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Clinical

Approach and Timeline...

Clinical Approach

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In Israel, the government and most physicians accept cannabinoids as useful medicine, and there are now more than 21,000 registered patients (proportionally equivalent to 865,000 people in the US) receiving cannabinoids for specific conditions with 200 more being approved each week by the Health Ministry Medical Cannabis Unit. Acceptance and use stem from major discoveries that have been made at Israeli universities, like the identification of tetrahydrocannabinol (THC) and cannabidiol (CBD), as well as the way these work in the human body (by their ability to control the endocannabinoid receptor system, a unique network that controls many important bodily functions). Israeli researchers and clinicians have been looking at cannabinoid human therapy for a long time as a consequence. They have experienced results so encouraging that cannabinoids as a treatment option continues to be a reality. This legal permissiveness, coupled with principled policies that make cannabinoid-related clinical studies acceptable from ethical and otherwise professional perspectives virtually anywhere, make Israeli hospitals ideal sites for human studies on cannabinoids. Furthermore, work done there will be of a sort acceptable to the US Food and Drug Administration (FDA) for approval purposes, once the rescheduling of cannabinoids in America becomes reality, and likewise with regulatory authorities elsewhere as legal climates shift. The bottom line is that clinical studies in Israel can be done now, which is not necessarily the case elsewhere, and taking advantage of this opportunity optimizes the prospect of first-to-market positioning for ANANDA Scientific.

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ANANDA Scientific has gotten clinically underway at a renowned Israeli hospital on a refereed Phase 1 clinical study of CBD pharmacokinetics and safety in humans. This may be an industry first and, more importantly, it is the necessary prelude to trials by ANANDA Scientific on CBD for treating particular conditions. Trials addressing particular conditions, concerning which these have already been arranged at accredited Israeli medical institutions. Their onsets only await the completion of the above-mentioned Phase 1 study.

Besides a progressive stance on cannabinoids as medicine, additional incentive for performing clinical work in Israel is that trials there are typically easier to manage than those in the United States. This is partly due to the fact that most Israelis belong to one of a few health insurance funds. Each fund maintains complete histories of its members. Consequently, it is rather easy to locate appropriate study subjects and to follow up with them over time if and when necessary. In addition, Israel’s dropout rate for clinical trial participation is less than 10%, compared with 35% in the United States. As a result, fewer patients need to be enlisted to get the same amount of data that would come elsewhere from a larger, much more-costly, subject base.

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As with the FDA, Israeli clinical work is accepted by the China State Food and Drug Administration (SFDA), where ANANDA Scientific is already pursuing relevant cannabinoid-related activities. What is being done by the Company in China is concerned with medical conditions of China Hospital — public health relevance. These involve more than 250 million patients, a huge sales base for suitable CBD-based products. ANANDA Scientific’s work in China entails clinical trial design and statistical methodology not unlike what is being done in Israel (and soon in the US). However, the costs are considerably less. Furthermore, the SFDA is able to “fast-track” or moderate the tasks and time needed to approve medicines that address huge unmet therapeutic needs, concerning which cannabinoid therapies being pursued by ANANDA Scientific well qualify. Encouraging meetings have been held with Chinese decision makers in that regard.