In the March 2019 Cannabis Business Times cover story, Dr. Andrea Small-Howard, co-founder and chief science officer of GB Sciences, said, “My personal mission is to take cannabis-based therapies to the U.S. FDA.”
More than two years later, Small-Howard, who was promoted to president of the Las-Vegas company in June, is close to her goal.
GB Sciences has completed animal studies on a treatment for Parkinson’s disease and is finalizing another animal trial of a slow-release, cannabis-based pain medication that Small-Howard calls a “game-changer” for people suffering from chronic pain. The next step is to get FDA approval on human trials, which Small-Howard hopes will be in 2022 for the Parkinson’s formulation and shortly thereafter for the pain management drug.
She also co-invented a “drug discovery platform” using artificial intelligence (AI) that is programmed to identify novel, plant-based formulations to treat multiple symptoms of conditions. The company is using the proprietary technology, known as “Phytomedical Analytics for Research Optimization at Scale,” or PhAROS, to expedite plant-based medicines that contain a combination of active ingredients and get them to market sooner.
"The PhAROS platform is a new version of the software that we developed earlier when we were exclusively studying cannabis-derived mixtures," Small-Howard said.
Cannabis Business Times spoke with Small-Howard, who shared more details about GB Sciences research, how the AI technology works, and what’s next for the biopharma drug development company.
See Small-Howard speak live at the upcoming Cannabis Conference during the session "Product Formulation Best Practices, Current Trends And Where The Future Will Take Us" at 3:10 p.m. PST Aug. 24, at the Paris Hotel & Casino in Las Vegas.
Michelle Simakis: Congratulations on your promotion to president of GB Sciences. What direction do you hope to take the company in?
Dr. Andrea Small-Howard: There was a time when producing cannabis-based products through state-run programs was the majority of what we were doing. Now, the majority of our effort is being spent on preparing cannabis-based formulations for the U.S. FDA (Food & Drug Administration) and other prescription drug markets, which is different. But we used to be a cannabis-based company that did some science. Now we're a science company that uses cannabis. We really feel there are certainly lots of responsible players that are allowing patients to have access to cannabis-based products through state programs. But where we can add something where other people aren’t is by taking that next step, and saying, “OK, how can we get these into a prescription drug format that everybody’s going to feel is approachable?” It’s got a lot more hoops to jump through, but we’re hoping for patients it makes it more approachable and that physicians have less of an issue with it. I’ve been in the business for more than seven years, and it’s great to see that the industry is becoming more and more destigmatized. But there are still folks [delivering] patient care who are still saying that a cannabis-based product would not be first-line medicine.
"How can we get these into a prescription drug format that everybody’s going to feel is approachable?"
MS: Of all the research you are working on, which project excites you most?
ASH: Our Parkinson's formulations are getting closer to human trial. So we are really pushing hard on that to finalize all the [requirements] needed to get it into a human trial. We're also really excited about the promise of our pain formulation, which you take as an oral nanoparticle – [meaning] it has time-release properties. Folks with pain, one of the things that they always complain about is that they're popping pills or they're hitting the pipe all day. In order to control their symptoms, they usually have to dose multiple times a day. These time-release formulations in a rodent model–granted, which is not humans, but it's that next step before a human trial–a single dose gave 11 days of continuous pain relief. And that is a game-changer for folks who are suffering with chronic pain. And so by bringing these plant-based compounds into novel delivery, we think that is going to really change the way people can use them to manage their pain.
MS: What would the timeline look like to get the Parkinson’s and time-release pain management formulations into human trials?ASH: We are hoping to get in a human trial for Parkinson's next year. The pain one should be a little bit beyond that. It’s hard because right now it's in animal studies. We had an animal study going, COVID happened, and we lost a year's worth of work because of that. Luckily, our Parkinson's animal trials were already done before COVID happened.
MS: GB Sciences recently announced it is using AI technology to help identify individual plant compounds that could become active ingredients in medicine to in tandem to treat many different conditions. Can you explain what “drug discovery research” looks like and how the Phytomedical Analytics for Research Optimization at Scale (PhAROS) platform works?
ASH: Not only does it look at plants like cannabis and help guide us to figure out which ingredients would be the best therapeutic mixtures for different human diseases, it can do it for all plants. We created a database that contains plants from traditional medicine from different areas in the world, like Chinese medicine, Japanese medicine, Indian medicine, from Europe, from South America, from Africa. And our program is able to look within all of these plant-based sources for new therapeutic formulations. We still believe that plants are the answer, but by adding this new AI-enabled technology, we can start to look within plants and more efficiently find new solutions to treat human diseases.
Traditional medicines have been helping people for thousands of years. But they do it in a way that's fundamentally different than the kind of drugs that you'd get from the pharmacy. Those were made with one ingredient, and as they call it, “the magic bullet approach.” But what we’ve found is that those magic bullets are very rare. What usually happens is you take one single ingredient drug, and then you need three more single ingredient drugs to deal with the side effects. Whereas what we're trying to do is think about the consequences of all of the ingredients in there at the same time, so that you're not really having a single ingredient that causes all kinds of side effects—you've already factored that in. We believe that the future of medicine will be multi-ingredient drugs, and we believe that the plant-based medicines are the place to go find those solutions.
"We believe that the future of medicine will be multi-ingredient drugs, and we believe that the plant-based medicines are the place to go find those solutions."
MS: When you say you’re looking at the different plant components and how they work together in medicine to treat different conditions, it reminds me of the entourage effect in cannabis. Is that essentially what you’re trying to do in creating these combinations that could be used as active ingredients in medicines?
ASH: That’s exactly it, but I don’t call it that because the "entourage effect" term has been used disparagingly. We call it synergy. We find evidence of molecular synergy, meaning when we put more than one ingredient in there at the same time, the effects of the mixture are greater than the sum of the individual effects. We’ve got a whole patent portfolio where we did that with cannabis and the ingredients inside cannabis. Now we’ve turned our attention to looking at other plants, [such as] the kava kava, that have a thousand-year history in traditional medicine for being used to treat different conditions, but that seem to also work better when you're using mixtures.
MS: Although the goal is to create mixtures of active ingredients, the technology singles out those individual components, then discovers what the synergies are among them? How is it programed to find and then mix those ingredients?
ASH: Exactly. One of the things [the AI technology] is thinking about is a holistic view of humans. One of the things that we've done with our program is we've trained it to think about medicine in the way that traditional medicine does, where it's not looking at a single aspect of a disease. For example, if you've got cancer, it's not just controlling the growth of the cancer that's important to you. It's also pain. It's also inflammation. It's also all these other aspects. So the AI program has been taught how to think about what are the multiple kinds of issues you're going to have with any one condition.
I think this is going to change the way people think about medicine, and 10 years from now, people are going to start asking for a multicomponent drug, not a single component drug.