Initial uptake slow, now gaining traction

South Africa’s first ethically-approved cannabis clinical trials, the Pharma Ethics Observational 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.

Biodata, a subsidiary of `Labat Africa, is the brainchild of Dr Shiksha Gallow a Cannabis Clincian, 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’ve been taking opioids for pain management for at least three months and are prepared to try cannabis as an alternative.

Dr Gallow says the trials are ground-breaking. She told Cannabiz Africa on 10 June 2022 “It’s 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”.

Dr Gallow said the chemovars currently being used in the Study are ‘Tallyman’ and ‘Exodus,’ which are being sourced from  Labat’s Sweetwaters Aquaponics SAHPRA-licenced facility a in the Eastern Cape.  Dr Gallow says other strains “specific for pain” are undergoing R&D at Sweetwaters.

She adds that 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”

Dr Gallow says  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;

Crowdfunding approach to ensure legal access for all to medical cannabis

Labat will pay for the costs of the Study by way of a Crowd Funded Project, with the aim of supporting future clinical trials as well. “The resultant outcome would be to ensure legal access to natural occurring medicines, like cannabis, to the South African public as a whole.

Crowdfunding is a way to raise funds for a specific cause or project by asking a large number of people to donate money, usually in small amounts, and usually over a period of time. This can also be conducted by way of a subscription. In a new industry such as the Cannabis industry, many countries have followed this model for research due to the large costs of a clinical trial.  In this regard, Catherine Ferguson, Innovation 

Project Lead and Cancer Research UK, points out that; “One key thing is tangibility. It’s an inherent part of crowdfunding that isn’t inherent in regular funding.” She also adds that, Crowdfunding enables a “more direct relationship with both the researchers and the research.” In addition to this, crowdfunding also enables researchers to create close relationships with donors and can engage with thousands of people on a regular basis.

Dr Gallow mentioned the current recruitment of the patients have been fairly slow, and lessons learnt from the pilot study have been implemented in the main study. There are various crowd funding contributions patients can choose from ranging from R90 to R850, all of which include the courier fee to the patient and the doctor’s consultation).

These include varying doses of pre rolls, flower, or oil.

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 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.”

Dr Gallow told a medical cannabis webinar in December 2021, that the basic question was: “Does opioid use increase or decrease following the taking of medicinal cannabis?”

“We know that cannabis is not so effective for acute pain, but we do know it appears to be very good for chronic pain, that is pain that outlasts the precipitating tissue injury”. This study will provide greater understanding into the use of cannabis in both pain treatment and opioid use reduction.

Online portal for medical cannabis registration

Labat purchased a majority stake in Biodata in 2019 and has placed it at the core of its cannabis healthcare strategy. It is the project’s sponsor and has set up an online portal for patients to register, giving the first dosage free to entice people to join. It says “the uptake on the website has still been slow, and the Company’s research shows that participants are more comfortable with going to physical sites to access the medicine”.

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.