TEL AVIV, Israel, June 21, 2022 /PRNewswire/ -- CannaLean Biotechs is happy to announce "first patient in," under its phase 2a, randomized, double-blind, placebo-controlled, multicenter clinical trial, for lowering blood cholesterol levels in patients with hyperlipidemia (increased levels of lipids in the blood).
CannaLean Biotechs headquartered in Israel, is a clinical stage company committed to the research and development of a novel proprietary and evidence-based formulation of Cannabidiol (CBD) and Chitosan for both the pharmaceutical and wellness markets that will potentially benefit millions of patients suffering from hyperlipidemia.
The purpose of the study will be to evaluate the tolerability, safety, and efficacy of the formulation as lipid lowering treatment in patients suffering from elevated cholesterol blood levels (hypercholesterolemia), who failed to respond to statins or are reluctant to continue with statins. Up to 60 participants with elevated cholesterol will be included in the study with a 2:1 CBD: placebo treatment ratio.
CannaLean, addresses a huge market, and will potentially benefit millions of patients suffering from hyperlipidemia, a condition in which one or more of the blood lipids such as total cholesterol, LDL cholesterol ("the bad") and/or triglycerides, are elevated. It is believed that about 50% of the adult population worldwide suffer from some kind of hyperlipidemia.
The current first line medical treatment for high cholesterol levels (Hypercholesterolemia), when lifestyle changes are insufficient, are statins.
While highly effective, statins often cause many side effects, including muscle pain and cramps, digestive problems, mental fuzziness, and liver damage. Often, patients discontinue statins and physicians avoid prescribing these agents to patients with borderline levels.
The study's principal investigator is Dr. Daniel Tsalichin, a specialist family physician, an expert in metabolic diseases, and Director, Ben-Yair Clinic of the CLALIT HMO services. Other investigators are expert physicians in several community clinics in Israel.
About CannaLean Biotechs, Ltd.
CannaLean develops cannabidiol-based anti-lipid treatments. Its formulation have been successfully tested in several experimental mod els. These pre-clinical experiments, demonstrated encouraging safety profile together with impressive efficacy. The clinical experience gained so far with cannabis derived components in other diseases provides further prospects for the future potential, and the ability to make an impact on the lipid lowering field.
CannaLean plans to commence a 2nd separate phase 2a clinical trials to clinically evaluate and confirm the safety and efficacy of the new formulation in patients with high levels of Triglycerides (hypertriglyceridemia) during 2022.
Thanks to its unique proprietary formulation which is IP protected, CannaLean plans pursuing sales in parallel to the drug development in FDA route. CannaLean has the ability to go to immediate sales around the world in the wellness/medical cannabis/edible markets, pending on local regulations.
CannaLean is a part of the Cannabis Innovation Center (The CIC), a group of companies that has established an active partnership with Mor Research Applications, the technology transfer company of CLALIT health services. CLALIT is unique since it provides community and hospital health services to 4.7 million people (52% of the Israel population). It has 11,000 physicians, 11,500 nurses, 1,300 pharmacists, 4,400 paramedics and laboratory/imaging technicians, 9,400 administrative personnel, a total of 14 general and special care hospitals and over 1500 primary care clinics, as well as a network of pharmacies and dental clinics.
For further information, contact [email protected].
Advertisement
CannaLean Biotechs headquartered in Israel, is a clinical stage company committed to the research and development of a novel proprietary and evidence-based formulation of Cannabidiol (CBD) and Chitosan for both the pharmaceutical and wellness markets that will potentially benefit millions of patients suffering from hyperlipidemia.
Advertisement
The purpose of the study will be to evaluate the tolerability, safety, and efficacy of the formulation as lipid lowering treatment in patients suffering from elevated cholesterol blood levels (hypercholesterolemia), who failed to respond to statins or are reluctant to continue with statins. Up to 60 participants with elevated cholesterol will be included in the study with a 2:1 CBD: placebo treatment ratio.
CannaLean, addresses a huge market, and will potentially benefit millions of patients suffering from hyperlipidemia, a condition in which one or more of the blood lipids such as total cholesterol, LDL cholesterol ("the bad") and/or triglycerides, are elevated. It is believed that about 50% of the adult population worldwide suffer from some kind of hyperlipidemia.
The current first line medical treatment for high cholesterol levels (Hypercholesterolemia), when lifestyle changes are insufficient, are statins.
While highly effective, statins often cause many side effects, including muscle pain and cramps, digestive problems, mental fuzziness, and liver damage. Often, patients discontinue statins and physicians avoid prescribing these agents to patients with borderline levels.
The study's principal investigator is Dr. Daniel Tsalichin, a specialist family physician, an expert in metabolic diseases, and Director, Ben-Yair Clinic of the CLALIT HMO services. Other investigators are expert physicians in several community clinics in Israel.
About CannaLean Biotechs, Ltd.
CannaLean develops cannabidiol-based anti-lipid treatments. Its formulation have been successfully tested in several experimental mod els. These pre-clinical experiments, demonstrated encouraging safety profile together with impressive efficacy. The clinical experience gained so far with cannabis derived components in other diseases provides further prospects for the future potential, and the ability to make an impact on the lipid lowering field.
CannaLean plans to commence a 2nd separate phase 2a clinical trials to clinically evaluate and confirm the safety and efficacy of the new formulation in patients with high levels of Triglycerides (hypertriglyceridemia) during 2022.
Thanks to its unique proprietary formulation which is IP protected, CannaLean plans pursuing sales in parallel to the drug development in FDA route. CannaLean has the ability to go to immediate sales around the world in the wellness/medical cannabis/edible markets, pending on local regulations.
CannaLean is a part of the Cannabis Innovation Center (The CIC), a group of companies that has established an active partnership with Mor Research Applications, the technology transfer company of CLALIT health services. CLALIT is unique since it provides community and hospital health services to 4.7 million people (52% of the Israel population). It has 11,000 physicians, 11,500 nurses, 1,300 pharmacists, 4,400 paramedics and laboratory/imaging technicians, 9,400 administrative personnel, a total of 14 general and special care hospitals and over 1500 primary care clinics, as well as a network of pharmacies and dental clinics.
For further information, contact [email protected].
View original content:https://www.prnewswire.com/news-releases/cannalean-biotechs-announces-a-phase-2a-clinical-trial-of-cannabidiol-based-formulation-for-lowering-blood-cholesterol-levels-301571891.html
SOURCE CannaLean Biotechs Ltd.
