Cannabis and cancer clinical trial


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THE COMPLUTENSE UNIVERSITY IN MADRID

RAISING MONEY FOR A CLINICAL TRIAL INTO HOW CANNABINOIDS CAN HELP TREAT BRAIN CANCER.

This is an image of a brain tumour and cannabis molecule, this research is investigating if cannabis can help people who receive the sad news that they have a tumour

How can cannabis help treat cancer? 

Associate Professor Guillermo Velasco, Dr Juan Sepulveda and their team in Madrid have completed research that suggests that cannabinoids (the active components of cannabis, CBD and THC) can help eliminate Glioma initiating cells (GICs). Glioma Initiating Cells (GICs) play a role in the growth of tumour cells.

One of the hurdles faced by current cancer drugs in their fight against tumours is GICs limiting their effectiveness.  Therefore, this research could lead to a major breakthrough in cancer therapy if used in combination with current treatments.  In order to test this hypothesis, Velasco and his team plan to conduct a clinical trial in Madrid, testing cannabinoids in combination with current therapies in 30-40 patients, the research is supported by  Spanish Group of Neur-oncological Investigation/El Grupo Español de Investigación en Neurooncología, GEINO, which is the main body for neurooncology in Spain.

What is the study protocol?

The clinical studies will give newly diagnosed glioma patients either cannabinoids (THC and CBD) in combination with other anti cancer agents or placebo in combination with other anti-cancer agents after their operation to remove the tumour.  The placebo arm is important so doctors can access the how effective the anti-cancer properties of cannabis are in a clinical setting.

From an investigational point of view, this will be monumental progress in the field of cannabis and cancer research.  There has been a lot of anecdotal evidence that cannabis can help cancer patients, with many people worldwide self medicating.

Through this research we hope to show cannabinoids to be effective for the treatment of certain types of cancer and give patients and health care professionals the opportunity to medicate with cannabinoids based on scientific data rather than anecdotal success stories.

How much does the trial cost?

The total cost of the trial is £230k, £170k has already been raised by the Medical Cannabis Bike Tour(MCBT), we are now raising the final sum through this campaign so the research can begin as soon as possible.

When will the study begin?

Once funding is raised the trial will commence with 30 -40 patients in 4-6 Spanish hospitals. The trials will be overseen by the Spanish Group of Neur-oncological Investigation/El Grupo Español de Investigación en Neurooncología (GEINO) with the backing of Spanish health authorities.

The science team is Spanish based and Spanish health authorities which makes this trial more feasible as  they are more supportive of medical research with cannabis. The crowdfunding target combined with the money raised from the MCBT will ensure these trials go ahead.

This is an image of Associate Professor Guillermo Velasco (left) and Dr Juan Sepulveda (right) in their lab in Madrid working on finding effective treatments for cancer. Guillermo obtained his PhD degree (1997) at the School of Biology of the Complutense University, Madrid, Spain. In 1999 he became an Assistant Teacher at the School of Chemistry of the Complutense University. In 2003 he became an Associated Professor of the Department of Biochemistry and Molecular Biology. Back in 2001 he started a line of research aimed at investigating the mechanisms underlying cannabinoid anti-tumoral action as well as at optimizing the potential clinical utilization of these agents in cancer therapies.

Why is funding this study important?

The sad current state of affairs is that glioma patients, are staring death in the face and their choice is to either use conventional treatments which we know do not work (they usually are given a life expectancy of up to 12 months post diagnosis) or they can try a drug where many people have claimed it has saved their life but is a schedule 1 drug that they can only access through illegal channels, at least in the UK.

Hence, many patients choose to break the law to treat glioma. These patients are taking a gamble that people like Rick Simpson‘s beliefs about cannabis are correct.  On Rick Simpson’s website, there are a number of studies that point towards cannabis being effective, however none of these are human trials.

Without human trials we will not know whether the drug works in cancer patients, nor what the most effective dose is or the best way for patients to manage side effects.  In addition, as cancer is such a complicated beast, the most likely effective therapy will be a combination of cancer drugs rather than just one holy grail. Therefore potential drug interactions will need to be considered and managed, which again requires health care professionals expertise.

The team’s research has already shown promise in cancers of the brain and skin and breast cancer, but so far only in animal models.  This study could show that cannabinoids are an effective cancer treatment, which means that the treatment has the potential to save lives in one of the most heart breaking and aggressive forms of cancer called glioma.  This research will also help grow the body of evidence for the medicinal uses of cannabis.

It is also worth being aware that patients choosing cannabis oil have treatment costs of up to £50 a day that they have to pay for and this will not be affordable for many patients, in addition as there are no controls they risk being scammed or having their medication confiscated through the post after already paying for it. Hence, even if this research does not lead to positive results it will prevent families from having false hope and throwing money at a treatment that does not work and just adds to side effects that patients are already having from current therapies.

If the scientists have already shown it works why can’t they just give it to patients?

Unfortunately it’s not as simple as that.  For a drug to be prescribed legally a lot of research needs to be conducted first.  One of the most important things is working out the best dose and making sure the drug has an acceptable safety profile.  Even though there have been a number of patients who have independently tried cannabis to treat cancer, some successfully, it is still unclear what the best dose is. Also there is the factor that people faced with the possibility of only a few months to live, may not want to experiment with a drug with little data to tell them whether it is going to work on not.

 

Could the Pharmaceutical Industry support this research to help get a drug to market?

Yes, they could and GW Pharma are already conducting clinical trials on a drug called Sativex which is a patented version of cannabis.  Their clinical trials shown on clinicaltrials.gov are investigating cannabinoids in brain cancer patients after they have already failed on conventional treatments instead of giving the patients the treatment as soon as their are diagnosed.  Velasco believes that cannabinoids are more likely to be effective when given at an earlier stage.

Glioma is incredibly aggressive so catching it and fighting it earlier is more logical than waiting until it has advanced, particularly as the side effects of cannabinoids are less disruptive than the side effects of many other cancer drugs.

We would primarily like this research to help people prescribing medical cannabis and patients who can benefit therefore our top two incentives are aimed at this audience. 

Perks for Medical Cannabis Patients and Prescribers

These materials will be created using the ABPI code of practice as guidelines, this is the code that pharmaceutical industry has to adhere to when their promote their medications.  They need to make sure that research is reported in an accurate not bias way.

Medical Cannabis Clinical Evidence for just £30

This is aimed at prescribers of medical cannabis. The material will be based on the scientific data currently available on cannabis and MS, cannabis and cancer and can be used to show patients how medical cannabis compares to traditional drugs for the treatment of specific conditions.  Please contact info@walacea.com for further information.

Medical Cannabis Patient Leaflet for just £20

This is aimed at patients and will include similar content to the clinical evidence but will include less statistics and graphs.  It will be non-bias and purely based on the scientific literature so you can make an informed decision.

Other perks…

£5 reward – Thank you tweet 

A personalised token of our appreciation from MCBT and Walacea.

£10 reward – Thank you postcard

A special edition postcard signed by the team will be sent to you to say thanks for your donation to this ground breaking trial.

£15 reward – Exclusive Webinar

Learn more about the exciting work of the scientists at the Complutense university. Associate Professor Guillermo Velasco will host an exclusive Webinar, talking about the research of the science team from the Complutense University and its possibilities in the field of medical science. Participants will get a chance to ask questions in a Q+A too.

 £25 reward – An MCBT 2015 T-Shirt

The official T-shirt for campaign supporters. An exclusive Medical Cannabis Bike Tour cotton t-shirt to show your support for the cause. Featuring the MCBT logo, this appeals to the sporting cannabist inside us all! We will contact you after the campaign to confirm sizes.

£30 reward – A special ‘how the drug works’ poster print edition

This will be a beautifully graphically designed A4 image for you to frame depicting how the drug works in an artistic interpretation. You can proudly hang it on your wall and tell your friends that it is an image inspired by research that you helped fund into how cannabis can help treat cancer.

£50 reward – A ticket to an exclusive Madrid seminar.
Attend a specially convened seminar in Madrid next spring for an audience with Associate Professor Velasco and the science team from Madrid’s Complutense University who are among the world’s experts on cannabionids and their use as a cancer treatment. Hear what they have to say, participate in a Q+A and enjoy drinks with team afterwards.

£75 reward – Limited edition Mau Mau street art print
A specially commissioned limited edition print from internationally renowned street artist Mau Mau (www.mau-mau.co.uk) is up for grabs. The print will be an adaptation of one of the artists’ most popular street pieces. This will be signed and numbered by the artists. We are very grateful to Mau Mau for offering this for such a bargain to backers who support this important research!

£100 reward – An official MCBT 2015 cycle shirt

An exclusive official Medical Cannabis Bike Tour 2015 lycra cycle shirt. These shirts have been specially produced for riders participating in the tour. We can promise you will stand out on the road with this beauty!

£300 reward – Limited Edition Mau Mau image on canvas.

Mau Mau/ZHE specially commissioned Medical Cannabis Bike Tour street art print on canvas with hand finish.

 £500 reward – A place on the 2016 medical Cannabis Bike Tour

Join the bike tour: Become part of the adventure and cycle 420km over 3 days with cyclists from all over the world.

£1000 reward – Dinner with the MCBT in Amsterdam

One night’s stay in Amsterdam for you and a friend as well as dinner with the MCBT team hosted by founder and head of the non-profit organisation, Luc Krol + complimentary party bag (includes print/postcard + T-shirt).

 £1000 Reward – Dinner with the Madrid Science Team

One night’s accommodation for you and a friend and dinner with Associate Professor Guillermo Velasco and other members of the Madrid scientists team responsible for pioneering groundbreaking research into cannabinoids’ potential as a cancer treatment + complimentary party bag (includes print/postcard + T-shirt).

£2000 reward

Become a silver sponsor of the 2016 bike tour. Have your logo added to the cycling gear of next year’s tour.

SOME FAQS ABOUT THE RESEARCH

 A video interview with Velasco following last years bike tour

Meet The Scientists: Associate Professor Guillermo Velasco explains their work:

How did the research begin?

In the late Nineties, researchers at the university were studying endocannabinoids, which are a set of molecules and their receptors in the brain dealing with a variety of physiological processes. They were observing the effects that cannabinoids had on metabolism but they also wanted to try some of these compounds on cells from the nervous system, specifically the brain. By chance they experimented with cannabinoids on Glioma cells and found that when the tumour cells were treated with these, the cells started dying. They began to treat mice, infused with tumours, and found that cannabinoids reduced the tumour size and this started the whole programme.

What are cannabinoid receptors?

They are proteins in the face of cells and neurons that are targets of cannabinoids (ie cannabinoids either produced by our own body or derived from the plant, interact with these proteins thereby activating different processes on these cells). Essentially it’s the action that happens when people smoke cannabis that creates the effects of the drug.

What do your studies involve?

As a team, we study the effects of cannabinoids on cancer cells. As a biochemist, my own work is to understand how cannabinoids act on cancer cells regulating different processes. Our work involves combining THC and CBDs with different anti-cancer agents, as well as studying them on their own. We look to see how the different combinations of cannabinoids with other anticancer agents can be applied to patients.

Is THC or CBD more effective in the treatment of cancer cells in your experience?

THC is more effective because in general you can use lower doses of THC than CBD to get an effect, although this depends on the type of cancer (for example THC is much more effective than CBD on gliomas).

How do you administrate the cannabinoids?

In mice we have tried administering locally (injecting close to the tumour), intraperitionally (injecting into the peritoneal cavity), and orally, the latter two being systematic processes (ie the drug is distributed through the blood)

Has any method proved more effective?

Oral administration, which was surprising as cannabinoid distribution in the body is supposed to be more erratic (unpredictable) using this method.

Would it be fair to say that smoking a joint provides a similar distribution of THC and CBD in the body than oral administration of these compounds?

To a degree. You are ingesting THC and CBDs by smoking, but you are also taking in other particles, and you don’t know what these necessarily are.

So, how much truth would there be to the statement, ‘If you smoke cannabis you won’t get cancer?

Well, that is a very simple statement! There has been no serious medical study to say that this is true – that smoking cannabis is like a vaccination against cancer. The only experiment that was done in animal models was an experiment in the USA (the 1996 Toxicity and carcinogenicity of delta 9-tetrahydrocannabinol in Fischer rats and B6C3F1 mice study by the National Institute of Environmental Health Sciences) to prove that cannabis caused cancer by exposing rats and mice for over a two year study with high doses of THC. But what they found was that there was either no change, or in some cases a decrease in the number of tumours appearing in the animals. Obviously if you are smoking anything it is not great for the health, particularly if you are mixing marijuana with tobacco.

So is there a therapeutic value in actually smoking it?

I think that it is better with other options. It could have, because at the end of the day you are getting the active principles of cannabis (THC and CBD), but you are also getting everything else. There has been no serious study in humans as to whether smoking is effective.

There are stories, but without studies they are hard to prove. If we are talking about illustrations, you could point to someone like Bob Marley who smoked a lot of cannabis and died of cancer. Besides, every type of cancer is different and every type of cancer has sub types.

Also in order to convince the medical community of its medicinal benefits, smoking is not an acceptable method of distribution to prove the effectiveness of cannabinoids. For this reason, we have to look at other options such as oral or capsules or suppositories.

Were you one of the first labs to study cannabis and cancer?

There were some studies done in the 1970s but they didn’t continue them and at that time, nobody knew about cannabinoid receptors. They knew the chemical structure of THC and CBD but they did not know how they were acting in the body. It wasn’t until the early Nineties that we were able to begin understand how these receptors work within the body. Our lab and labs in Italy began working with cannabinoids, using this knowledge.

And when did people start taking this research seriously?

There was an article published in the scientific journal, Nature Medicine in 2000 (titled ‘Anti-tumoral action of cannabinoids: Involvement of sustained ceramide accumulation and extracellular signal-regulated kinase activation’), discussing the significance of the anti-tumour effects of cannabinoids. It really opened scientific eyes to the potential anti-cancer qualities and led to more media coverage and more laboratory studies to show how cannabinoids affected cancerous cells in conditions such as Glioma (brain cancer), Melanoma (skin), breast, pancreatic and lymphatic cancers. These studies looked at not only how cannabinoids destroy cancer cells but they starve them of the nutrients needed to grow. This is significant, because many people die from cancer because it spreads from the original source to other points of the body. Cannabinoids seem to inhibit this process of migration of the cells.

What happened as a result?

At the beginning, people were very sceptical of our research, but when they saw the results of our studies in serious journals, perceptions began to change. Also perceptions began to change in society. There was more acceptance among people which came with many claims that cannabis worked as a treatment. Therefore, there came a time when attitudes shifted and the feeling was, ‘ok, let’s see if there is any truth in this.’ I would say that now there is definitely more curiosity to study how cannabinoids may be used in treatments for cancer sufferers.

Did you have interest from pharmaceutical industry.

Yes, from the likes of GW Pharma, who produce Sativex. They are currently running a study on glioma patients based on our results.

But you are independent researchers?

Yes. Our main sources of funding are the Spanish Ministries of Health and Economy, as well as funding by charities including the Medical Cannabis Bike Tour.

What do you say to those who view pharmaceutical companies as wanting to control cannabis research for profit?

That’s a complicated idea. Traditionally, with a medical condition, people are looking for a product produced in a laboratory with some kind of track record. But cannabis is different. We (as scientists) have shown THC and CBD to work very well in cancer patients. So, based on this, you could grow some plants and extract the product, but to control the actual amounts of THC and CBD is not so easy.

You need to have precise amounts so you can know how to administer it and be aware of the effects. For example, if you have a headache you know to take enough paracetamol to cure the headache and not enough that it’s toxic. The same may be true with cannabis. You need the dose you need. Not more, not less. I don’t say that there are people processing oil from cannabis plants that don’t know what they are doing, I am just saying that it is easier when you know exactly what the dose is. In the case of cancer, doses are critical.

At the end of the day pharmaceutical companies want to make money, but they also have the resources to invest in the research and development to prove something works. Creating commercial medicines can also make it more acceptable to people. However, I can understand how people in the cannabis community might have concerns about the involvement of the pharmaceutical industry. For this reason, I think there is a place for both types of research – industry and independent.

In your experience, do you have much anecdotal evidence that cannabis cures cancer?

The problem is that, scientifically, you can’t show what happened to these patients. So, one person smoked a lot of marijuana and was cured but you don’t know if it was specifically because of the cannabinoids, the diet the person had, the type of tumour or any other factors. This is not scientific evidence. These stories on their own are not proof. They may suggest something is happening, but it’s only by serious study that you can confirm.

This is why clinical studies (using human patients) are crucial, using measured doses to provide the statistical analysis. You have a number of patients having the same dose, in the same situation, combined or not with another therapy. This way you can compare the statistics and measure the effectiveness. Only statistical evidence will show that something doesn’t happen by chance.

Have there been any clinical studies?

The only clinical study at the moment is being conducted by GW Pharma in the UK, and is focused on second line therapy. This is where a cancer patient has been treated with standard therapy and then had a relapse and so are getting a new treatment, combining Sativex with other agents. It will give results but you have to be aware that these patients are already very resistant and life expectancy is quite low.

If your team at the Complutense University could carry out a clinical study, using your research findings to treat human patients, what would you hope to achieve?

We would like to conduct clinical studies using cannabinoids and other anti cancer agents as a first line therapy. Patients diagnosed with brain cancer would be operated on and then receive standard therapy in combination with THC and CBD. I think that this way, we would be able to research if THC and CBD actually adds something to the patient’s treatment. Such a study would also allow us to study tumour samples, in order to dictate what combination of drugs and cannabinoids could be used most effectively for each patient. From an investigational point of view, that would be real progress.

Do you think there is a general shift in the way cannabis is perceived in popular culture, compared to when you began your research?

Definitely. Ten years ago more people were smoking mostly for fun but since then there has been a general trend, worldwide, moving to medical cannabis. We have seen this with many more clinical studies, researching cannabis’s use with other diseases, with scientific proof of its effectiveness in treating various conditions. This has definitely helped to change perceptions.

In wider culture, there comes a point when banning cannabis is no longer logical, not only for medical reasons but also because it does not seem to have prevented trafficking. That’s why the Uruguay idea to control supply is very interesting. They have identified that if people are using, then it is better to control the product – the quality, how the product is being sold to people etc. I think worldwide people are looking to move forward and not backwards on this subject.

 

6 Comments

  1. Omar

    Hi. Have these clinical trials been completed? When will they be completed? Have you achieved enough funding? And if and when they are completed, where will you publish the results?

    • Natalie Jonk

      We have not processed any of the funds for this campaign, our understanding is that the trial is underway and we are keen to follow up with the scientists involved and perhaps help them raise further funding for the next stage of the trial.

  2. alex

    While I am grateful for the work done at Complutense this study seeks to add thc/cbd to the treatment regimen of patients already undergoing chemo and radiation. That is not the best case scenario to prove efficacy and discover dosage as first line of defense. If you want to call this a first line of defense tx you would treat the patient upon diagnosis with the cannabinoids. Otherwise this is misleading. And you have the unpromising variables of the drug interactions. If you want you can call this a drug interaction study?

    • Natalie Jonk

      Hi Alex, thank you for you comment. The patients will be treated at the point of diagnosis with cannabinoids in addition to other oncology drugs.

      • Thomas

        Hi Natalie,

        What’s the point then? I believe most people, including myself, would like to hear from clinical trials on cannabinoids only (and ideally THC separately from CBD) not combined with other drugs.

        I’m wondering why such a trial has not taken place so far! I believe it would attract more backers globally.

        • Natalie Jonk

          Hi Thomas, thank you for your thoughts on this. We will look into this, may I ask if you are coming from a perspective of someone who has experienced cancer either directly or through a friend or relative? As you can imagine cancer trials are complicated to get ethical approval for and if there is a drug that already works to an extent for a type of cancer it is ethically questionable in most cases to deprive patients of this drug and just give them a drug that may or may not work.
          Natalie

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  • 7 Backers

    Pledge £2 just because you think this is an important research project and you would like to help make it happen! If you would like to pledge a different amount and not collect a reward just make your pledge by selecting the amount then drop us an email (info@walacea.com)

  • 8 Backers

    Thank you tweet: A personalised token of our appreciation from MCBT and Walacea.

  • 11 Backers

    Thank you postcard: A special edition Medical cannabis Bike Tour /Walacea postcard will be sent to you to say thanks for your donation (and brighten up a little corner of your office or living space!)

  • 8 Backers

    Exclusive Webinar: Learn more about the exciting work of the scientists at the Complutense university. Dr Guillermo Velasco will host an exclusive Webinar, talking about the research of the science team from the Complutense University and its possibilities in the field of medical science. Participants will get a chance to ask questions in a Q+A too.

  • 6 Backers

    Medical Cannabis Patient Leaflet, this will be a leaflet on the condition of your choice that will explain what the scientific evidence shows and how it compares with the safety and effectiveness of the licensed drugs in the pharmaceutical industry. It will be written in an accurate, easy to understand way and will be based on the scientific evidence and will not be biased towards pharma or medical cannabis.

  • 21 Backers

    An MCBT 2015 T-Shirt The official T-shirt for campaign supporters. An exclusive Medical Cannabis Bike Tour cotton t-shirt to show your support for the cause. Featuring the MCBT logo, this appeals to the sporting cannabist inside us all! We will contact you after the campaign to confirm sizes.

  • 8 Backers

    Medical Cannabis Clinical Evidence for prescribers, this will be a pdf pulling out the key points from the main studies for a range of conditions where there is evidence that medical cannabis may be beneficial. It will also include an analysis of the drugs available in pharma for the same conditions and how medical cannabis stacks up in terms of effectiveness for treating the condition and the side effect profile.

  • 11 Backers
    Limit of 500 — 489 remaining

    A Limited Edition 'how the drug works' poster print edition This will be a beautifully graphically designed A4 image for you to frame depicting how the drug works in an artistic interpretation. You can proudly hang it on your wall and tell your friends that it is an image inspired by research that you helped fund into how cannabis can help treat cancer.

  • 6 Backers
    Limit of 100 — 94 remaining

    A ticket to an exclusive Madrid seminar: Attend a specially convened seminar in Madrid next spring for an audience with Dr Velasco and the science team from Madrid's Complutense University who are among the world's experts on cannabionids and their use as a cancer treatment. Hear what they have to say, participate in a Q+A and enjoy drinks with team afterwards.

  • 2 Backers
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    Early Bird Limited Edition Mau Mau print: Mau Mau/ZHE specially commissioned Medical Cannabis Bike Tour street art print on canvas with hand finish.

  • 1 Backer

    An official MCBT 2015 cycle shirt: An exclusive official Medical Cannabis Bike Tour 2015 lycra cycle shirt. These shirts have been specially produced for riders participating in the tour. We can promise you will stand out on the road with this beauty!

  • 1 Backer
    Limit of 100 — 99 remaining

    Limited Edition Mau Mau image on canvas: Mau Mau/ZHE specially commissioned Medical Cannabis Bike Tour street art print on canvas with hand finish.

  • 1 Backer
    Limit of 100 — 99 remaining

    A place on the 2016 medical Cannabis Bike Tour Join the bike tour: Become part of the adventure and cycle 420km over 3 days with cyclists from all over the world.

  • Backers
    Limit of 10 — 10 remaining

    Dinner with the MCBT in Amsterdam: One night's stay in Amsterdam and dinner with the MCBT team (flight not included) hosted by founder and head of the non-profit organisation, Luc Krol + complimentary party bag (includes print/postcard + T-shirt).

  • 1 Backer
    Limit of 10 — 9 remaining

    Dinner with the Madrid Science Team: One night's accommodation and dinner with Dr Guillermo Velasco and other members of the Madrid scientists team responsible for pioneering groundbreaking research into cannabinoids' potential as a cancer treatment.

  • Backers

    Silver Sponsor: Become a silver sponsor of the 2016 bike tour. Have your logo added to the cycling gear of next year's tour.