LONDON, ON (September 10, 2019) – KGK Science Inc. (“KGK”), a subsidiary of Auxly Cannabis Group Inc. (TSX.V: XLY) (OTCQX: CBWTF) (“Auxly”), has been issued a Cannabis Research License by the Licensing and Medical Access Directorate of Health Canada, Controlled Substances and Cannabis Branch, allowing the company to possess and administer cannabis for a Phase I human clinical trial. KGK was contracted to conduct this trial by U.S. firm, New Age Nanotech (“NAN”). The trial is designed to demonstrate the pharmacokinetics, pharmacodynamics, and safety of orally administered THC and CBD in healthy adults, delivered through Solutech™, New Age Nanotech’s proprietary delivery technology for cannabis and hemp. The research license completes a series of prior regulatory approvals, including the Health Canada Therapeutic Products Directorate No Objection Letter, that needed to be secured for the purpose of this Phase I trial.
“As a science-driven organization, effectively securing the required licensing is an important step, allowing us to move forward with supporting business partners like New Age Nanotech who value science in substantiating the safety and efficacy of their cannabis-derived products through clinical trials,” says Najla Guthrie, President and CEO of KGK Science.
“With KGK as a great partner on our side, we are excited that the research license now clears the way to conducting our pivotal clinical trial for SolutechTM”, said Mark Frank, Chief Operating Officer of New Age Nanotech, “Our early research on Solutech™ has displayed desirable PK and PD characteristics for orally ingested cannabinoids in humans, increasing the speed of absorption and elimination, peak blood levels and overall bioavailability, and providing a fast onset and fast offset of effects, compared to a standard commercial oil formulation. These properties can be favorable for medical and pharmaceutical applications, and particularly for use in a recreational environment, where safety concerns arise from the lag times associated with edibles, from unpredictable high duration and intensity, and from inaccuracies associated with their dosing. In anticipation of the Canadian rollout of accurately dosed edibles and drinkables with improved delivery and absorption, and with the increasing popularity of these novel form factors over vaping or smoking, we are encouraged to move forward with this pioneering and differentiating government-approved Phase I human clinical trial on Solutech™”
This license is one of the first of its kind to be issued to a contract research organization in Canada, following the federal legalization of cannabis in October of 2018. Based on a protocol developed by KGK researchers with the support of New Age Nanotech, the trial will commence in October at the KGK in-house clinic in London, ON. With many more cannabis trials in their pipeline, KGK is well on its way to demonstrating its maturity as a leader in research and regulatory services to support cannabis and cannabis-derived products.
Contact: Lauren Redman, Director of Marketing | (519) 438-9374 x 254 | lredman@kgkscience.com
For Inquiries about Solutech™: (800) 210-9809 | info@newagenanotech.com
About KGK Science Inc.
As a leading global Contract Research Organization (CRO), KGK Science performs a productive and pioneering role in the realm of scientific study. For over two decades, it has offered well-designed, customized solutions to each of its clients, consolidating its scientific, clinical, commercial, and regulatory abilities into one full-service package. Equipped with state-of-the-art technologies, novel research techniques, and a seasoned team of thought leaders, KGK Science remains at the forefront of its industry.
About New Age Nanotech
New Age Nanotech is an industry leader in the development and commercialization of superior, clinically-proven downstream product solutions for the Cannabis industry. Its flagship, Solutech ™, is a water-soluble patented cannabinoid delivery platform, enabling the turn-key creation of beverages, edibles, topicals, etc. with distinct advantages in shelf-stability, clarity, taste, absorption, and dosing.