TEL AVIV, Israel and BETHESDA, Maryland, Oct. 16, 2019 /PRNewswire/ — Cannabics Pharmaceuticals Inc. (OTCQB: CNBX), a leader in personalized 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 bioavailability, 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.
To the best of our knowledge, 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, 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.”
Findings are available online and can be found here.
About Cancer-Related Cachexia and Anorexia Syndrome (CACS)
Cachexia is defined as a “multifactorial syndrome characterized by an ongoing loss of skeletal muscle mass (with or without loss of fat mass) that cannot be fully reversed by conventional nutritional support and leads to progressive functional impairment. Cachexia may be masked by excess weight, obesity, edema or tumor mass. Anorexia is a subjective term describing reduction or loss of appetite. Although it is commonly known that patients coping with cancer and cancer treatments experience loss of appetite, the exact prevalence of anorexia is unknown. In one study on advanced cancer patients, more than half the patients experienced anorexia. A North Central Cancer Treatment Group study of 1115 patients with colorectal and lung cancer found that cancer patients with anorexia had lower survival rates and experienced more toxicity from chemotherapy than similarly matched patients who maintained their appetite. Cachexia primarily caused by anorexia or reduced intake has been defined as cancer-related cachexia and anorexia syndrome (CACS). CACS, unlike cachexia, includes weight loss caused by muscle wasting, as well as lipolysis and decreased intake.
About Cannabics SR capsules
The cannabis capsules used in this study contains 2 fractions of oil-based compounds. A liquid and transparent fraction, which contains pure cannabinoid extract dissolved in organic coconut oil, is responsible for the quick onset of the therapeutic effects within 20 to 60 minutes. A consolidated cannabinoid, lipid-based drug delivery systems fraction is responsible for a gradual and long-lasting therapeutic effect (6-8 hours), due to a proposed constant and steady release of active cannabinoids. The formulation contains a pure extract of cannabinoids, monoglyceride, and diglyceride (E471), combined with carrageenan, which is known for its controlled release properties and organic coconut oil. The 2 highly abundant cannabinoids in cultivated cannabis plants are THC and CBD (cannabidiol).
The study capsules contained either 10 mg of active cannabinoids of which THC is 9.5 mg and CBD is 0.5 mg or 5 mg of active cannabinoids (THC 4.75 mg and CBD 0.25 mg).
About Cannabics Pharmaceuticals
Cannabics Pharmaceuticals Inc. (OTCQB: CNBX) is a U.S public company that is developing a platform which leverages novel drug-screening tools and artificial intelligence to create cannabinoid-based therapies for cancer that are more precise to a patient’s profile. By developing tools to assess effectiveness on a personalized basis, Cannabics is helping to move cannabinoids into the future of cancer therapy. The company’s R&D is based in Israel, where it is licensed by the Ministry of Health to conduct scientific and clinical research on cannabinoid formulations and Cancer.
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