Don't miss our October issue focused on pediatric cancer.

Cannabis Patient Care October 2022

On this month’s episode, we are joined by Dr. John MacKay, Co-founder of Synergistic Technology Associates. 

Ep 11: Cannabis Formulations: A Deep Dive on Processing with Dr. John MacKay

Check out our July/August issue focused on autoimmune diseases

Cannabis Patient Care July/August

Check out our March/April issue focused on chronic pain

Cannabis Patient Care March/April

Meg is the Group Editorial Director for Cannabis Patient Care and Cannabis Science and Technology magazines at MJH Life Sciences.


Michelle Kendall was a scientist. She had a scientific mindset and tackled problems strategically. When she was diagnosed with ovarian cancer, she took those skills and put them to use. She followed the doctor’s treatment plans until they stopped working and then she started her own scientific pursuit into medical cannabis research—going so far as to personally fund research in Israel with Dr. Hinanit Koltai of the Volcani Institute. Michelle also documented her experience in the film Schedule 1, which is available for free on 

. Tragically, Michelle passed away from her ovarian cancer before seeing the research efforts fully come to fruition. However, her husband Bruce Kendall and Professor Koltai are continuing the efforts that Michelle started and hoping to one day find improved treatment options for patients with ovarian cancer. Here, Bruce and Professor Koltai share their story and the current state of their research into medical cannabis.

This research is still moving forward today, with the most recent findings published in early November 2022 in the journal 

 (1). That article was part of a special issue called “Natural Compounds with Activity against Ovarian Cancer: In Memory of Michelle Kendall, an Ovarian Cancer Warrior” (2).

Bruce, can you tell us about your background and how you and your wife, Michelle Kendall, started Canna Onc Research?

: I'm a professor of environmental science and ecology at University of California, Santa Barbara. That's completely unrelated to how we got into cannabis medicine. But I do have a background broadly in biology, and Michelle also worked in the environmental field. So, we were both environmental scientists.

Back in the winter of 2016 Michelle was diagnosed with advanced stage ovarian cancer. She responded well to the initial treatment, but had a recurrence after about a year, setting a pattern in motion of repeated treatment, remission, and recurrence.

Toward the end of her second remission, Michelle was introduced to the idea of medical cannabis by a neighbor who was a retired physician. Never having used anything stronger than alcohol, she started taking cannabis with great trepidation, hoping for nothing more than better sleep. At the same time, she was getting bloodwork for a cancer marker every three weeks. At this point, the levels were starting to increase as her next recurrence began. She quickly noticed that the rate at which the marker increased or even whether it increased at all was dramatically affected by whether she was using cannabis during those three weeks and what sort of cannabis she was taking—whether it was high tetrahydrocannabinol (THC), high cannabidiol (CBD), or so forth. She talks about this quite a bit in the movie we produced called “Schedule 1.” She started reading about cannabis and cancer online, discovering “crazy” patient testimonials claiming that cannabis cured their cancer. But with a background in science, she was unfazed by the peer-reviewed literature and dove into PubMed reading the preclinical studies on cannabis and cancer that, at that point, were just starting to accelerate. Michelle also watched lots of videos of talks by the scientists who were working in this field.

So that was exciting because we really saw that cannabis had potential through our personal experiences. And all through this I was cheering her on, but she was really leading the charge to learn about medical cannabis. When she showed me the literature on the endocannabinoid system, I realized that there's real science, there's a real biological mechanism here. I really became convinced. So, there we were. The challenge was, as we know, that cannabis is a complex plant biochemically and cancer is also very complex. And every cancer, it seems like, is different in its underlying mode of action. So, finding a cannabinoid-based treatment for glioblastoma doesn't necessarily say anything about what's going to work for ovarian cancer. And it was clear that there were probably some key cannabinoids that she needed to be focusing on. But at that time, as far as we could find, nobody was doing research on cannabis in ovarian cancer.

So, in the summer of 2020, Michelle started contacting scientists who were working in the cannabis and cancer space, and Professor Hinanit Koltai (PhD) responded enthusiastically. From there, she and Michelle had a series of conversations about what Michelle was looking for in terms of finding which cannabinoids might be most effective in treating ovarian cancer. Professor Koltai’s laboratory at the Volcani Institute in Israel is leading research on cannabis and cannabinoids to identify optimal combinations of cannabis compounds for the treatment of different medical conditions. Professor Koltai came up with a proposed research plan, and we came up with some money from our personal savings. Then we then formed the company Canna Onc Research as a venue to contract with Professor Koltai’s organization to fund research in her lab to identify the key cannabinoids that are most effective in killing ovarian cancer cells in lab culture. So, that was how it all got started—it was Michelle trying to hack her way to finding the set of cannabinoids that might treat her disease.

Professor Koltai, can you share a little bit about your background, how you how you felt about getting involved with the Kendalls, and an update on where things stand with your research?

: Yes, I'm a senior research scientist at Volcani Institute. Volcani Institute is a governmental institute in Israel for agricultural research. I have been a scientist at Volcani for more than 20 years now and I have worked on several different subjects during my career. At some point, when I became a full professor grade scientist, I began to feel that I was not fulfilling my destiny. I worked on the very interesting subject of plant hormones, but I felt that it was not enough. So, my lab and I turned to the research of medicinal plants.

This gave me and my team the clear aim of having products that could benefit people, could benefit patients. We bear this aim in mind. The interest in cannabis started to rise worldwide. When I started to read more about it, most of the research papers were quite old at that time. When I started to read and study the subject of medical cannabis use, I realized that there was a gap in knowledge in the medical use of this plant, among other things of course. This gap was based on the lack of knowledge about the active compounds. What I mean is that there were quite a number of scientific papers that were describing the use of the whole flower, of the inflorescence as we call it, or maybe full spectrum extracts. There were quite a number of scientific papers that described the use of a single compound from cannabis such as THC or CBD. But nobody looked at the composition of compounds from cannabis that could be efficient, beneficial, or optimal for the treatment of different medical conditions.

Cannabis produces hundreds of different compounds as a species, and in each strain you can find several dozen compounds that are being produced. And yet, even today, for medical use, people are looking primarily at CBD or THC. You can find high CBD extract or flowers or high THC extract or flowers. This is maybe fine for recreational use, but it's not good enough for medical use. This is because we know and we have found that cannabis compounds can act in synergy and therefore, finding the best combination of compounds for the treatment of specific disease is highly important. We believe that finding that best combination can lead to proper and efficient use of cannabis. So here I laid out in a few words our basic thinking and hypothesis as well as the aims that drive our research.

About two years ago or so, I got an email. At that time, I used to get quite a number of emails from different entities or commercial companies that asked me about our activity. One of the emails asked me very shortly if we're working on ovarian cancer. And of course, this email was from Michelle. I answered her as I answered everybody and said, no, unfortunately, we have not yet started working on ovarian cancer. Although even at that time, I have to say that we had up until today, two main questions: One, what is the best composition of compounds from cannabis for the treatment of inflammation? And two, what is the best composition of compounds from cannabis that may act as an anti-cancer agent? But at that time, indeed, we were not working on ovarian cancer.

So, Michelle asked me if maybe I would be interested in working on cannabis and this disease. And I said, let's talk. Then we had a Zoom meeting and from the first moment, I was completely captivated by Michelle’s personality, by her hope, and interest in cannabis. I was completely convinced after talking with her that this should be one of the avenues that we should take on with our research. So, since then, we have been collaborating. In the last year of Michelle's life, we were able to move forward together and to uncover initial findings.

Can you please share some of the most interesting findings from the study so far? And how do those relate back to Michelle's journey?

: During our collaboration, what we were able to find is the actual combination of compounds, of vital cannabinoids, and cannabinoids from cannabis that act efficiently and specifically against ovarian cancer cells. We started with cell lines, with cells of ovarian cancer, and looked for different composition of compounds from cannabis.

We found two compositions that were highly cytotoxic to these cells. It means that these two compositions—both of them, by the way, contain THC and additional compounds as well—acted efficiently and killed the ovarian cancer cells. And yet they were much less potent against normal cells. This was very encouraging. Following this finding, we looked at the effect of these combinations against cells that were extracted from a lymph node of Michelle. These cells were grown in the US after they were extracted and then were sent to us. We found that we could effectively kill these cancer cells.

We also found out more about the ability of cannabis compounds in these certain compositions that were effective: The ability to work synergistically with monotherapy and chemotherapy agents. This was so exciting to show first that the compounds from cannabis were working and killing Michelle’s cancer cells. That's one. And two is the ability of these compounds to work synergistically against the cancer cells with chemotherapy, and the chemotherapy (monotherapy) that we examined, mostly at that time was niraparib. This is one of the treatments that Michelle indeed was receiving at some point, at least for her disease.

Another set of findings that we had and are still working on is the mode of action. We were very much intrigued, all of us, about the synergy between cannabis and chemotherapy. And what we have done up until now is that we are looking at the gene expression that is induced in these cells, in the cell lines in response to the synergistic treatment.

That's just incredible groundbreaking work that you've been doing. So, where does the study stand currently? What are you working on now and what are the next steps?

What we emphasize is to examine the combination of cannabis compounds and sets with various chemotherapies. This is so important because it is quite clear that ovarian cancer patients will not use cannabis only or stop receiving chemotherapy or radiotherapy and use cannabis only. Rather, we see cannabis as a complementary and supportive treatment for these patients. And what we found is that cannabis is able to sensitize the cells to chemotherapy. So, they make the ovarian cancer cells more sensitive to niraparib. And we also have some findings as to the ability of cannabis to make these cells more sensitive to other chemotherapies.

In one approach, we think that cannabis should be part of the treatment, though not the only treatment, and be combined with chemotherapy. This view of a treatment is leading the questions that we ask now as well as what we’ll askin the next few months. One question would be about the mode of action. What is the base of this increased sensitivity of cells by cannabis in terms of gene expression, of protein expression, involvement of other genetic elements in this cannabis activity?

Another subject is targeting the stem cells that are developed in between the cancer cell population. I will explain. The recurrence of the disease that was described by Bruce is usually a result of stem cells that are resistant to chemotherapy and are able to invade tissues and to form new tumors. And of course, this is the basis for metastasis. We set forth to target these stem cells of ovarian cancer. And what we ask now is whether cannabis can target these cells specifically, that are part of the cancer cell population and are the most dangerous ones, you may say. And targeting them is so important. So, that's also very exciting. And we're looking into this ability of cannabis to directly target stem cells.

 studies. In these studies, we look for the ability of cannabis compounds in combination with chemotherapy to target tumors that are formed in mice. This is so important to look at because only looking at cells is not good enough. In so many cases, different compounds are working very nicely or wonderfully in stem cells, but not 

What we can say already about this ongoing work is that we have completed one experiment on mice, and we definitely see that cannabis is able to support and even promote—to some extent—niraparib activity, the monotherapy activity in mice, and lead to a significant reduction in tumor size or volume. But this is only one.

The last avenue that I would like to raise and talk about is clinical trials. We will never be able to say that we have succeeded or that cannabis has anticancer activity unless we have successful clinical trials. Clinical trials are urgently needed because women are diagnosed with this disease and there is not much to offer them today.

As we see, once we find these compounds that might be helpful, we need to go into clinical trials as soon as possible. And here I will leave science for a minute and tell you that clinical trials are usually highly expensive, and we are desperately looking for somebody or entity that could help and finance clinical trials. We feel the urgency in doing so.

Can you discuss the difference in doing research where you're based in Israel compared to the US? I know the funding is a huge issue, but is it relatively easy in Israel to do a clinical trial and conduct this type of research compared to the US?

: Yes, here in Israel we are in a very productive atmosphere regarding cannabis research at both the preclinical and clinical levels. Thanks to our Ministry of Health we are able to promote the medical use of cannabis in a few ways, although cannabis is illegal in Israel for recreational use.

One of the ways we can promote the medical use of cannabis is the qualification of physicians to register cannabis to patients for medical care. The second is the ability to conduct research. Everything we do, we do under authorization of the Ministry of Health. For example, we can conduct research in the lab and also as clinical trials in hospitals.

This ability to be authorized to conduct research, both preclinical and clinical, has paved the way for making real progress in cannabis medicalization. Yet, the fuel we need to keep moving is funding.

I would like to say that without Michelle and Bruce, we would not be able to move. They were very supportive, and Bruce is still supporting this research. Through this kind of support, they're the ones that have allowed the progress of this research.

Why is this research into cannabis and cancer treatment is so necessary?

: Maybe I can start, and Bruce can add his thoughts as well. I would reiterate that there are currently no good solutions, unfortunately, and no good treatments. Bruce can say more for ovarian cancer. Ovarian cancer occurs in about one out of every 60 women. So, it's not rare. And still, modern medicine has nothing to offer yet.

Patients, in some cases, are reporting that the use of cannabis led to some halt in the progress of cancer (for this cancer and others). Even if we are not talking about the miraculous recovery or healing, if we are able to get the disease into remission and allow the patients to live longer and better, then I think it's worth any effort.

: I think all cancers are horrible diseases, but ovarian cancer is particularly challenging because it doesn't present obvious symptoms and so most women are diagnosed at a very advanced stage when the cancer has already spread through the body. So, the prognosis at that point is always challenging.

From what I understand, the primary treatment for ovarian cancer is usually surgery to remove the gross tumors and then chemotherapy. And for patients, as far as I can tell, it's a binary outcome at that point. Either the disease never recurs and so the patient can be considered cured or there is a recurrence.

If there is a recurrence, then subsequent treatments are never curative. There can be multiple remissions, but it just keeps coming back. And the challenge is that the chemotherapy agents themselves are so toxic that, first of all, patients develop allergic reactions to them after a certain amount of time. And the cancer can develop resistance to them. So, each recurrence becomes harder to treat and eventually becomes untreatable.

That's what happened with Michelle. Her final recurrence came back raging much faster than previous ones. They had to take her off the platinum-based therapy, which had worked so well before. So, that's the context of where we are. If that first line treatment is not successful at eradicating the disease, then there is no long-term cure or even long-term living with the disease.

I think there's still not much known even in terms of patient stories about ovarian cancer, in particular with cannabis. But the fact that Michelle had this initial response that was so encouraging should be discussed. I think this is a disease where we need as many tools as we can get. Cannabis looks like it has the potential to be another powerful tool in the fight against this disease, so we need to learn as much about it as we can and bring it into therapeutic use as quickly as possible.

But I also want to come back to what Professor Koltai was talking about with stem cells. From talking with the cannabis physicians that Michelle worked with and the stories that she had heard when she reached out to other patients, it appears that in many cases, when patients are able to control their disease using cannabis, as soon as they stop taking cannabis, the cancer comes back. So, it seems as though it's not that cannabis is eradicating the cancer altogether, but it may be preventing the cancer cells from proliferating. There are still cancer cells lurking in the body, but the cannabis is preventing them from turning into stem cells and launching a new recurrence, building new tumors, and metastasizing.

There are certainly conventional medicines that are trying to do this same thing, but they're not very effective, at least the ones that we have on the market now. Michelle was on one, and the clinical studies for that drug show the average increase in time to recurrence was just two months. So, it is a very expensive drug that adds just a couple of months to a remission and cannabis seems like it might have the potential to be more effective in that role. If we can make that happen, that would be wonderful.

What role do you think cannabis can play in cancer research and treatment? Bruce, can you share a little bit more about Michelle's experience?

: Yes, I sort of touched on that in the previous answer. But I think Michelle's experience was one with a lot of frustration at how little was known about the mode of action and which compounds to take. She was working with a cannabis physician in Southern California who had worked with lots of cancer patients, although not ovarian cancer patients.

In the absence of research, the physician was just basing the treatment on her own clinical experience. Her recommendation was simply to take high doses of all the major and “major minor” cannabinoids, so that was what Michelle was taking in 2020 and 2021. It was unclear whether it provided any benefit—I mean, it was high in THC, but it didn't have some of the compounds that Professor Koltai’s research identified as being part of the mix for ovarian cancer.

So, it was very frustrating. As Michelle used to describe it, it's as if the oncologist was just picking chemotherapy drugs at random to apply to her disease. And that's, of course, not how medicine works. The other challenge that Michelle faced—and everybody who tries to use cannabis to cure cancer faces—is just basically taking a very broad spectrum approach and hoping that there's something in there that works. It's very high amounts of THC, far more than anybody uses recreationally, so it interfered with her ability to focus and get things done. That was very frustrating. Her hope was that a more targeted formulation would be as effective at a much lower dose, so that she could live a normal life at the same time that she was taking this medication.

I think the main thing is that we know from the preclinical research that different compounds—the various cannabinoids, terpenes, and flavonoids—each have different effects on different cancers. The more targeted we can be, the more effective and efficient it can be as a medicine. I think that's really the goal here.

: I think Bruce summarized it very nicely. I would just add one element of the endocannabinoids. We know today that cannabis compounds bind to receptors that belong to the endocannabinoid system. We also know that the endocannabinoid system is deeply involved with different states of health and disease. And we know that many diseases are associated with the changes and malfunction of the endocannabinoid system. Thus, because of that, we think that the cannabis by binding to the same receptors that are part of the endocannabinoid system, just by doing that, is able to affect many, many processes in the body and then perhaps improve the different medical conditions, the symptoms, and to contribute to the homeostasis of the body, which is of course, desired.

In the cannabis industry, one of the most amazing things is seeing how patients become activists themselves, and they take on this role of wanting to help others where they needed help and pave their own way. Bruce, can you tell us a little bit about how the idea for the documentary, Schedule 1, came about and what were Michelle's goals with creating that?

: It was a bit of a serendipitous moment that led to the film. The back story, as we discussed, was that Michelle was really frustrated by the lack of research happening in the US and the fact that while medical cannabis was legal in many states, it was still completely separate from the medical system and largely discounted by most physicians, including her oncologists. They didn't dissuade her from taking cannabis, but they just expressed no opinion and not really any interest in it. At the same time, Dr. David Bearman is here in Santa Barbara, California and so Michelle got a crash course from him on the history of medical cannabis use and regulation. She knew nothing about cannabis before she started this. She had no interest in recreational drugs or any of that sort of thing.

This was a new territory for her. But then she started trying to be active in in the fight to reschedule cannabis to make it easier to do research in the US and was frustrated by the administrative foot-dragging with the US Drug Enforcement Administration (DEA) and the US Food and Drug Administration (FDA). She was having coffee one day with an old friend, who she'd worked with probably 20 years previously and was telling him the story. He is a documentary filmmaker who mostly does environmental and marine documentaries. It turned out he had just finished a big project and didn't have anything else major lined up. He said, “Well, let's make a film together.” So very quickly, they got excited and sketched out what that might look like.

Articles


In this recent interview, Bruce Kendall  and Dr. Hinanit Koltai of the Volcani Institute share the inspiring story of the late Michelle Kendall and how her passion for science and research brought them all together to study medical cannabis as a potential treatment for ovarian cancer.

Ovarian Cancer and Medical Cannabis Research: Michelle Kendall’s Legacy of Research, Advocacy, and Change

Recently King’s College London announced the start of the world’s largest independent cannabis use research study called Cannabis & Me (1). King’s College, located in London, England, is a research college with “£273m annual research income and ranked 6th in the world for research ‘power’ (2021 Research Excellence Framework)” (2). The Cannabis & Me study was allocated more than £2.5 million of funding by the Medical Research Council (1).

The Cannabis & Me study reportedly aims to understand the wider impact of cannabis use on the physical and mental health of cannabis users (3). “It also aims to identify environmental and biological factors, which can explain the different effects people experience when using cannabis, and in particular, identify those users more likely to experience mental health and social issues,” as was stated in the survey provided to potential participants (3). The study will use a combination of DNA genetic and epigenetic testing, psychological and cognitive analysis, and virtual reality to understand how a user’s biological makeup is affected by cannabis use. It also intends to identify the environmental and biological factors that are most likely to cause mental health and social problems in cannabis users (3).

The study will be headed by Medical Research Council Senior Clinical Fellow Dr. Marta Di Forti. “Cannabis is consumed daily by many recreationally but also for medicinal reasons,” said Dr. Di Forti (1). “But in the UK, the prescription of medicinal cannabis remains rare. Our study aims to provide data and tools that can make physicians in the UK [United Kingdom] and across the world more confident, where appropriate, in prescribing cannabis safely.”

The study is looking for 6000 participants between the ages of 18-45 who are living in the London area and who currently use cannabis, have used it less than three times, or have never used it before. The 40-minute survey will be conducted in two parts: a survey and face-to-face interviews (3).

The full details of the survey can be found here: 

https://kings.onlinesurveys.ac.uk/cannabisme

https://www.kcl.ac.uk/news/kings-college-london-spearheads-the-largest-ever-independent-study-into-cannabis-use

The Cannabis & Me research study will reportedly study the effects of cannabis on the human brain, particularly in terms of a user’s prior psychological conditions. 

King’s College London Launches Largest-Ever Independent Study on the Impact of Cannabis Use

Recently, the nation’s first cannabis-trained nurse guidance service, Leaf411, announced the resumption of their affordability program for patients in need of cannabis products (1). Leaf411 was founded in 2019 with a mission to provide education and directional support to the general public about the safe and effective use of cannabis (1). Their affordability program connects participating patients with free or low-cost cannabis products donated from business partners.

“We recently accepted a very generous donation of product from Elixinol, a long-time vetted Leaf411 member,” Katherine Golden, CEO of Leaf411, said in a press release (1). “It could not have come at a better time because we have seen such a large increase in need from the Leaf411 community. We are receiving more requests for affordable medicine than ever in the history of the organization.”

Enrollment in the program reportedly quadrupled in recent weeks to a current total of 600 participants.

The typical donation process involves dispensaries or manufacturers, who are vetted Leaf411 business members, providing donations when their products are nearing their expiration date. The products enter Leaf411’s Affordability Program, which then assigns a program participant to the donated product that is then picked up at a participating dispensary or shipped directly if it is a hemp product. Products are distributed on a first come, first served basis, which means a patient’s preferred product might not be readily available. Leaf411 is reportedly working to grow its partnerships to continue to gain access to more products and connect them with patients.

“Affordable access to medical cannabis can often be critical for many patients who are undergoing financial hardship,” Golden continued (1). “This program helps to fill in the gaps to safe, affordable access while organizations like 

 work to find policy solutions to ensure that no patient is without safe access.”

Patients interested in participating in the Leaf411 Affordability Program can complete an Affordability Program application 

Cannabis businesses interested in donating products to the program should contact Leaf411 at 

To learn more about the program, visit the 

https://www.globenewswire.com/news-release/2022/11/07/2549500/0/en/Leaf411-Resumes-Affordability-Program-as-Economic-Conditions-Create-More-Patients-in-Need.html

Due to inflation and rising costs of living, Leaf411 resumed its affordability program to address the needs of patients seeking medical cannabis.

Cannabis Guidance Service, Leaf411, Resumes its Affordability Program for Patients in Need

PQE Group, an international life sciences consulting company, announced the establishment of the world’s first start-up to support pharmaceutical companies in medical cannabis development in a recent press release (1). The start-up, called Glocal Quality Cannabis (GQC) will reportedly provide services including engineering, GxP quality compliance, regulatory affairs, medical-scientific advisory, clinical studies, and a GQC academy. According to their website (2), “PQE Group is a woman-owned, ISO 9001-certified technology solutions and compliance consulting services company for the life sciences industry, providing global capabilities deliverable throughout the entire product quality life cycle.”

In their press release (1), Gilda D'Incerti, PQE Group CEO and Founder and President of GQC, explained that this project represents an important challenge for her, adding that she strongly believes in the therapeutical power of cannabis. “I wanted to support the field of research as well as the development and dissemination of medical cannabis through the creation of this new start-up,” said D'Incerti. “I personally, and with great care, researched the professionals who make up the new GQC team: chemists, pharmacists, physicians, and biologists who take care of the supply chain at three hundred and sixty degrees.”

QGC will address the market’s struggles with fragmented legislation by applying “the highest international standards locally to always guarantee efficacy, safety, and quality to the end patient” (1).

"I believe that medical cannabis should be treated the same as any other pharmaceutical product,” Riccardo Salvagnini, GQC VP Executive, said during the start-up's launch ceremony (1). “Our vision is to support the development of new therapies through effective management of data quality by accelerating the registration of cannabis products and reducing the timing of the supply chain to be faster for the patients. Therefore, we want to provide effective technological solutions to medical cannabis products to accelerate our go-to-market strategy through a local approach but with a global mindset.”

https://www.businesswire.com/news/home/20221024005107/en/GQC-Is-Born-the-First-Start-up-Federated-by-PQE-Group-to-Support-Medical-Cannabis

International company PQE Group announced in late October their first ever start-up to provide support for medical cannabis.

New International Start-Up Established to Support Pharmaceutical Companies in Medical Cannabis Development

(1), a study sponsored and co-published by Gb Sciences Inc. has reportedly “identified and validated cannabinoid ratio-controlled, Minimum Essential Mixtures (MEM) for the treatment of Parkinson's disease symptoms.” Gb Sciences Inc., is a plant-inspired, biopharmaceutical research and development company that creates patented, disease-targeted formulations of plant-inspired therapeutic mixtures for the prescription drug market (2).

“Our drug discovery process has identified promising ratio-controlled mixtures of cannabis-inspired compounds for the treatment of Parkinson's disease, which have proven effective at reducing Parkinsonian motor symptoms in an animal model of the disease," said Dr. Andrea Small-Howard, President, Chief Science Officer, and Director of Gb Sciences in a press release (2). Dr. Small-Howard presented this study and others at Canna Pharma 2022 in San Diego, California earlier this month in a talk titled “Identification of Minimum Essential Therapeutic Mixtures from Cannabis Plant Extracts by Screening in Cell and Animal Models.”

According to the press release (2), the company-sponsored study was conducted with discovery research using cell models of Parkinson's disease performed at Chaminade University (Honolulu, Hawai'i), and the MEM refinement and validation research was performed in a zebrafish model of Parkinson's disease at the National Research Council of Canada (NRC). The study is titled "Identification of minimum essential therapeutic mixtures from Cannabis plant extracts by screening in cell and animal models of Parkinson's disease

 and was co-authored by Andrea Small-Howard and her collaborators Michael G. Morash, Jessica Nixon, and Lee Ellis from the National Research Council of Canada; Lori M.N. Shimoda and Helen Turner from Chaminade University of Honolulu; and Alexander J. Stokes from the University of Hawai'i at Manoa (Manoa, Hawai'i).

“The sequentially reductionist process implemented in this multi-site study preserves some of the entourage-like effects of whole plant extracts while achieving ‘relative’ simplicity within MEM that is a requirement for obtaining the manufacturing and quality control advantages of single-ingredient drugs,” the press release stated (2). “Gb Sciences' Parkinson's therapeutics are currently being tested in a rodent model of Parkinson's disease and these Parkinson's MEM have been formulated as oral dissolving tablets in preparation for human clinical trials. They are preparing for the final rounds of toxicology and pharmacology testing required for filing an Investigational New Drug (IND) Application with the US Food and Drug Administration.”

For more coverage of Canna Pharma 2022, please click here: 

https://www.cannabissciencetech.com/view/highlights-from-canna-pharma-2022-driving-cannabis-science-and-therapeutics-forward

https://www.frontiersin.org/articles/10.3389/fphar.2022.907579/full

https://www.globenewswire.com/en/news-release/2022/10/10/2530872/0/en/Gb-Sciences-Co-Publishes-Study-Demonstrating-Efficacy-of-Its-Proprietary-Cannabinoid-Mixtures-for-the-Treatment-of-Parkinson-s-Disease.html

Research sponsored by biopharmaceutical drug development company Gb Sciences Inc. identified and validated mixtures of cannabis-inspired compounds for the treatment of Parkinson's disease.

A New Study Demonstrates the Efficacy of Cannabinoid Mixtures for the Treatment of Parkinson's Disease

In San Diego, California, presenters, attendees, and others in the cannabis industry gathered from October 12-13, 2022 at 

 to share current strategies and knowledge to move cannabis science and medicine forward. The two-day conference featured nearly two dozen presentations, poster presentations, and opportunities for networking, including a post-conference mixer. Here we present highlights from each presentation at the event.

A half day pre-conference workshop led by Charlotte Peyton on October 11th, an independent consultant from EAS Consulting Group, instructed attendees on an overview of good manufacturing practices (GMP) in the cannabis industry, including expectations and compliance requirements to help employees stay on top of critical quality and safety issues.

Plenary keynote speaker Stephen Goldner, Esq., CEO and Chair of Pure Green Pharmaceuticals, gave an overview of methods to decentralize clinical trials in cannabis medical research. Using a recent proof-of-concept study involving cannabidiol (CBD), Goldner presented a detail-rich explanation of the clinical, scientific, business, and legal approaches to decentralized clinical trials; the challenges and benefits; and how they can become commercial and professional opportunities.

Dr. Ethan Russo, Founder and CEO of CReDO Science, gave an in-depth exploration of two minor yet important cannabinoids in his presentation “Cannabigerol (CBG) and Tetrahydrocannabivarin (THCV): Sources of Novel Cannabis Therapeutics.” Dr. Russo explained the genetics of the two cannabinoids, compared their mechanisms and roles to other cannabinoids’, plus explained the therapeutic potential of CBG for treatment of anxiety, pain, primary cancer treatment and antibiotic-resistant bacterial infections, and the potential of THCV for treating obesity, metabolic syndrome, Type II diabetes mellitus, and drug addiction. He also gave an overview of past and recent studies on these cannabinoids in humans. Following Dr. Russo’s presentation, Hunter Land presented “Active Pharmaceutical Ingredients: Strategic Considerations for Cannabinoid Development,” in which he explained the benefits of synthetic and biosynthetic production of cannabinoids versus extraction and explored their development as medicines.

Medical topics were covered in several more presentations as well. Marilyn Barrett, PhD, gave an in-depth explanation of the proof-of-concept study that Stephen Goldner had mentioned in his talk. In “Diabetic Neuropathic Pain Decreased Upon Coadministration of CBD and PEA,” Dr. Barrett explained how cannabis-derived medicine can be an opportunity for both patients and the pharmaceutical industry. She explained the details of the randomized, double-blind, placebo-controlled trial, including the patient selection process, dosing, endpoints, and treatment period, then analyzed the results. In “Case Studies: Identification of Minimum Essential Therapeutic Mixtures from Cannabis Plant Extracts by Screening in Cell and Animal Models,” Andrea Small-Howard, PhD, explained the rationale behind patients using essential compounds rather than whole plant extracts. Dr. Small-Howard gave an explanation of three case studies using cannabis components to examine the potential for treatment of conditions such as Parkinson’s disease, chronic pain, and inflammation. For a global perspective, S. Zev Barnett explained in his presentation, “Hemp Derived Medicine: The Need for Fast Global Adoption,” how cannabis could improve healthcare in the US, using examples and personal stories. He also gave an overview of a large trial study of CBD and its implications for further study.

Chairperson Monica Taing from Holistic Industries moderated a panel discussion and audience Q&A on industry regulation and practice. The three panelists were Lori Dodson, Maryland Medical Cannabis Commission, Heather Krug, Colorado Department of Public Health and Environment, and Susan Audino, PhD. The panel answered questions from the audience on topics such as how to ensure laboratory competency, laboratory shopping, vape testing requirements, delta 8 regulations, and what federal oversight on state regulations could look like. Dr. Audino also gave a separate, in-depth presentation titled “The Triangulation (Or Strangulation) Consuming Cannabis-Testing Laboratories” which explained the issues currently restricting cannabis laboratories.

In a spotlight on technology, two presentations covered improving bioavailability and formulation challenges. In her presentation titled “Overcoming Formulation Challenges of Cannabinoids,” Inayet Dumanli-Ellis, PhD, explained methods of drug delivery modalities and covered topics such as the development of oral THC and CBD self-emulsifying formulations and improving the stability of cannabinoids in lipid vehicles. In “Emerging Formulation Technologies for Pharmaceutical Applications of Cannabinoids,” Andreas Papas, PhD, explained the role of formulation technologies on solubility, stability and enhanced absorption, and bioavailability of cannabinoids, plus examples of commercial applications in product formats.

Two presentations explored the legal interests in the cannabis industry nationally and globally. Scheril Murray Powell, Esq. gave a talk titled “Managing Consumer Protections while Growing a Robust Inclusive Cannabis Space,” in which she elaborated on the need for industry standards to protect consumers and the JUSTÜS Foundation’s work in assisting legacy cannabis companies with integration. Dale Hunt, Esq. presented “Navigating IP Opportunities and Risk in Cannabis – What Everyone in the R&D Business Should Know,” and explained what companies can and cannot do with patents and why.

Several presentations covered the cannabis industry in Canada. Presenting virtually were Andrew Waye, PhD, and Sophie-Anne Lamour, PhD, both from Health Canada. Dr. Waye presented “An Overview of Chemical and Microbial Contaminant Requirements for Cannabis Products in Canada,” and explained supply chain regulation, quality control, and integration with existing frameworks. Expanding on these topics, Dr. Lamour presented “A Risk-based Framework to Facilitate Non-therapeutic Research on Cannabis in Humans in Canada,” in which she explained current regulations and the benefits to the proposed framework changes. Karolina Urban, PhD, presented “Advancing the Potential Use and Efficacy of Cannabinoid-based Medicine,” which explained what factors contribute to the current mixed results of cannabinoid-based medicine and what research is being done. Presentations and audience questions included comparisons to the United States’ cannabis industry.

Other presentations covered various topics such as the importance of cleaning procedures for all cannabis equipment as explained by Michael Moussourakis in his presentation “Critical Cleaning: the Key to Quality and Safety;” an argument for choosing mass spectrometry over ultraviolet (UV) detection presented by Anthony Macherone, PhD, in his talk “Why Are We Using Non-Selective UV Detectors for Regulatory Cannabinoid Profiling and Agency Testing?”; an explanation of the various benefits of cannabis tissue culture as presented by Hope Jones in “Tissue Culture Techniques;” and an explanation of the FDA’s “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research” draft guidance as presented by Nandu Sarma, PhD, in his talk “Quality Considerations for Cannabis Clinical Research.”

The 2022 Canna Pharma Conference was held October 12-13 in San Diego, California.

Highlights from Canna Pharma 2022: Driving Cannabis Science and Therapeutics Forward

President Biden announced three steps as part of enacting this plan. “First, I am announcing a pardon of all prior Federal offenses of simple possession of marijuana. I have directed the Attorney General to develop an administrative process for the issuance of certificates of pardon to eligible individuals,” said President Biden (1). “There are thousands of people who have prior Federal convictions for marijuana possession, who may be denied employment, housing, or educational opportunities as a result. My action will help relieve the collateral consequences arising from these convictions.”

President Biden’s second step is to call on all US Governors to offer the same pardons for state-level offences regarding marijuana possession.

“Third, I am asking the Secretary of Health and Human Services and the Attorney General to initiate the administrative process to review expeditiously how marijuana is scheduled under federal law,” said the President. “Federal law currently classifies marijuana in Schedule I of the Controlled Substances Act, the classification meant for the most dangerous substances. This is the same schedule as for heroin and LSD, and even higher than the classification of fentanyl and methamphetamine – the drugs that are driving our overdose epidemic.”

This monumental announcement has been a long time coming for many cannabis activists and advocates. As stated in an article from 

 (2), it’s not clear how long this review process could take, but the call to review is a big first step.

https://www.whitehouse.gov/briefing-room/statements-releases/2022/10/06/statement-from-president-biden-on-marijuana-reform/

https://www.marijuanamoment.net/biden-announces-mass-marijuana-pardons-and-calls-for-cannabis-scheduling-review/

In a statement released from the White House on October 6, 2022, President Joe Biden announced plans to pardon Federal convictions for simple possession of marijuana and issued a call to review the scheduling of cannabis (1).

US President Joe Biden Announces Cannabis Possession Pardons at the Federal Level and Calls for a Schedule Review

Here, Dr. Dustin Sulak discusses how his patients, who have sometimes failed to respond to traditional treatments, see symptom improvement and other positive results after being treated with cannabis and psychedelics such as ketamine.

View the video for more of the discussion.

In this video interview, Dr. Dustin Sulak of Healer.com and Integr8 Health shares the most surprising results and quality of treatment response he sees when treating his patients with medical cannabis and psychedelics.

Cannabis Science Conference East 2022: Dr. Dustin Sulak Shares Surprising Results when Treating Patients with Cannabis and Psychedelics

In early September, the Cannabis Center of Excellence (CCOE), Undoo, LLC, and Patriots Helping Vets launched a new national research project for US military veterans. According to the press release (1), “the Undoo® Veterans Study will be conducted in tandem with the CCOE iCount for Veterans - Veterans Cannabis Access Program (VCAP).” The CCOE’s iCount for Veterans program connects veterans to cannabis products to participate in research and educational programs (1). The study will include 500 qualifying veterans and will study the effects of three Undoo® products (1).

Undoo, LLC develops products that address some of the after-effects of cannabis consumption (1). Patriots Helping Vets is providing support for the research study. Their mission is to provide US service veterans the materials, support, and education to start their own gardens (2). The goal of the CCOE, a 501c(3) non-profit, is to bring together citizens, medical patients, academics, researchers, community members, healthcare professionals, and policy makers to drive change in access, best practices, and social justice in cannabis industry (3).

According to the CCOE press release (1), “veterans will receive Undoo® products as a part of their participation in ongoing CCOE studies and report on their effectiveness for the intended outcomes.” The three products are Undoo® Rescue softgels intended to lessen the effects of tetrahydrocannabinol (THC) consumption, Undoo® Refresh softgels for lingering haziness and mental fog from cannabis consumption, and Undoo® Reset for restoring THC tolerance (1). “Veterans can share their experiences, voice, and opinions to drive changes in the cannabis industry,” the CCOE further stated (1).

This study is approved by the University of Massachusetts Dartmouth Institutional Review Board (1).

For more information on the research project or to register, please visit: 

https://www.cannacenterofexcellence.org/offers/b82wt2hw/checkout

https://www.cannacenterofexcellence.org/undoo

On September 7th, 2022, the Cannabis Center of Excellence (CCOE), Undoo, LLC, and Patriots Helping Vets launched a new national research project for US military veterans to study the efficacy of three products that address the after-effects of cannabis usage.

New Research Project for Veterans Launched to Study the Efficacy of Products Addressing After-Effects of Cannabis Consumption

Here, Dr. Dustin Sulak explains how the attitudes of healthcare professionals have changed over the years and how he has responded. He also notes a positive outcome he has seen recently when training clinicians on medical cannabis.

In this video interview, Dr. Dustin Sulak of Healer.com and Integr8 Health shares the biggest challenge he encounters when educating other healthcare professionals on medical cannabis, both in the past and today.

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