Cannabis Patient Care - March/April 2022

Cannabis Patient Care March/April 2022

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37 doctor focus march/april 2022 | cannabis patient care Nowadays, there are five approved anti-TNF drugs in the US There are probably another eight or nine anti-TNF biosimilars coming along because the market is very large. It's a $40 bil- lion a year industry. It's the largest selling class of drugs be- cause it has so many uses and it's so effective. Although it has some side effects, there are no patients with rheumatoid ar- thritis in wheelchairs in the whole world because of that drug. That's what Remicade does. It's been quite a success story. Patients with rheumatoid arthritis or Crohn's disease can now live normal lives without pain. Q: How did you get involved in the cannabis industry? A: Dr. Woody: As I mentioned, one of the three companies involved in the 180 Life Sciences merger was specializ- ing in cannabis. My colleagues, Dr. Feldmann and Dr. Raphael Mechoulam, have been spearheading this research. Dr. Mechoulam is probably the world's top expert on can- nabinoids. He discovered the endocannabinoid system and has published hundreds of research papers on it. He's been work- ing with Dr. Feldmann to find a specific compound that reduces pain and inflammation, be non-addictive, and not have hallu- cinogenic potential. They've been researching this for 10 years. That research is now part of our 180 Life Sciences program. Q: How do you assist others in their battle with chronic pain? A: Dr. Woody: Chronic pain is a severe global problem. There's probably 60 million people experiencing some type of chronic pain. Quite a bit of it is associated with inflammation. That's when the tissue or joints become inflamed with white blood cells, red blood cells, and cytokines in the joint or in the tissue, causing swelling. That swelling presses on the nerves and creates pain. Inflammation and pain often go together. If that pain is not too serious, it's treated with Advil, Aleve, or something similar. Those are non-steroidal anti-inflamma- tory drugs. Cortisone is another option, and that has a lot of side effects. You don't want to use that unless you must. The next step up beyond that is opioids, which of course, are high- ly addictive. There's a need for some non-addictive anti-in- flammatory and pain-relieving substances in between the Ad- vil and Aleve options and opioids. A cannabinoid compound could have the properties needed to address this global chronic pain problem. Q: How has medical cannabis helped patients suffering from chronic pain? A: Dr. Woody: I think there's data to suggest that it's helpful in some patients with chronic pain. I don't know that it's as effective as, say, opioids, but it certainly seems to help some people. The data on medical cannabis and pain is a little weak. That's why we've decided to try to make a specific compound that has these properties. Q: The company has three ongoing programs in inflammation and pain. Can you give us a high-level overview of those programs? A: Dr. Woody: We have three clinical trials in progress with anti-TNF biologic agents and they're being studied to treat pain, fibrosis, and other conditions. The three anti-TNF clinical trials are in Dupuytren's contracture, frozen shoulder, both of them fibrotic diseases that we feel are driven by TNF, and lastly post-operative dementia, again thought to be driven by TNF. For our post-operative dementia study, we're looking at how TNF is released by the tisssue damage during surgery, causing inflammation of the brain which leads to dementia. If patients are treated with anti-TNF at the time of their surgery, we hope we can prevent the post-operative dementia. Our second program is with a nicotinic acid receptor ago- nist. We know that nicotine is a mild anti-inflammatory. We're making specific medicines with this anti-inflammatory without the addictive properties of nicotine. There are several programs aimed at treating inflammation and pain, including the cannabinoid compounds that we're de- veloping. We hope these compounds will be effective for both reducing the inflammation and the pain, and we have some data to suggest that we can do that. Q: Can you tell us about your synthetic CBD analog program for inflammation and pain? A: Dr. Woody: The cannabis available at a dispensary can have more than 100 compounds in it. Some of them are good, some of them are not so good. Some of them lead to side effects. But it's not a very pure agent. It's time for us to figure out what's the best active ingre- dient and then figure out which specific compound gives you the effect that you want. And that's what we've been working on with Dr. Mechoulam. He's been able to create very specif- ic compounds that have the desired effect. They have the ben- efit of being orally absorbable. Most of the cannabis sold at dispensaries is not absorbable orally. If we can make a pill out of this, we hope it will be highly specific for the tissues where relief is needed. We also hope it will be non-addictive and be able to reduce both inflammation and pain. We've been working on this for five or six years, and we have compounds that seem to have the right characteristics. These will be synthetic, they'll be made in a laboratory, and be very pure. Those are the requirements that the Food and Drug Administration (FDA) wants for a new medicine. All those things fit together and make a lot of sense. It's something I've done several times before in making new medicines.

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