Studies proving the advantages of medical cannabis and the efficiency and therapeutic potential of its components in a range of diseases and symptoms are at the forefront of activity at the Israeli Company OWC, which has already chalked up a number of impressive achievements and breakthroughs to its credit. A situation report | Anat Yaffe
The medical cannabis market is changing face. If in the past, the cultivation and extraction of the plant focused on social (recreational) needs, the focus today is on the scientific side, following numerous studies that have proven the medical advantages, efficiency and therapeutic potential of the plant and its components in a broad range of diseases and symptoms. Furthermore, regulations in many countries throughout the world (primarily in the United States, Canada and European countries) are changing, with a trend toward regularization of cannabis products and their registration for medical indications.
In Israel, considered a leading country in the study, development and use of cannabis for medical purposes, the Company One World Cannabis (OWC) Ltd., an Israeli subsidiary of OWC Pharmaceutical Research Corporation, a public company listed on the OTC Exchange, promotes pioneering medical and breakthrough studies of cannabis-based pharma products.
OWC Ltd. was established in 2014. The company identified the global trend, the clinical and research need and the market potential, and was among the first to formulate a long-term strategy focusing on the medical-research market. The company is leading medical studies and clinical trials of cannabis-based innovative products and treatments and developing unique delivery and dosage systems for the treatment of various medical conditions and diseases, including multiple myeloma, skin diseases such as psoriasis, and diseases accompanied by chronic pain.
The company’s research projects are conducted at large and leading medical centers and scientific institutions in Israel by a staff of scientists with many years of proven experience in the fields of research, treatment, management and regulation. The company’s scientific staff includes Company Chairperson Dr. Stanley Hirsch; Dr. Oron Yakobi-Ze’evi, the company’s Chief Scientist; Prof. Yuval Ramot, a senior dermatologist and Director of the Psoriasis Clinic at Hadassah Hospital; and Dr. Yehuda Baruch, founder of the regulatory field in Israel and a pioneer in the field of cannabis research for medical use in Israel.
OWC Ltd. operates with the approval of the Medical Cannabis Unit at the Israeli Ministry of Health and conforms with international regulatory standards. Despite being a relatively young company, it has chalked up impressive achievements in the fields of research and intellectual property, with more than 30 patent submissions in various countries throughout the world.
Pioneering research for the treatment of multiple myeloma
Multiple myeloma is a cancer of the plasma cells in the bone marrow, constituting about 1% of all cancer cases and about 2% of all fatal cancer cases. Every year, about 500 new patients are diagnosed with the disease in Israel (30,000 patients are diagnosed annually in the United States) and the numbers are on a constant rise.
The scientific study conducted by OWC demonstrated impressive results: in vitro trials demonstrated that a specific combination of THC and CBD is efficient in killing the multiple myeloma cells – without causing any harm to healthy cells. It was further demonstrated that the addition of the aforementioned combination of cannabinoids to the known drugs administered for disease treatment results in a synergistic effect (an effect that is greater than the sum of the effect of each of the separate components).
Based on the results received, OWC is developing an innovative formulation administered by a unique method, which currently does not exist in the medical cannabis market. In a recent preclinical animal trial, the maximum dosage was determined and it was found that the formulation is safe for use and can be administered at the relatively high therapeutic doses required for treatment of the disease.
The company is continuing development in preparation for an initial clinical trial slated for development in a pharmaceutical course later to be submitted for FDA approval.
A salve for the treatment of psoriasis
An additional development by OWC is a salve based on a high concentration and unique combination of the active components of the cannabis plant, designed for external application for the treatment of various infectious skin diseases, primarily psoriasis.
The company has completed a preclinical study a human skin tissue model, the results of which indicate a significant decrease in the parameters that characterize psoriasis (such as reproduction of skin cells and expression of inflammatory factors) and demonstrated a possibility for efficient treatment of the clinical and aesthetic aspects of the disease.
The safety study with the salve in healthy volunteers, conducted at one of the large hospitals in central Israel, will soon be completed. Interim results prove that the salve is safe for use and is active at a local level in the skin, i.e. the cannabinoids do not reach the circulatory system, and there are therefore no concerns of psychoactive effects.
The company is preparing to conduct an efficacy trial in psoriasis patients at one of the medical centers in Israel, an additional step on the path to receiving approval for marketing of this product to psoriasis patients in Israel, Europe and other markets. The salve is currently permitted and scheduled for marketing in the US and Canada, countries in which the use of cannabis for medical purposes has been legally permitted and approved.
A soluble sublingual tablet
OWC has developed a soluble sublingual tablet that enables rapid absorption of the cannabinoids directly into the circulatory system via the oral mucosa. The tablet contains a high concentration of cannabinoids at various ratios for the treatment of the range of medical conditions and diseases at precise doses.
Among other things, the tablet is designed to serve as an alternative option to smoking, due to the risks involved in smoking and the discomfort caused to the patient and his surroundings as a result of smoking and the accompanying odor. In addition and, even more importantly, it enables administration of the precise dosage of cannabinoids, in contrast to the other common administration forms currently on the market.
The company has completed the development of the tablet and will be initiating the clinical study during the first half of 2019. The study is designed to examine the safety of use of the tablet and the profile of the cannabinoids in the blood following sublingual administration in comparison to another cannabinoid-containing drug approved for use in various countries.
These studies represent milestones in the development of cannabis-based treatments for various diseases, and have drawn the attention of researchers and investors throughout the world.
According to the Israeli Company’s CEO, Mordechai Bignitz, “despite being young, the company is leading groundbreaking studies in the field of cannabis treatment for medical purposes, while keeping considerations of patient benefit and welfare at the forefront of its activity. Moreover, the company intends to expand its product portfolio while forming research and business collaborations with large companies in the pharma industry, and to launch its products in both the medical cannabis track and the FDA track.”