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Cannabics Pharmaceuticals Inc., a leader in personalised cannabinoid medicine focused on cancer and its side effects, announced today that the final results of its pilot study to test the efficacy of Cannabics’ Dosage-Controlled capsules for the treatment of cancer anorexia-cachexia syndrome (CACS) in advanced cancer patients have been published on the Journal of Integrative Cancer Therapies.
The study was performed at the Rambam Health Care Campus (HCC), Division of Oncology, in Haifa, Israel, and led by Dr. Gil Bar Sela (MD). The study objective was to evaluate the effect of dosage-controlled cannabis capsules on CACS in advanced cancer patients, and more specifically, on patient weight variation.
Inclusion criteria comprised: age older than 18 years, histological evidence of an incurable malignancy, estimated life expectancy ≥3 months, performance status ≤3 (ECOG [Eastern Cooperative Oncology Group]) classification, weight loss of at least 5% during the preceding 2 months (as documented in the patient’s medical file), and the patient’s belief that loss of appetite or weight loss is an ongoing problem for him/her. The use of chemotherapy or radiotherapy was allowed.
The study protocol was approved by the Ministry of Health Unit for Medical Cannabis and by the hospital’s institutional ethics committee (0275-14-RMB). The study (NCT02359123) was conducted in accordance with good clinical practice and the Helsinki Declaration.
The cannabis capsules used in this study contained 2 fractions of oil-based compounds, provided by Cannabics Pharmaceuticals Inc. All stages of the technology are being protected under Cannabics’ rapidly expanding patent portfolio.
The formulation of the study capsule is a lipid-based drug delivery system, which highly improves the relatively low oral bio-availability, related to absorption, degradation, and metabolism.
During the study, some patients reported several psychoactive side effects and it was decided to reduce the capsules’ dosage to 5 mg. Almost no side effects were reported with the Cannabics 5 mg dosage. It seems that this dosage is appropriate for the treatment of CACS in advanced cancer patients under active treatment.
This is the first study investigating the effect of dosage-controlled cannabis capsules on CACS and, more specifically, on weight variations in advanced cancer patients, according to the Good Clinical Practice criteria.
Despite various limitations, the current preliminary study demonstrated a weight increase of ≥10% in 3/17 (17.6%) of the patients with doses of 5 mg × 1 or 5 mg × 2 capsules daily, without significant side effects. The results justify a larger study with dosage-controlled cannabis capsules in CACS.
Eyal Barad, CEO and Co-Founder of Cannabics, said: “This study is an important milestone in our mission to bring clinically tested products to cancer patients around the world. We always believed that our Cannabis based products have the potential to help support cancer patients as part of their treatment plan, and today we have clinical data indicating we are on the right track. Based on these results we are now in the process of initiating collaborations with leading international medical institutions to continue and expand our research and commercial activities.”
The Medical Cannabiz World Summit will take place from the 4th to 5th November at the Intercontinental, St Julian’s, Malta, to be followed by the inaugural launch of the Medical Cannabiz World Asia Summit which will be held in Bangkok on the 22nd and 23rd of June 2020 at the Centara Grand Hotel.