PreveCeutical Medical Inc (PRVCF)

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PreveCeutical Confirms Encouraging Results from Sol-gel Applicator Trials for Achieving Direct Nose-to-Brain Delivery in an Adult Human Nasal Cast
 

November 19, 2018, Vancouver, British Columbia:  PreveCeutical Medical Inc. (the “Company” or “PreveCeutical”) (CSE: PREV, OTCQB: PRVCF, FSE: 18H), is pleased to provide an update on the soluble gel (“Sol-gel”) drug delivery research and development program (the “Sol-gel Program”), that involves testing and formulating an array of cannabis strains for the development and commercialisation of cannabinoid-based Sol-gels. The Sol-gels are administered using a custom applicator device (the “Sol-gel Applicator”) for direct and sustained nose-to-brain drug delivery.
 
Achieving patient benefit from use of medicinal cannabis for the management of central nervous system (the “CNS”) conditions, such as epilepsy, anxiety and depression, is reliant upon achieving effective and sustained delivery of the cannabis-based therapeutic to brain tissue. When taken orally medicinal cannabis can cause gastrointestinal upset, and when absorbed across the gut it is rapidly broken down by enzymes.  As common drug delivery methods do not provide effective and sustained delivery to the brain,  the delivery of cannabinoids to the CNS is a universal problem. PreveCeutical is pleased to announce that it expects to address this issue through its Sol-gel platform and Sol-gel Applicator device for direct nose-to-brain delivery of cannabis-based therapeutics.
 
Traditional liquid nasal sprays are not retained in the nasal cavity for any appreciable time, and are only capable of generating random spray and deposition profiles as depicted in Figure 1a and Figure 1b, respectively.

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Figure 1a Liquid spray profile into adult human nasal cast from applicator device (no inhalation, cast temperature 34 °C).

?Figure 1b Liquid deposition profile into adult human nasal cast from applicator device (no inhalation, cast temperature 34 °C).

In contrast, the Company’s Sol-gel Applicator generates a precise spray profile that directs the Sol-gel formulation high into the upper nasal cavity (Figure 2a), where it remains following rapid gelation (Figure 2b). This is an important development, as the region targeted by the Sol-gel is adjacent to the olfactory epithelium (depicted by red arrows in the figures below), which serves as a direct passage for molecules into the brain.

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Figure 2a Sol-gel spray profile into adult human nasal cast from applicator device (no inhalation, cast temperature 34 °C).

?Figure 2b Sol-gel deposition profile in adult human nasal cast from applicator device (no inhalation, cast temperature 34 °C).To exemplify the Sol-gel and Sol-gel Applicator’s capabilities, an inhalation model was developed to mimic the inhalation action performed by patients when using nasal sprays, which combines an action of simultaneously spraying into a nostril accompanied by steady and deep nasal inhalation.
 
In the inhalation model, liquid sprays and Sol-gel sprays were compared for their delivery high into the nasal cavity along the target region, the olfactory epithelia. As shown in Figure 3a, the liquid spray profile shows random spray distribution with distinct large droplets, which is undesirable for the nose-to-brain delivery of therapeutics. In stark contrast, the Sol-gel formulation (Figure 3b) was drawn high into the nasal cavity, rapidly gelling and coating the target olfactory epithelium region. This encouraging development paves the way for the use of Sol-gels and the Sol-gel Applicator for direct nose-to-brain delivery.?Figure 3a Liquid spray generates a random droplet profile (inhalation model, cast temperature 34 °C).?

Figure 3b Sol-gel spray profile gels and coats olfactory epithelia (inhalation model, cast temperature 34 °C).

The following video links showcase the contrasting spray profiles, in real-time, between a liquid and a Sol-gel being dispersed using the Sol-gel Applicator.
 
Video link to liquid spray profile demonstration
Video link to Sol-gel spray profile demonstration
 
The Company’s Chief Research Officer, Dr. Harendra Parekh stated, “This is an important development for PreveCeutical, having demonstrated that its engineered Sol-gels and applicator device achieve delivery and retention directly at target tissue high in the nasal cavity, a feat that cannot be claimed by liquid sprays existing in the market currently. What’s more exciting is that this outcome opens the door for PreveCeutical to potentially deliver a host of therapeutics from nose-to-brain in a reliable and sustained manner, which remains a significant challenge for many companies, globally.”
 
The CBD Sol-gel formulations, when used with the Company’s custom Sol-gel Applicator, will facilitate prolonged delivery of cannabinoids to patients’ central nervous system. The Company’s medicinal cannabis division expects to be able to offer a broad product range that can be tailored to specific medical conditions. For example, the Company is currently developing a CBD Sol-gel formulation with a cannabinoid composition designed to treat patient anxiety (see news release dated August 8, 2018).
 

About PreveCeutical
 
PreveCeutical is a health sciences company that develops innovative options for preventive and curative therapies utilising organic and nature identical products.
 
PreveCeutical aims to be a leader in preventive health sciences and currently has five research and development programs, including: dual gene therapy for curative and prevention therapies for diabetes and obesity; the Sol-gel Program; Nature Identical™ peptides for treatment of various ailments; non-addictive analgesic peptides as a replacement to the highly addictive analgesics such as morphine, fentanyl and oxycodone; and a therapeutic product for treating athletes who suffer from concussions (mild traumatic brain injury).
 
PreveCeutical sells CELLB9®, an Immune System Booster.  CELLB9 is an oral solution containing polarized and potentiated essential minerals extracted from a novel peptide obtained from Caribbean Blue Scorpion venom.  This product is available on the Company’s website.
 
For more information about PreveCeutical, please visit www.PreveCeutical.com, follow us on Twitter: http://twitter.com/PreveCeuticalsand Facebook: www.facebook.com/PreveCeutical.