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In the March 2019 cover story of the Cannabis Business Times, Dr. Andrea Small-Howard, Co-Founder and Chief Science Officer of GB Sciences: “My personal mission is to have cannabis-based therapies placed with the US FDA.”
A little over two years later, Small-Howard, who was promoted to president of the Las Vegas corporation in June, is close to her goal.
GB Sciences has completed animal studies on a treatment for Parkinson’s disease and is completing another animal trial with a slow-release cannabis-based pain reliever that Small-Howard calls a “game changer” for people with chronic pain. The next step is to get FDA approval for human studies, which Small-Howard hopes for the Parkinson’s formulation in 2022, and for the pain reliever shortly thereafter.
RELATED: Clinical Cannabis: How GB Sciences is Redefining the Industry through Research
She also co-invented a Drug Discovery Platform that uses artificial intelligence (AI) programmed to identify novel herbal formulations to treat multiple disease symptoms. The company uses proprietary technology known as Phytomedical Analytics for Research Optimization at Scale, or PhAROS, to bring herbal medicines containing a combination of active ingredients to market faster.
“The PhAROS platform is a new version of the software we developed earlier while studying cannabis-only mixtures,” said Small-Howard.
Small-Howard spoke to Cannabis Business Times to provide more details on GB Sciences’ research, how AI technology works, and next steps for the biopharmaceutical drug development company.
Michelle Simakis: Congratulations on your promotion to GB Sciences President. In which direction do you want to lead the company?
Dr. Andrea Klein-Howard: There was a time when making cannabis-based products through government programs was most of our work. Now we are devoting the bulk of our efforts to preparing cannabis-based formulations for the U.S. Food & Drug Administration (FDA) and other prescription drug markets, which is different. But we used to be a cannabis-based company doing something scientific. Now we’re a science company that uses cannabis. We believe that there are certainly many responsible actors out there giving patients access to cannabis-based products through government programs. But we can add something other people don’t by taking the next step and saying, “OK, how can we get this into a prescription drug format that is available to everyone?” There are many more hurdles to overcome, but we hope it becomes more accessible to patients and doctors have fewer problems with it. I’ve been in business for more than seven years and it’s great to see the industry becoming more and more destigmatized. But there are still people [delivering] Patient care who still say a cannabis-based product is not a first-line medicine.
“How can we get these into a prescription drug format that everyone will feel available?”
MS: Of all your research, which project do you find most exciting?
ASH: Our Parkinson’s formulations are approaching human testing. So do we have a real push to get everyone ready? [requirements] needed to put it into a human process. We are also very excited about the promise of our pain formulation that you ingest as an oral nanoparticle – [meaning] it has time-delaying properties. People in pain, one of the things they always complain about is they pop pills or hit the whistle all day. They usually need to dose several times a day to control their symptoms. These sustained-release formulations in a rodent model – admittedly, this is not a human, but it’s the next step before a human trial – a single dose resulted in 11 days of continuous pain relief. And this is a turning point for people suffering from chronic pain. We believe that with the introduction of these plant-based compounds in a novel form of delivery, the way people can use them to manage their pain will really change.
MS: What would the schedule be to receive the Parkinson’s and delayed pain management formulations in human trials?ASH: We hope to participate in a human study for Parkinson’s next year. The pain should go a bit beyond that. It’s hard because it’s just in animal studies. We had an animal study in progress, COVID occurred and we lost a year of work as a result. Fortunately, our Parkinson’s animal studies were done before COVID occurred.
MS: GB Sciences recently announced that it is using AI technology to identify individual plant compounds that could be used as active ingredients in medicine to treat many different diseases at the same time. 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 us figure out which ingredients are the best therapeutic blends for various human diseases, but it can do it for all plants. We have created a database containing plants from traditional medicine from different areas of the world, such as Chinese medicine, Japanese medicine, Indian medicine, from Europe, from South America, from Africa. And our program is able to search for new therapeutic formulations in all of these herbal sources. We still believe plants are the answer, but by adding this new AI-enabled technology we can begin to look inside plants and find new solutions to treat human diseases more efficiently.
Traditional drugs have been helping people for thousands of years. But they do it in a way that is fundamentally different from the kind of medication you get at the pharmacy. These were made with one ingredient, and what they call “the magic ball neck”. But we found out that these magic bullets are very rare. What usually happens is you take a single ingredient drug and then you need three more single ingredient drugs to manage the side effects. While we’re trying to think about the consequences of all of the ingredients in it at the same time so that you don’t really have a single ingredient causing all sorts of side effects – you’ve already considered that factor in. We believe that the future of medicine will be multi-ingredient active ingredients , and we believe that herbal medicines are the right place to find these solutions.
“We believe that the future of medicine will be multi-ingredient drugs, and we believe that herbal medicines are the right place to find these solutions.”
MS: When you say you look at the different plant components and how they work together in medicine to treat different diseases, it reminds me of the entourage effect of cannabis. Is that essentially what you are trying to do in creating these combinations that could be used as active ingredients in medicines?
ASH: It is exactly that, but I don’t call it that because the term “entourage effect” has been used disparagingly. We call it synergy. We find evidence of molecular synergy, which means that if we add more than one ingredient at the same time, the effect of the mixture is greater than the sum of the individual effects. We have a whole portfolio of patents where we did that with cannabis and the ingredients in cannabis. Now we have turned our attention to other plants [such as] the kava kava, which have a millennial history in traditional medicine for treating various ailments, but which also seem to work better when you use blends.
MS: Although the goal is to create mixtures of active ingredients, does the technology select these individual components and then discover the synergies underneath? How is it programmed to find these ingredients and then mix them?
ASH: Exactly. One of the things [the AI technology] thinks is a holistic view of people. One of the things we’ve done with our program is that we’ve trained it to think about medicine the way traditional medicine does, where it doesn’t look at just one aspect of a disease. For example, if you have cancer, it is not only important for you to control the growth of the cancer. It’s pain too. It’s inflammation too. So are all of these other aspects. So the AI program has been taught how to think about the different types of problems you will have with a particular medical condition.
I think this is going to change the way people think about medicine and in 10 years time people will start asking for a multi-component drug, not a single-component drug.
