Sharenet Sites 
Sharenet Sites
Voluntary Ann re Approval of Observational Research Trials re the replacement of Opioids with Medical Cannabis in SA
LABAT AFRICA LIMITED
(Incorporated in the Republic of South Africa)
(Registration number 1986/001616/06)
(“Labat Africa” or “the Company”)
ISIN Code: ZAE000018354 Share code: LAB
VOLUNTARY ANNOUNCEMENT RELATING TO THE APPROVAL OF OBSERVATIONAL RESEARCH TRIALS
TO INVESTIGATE THE REPLACEMENTS OF OPIOIDS WITH MEDICAL CANNABIS FOR PAIN
MANAGEMENT WITHIN THE SOUTH AFRICAN POPULATION BY THE PHARMA-ETHICS COMMITTEE
FIRST SOUTH AFRICAN COMPANY TO RECEIVE PHARMA-ETHICS COMMITTEE APPOVAL FOR CANNABIS
RESEARCH
Shareholders are advised that Labat Africa’s subsidiary, Biodata (Pty) Limited (“Biodata”), headed
by Dr Shiksha Gallow as the Principal Investigator of the study, has received the Ethics Committee
approval to conduct an observational research trial to replace Opioids with Medical Cannabis for
Pain Management. The sponsor of the study is Labat Healthcare and is one of the first Medical
cannabis research observational trials in South Africa.
Biodata is focused on the Cannabis industry and was initially set up as a Holistic Healing Enterprise
incorporating Cannabinoid healing. The Company is currently well positioned to commence with
formalised Clinical Trials focused on Pain Management and Insomnia.
The research conducted by Dr Gallow on Cannabinoids, Ayurvedic medicine as well as
Homeopathic medicines is a significant enhancement to Labat Africa’s Nutraceutical and
Pharmaceutical offerings. With the growing international trend of opiate addiction and its impact
on overdoses, ill-health and crime, with countries worldwide searching desperately for safer
alternatives to treat severe and mild pain. The Research study has been accepted as complying
to the Ethics Standards for Clinical Research with a new drug based on FDA, ICH, GCP and the
declaration of Helsinki guidelines.
The study investigates the replacement of opioids with medical cannabis, and would help
practitioners understand the effects of cannabinoids for pain management and stress related
disorders. Dr Gallow has received Pharma Ethics approval for this study, making it the first cannabis
study receiving ethics approval in SA. This is a large-scale study using Medical Cannabis Real World
Evidence (MC-RWE), as 1 000 participants will be recruited using three different sites. Patients pain
management while on medical cannabis will be observed and documented, side effects will also
be noted as well as drug interactions. The study includes the use of both the cannabis flower and
cannabis oil, patients will be recruited once they are eligible for the study according to the inclusion
and exclusion criteria set out by Dr Gallows protocol. There are innumerable benefits that will result
from this research and practitioners and researchers alike, are anxiously waiting for this study to go
live. Now that the trials have been approved, Dr Gallow and her team of doctors will begin the
recruitment of patients. Dr Gallows’ team includes likeminded practitioners, who understand the
benefits of cannabis for medicinal purposes. Her team includes: Dr Regina Hurley, Dr Ahmed
Jamaloodeen, Dr Xavagne Fransman and Dr Omphemetse Mathibe. Other collaborators include
Dr Marian Tupy.
The Ethics Committee further commented: “THE ETHICS COMMITTEE (IRB) grants this approval in
compliance with the guidelines for Good Practice in the Conduct of Clinicals Trials in Human
Participants in South Africa (200), ICH Harmonised Tripartite Guidelines EC; Note for the guidance in
Good Clinical practice (CPMP/ICH/135/95) and FDA code of Federal Regulation, Part 50, 56 and
312.”
In correspondence sent to Biodata by The Ethics Committee on 9 June 2021, they informed Biodata
that all conditions were met to the satisfaction of the Committee and thus this constitutes the final
Ethics Approval.
The approval is as a result of many hours of hard work by the research team for which they must be
congratulated and it certainly places Labat Africa a few years ahead with respect to Medical
Cannabis and opens the door for Labat Africa’s growing and cultivation operation in Upington to
accelerate the development of its medical strains.
Johannesburg
18 June 2021
Sponsor
AcaciaCap Advisors Proprietary Limited
Date: 18-06-2021 03:40:00
Produced by the JSE SENS Department. The SENS service is an information dissemination service administered by the JSE Limited ('JSE').
The JSE does not, whether expressly, tacitly or implicitly, represent, warrant or in any way guarantee the truth, accuracy or completeness of
the information published on SENS. The JSE, their officers, employees and agents accept no liability for (or in respect of) any direct,
indirect, incidental or consequential loss or damage of any kind or nature, howsoever arising, from the use of SENS or the use of, or reliance on,
information disseminated through SENS.
