Harvest One Phase II Clinical Trials on Satipharm CBD GelPell®
Published in Peer-Reviewed Medical Journal
August 13, 2019 – Vancouver, British Columbia – 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.
- 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:
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 , 82% of whom will be under the age of 10 . 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 . Apart from the severe morbidity and significantly increased mortality among patients with TRE , , early onset comes along with high incidence of cognitive, behavioral, motor, and neurodevelopmental delays .
Accessing Satipharm 50mg CBD GelPell® Capsules
Satipharm CBD 50mg GelPell® capsules are available in the UK through Health House who distribute to pharmacies and healthcare professionals.
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.
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.
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