Avicanna Inc. ("
Avicanna" or the
"
Company) (TSX: AVCN) (OTCQX: AVCNF) (FSE: 0NN) a
biopharmaceutical company focused on the development, manufacturing
and commercialization of plant-derived cannabinoid-based products
is pleased to announce that it has completed product registration
and its first commercial export of its Pura Earth branded
dermacosmetics products in Ecuador.
The initial export includes four SKUs of the
Pura Earth branded products that have been manufactured in Colombia
under GMP conditions and will be commercialized and distributed
through a partnership with Spenta S.A. through retail and
e-commerce channels. The CBD dermacosmetics have also been
registered and approved for sales as consumer cosmetics products by
the Ecuadorian health authorities, Agencia Nacional de Regulación,
Control y Vigilancia Sanitaria (“ARCSA”).
Pura Earth and the Potential of CBD
Skincare
The Pura Earth product formulations have been
developed and optimized to deliver purified, THC-free cannabidiol
(“CBD”) in synergistic combinations with other
natural ingredients known to provide specific functional benefits
in skincare 1 - 2. CBD has been shown to promote
skin health by inducing antioxidant, anti-inflammatory, and
anti-apoptotic responses that could be beneficial for a variety of
dermatological conditions as eczema or atopic dermatitis 1-3.
In addition, CBD can down-regulate the activity of cells that are
critical in the production of skin oils and therefore may dampen
the production in acne-prone skin4.
Three (3) out of the four (4) Pura Earth
products are dermatologist tested to ensure there are no
occurrences of skin irritation or sensitization, they are
demonstrated to have physical and chemical stability and each have
a shelf life of at least two (2) years. The formulations have been
optimized over the last three (3) years through Avicanna’s R&D
infrastructure, to increase CBD uptake into the skin and address
various consumer needs. In addition to the completed clinical
trials all Pura Earth products are not tested on animals and are
vegan.
“After years of R&D and clinical development of what we
believe is the most advanced line of CBD skin care products, we are
thrilled to expand our distribution capabilities
into Ecuador. Although this is an early stage for the
Latin American market, we believe this shows the potential of Pura
Earth as a leading skin care brand in the region,” stated Lucas
Nosiglia, President of Avicanna LATAM.
About the Initial 3 Pura H&W Products and the
Clinical Studies
The 3 cosmetic clinical studies were completed
on Avicanna’s formulations targeting cosmetic factors associated
with aging, acne-prone skin, and eczema-prone skin. The
successfully completed studies involved 156 patients that were
tested for safety and specific dermacosmetic endpoints, including
hydration and excess oil production. All three studies achieved
positive results in the endpoints with no adverse effects, making
Pura Earth one of the only cannabinoid consumer lines with human
safety and efficacy data. For more information please
see Clinicaltrials.gov Registry.
-
Clear Skin Gel: Water-based gel contains
beta-caryophyllene and tea tree extract that are known to have
antibacterial and anti-inflammatory properties 5-7. In
addition, rosemary oil extract has demonstrated actions against the
symptomatic treatment of acne 8,9. In Avicanna’s clinical
study, the Rosemary and Tea Tree Gel was investigated for its
short- and long-term effects on skin hydration and sebum (oil)
production on acne-prone or oily skin. The results showed
significant increase in skin hydration and a significant decrease
in oiliness in 93% of participants who had oily skin.
-
Intersive Moisturizing Cream: Oil-based
formula uniquely marries CBD, colloidal oatmeal and hemp seed oil
aimed at relieving skin redness 2,10. Colloidal oatmeal has
been shown to improve skin dryness, roughness, and itch
intensity 10. Avicanna’s clinical study of Colloidal Oatmeal
Cream evaluated its effect on skin hydration and erythema and found
that 86% of participants had decreased skin redness after 3 hours
and increased skin hydration.
-
Anti-Aging Cream: Rich, lightly scented white
cream with a unique amalgamation of purified CBD, Japanese cedar
bud, tocopheral and hemp seed oil. This formula targets aging skin
and is aimed at enhancing skin texture and skin
renewal 11 .
References:1. Tóth, K. F., et
al. (2019). Cannabinoid Signaling in the Skin: Therapeutic
Potential of the “C(ut)annabinoid” System. Molecules (Basel,
Switzerland), 24(5), 918. htt
ps://doi.org/10.3390/molecules24050918
2. Baswan, S. M., et al. (2020). Therapeutic
Potential of Cannabidiol (CBD) for Skin Health and Disorders.
Clinical, cosmetic and investigational dermatology, 13, 927–942.
htt ps://doi.org/10.2147/CCID.S286411
3. Atalay S, et al. (2020). Anti oxidative and
Anti -Inflammatory Properties of Cannabidiol. Anti oxidants.
9(1):21.
4. Oláh, A., Tóth, B., et al. (2014).
Cannabidiol exerts sebostatic and anti-inflammatory effects on
human sebocytes. The Journal of clinical investigation, 124(9),
3713–3724.
5. Committee on Herbal Medicinal Products
(HMPC). (2013). Assessment report on Melaleuca alternifolia (Tea
tree oil) and other species of Melaleuca, aetheroleum. European
Medicines Agency. Article 16d(1), Article 16f and Article 16h of
Directive 2001/83/.
6. Carson, C. F., Hammer, K. A., & Riley, T.
V. (2006). Melaleuca alternifolia (Tea Tree) oil: a review of
antimicrobial and other medicinal properties. Clinical microbiology
reviews, 19(1), 50–62.
7. Bassett IB et al. (1990). A comparative study
of tea tree oil versus benzoyl peroxide in the treatment of acne.
Medical Journal of Australia, 153:455-458.
8. Andrade, J. M., Faustino, C., et al, (2018).
Rosmarinus officinalis L.: an update review of its phytochemistry
and biological activity. Future science OA, 4(4), FSO283.
9. Tsai, T. H., Chuang, L. T., et al, (2013).
Rosmarinus officinalis extract suppresses Propionibacterium
acnes-induced inflammatory responses. Journal of medicinal food,
16(4), 324–333.
10. Reynertson, K. A., Garay, M., Nebus, J.,
Chon, S., Kaur, S., Mahmood, K., Kizoulis, M., & Southall, M.
D. (2015). Anti-inflammatory activities of colloidal oatmeal (Avena
sativa) contribute to the effectiveness of oats in treatment of
itch associated with dry, irritated skin. Journal of drugs in
dermatology : JDD, 14(1), 43–48.
11. Horiba, H., et al. (2016). Biological
Activities of Extracts from Different Parts of Cryptomeria
japonica. Natural product communications, 11(9), 1337–1342.
About Avicanna
Avicanna is a commercial stage Canadian
biopharmaceutical company and an established leader in cannabinoid
research, development, and evidence-based products for the global
consumer, medical, and pharmaceutical market segments. Avicanna
conducts its research in Canada including its R&D headquarters
in the Johnson & Johnson Innovation Centre, JLABS @ Toronto,
Canada, located in the MaRS Discovery District, and in
collaboration with leading Canadian academic and medical
institutions. Avicanna has established an industry leading
scientific platform including advanced R&D and clinical
development which has led to the commercialization of over twenty
products across four main market segments:
- RHO Phyto™: these
medical and wellness products are an advanced line of
pharmaceutical-grade cannabis products containing varying ratios of
CBD and THC. The product portfolio contains a full formulary of
products including oral, sublingual, topical, and transdermal
deliveries that have controlled dosing, enhanced absorption and
stability studies supported by pre-clinical data. These products
are developed using pharmaceutical drug development processes and
are supported with pre-clinical data. The advanced formulary is
marketed with consumer, patient and medical community education and
training.
- Pura H&W™/Pura
Earth™: these registered, clinically
tested, cosmetic products include a portfolio of functional CBD
consumer derma-cosmetic and topical products.
- Aureus™: as a part
of Avicanna’s vertical integration based out of Santa Marta,
Colombia its supply chain business units are primarily dedicated to
providing consistent source of cannabinoid raw materials for
Avicanna and its global partner’s food, cosmetic, medical and
pharmaceutical needs. Aureus branded products are cultivated,
extracted, and manufactured by Avicanna’s subsidiaries in Colombia
where they benefit from optimal environmental conditions to produce
cannabinoid active pharmaceutical ingredients economically,
organically, and sustainably and include a range of CBD, THC and
rare cannabinoids such as CBG extracts and standardized seeds.
Company is well positioned to be a global supplier of cannabinoid
raw materials demand and has already successfully exported its
products to over 10 countries in 4 continents.
- Pharmaceutical
pipeline: leveraging from the company’s scientific
platform, vertical integration, and real-world evidence, Avicanna
has established a pipeline of indication specific cannabinoid-based
drug candidates that are in various stages of clinical development
and commercialization. Avicanna’s drug candidates are in
pre-clinical stage and are dedicated to providing solutions for
unmet medical needs in the areas of dermatology, chronic pain and
various neurological disorders.
SOURCE Avicanna Inc.
Stay Connected
For more information about Pura Earth,
visit www.puraearth.com/es
For more information about Avicanna, visit
www.avicanna.com, call 1-647-243-5283, or contact IR
representative, Iryna Zheliasko, by email at iryna@chfir.com or by
phone at 416-868-1079 x 229.
The Company posts updates through videos from
the official company YouTube
channel https://www.youtube.com/channel/UCFXPBGdKSxOUOf_VZoSFSUA.
Cautionary Note Regarding Forward-Looking Information
and Statements
This news release contains "forward-looking
information" within the meaning of applicable securities laws.
Forward-looking information contained in this press release may be
identified by the use of words such as, "may", "would", "could",
"will", "likely", "expect", "anticipate", "believe, "intend",
"plan", "forecast", "project", "estimate", "outlook" and other
similar expressions, and includes statements with respect to the
ability of CBD to promote skin health by inducing antioxidant,
anti-inflammatory, and anti-apoptotic responses that could be
beneficial for a variety of dermatological conditions such as
eczema or atopic dermatitis, the ability of CBD to down-regulate
the activity of cells that are critical in the production of skin
oils and therefore may dampen the production in acne-prone skin,
the Company’s ability to ensure that the Pura Earth products will
not cause skin irritation or sensitization, the Company’s
ability to continue to supply the market in Ecuador with any Pura
Earth products, the Company’s ability to continue to manufacture
Pura Earth products, and Pura Earth being a leading skincare brand.
Forward-looking information is not a guarantee of future
performance and is based upon a number of estimates and assumptions
of management in light of management's experience and perception of
trends, current conditions and expected developments, as well as
other factors relevant in the circumstances, including assumptions
in respect of current and future market conditions, the current and
future regulatory environment; and the availability of licenses,
approvals and permits.
Although the Company believes that the
expectations and assumptions on which such forward-looking
information is based are reasonable, undue reliance should not be
placed on the forward-looking information because the Company can
give no assurance that they will prove to be correct. Actual
results and developments may differ materially from those
contemplated by these statements. Forward-looking information is
subject to a variety of risks and uncertainties that could cause
actual events or results to differ materially from those projected
in the forward-looking information. Such risks and uncertainties
include, but are not limited to current and future market
conditions, including the market price of the common shares of the
Company, and the risk factors set out in the Company's annual
information form dated September 3, 2021 and final short form
prospectus dated November 27, 2020, filed with the Canadian
securities regulators and available under the Company's profile on
SEDAR at www.sedar.com.
The statements in this press release are made as
of the date of this release. The Company disclaims any intent or
obligation to update any forward-looking information, whether as a
result of new information, future events or results or otherwise,
other than as required by applicable securities laws.
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