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CBD may improve steroid therapy in autoimmune, Covid-19 patients Israeli startup Stero Therapeutics says cannabis component could enhance steroid treatment or enable reduced steroid dosage to avoid negative effects. By Brian Blum JUNE 18, 2020, 8:30 AM Cannabis component CBD may enhance effects of steroids. Image by HQuality via Shutterstock.com Can cannabis help treat Covid-19? Israeli canna-tech startup Stero Therapeutics wanted to find out. But unexpectedly good news threw a hitch in those plans. At the height of the corona crisis, the Bnei Brak-based company was set to launch a clinical trial with 10 Covid-19 patients at Rabin Medical Center in Petah Tikva when the hospital ran out of patients. Rabin and several other Israeli medical centers closed their coronavirus wards as the number of new cases slowed to a trickle. Stero is now turning its attention toward Europe, where there is, unfortunately, still no shortage of people suffering from the virus. With cases spiking again in Israel, though, a clinical trial closer to home is no longer out of the question. While Covid-19 has occupied Stero’s interest for the past two months, it was never the company’s main focus. The overlap was steroids. Stero aims to determine if CBD, the non-psychoactive component in cannabis, can enhance the effect of corticosteroids — the first line of treatment for autoimmune illnesses like inflammatory bowel disease and lupus — or enable reducing steroid dosage while maintaining or improving its therapeutic effects. Stero founder and CEO David Bassa. Photo: courtesy Stero founder and CEO David Bassa’s previous company, Talent Biotech, had developed expertise in using CBD to prevent and treat graft vs. host disease (GvHD), a life-threatening immune condition that can occur following an organ transplant. In GvHD, immune cells from the donor attack the recipient’s tissues. The primary therapy for GvHD is also steroids. Talent had reached Phase 2b trials when Canadian cannabis company Kalytera bought the company for $10 million in 2017 — the Israeli cannabis industry’s first major “exit.” Kalytera has taken Talent’s technology toward Phase 3 trials with an eye on FDA and European CE approval as early as the end of this year. Now no longer with Kalytera, Bassa set his sights on an even bigger medical goal: whether CBD could reduce, improve and possibly even replace steroids as a first line of treatment in just about any kind of immune system overreaction. Crohn’s, hives… and Covid? Bassa established Stero after receiving a broad US patent covering 130 autoimmune and inflammatory diseases, including Crohn’s disease, hepatitis, arthritis and chronic urticaria (hives). “The patent covers botanic and synthetically produced CBD, at any dosage and in combination with other drugs,” Bassa tells ISRAEL21c. Stero chose two indications to start with – Crohn’s and urticaria. They had enrolled Crohn’s disease patients in a clinical trial and were just starting with urticaria when Covid-19 upended everything. Steroids are also used to fight off Covid-19’s most deadly effect in acute infections: an immune system over-response known as a cytokine storm. Cytokines are a signalling molecule released in response to a virus. They activate inflammation as a way of containing and eradicating the pathogen. In a cytokine storm, the immune system releases too many of these molecules. The result is often more collateral damage than the virus itself would have caused. In a landmark UK trial, researchers found that use of dexamethasone, a type of steroid, reduced deaths for COVID-19 patients on ventilators by a third and cut deaths for those receiving just oxygen by 20%. The researchers say that if the drug had been used at the beginning of the pandemic, up to 5,000 British lives could have been saved. Stero had proposed to investigate whether CBD can boost the therapeutic effectiveness of steroids in Covid-19 patients. For its trials with Crohn’s and urticaria research, the aim is to see if CBD can reduce the need for high dosages of steroids with all the negative side effects they cause. Meanwhile, the Medical Cannabis Research and Innovation Center at Rambam Health Care Campus in Haifa has proposed a trial of its own to determine if certain strains of cannabis can save severely ill Covid-19 patients from cytokine storms. Four-month trial Stero’s first focus is the approximately 30 percent of Crohn’s disease patients who are steroid dependent, Bassa explains. In the four-month randomized, double-blind trial, half the patients will get CBD oil and half will get a lookalike placebo. In the first month, the steroid dosage will be reduced while the CBD (or placebo) is introduced. If a patient has a major Crohn’s flareup and is receiving the placebo, he or she will be dropped from that arm of the trial and given CBD instead. Patients who flare up while receiving CBD will be put back on their regular dose of steroids. Bassa cautions readers with inflammatory conditions against experimenting at home. The amount of CBD in the trial is 300 mg a day – about 10 times the amount usually used by consumers of CBD as a wellness product where it’s legal. Stero’s CBD is synthetically produced, making it more expensive than CBD from plants, but Bassa says synthetic CBD “assures us a clearer eventual path with the FDA.” Serendipity and a promise The CBD-steroid connection was discovered by accident. Dr. Moshe Yeshurun, Stero’s senior medical adviser, directs the bone marrow transplantation unit at Rabin Medical Center. He had GvHD patients “who were suffering very much and he wanted to ease their pain by giving them medical cannabis,” Bassa tells ISRAEL21c. But the patients also started to get better and show less signs of disease. Bassa’s story has a similar unexpected twist. He was a successful software entrepreneur when his mother was diagnosed with multiple myeloma, a deadly blood cancer. In looking for a drug that could help her, he discovered that Prof. Moshe Mittleman, from Tel Aviv Sourasky Medical Center, was investigating whether off-label use of erythropoietin, a molecule generally used to boost blood hemoglobin, could ease multiple myeloma. Bassa’s mother began taking erythropoietin. “She lived another 11 years instead of the three that was predicted,” Bassa says. Bassa’s mother made him promise to “take the solution that worked for her to the world,” he recalls. He raised $2 million to build a company to commercialize erythropoietin for blood cancer, but he was ultimately not successful. “Luckily for patients, there are newer treatments today that have already replaced erythropoietin,” he explains. What he couldn’t do for erythropoietin he is trying to do in the cannabis space. Cannabis Innovation Center Stero, which has raised $1 million, is one of a half-dozen companies Bassa operates out of his Cannabis Innovation Center in Bnei Brak. He has a partnership with Clalit, Israel’s largest HMO. Indeed, most of Bassa’s team of 20 works in Clalit hospitals and clinics. Mor Research Applications, the technology-transfer office of Clalit, is Stero Biotech’s main shareholder. Bassa’s other companies include CannaLean Biotechs, which is exploring whether CBD can help lower cholesterol; CannaMore, which is studying CBD’s potential role in treating bronchiolitis obliterans, a pulmonary disease; and BioSeedXL, a tech incubator for cannabis companies. For more information on Stero Biotechs, click here. https://www.israel21c.org/cbd-may-improve-steroid-therapy-in-autoimmune-covid-19-patients/ https://www.israel21c.org/13-promising-covid-treatments-emerging-from-israel/
Israeli autoimmune disease treatment with parasitic worms has ‘marvelous’ results Professor Yehuda Schoenfeld of Tel-Aviv University, co-founder of medical startup TPCera, uses parasitic worms to treat autoimmune diseases, and the results have been “marvellous.” An expert in SLE & autoimmune diseases, such as MS & Rheumatoid Arthritis.
7 food additives that raise risk for autoimmune disease Shockingly common ingredients in processed foods are found to weaken intestinal resistance and lead to autoimmune diseases. By ISRAEL21c Staff January 7, 2016, 8:00 am You may already know that whole foods pack a much more powerful nutritional punch than do processed foods because of vitamins and fiber lost along the way. Now a study from Israel and Germany proves that seven commonly added ingredients in processed foods weaken intestinal resistance to bacteria, toxins and other harmful elements. This weakening increases the risk of autoimmune diseases such as type 1 diabetes, celiac, lupus, multiple sclerosis, autoimmune hepatitis and Crohn’s, among many others that cause the body to attack its own tissues. The study was led by Prof. Aaron Lerner, of the Technion-Israel Institute of Technology Faculty of Medicine and Carmel Medical Center in Haifa, and Dr. Torsten Matthias of the Aesku-Kipp Institute in Germany. Their results, published recently in Autoimmune Reviews, provide an important clue to the mystery of why the incidence of autoimmune diseases is increasing worldwide and especially in Western countries. http://tx.technion.ac.il/~presstech/lerner/Food%20additives%20and%20TJ%20and%20AD%20hypotheses%20Autoimm%20Review%202015.pdf “In recent decades there has been a decrease in incidence of infectious diseases, but at the same time there has been an increase in the incidence of allergic diseases, cancer and autoimmune diseases,” said Lerner. “Since the weight of genetic changes is insignificant in such a short period, the scientific community is searching for the causes at the environmental level.” The researchers started out with two known facts: first, that many of the convenience foods Westerners eat are laced with industrial food additives aimed at improving qualities such as taste, smell, texture and shelf life; second, that many autoimmune diseases stem from damage to the tight-junctions that protect the intestinal mucosa. When functioning normally, tight-junctions serve as a barrier against bacteria, toxins, allergens and carcinogens. In a condition sometimes called “leaky gut,” damaged tight-junctions can lead to the development of autoimmune diseases. Watch out for these seven additives Lerner and Matthias therefore decided to examine the effects of processed food on the intestines to see if there is a direct correlation between the increased use of processed foods and the increase in the incidence of autoimmune diseases. Their study showed circumstantially that at least seven common food additives weaken the tight-junctions: sugars, salt, emulsifiers (used in bakery, confectionary, dairy, fats and oils, sauces, butter and margarine, ice cream, cream liqueurs, meat, coffee, gum, beverages and chocolate), organic solvents (such as hexane, used to produce soy oil, and others added as antioxidants, stabilizers, preservatives and flavorings), gluten, microbial transglutaminase (a food protein “glue” added to processed meat, fish, dairy and bakery items) and nanometric particles (used to improve the taste, color, uniformity and texture of foods, as well as in food packaging). Lerner said that food additives are not carefully controlled and supervised as are pharmaceuticals. His research suggests that they should be. “We hope this study and similar studies increase awareness about the dangers inherent in industrial food additives, and raise awareness about the need for control over them,” Lerner said. Meanwhile, the researchers advise patients with autoimmune diseases, and those who have a family background of such diseases, to consider avoiding processed foods whenever possible. “Major shifts in dietary patterns are continually occurring, even in basic staples consumption towards more diversified and industrially processed food products,” Lerner and Matthias write. “Living in westernized countries has a strong impact on nutritional patterns collectively termed the ‘Western diet’ including high fat, trans fatty acids, cholesterol, proteins, sugars, salt intake, as well as frequent consumption of processed and ‘fast food.’ … Further studies on the effects of industrial food additives on intestinal permeability functions resulting in enhanced autoimmune, allergic and cancer diseases will impact on the food industry additive policy, food products labeling, consumer awareness, regulatory authorities and public health implementation.”