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24 caregiver focus cannabis patient care | vol. 3 no. 3 cannapatientcare.com models but also into the cells directly. And I could not see any death in those cells yet. But this synthetic cannabinoid that I'm working on is doing the job." Dr. Jewett saw other patients on cannabis also had much better NK activity than even healthy individuals. "So that was intriguing to me also," she said. "I wanted to know how that is happening, and why that is happening. So I started working on a humanized mouse model system, because I know that is the most relevant model to the human system. And when I inject- ed the same synthetic cannabinoids into a mouse, I saw very high levels of activation of NK cells." She said that one of her plans for the future is to actually modif y these synthetic cannabinoids in such a way that they could increase the activation of the NKs, and use it as therapeutics. The Door to Successful Treatment Opens Ryan said that now they can go forward with more clinical work based on what Dr. Jewett has discovered—such as her findings about cannabinoids, targeting and killing cancer stem cells, and rebooting the immune system. All of those findings were published in a peer-reviewed can- cer journal (9). "So, we're working on getting FDA approval," Ryan said. "We're going to be submitting our application here in the next few weeks for our human trials. And we're working on setting up other human trials through medical tourism in countries where it's much easier to get approved." Going Forward Ryan and Dr. Jewett, along with two other partners, created NKore BioTherapeutics (10), a biotech company that has licensed Dr. Jewett's core suite of patents for both her supercharged NK cells, her suite of diagnostics that test the NK cell system, and a synthetic cannabinoid that they intend to use as a booster to NKore's therapy, as well as other chemotherapies available today. Sophie is much healthier today, especially after getting her fa- ther's activated NK cells. "The NK cell therapy that she got was her dad's natural killer cells that were activated. And what that means is that they use interleukin 2 (11) that also comes from the body but it's unfortunately pretty toxic to patients," explained Ryan. "It is a short-lived five-day course of this as a booster to the cells. It's used in activating the cells, simply turning on their killing ability. And then the patient has to get several days of shots of it. "The NK cells from her father were not supercharged like the ones that Dr. Jewett has invented and that NKore is now working to bring to market," Ryan said. "However, not only is the ther- apy working, but it started working basically immediately af- ter the first two-and-a-half months' scan. We're seeing the tu- mor at about an 85% overall reduction in size, and it continues to die off with therapy." The reason Sophie got her dad's cells instead of the NKo- re's supercharged cell therapy now is because Dr. Jewett creat- ed a whole new cell that's never existed before. The body sees it as a natural component of their immune system, so there's no possibility of rejection. "But because we are changing the cell structure of our natural killer cells with this new cell, not the DNA, but just the cell itself, we have to get FDA approval," Ryan said. She said that they are close to being ready to submit their FDA application to get what's called investigative new drug (IND) approval, which means they can start to move forward with human trials in the US with their first focus being pan- creatic cancer (12). "Once that is approved, under the FDA's Ex- panded Access, sometimes called compassionate use (13), which states that if a patient has exhausted everything West- ern medicine has to give them and are deemed terminal, they can treat individuals with any type of cancer once approved," Ryan said. They can get approval for them in 30 days after submit- ting the application for that patient to the FDA. "So, while we're going through these very structured human trials here in the United States, we are also planning on opening up the Josh and Sophie Ryan at Cannabis Science Conference West 2022.