Pressure BioSciences, Inc. (OTCQB: PBIO) announced earlier this month that it had, "released a new, short video demonstrating the ability of the Company's proprietary Ultra Shear Technology (UST(TM)) platform to create water-soluble CBD oil that disperses instantly, resulting in improved dosing effectiveness, enhanced absorption, and more aesthetically-pleasing products when added to carbonated soft drinks, vitamin-infused sports drinks, and beer.
Link to video: https://www.youtube.com/watch?v=gAqFQmsGHcA
In addition to superior aesthetic quality, the Company believes the resulting low nanometer-scale emulsions ("nanoemulsions") of UST-processed CBD oil should also result in optimized and reproducible bodily absorption, bioavailability, and dosing safety for CBD oil and other UST-processed materials, when compared to many of the processed CBD oils and products that are commercially available today.
Mr. Edgar Ward, President and CEO of NutraLife Biosciences (OTCQB: NLBS), said: 'NutraLife manufactures and sells NUTRAHEMPCBD, a line of CBD-infused products that includes creams, sprays, and other products that support daily health and wellness uses. We strive to ensure that our CBD-infused products will always be of the highest quality possible; therefore, we are constantly looking for advanced technologies to continue to improve our manufacturing processes. After reviewing available data and PBI's videos, we believe methods like PBI's UST platform may enable us to offer products with superior quality and effectiveness.'
CBD is a non-psychoactive, oil-soluble compound extracted from the cannabis plant, and is typically marketed dissolved in plant oil. It has been widely reported to offer numerous health benefits from stress and anxiety relief, to decreased muscle, joint, cancer and other pain, reduced inflammation, and to nearly miraculous relief of persistent seizures. However, because CBD is an oil-based product, its ingestion typically results in poor absorption in water-based living systems. There has been enormous interest in the development of truly water-soluble CBD, to achieve efficient absorption and bioavailability from foods and beverages. The market for CBD beverages alone could achieve revenue of $260 million in just the U.S. by2022 (Bloomberg, September 27, 2018) and much more world-wide. Unfortunately, because of solubility issues, many CBD products on the market today contain an inefficient over-abundance of CBD and/or undesirable chemicals to improve and stabilize its solubility in water. PBI believes that all of these beverages and other CBD-based products could substantially benefit from PBI's Ultra Shear Technology platform, to achieve water solubility and stability from the physics of high-pressure shearing - rather than from dependency upon chemistry and reliance upon use of undesirable chemicals.
Dr. Brad Young, Chief Commercial Officer of PBI, commented: 'We are very pleased to now show (in this follow-up video) the ability of our proprietary UST platform to mix CBD oil in water and infuse carbonated soft drinks, vitamin-infused sport drinks, and beer. This latest video further highlights the power of our UST platform to make nanoemulsions and its potential to help nutraceutical and beverage manufacturers make high-quality, oil-based products. With such compelling results to rely on, and with numerous opportunities ahead of us, we intend to accelerate the development of our UST platform to better address what we believe are several multi-billion-dollar markets in nutraceuticals, cosmetics, and food & beverages.'
About Pressure BioSciences, Inc: Pressure BioSciences, Inc. (OTCQB: PBIO) is a leader in the development and sale of innovative, broadly enabling, pressure-based solutions for the worldwide life sciences industry. Our products are based on the unique properties of both constant (i.e., static) and alternating (i.e., pressure cycling technology, or PCT) hydrostatic pressure. PCT is a patented enabling technology platform that uses alternating cycles of hydrostatic pressure between ambient and ultra-high levels to safely and reproducibly control bio-molecular interactions (e.g., cell lysis, biomolecule extraction). Our primary focus is in the development of high pressure-based products for biomarker and target discovery, drug design and development, biotherapeutics characterization and quality control, food science, soil & plant biology, forensics, and counter-bioterror applications. Additionally, we are actively expanding the use of our pressure-based technologies in the following areas: (1) the use of our recently acquired protein disaggregation and refolding technology from BaroFold, Inc. to allow entry into the biologics manufacturing and contract research services sector, and (2) the use of our recently-patented, scalable, high-efficiency, pressure-based Ultra Shear Technology (UST(TM)) platform to (i) create stable nanoemulsions of otherwise immiscible fluids (e.g., oils and water) and to (ii) prepare higher quality, homogenized, extended shelf-life or room temperature stable low-acid liquid foods that cannot be effectively preserved using existing non-thermal technologies."
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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".
Intec Pharma Ltd. (NASDAQ: NTEC) is a clinical-stage biopharmaceutical company focused on developing drugs based on its proprietary Accordion Pill platform technology. Intec Pharma Ltd. recently announced the dosing of the first patient in a Phase 1 pharmacokinetic (PK) study of AP-THC, its proprietary Accordion Pill(TM) platform containing synthetic tetrahydrocannabinol (THC), one of the primary cannabinoids contained in cannabis. The Phase 1 PK study is a single-center, single-dose, randomized, open-label three-way crossover study to investigate the PK, safety and tolerability of AP-THC in up to 18 normal healthy volunteers. "We are very pleased to be advancing our medical cannabinoid development program as we believe the Accordion Pill's gastric retentive technology is ideally suited to extend the absorption phase of THC, with the goal of a slower rate of rise and more consistent drug plasma levels after oral delivery. The combination of the slower rate of rise with sustained and consistent plasma levels is expected to lead to an improved therapeutic effect and reduce the adverse events that are correlated with rate of rise and peak THC plasma levels," said Jeffrey A. Meckler, Vice Chairman and Chief Executive Officer of Intec Pharma.
Zynerba Pharmaceuticals, Inc. (NASDAQ: ZYNE) is the leader in pharmaceutically-produced transdermal cannabinoid therapies for rare and near-rare neuropsychiatric disorders. Zynerba Pharmaceuticals, Inc. recently provided an update on its clinical progress. Zynerba remains on track to report top line results from the CONNECT-FX (Clinical study of Cannabidiol (CBD) in Children and Adolescents with Fragile X) study in Fragile X Syndrome in the second half of 2019. The Company has completed enrollment in its Phase 2 BELIEVE 1 (Open Label Study to Assess the Safety and Efficacy of ZYN002 Administered as a Transdermal Gel to Children and Adolescents with Developmental and Epileptic Encephalopathy) clinical trial in children and adolescents with developmental and epileptic encephalopathies (DEE). Top-line results will be reported in the third quarter of 2019. "Our aspirations and expectations are clear: To work closely with the U.S. Food and Drug Administration to expand the opportunity for pharmaceutically-developed CBD treatments that meet their rigorous medical and manufacturing standards, and in doing so, continue toward our goal of addressing significant unmet medical needs in neuropsychiatric disorders," said Armando Anido, Chairman and Chief Executive Officer of Zynerba. "With the new indications of ASD and 22q, in addition to FXS and DEE, we now have four shots on goal to show the clinical benefit of ZYN002 transdermal gel in patient populations that have few, if any, therapeutic options available."
Neptune Wellness Solutions Inc. (NASDAQ: NEPT) (TSX: NEPT) specializes in the extraction, purification and formulation of health and wellness products. Neptune Wellness Solutions Inc. recently announced that its Solutions Business has begun offering turnkey product development solutions with hemp-derived ingredients to business customers in the United States. A U.S.-based supply chain of licensed hemp extract producers has been established, and initial purchase orders are now being processed. Neptune boasts long-standing experience in the management of custom and white label turnkey product development solutions comprising a diverse array of product forms including softgels, liquids, topicals, emulsions, and water-dispersible powders. Branded ingredients and products that have contributed to Neptune's success, such as MaxSimil® and ECSentials(TM) formulations, could potentially be used in unique combinations with hemp ingredients, particularly as the U.S. regulatory framework around hemp extracts and cannabidiol (CBD) evolves. "The U.S. market for hemp is developing rapidly and represents a significant opportunity for the consumer products industry. Neptune is now offering products and services to American brands that want to create a unique hemp-based portfolio, with products made exclusively in the U.S. for the U.S.," said Jim Hamilton, President and Chief Executive Officer of Neptune.
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