VANCOUVER, Aug. 13, 2019 /CNW/ - Harvest One Inc.
("Harvest One" or the "Company") (TSXV: HVT;
OTCQX: HRVOF), through its wholly-owned subsidiary Satipharm
Ltd. ("Satipharm"), today announced positive results of a
Phase 2 clinical trial of its CBD GelPell® capsules in
the management of Treatment Resistant Epilepsy (TRE) have been
published in Epilepsy & Behaviour, a bimonthly peer-reviewed
medical journal covering behavioral aspects of epilepsy.
Highlights include;
- Phase 2 open label clinical trial is aimed at measuring safety
and efficacy of Satipharm CBD capsules for reducing seizure
frequency in children with refractory, or treatment-resistant,
epilepsy
- The median reduction of monthly seizures was -82% in the
12-week treatment period in treatment-resistant children when added
to current medications
- 56% who started the treatment had a reduction of at least 50%
in total number of seizures during the entire treatment period,
compared to observation
- 73% were rated as "very much improved/improved" in overall
condition on the Caregiver Global Impression of Improvement
scale
- 82% were rated as "very much reduced/reduced"
- A mean 73.4% reduction from baseline monthly seizure
frequencies was observed
- Two patients were fully seizure-free within 5 weeks of
treatment
- An additional seven patients reported >50% seizure frequency
reduction
A fulsome description of the study and results can be found in
the Harvest One background document available on our website at
https://www.harvestone.com/portfolio/satipharm/#clinical-trials
"The results of our second stage of clinical trials on our
Satipharm 50mg CBD GelPell® products are very
encouraging for the patients we serve, our shareholders and our
company" said Grant Froese, Chief
Executive Officer of Harvest One. "We continue to be focused on the
best in class health, wellness, and self-care products at Harvest
One and we believe that our unique products, including the
proprietary GelPell®, will be highly sought after as
cannabis legalization takes hold around the world".
GelPell® capsules contain full spectrum hemp
extract CBD in a seamless gelatine bead. This bead is placed
inside a hard gastro-resistant capsule ensuring the release of CBD
in the small intestine where it has the greatest effect.
Manufactured in Switzerland and EU
GMP Certified, every 50mg GelPell® capsule has been
clinically proven to improve the body's absorption of CBD and other
cannabinoids. They are easy to take and contain a consistent and
precise dose of CBD.
"The efficacy of Satipharm's CBD capsules as an add-on therapy
in the treatment of pediatric, intractable epilepsy has been shown.
Moreover, these results compare favourably to other similar studies
of cannabidiol" said Prof. Uri
Kramer, Director of Pediatric Epilepsy Service, Tel Aviv
Sourasky Medical Centre and Principal Investigator of the trial.
"Importantly, the significant reductions in seizure frequency while
demonstrating satisfactory safety and tolerability profile, in
these very difficult to treat patients, have the potential to be a
life-altering event for these patients and their families. I would
be greatly interested in prescribing such standardized and
clinically tested product as Satipharm's 50mg CBD
GelPell®"
Find full details of the Clinical Trial results here:
https://authors.elsevier.com/sd/article/S1525505019303051
About Treatment Resistant Epilepsy (TRE)
Epilepsy
encompasses a wide range of chronic syndromes characterized by
recurrent, unprovoked, and unpredictable seizures. The disease is
estimated to affect over 65 million people worldwide, including
approximately 0.6% of children under the age of 18 [1], 82% of
whom will be under the age of 10 [2]. Treatment-resistant
epilepsy (TRE), defined as failure to achieve sustained seizure
remission after appropriate calibration of at least two
antiepileptic drugs (AEDs), affects approximately 30% of patients
with epilepsy [3]. Apart from the severe morbidity and
significantly increased mortality among patients with
TRE [4], [5], early onset comes along with high incidence
of cognitive, behavioral, motor, and neurodevelopmental
delays [6].
Accessing Satipharm 50mg CBD GelPell® Capsules
UK
Satipharm CBD 50mg GelPell® capsules
are available in the UK through Health House who distribute to
pharmacies and healthcare professionals.
www.healthhouse.uk
info@healthhouse.uk
+44 (0) 1420 487501
Australia
Satipharm CBD 50mg
GelPell® capsules are available in Australia through the Therapeutic Goods
Administration (TGA) Special Access Scheme (Category B) or through
the Authorised Prescriber Scheme. Patients wishing to access
medicinal cannabis products should discuss access with their
physician and make themselves familiar with the processes by
reading the TGA advice at www.tga.gov.au. Once the physician has
the required approval, this prescription can then be sent to our
distributor, Health House International, who will arrange delivery
to a dispensing pharmacy.
About Harvest One Cannabis Inc.
Harvest One is a
global consumer packaged goods company that develops and
distributes premium health, wellness, and lifestyle products to
patients and consumers in regulated markets around the world. The
Company's portfolio of premium products is designed to enhance
quality of life. Shareholders have significant exposure to the
entire cannabis value chain through four wholly-owned subsidiaries:
United Greeneries, a Licensed Producer; Satipharm (medical and
nutraceutical); Dream Water Global and Delivra (consumer products
with an emphasis on sleep, pain, and anxiety), and a minority
interest in Burb Cannabis (retail operations). For more
information, please visit www.harvestone.com.
About Satipharm
Satipharm is a health and
wellness company which is specialised in the development and
manufacture of cannabinoid-based products from the hemp plant. Our
mission is to deliver the highest quality products that are
designed specifically with the needs of our customers in mind. For
more information, please visit www.satipharm.com.
Cautionary Note Regarding Forward-Looking Statements
Certain statements contained in this press release constitute
forward-looking information. These statements relate to future
events or future performance. The use of any of the words "could",
"intend", "expect", "believe", "will", "projected", "estimated" and
similar expressions and statements relating to matters that are not
historical facts are intended to identify forward-looking
information and are based on the Company's current belief or
assumptions as to the outcome and timing of such future events.
Actual future results may differ materially. The forward-looking
information contained in this press release is made as of the date
hereof, and the Company is not obligated to update or revise any
forward-looking information, whether as a result of new
information, future events or otherwise, except as required by
applicable securities laws. Because of the risks, uncertainties and
assumptions contained herein, investors should not place undue
reliance on forward-looking information. The foregoing statements
expressly qualify any forward-looking information contained
herein.
Neither TSX-V nor its Regulation Services Provider (as that
term is defined in the policies of the TSX-V) accept responsibility
for the adequacy or accuracy of this release.
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SOURCE Harvest One Cannabis Inc.