Stero Biotechs to Commence Phase 2 Clinical Trial of ST-AH-01 Cannabidiol Formulation for Ground Breaking Maintenance Therapy and Steroid Reduction in Patients With Autoimmune Hepatitis
BNEI BRAK, Israel, Feb. 28, 2019 /PRNewswire/ -- Stero Biotechs has received Ethics Committee approval by Israel's Ministry of Health and will soon enroll the first patients in a ground-breaking study to use CBD to reduce steroids in patients with liver disease.
Stero discovered that by introducing CBD to patients treated with steroids on regular basis, as their standard of care, allows physicians to lower the dose of the steroids prescribed, and by extension, the steroid's unwanted harmful side effects. The treatment will also bring back the therapeutic effect to those who are currently resistant and do not respond to steroids treatments.
Stero will commence Phase 2 Clinical Trial of ST-AH-01 Cannabidiol formulation for maintenance therapy and steroid reduction in 15 patients with autoimmune hepatitis in the near future at the Rabin Medical Center, near Tel Aviv.
Autoimmune hepatitis is liver inflammation that occurs when the body's immune system turns against its own liver cells. Untreated autoimmune hepatitis can lead to scarring of the liver (cirrhosis) and eventually to liver failure. A liver transplant may be an option when autoimmune hepatitis doesn't respond to drug treatments or in cases of advanced liver disease.
Corticosteroids such as prednisone are most often used to help suppress the overactive immune system and may be taken long term with most for at least 18 to 24 months. Many remain on Corticosteroids for life. The use of such steroids is associated with a wide range of serious side effects, including diabetes, thinning bones (osteoporosis), broken bones (osteonecrosis), high blood pressure, cataracts, glaucoma, and weight gain.
Cannabidiol, a known anti-inflammatory and Immunosuppressant cannabinoid, may provide a means to reduce the dose and duration of the steroid therapy.
Dr. Assaf Issachar, MD - AIH Medical Director noted, "Any treatment option that assists us in reducing the dose and duration of steroid treatments is one that would greatly benefit my patients. I am interested in the results of this study as a first step in realizing the potential of CBD to treat this difficult disease."
Stero is planning an additional study for a different indication During Q2 of 2019. Additionally, Stero is looking for more funding during 2019 in order to initiate additional studies for other indications, from its one hundred optional indications that are available to Stero under its proprietary patent.
About Stero Biotechs, Ltd.
STERO Biotechs Ltd., founded in 2017 and headquartered in Israel, is a clinical-stage company committed to the research and development of novel Cannabidiol (CBD) based treatment solutions that will potentially benefit millions of patients by reducing the side effects and the need of steroid therapy. STERO was granted a U.S. patent on over 100 potential indications and is planning to commence more clinical trials in 2019 on various indications.
STERO has established an active partnership with one of its shareholders - MOR Research Applications, the tech transfer company of CLALIT HEALTH SERVICES. CLALIT is the is the 2nd largest HMO in the world, with over 4.5 million members. CLALIT operates 14 full-scale hospitals specializing in all fields of medicine, as well as over 2000 community clinics with over 9000 physicians. The MOR-STERO partnership allows the company to reach vast numbers of patients and data while collaborating with the physicians, labs and hospitals of Clalit.
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SOURCE STERO Biotechs