Wrap Text
At long last SA’s first Cannabis clinical trial begun! Biodata’s study on pain mngmnt using Cannabis gains momentum
LABAT AFRICA LIMITED
Incorporated in the Republic of South Africa
(Registration number 1986/001616/06)
JSE code: LAB ISIN: ZAE000018354
(“Labat” or “the Company” or “the Group”)
FSE Code: LEI 9845000R73DF5EE41J88
PRESS RELEASE: AT LONG LAST SOUTH AFRICA’S FIRST CANNABIS CLINICAL TRIAL HAS BEGUN! THE
BIODATA STUDY ON PAIN MANAGEMENT USING CANNABIS IS GAINING MOMENTUM
Shareholders are advised that South Africa’s first ethically-approved cannabis clinical trials, the
Pharma Ethics Observational Study ("Study"), have kicked off and are “gaining traction”. The Biodata
research project is to test whether cannabis can replace opioids in the management of chronic pain.
INITIAL UPTAKE SLOW, NOW GAINING MOMENTUM
Biodata, a subsidiary of `Labat Africa, is the brainchild of Dr Shiksha Gallow, a Cannabis Clinician,
and the principal investigator in the trials, which took over 18 months to get official clearance.
Ultimately the Study, which will involve 1 000 participants who have been taking opioids for pain
management for at least three months and are prepared to switch to cannabis as an alternative.
Dr Gallow says the trials are ground-breaking, it has been called South Africa’s first real-world study
of medical cannabis and researchers predict that it will provide much-needed insight into the link
between cannabis genetics and patient outcomes. This study will also assist doctors across the globe
with a safer alternative for their patients to treat chronic pain”. She said the chemovars currently
being used in the Study are ‘Tallyman’ and ‘Exodus,’ which are being sourced from Labat’s
Sweetwaters Aquaponics SAHPRA-licensed facility in the Eastern Cape. Other strains “specific for
pain” are undergoing R&D at Sweetwaters. Aquaponics as a cultivation technique offered health
benefits in and of itself. “Aquaponics is also a niche, and patients receive chemical-free super-
organic medicine. ‘9 Pound Hammer’ will be the next strain introduced into the Study as it also has a
high THC and CBG cannabinoid profile, and is rich in Beta Caryophyllene and Myrcene terpenes,
which should assist patients with their chronic pain” various formulations have been introduced
based on the needs of patients. The two main formulations include the following:
• Flower: High THC: 15 – 25 mg THC/ 0,5 mg of CBD;
• Oil (1:1 ratio): Balanced formulation: 15 – 20 mg THC/15 – 20 mg CBD;
PILOT RESULTS VERY PROMISING
Dr Gallow told Cannabiz Africa: “We are currently recruiting patients, and data-capturing all the
questionnaires and feedback from the patients for the live Study. It has been fairly slow. However,
more options have been introduced in the live study as suggested by the patients in the pilot study.
The pilot results of the Study were very promising, as it showed 98% of the patients have some sort of
pain relief from the cannabis. We were able to wean these patients off their opioid treatment. In the
pilot group of patients below the age of 55, it was shown this group preferred to smoke the cannabis,
and patients older than 55 years preferred the oil. The patients who smoked the cannabis had relief
almost immediately, while the oil took some time to alleviate their pain.”
“Once we reach the sample size required and all of the relevant data has been collated, the results
of the study will be published. We have currently renewed this study for another year, due to the
initially slow uptake of research participants.”
ONLINE PORTAL FOR MEDICAL CANNABIS REGISTRATION
How it works is that the patient will apply on the Biodata website www.biodataresearch.co.za to be
a research participant. Dr Gallow says “We are improving this and will soon be launching a Biodata
Research mobile app. Once the patient is approved by the doctor as a research participant, an
informed consent form and baseline questionnaires would have to be completed by the participant.
Once the questionnaires are completed, the prescribing doctor will assist the patient with the correct
dosages that need to be taken. The doctors’ visits are all online, and there will be a total of four online
consults with the doctors. Should a doctor need to see the patient in person due to severity of their
medical condition, the doctor will arrange this.”
Labat is expanding its retail footprint over the next few months with the introduction of CannAfrica
kiosks in major shopping malls and believes these will be the “ideal locations for physical-sign-up-
points for the study” Labat says the kiosks will also serve as Biodata dispensaries and is engaging with
a number of vape stores to do the same, although these would have to be subject to SAHPRA’s
pharma-ethics requirements.
Johannesburg
21 June 2022
Sponsor
AcaciaCap Advisors Proprietary Limited
Date: 21-06-2022 01:31:00
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