TSXV –
HVST
VANCOUVER,
Feb. 1, 2018 /CNW/ - Harvest One Cannabis Inc. (TSXV:
HVST) ("Harvest One" or the "Company") through its
wholly-owned subsidiary Satipharm AG ("Satipharm") is
pleased to announce its proprietary capsules were used in a Phase 2
Clinical Trials undertaken by Israeli-based PhytoTech Therapeutics
Ltd ("PTL") a wholly owned subsidiary of MMJ PhytoTech limited
("MMJ"). The Phase 2 trial is an open-label, single-centre
clinical study to evaluate the safety, tolerability and efficacy of
oral administration of Satipharm CBD capsules as an adjunctive
treatment. Results from the first 10 patients who participated in
the Phase 2 clinical trials are now available.
Highlights:
- PTL's 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.
- Satipharm CBD capsules are a proprietary oral formulation
developed using the Gelpell-CBD™ product technology.
- Satipharm CBD capsules reduced monthly seizure frequency in
the treatment-resistant children when added to current medications.
The treatment was generally well tolerated, with a safety profile
consistent with prior experience.
- Promising evidence of efficacy has been reported. In 6
patients a reduction of 59-91% in mean monthly seizure frequency
was observed following 12 weeks of treatment.
- The median reduction was -79.5% in the 12-week treatment
period compared to the 4-week observation period.
Importantly, the initial results received to date indicate that
Satipharm's capsules significantly reduce monthly seizure frequency
when added to current medications, with strong evidence of efficacy
reported.
PTL's near-term focus is on recruiting the final patients
required for the Phase 2 trial, in the next few weeks, with the
study expected to be completed by mid-2018. The full results for
the entire patient cohort would then be published shortly
thereafter.
Phase 2 Clinical Trial Background
The Phase 2 trial is an open-label, single-center clinical
study, designed to evaluate the safety, tolerability and efficacy
of the Satipharm CBD capsules as an adjunctive treatment to 15
children with treatment-resistant epilepsy, aged 2-15 years.
The study comprised of 3 periods: observation (4 weeks),
dose-titration and treatment (12 weeks), and follow-up (2
weeks). Patients were eligible to participate in the study if
they had tried at least four prior anti-epileptic drugs (AEDs),
including one trial of a combination of two AEDs, without
successful seizure control. Daily doses were limited to 25mg/kg or
450 mg, whichever is lower.
Eight patients completed the study, while two patients were
discontinued due to worsening seizures. Following 12 weeks of
treatment, 6 of the 8 patients were rated as "very much
improved/improved" in overall condition on the Caregiver Global
Impression of Improvement scale and 7/8 patients were rated as
"very much reduced/reduced" on Caregiver Global Impression of
Seizures Severity scale. In these patients the mean monthly
seizure frequency reduction was 59-91% after the 12-week treatment
period, compared to the 4-week observation period.
One patient had a small response (12% reduction in seizures).
For one patient, the critical data is missing from the later part
of the diary (last 5 weeks) as it was destroyed in a fire,
therefore, the daily seizure count is missing. The median reduction
was -79.5% in the 12-week treatment period compared to the 4-week
observation period.
Treatment with the capsules was generally safe and well
tolerated. No serious adverse events were observed. A total of
20 treatment related adverse events (1.5% of total administrations)
were reported, from 1.5% of administrations (20 out of total of
1329 administrations). Most adverse events were mild, a few were
moderate, and all transient.
Satipharm CBD Capsules Background
Satipharm CBD capsules utilise a proprietary formulation
developed using the Gelpell-CBD™ product technology. These capsules
are produced under an exclusive contract manufacturing arrangement
with Gelpell AG. The capsules contain organically derived, highly
purified cannabidiol, (CBD), a non-psychoactive cannabinoid. The
capsules are currently available in dosage units of 10, 50 and 100
mg CBD in Europe and Australia.
Refractory Epilepsy in Children Background
Severe childhood epilepsies are characterised by frequent
seizures, neurodevelopmental delays and impaired quality of life.
Approximately one third of patients with epilepsy are resistant to
treatment, meaning they do not respond to drug therapy and continue
to experience seizures. This can be the result of the drug therapy
failing to control the seizures, or patients not being able to
tolerate the related side effects. A number of currently available
epilepsy drugs have been found to have significant side effects
including the impairment of a patient's motor skills and cognitive
abilities.
The incidence of refractory epilepsy remains high despite the
influx of many new antiepileptic drugs (AEDs) over the past 10 to
15 years. It is estimated that approximately 100,000 children
in North America suffer from
treatment resistant epilepsy, causing uncontrollable
seizures.
Harvest Ones's CEO and Managing Director, Andreas Gedeon, commented:
"Notwithstanding the small number of patients treated to date,
these results compare very favourably to other similar studies of
cannabidiol, including those published by GW Pharmaceuticals.
"Importantly, these stark reductions in the number of seizures,
in these very difficult to treat patients, have the potential to be
a life-altering event for these patients and their families.
"The completion of this Phase 2 clinical trial, which has been
earmarked for the middle of 2018, is a major step towards the
commercial development of our Satipharm CBD capsules and we look
forward to providing further updates on progress in due
course."
Harvest One wishes to caution investors that the study conducted
by PTL had a limited sample size and duration. Definitive
conclusions with respect to the efficacy of Satipharm CBD capsules
cannot be drawn from the results described herein. Statements with
regards to the application of Satipharm CBD capsules are based on
this preliminary study, and any application or result of use of
Satipharm CBD capsules may not be realized, or realized in the
manner described herein.
About Harvest One Cannabis Inc. (TSXV: HVST)
Harvest
One is a global cannabis company focused on delivering high
quality, innovative cannabis products and technology to regulated
markets around the world. Our shareholders have significant
exposure to the entire cannabis value chain through three business
units, with Harvest One serving as the parent company over
horticultural arm United Greeneries and medical arm Satipharm
AG. Harvest One's businesses are all strategically located in
favourable jurisdictions with supportive regulatory frameworks in
place. United Greeneries has a Canadian ACMPR cultivation and
sales license, making Harvest One a unique global company with the
capacity to commercially cultivate and sell medicinal grade
cannabis in a federally regulated environment.
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. In particular, this
release contains forward-looking information with respect to
statements regarding the use and application of Satipharm CBD
capsules, the completion of further clinical studies relating to
Satipharm CBD capsules, the results of future clinical studies,
conclusions drawn on the limited study described herein, and the
potential application, uses or outcomes arising from use of
Satipharm CBD capsules. 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) accepts
responsibility for the adequacy or accuracy of this
release.
SOURCE Harvest One Cannabis Inc.