Advances in Drug Delivery Hold the Promise of Reducing Inevitable Side Effects

NEW YORK, September 19, 2017 /PRNewswire/ --

The hazards of pharmacology have hardly changed since Paracelsus, a famous Renaissance physician, astoundingly declared that it was only the dosage that separated a medicine from a poison, bundled with adverse side effects. Despite considerable advances in medicine, many medications are still as injurious as their Renaissance precursors. Nevertheless, recent developments in drug delivery technologies increasingly suggest that safer, more efficient treatment options are on the horizon. At the core of this potential are cannabinoids. Developments in this rapidly growing segment of the medical marijuana market are pioneered by a vast number of innovators, including Lexaria Bioscience Corp. (OTC: LXRP) (CSE: LXX) (LXRP Profile), GW Pharmaceuticals (NASDAQ: GWPH), Zynerba Pharmaceuticals (NASDAQ: ZYNE), Cara Therapeutics (NASDAQ: CARA) and Philip Morris (NYSE: PM), all of which are invested in the cannabis space.

Research findings in the cannabinoid field continue to astonish and elate. In August 2017, Lexaria Bioscience (OTCQB: LXRP) (CSE: LXX.CN) announced (http://nnw.fm/h7aG8) the world's first clinical study on human volunteers of cannabidiol (CBD) within Lexaria's high absorption TurboCBD™ product. The study will evaluate the effects of CBD on cardiovascular health and cognitive function. Lexaria's TurboCBD, a brand of technologically enhanced, high absorption hemp oil capsules, came to market in March 2017. Its CBD content is fortified with high-quality American ginseng and ginkgo biloba for support of enhanced focus and memory, and reduced stress and fatigue.

TurboCBD capsules contain a combination of CBD and minute quantities of long chain fatty acids like sunflower oil, utilizing a proprietary technology to create an amalgam that increases the ability of the human gastrointestinal system to absorb CBD. In vitro and human focus study testing has shown increases in CBD absorption using Lexaria's technology by as much as 5-10 times more than conventional preparations. Those studies also demonstrated rapid onset of action in as little as 15 minutes.

The TurboCBD study is designed to test a number of hypotheses expected to follow after its supplementation: (i) that circulating CBD and nitric oxide will increase in both young and old participants; (ii) that glucose and blood pressure will remain stable; and (iii) that vascular function, and cognitive and physical exercise performance will improve to a greater extent in older participants. The study will be conducted by researchers at the University of British Columbia, which has consistently been ranked as one of the top three universities in Canada. The institution is also considered one of the top research universities in the world and has conducted several earlier studies in the cannabis sector, available for review at http://nnw.fm/o8O9a.

Lexaria has also developed and commercialized a patented and cost-effective delivery technology, DehydraTECH™, which has been both laboratory and market proven to enhance the performance of beneficial compounds in ingestible products across four categories: taste, smell, speed of action, and bio-absorption and bio-availability.

At present, Lexaria is the only company in the world that has been awarded a patent for the improved (oral or ingestible, including pills) delivery of all non-psychoactive cannabinoids. Patents have been awarded in the U.S. and Australia and are pending in 40 more countries. This puts the company in the unusually advantageous position of owning proprietary technology that can deliver a vast range of non-psychoactive cannabinoid-based drugs.

Notably, because Lexaria's technology is complementary to all ingested forms of cannabinoids, the company is positioned to license its intellectual property to clinical-stage biotechnology companies, becoming an enabler - rather than a competitor - that works with other research and development pertaining to cannabinoids.

Collaboration with a company like GW Pharmaceuticals (NASDAQ: GWPH), for example, could yield considerable outcomes. The British company, best known for its multiple sclerosis (MS) cannabinoid product, Sativex, is working feverishly to bring another to market. Currently, its lead cannabinoid product candidate Epidiolex is in phase III clinical trials. This drug is a proprietary oral solution of pure plant-derived cannabidiol (CBD) for the treatment of severe, orphan, early-onset, treatment-resistant epilepsy syndromes including Dravet syndrome, Lennox-Gastaut syndrome (LGS), Tuberous Sclerosis Complex (TSC) and Infantile Spasms (IS).

Also developing treatments for epileptic conditions, with rather less encouraging outcomes than GW Pharmaceuticals, is Zynerba Pharmaceuticals (NASDAQ: ZYNE). In August 2017, the company published disappointing results of phase II studies of its cannabidiol (CBD) product, ZYN002, aimed at treating adult epilepsy patients with focal seizures. Since CBD has shown some promise in reducing epileptic seizures, as in the GW Pharmaceutical studies, this raises the possibility that Zynerba's setback may be due, not to the payload, but the delivery system. ZYN002 employs a transdermal gel that is applied topically on the surface of the skin. However, an oral delivery system, like the one developed by Lexaria, may prove more effective.  

Cara Therapeutics (NASDAQ: CARA) is another biotech now coming to terms with disappointing clinical trial results. Trials for an oral formulation of its drug candidate CR845, an opioid derivative, studied in osteoarthritis patients, did not turn out so well. However, the study tested patients on low dosages (1.0 mg and 2.5 mg) of CR845 taken orally. Higher oral dosages and CR845 taken intravenously have shown more promising outcomes. The company's research into opioids has spilled over into cannabinoids. Current preclinical research involves CR701, a cannabinoid receptor agonist, designed to treat chronic pain. The incentive to develop cannabinoid products to treat chronic pain is driven, in part, by the opioid epidemic. While opioid overdose deaths are in the tens of thousands, there appears to be no clearly documented account of anyone dying from an overdose of marijuana.  

Smoking marijuana is, of course, one method proven to deliver cannabinoids effectively. Alas, the now well-known deleterious effects on the respiratory system are spurring efforts to develop other delivery mechanisms, such as non-smoke cigarettes, which perhaps is why Philip Morris International (NYSE: PM) invested $20 million in Israeli startup Syqe Medical. The company manufactures delivery devices for cannabis, like its inhaler. Syqe's pocket-sized Inhaler delivers precision dosages of its payload: 100 micrograms, every time the device is activated. This overcomes a major barrier to adoption of medical cannabis by doctors: the lack of standardization in dosage regimens. Syqe has tested a similar device in hospitals in a clinical trial that demonstrated its dosing precision superiority to other modes of THC administration. With Philip Morris' involvement, nicotine may just be next.

As the research into cannabinoids continues to unearth excitingly novel ways to treat a variety of medical conditions, delivery systems are proving to be just as important as payloads. As a result, companies with advanced delivery systems, like Lexaria, are likely to find cannabinoid biotechs beating that proverbial path to their door.

For more information on Lexaria Bioscience please visit: Lexaria Bioscience Corp. (CSE: LXX) (OTCQB: LXRP)

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