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Meds Cannabis and Cancer

momofthegoons

Vapor Accessory Addict
Staff member
FDA Approves Cannabis For Brain Cancer Treatment

Insys Therapeutics announced that the United States Food and Drug Administration had granted orphan drug designation to its proprietary cannabidiol product for the treatment of glioma. (A glioma is a type of tumor that starts in the brain or spine.)

CEO OF INSYS, MICHAEL BABICH STATED, “WE WILL MOST LIKELY FOCUS INITIALLY ON PONTINE GLIOMA, OR PG, WHICH HAS MULTIPLE SIMILARITIES WITH GLIOBLASTOMA MULTIFORME, FOR WHICH OUR PHARMACEUTICAL CBD WAS GRANTED ODD LAST MONTH. WE BELIEVE THAT THIS PRODUCT HAS EXCELLENT POTENTIAL AS TREATMENT FOR PG, AND LOOK FORWARD TO ADVANCING ITS DEVELOPMENT AND OFFERING A POTENTIAL EFFICACIOUS TREATMENT FOR PATIENTS.”

To be granted orphan drug designation, the pharmaceutical must generally be intended to treat a disease that affects less than 200,000 people, although there are exceptions. Companies can apply for ODD through an FDA application. Part of this application includes a discussion of the scientific rationale for why the drug could benefit the intended disease. Acceptable evidence includes in vitro studies, preclinical animal testing, and any relevant human experience. If the rationale is not strong enough, then the FDA would reasonably deny the application.

Orphan Drug Designation for CBD
The fact that the FDA has granted ODD to a CBD product for treating glioma is remarkably important. It means the United States government believes the scientific evidence is strong enough to justify directly treating brain cancer in humans with a cannabinoid. They would have simply denied the application if there were no tangible merits, but such approval expressly implies real therapeutic potential.

This progress is impressively significant, but there is still much to be desired.
First, cannabinoids work best when used together, so a CBD-only treatment will probably yield poorer results than a formula with CBD, THC, and the dozens of other cannabinoids. It is also likely that the CBD being used by Insys is synthetic. While organic whole-plant, full-spectrum cannabis extracts are best, the FDA approval for CBD alone is still a major step.

The scientific and anecdotal evidence supporting glioma treatment with cannabis is quite strong. Dr. Manuel Guzman from Spain is well known for his study showing how THC induces programmed cell death in glioma cells. CBDhas also been shown to kill multiple types of glioma cell lines, in addition to inhibiting migration, proliferation, growth, invasion, and angiogenesis. With such powerful properties, it’s no surprise that anecdotal evidence is supportive.

Sophie Ryan, an optic pathway glioma patient, has been featured in the journal O’Shaughnessy’s, with documentation supporting amazing anticancer effects of cannabinoids (THC & CBD) against her tumor. While she was also on chemotherapy, the traditional treatment was only expected to stabilize the tumor, not shrink it. Another observational study in the same journal documents an optic pathway glioma reducing more than 95% in 16 months; in this case, cannabis oil was the sole treatment. (Editors note: Sophie is only 2 years old. Yes, a two year old cannabis patient.)



For years, many other people have reported amazing success against brain cancers with cannabis oil. It is undeniable that this is working, at least in some cases. Given this reality, cannabis extracts should be made available to any brain cancer patient who desires it, and clinical testing should begin immediately to optimize cannabis treatment.

UPDATE: It is important to note that Insys is also evaluating the potential use of pharmaceutical CBD in several additional indications, including: adult epilepsy; chemotherapy-induced peripheral neuropathy; and addiction in cocaine, amphetamines and opioids.
 

momofthegoons

Vapor Accessory Addict
Staff member
World’s First Trial to Treat Brain Cancer with Medical Cannabis is About to Start

Researchers are still recruiting volunteers for the world-first study on cannabis and glioblastoma, an aggressive type of brain tumor.

A pair of Australian researchers are getting ready to conduct the world’s first clinical trial to determine if medical cannabis can slow the growth of glioblastoma, a highly aggressive type of brain tumor. There are about 1,000 people diagnosed with glioblastoma each year in Australia alone, with fewer than 5 percent surviving past five years. Horrifically, survival in most cases is less than a year, with some patients passing away in as quickly as six months. But the possibility of medical cannabis treatments are bringing people with the severe brain tumors hope.

Researchers have conducted several animal studies on cannabis and cancer. There have also been some landmark human studies on cannabis and brain tumors. But Brisbane naturopath Dr. Janet Schloss and renowned neurosurgeon Professor Charlie Teo will be the first to study the effectiveness of THC as a companion treatment to standard surgery, chemotherapy, and radiation in patients with glioblastoma.

Australian Researchers to Conduct World-First Study on Brain Cancer and Medical Cannabis
Australia legalized certain medical cannabis products in 2017, making it legal for doctors to prescribe medical cannabis treatments. But legalization also removed long-standing restrictions on scientific cannabis research. Previously, researchers were only able to conduct trials that studied the side-effects of cannabis use. Now, researchers can conduct clinical trials on the use of cannabis as a medical treatment.

Dr. Janet Schloss, a naturopath and nutritionist with The Endeavour College of Natural Health, and neurosurgeon Charlie Teo are doing just that. They want to determine whether high-potency cannabis oil can aid and assist standard cancer treatments. Their hope is that alongside chemo and radiation therapies, cannabis can help reduce tumor size. But, most importantly for patients with glioblastoma, they’re also hoping THC can help reduce tumor regrowth. Reducing tumor regrowth is essential to increasing survival rates, lifespan and quality of life for people with brain cancer.


Dr. Schloss, speaking with 4BC, cited two key precedents for her and Prof. Teo’s upcoming trial. In Spain, researchers found medicinal cannabis injections reduced tumor size and expanded patient lifespan. Another, smaller study by GM Pharmaceuticals demonstrated “proof of concept” with medical cannabis treatments that reduced tumor size and regrowth.

Researchers Still Need Volunteers for Clinical Trial
Dr. Schloss and Prof. Teo are running their clinical trial at the Endeavour College of Natural Health. The study will involve a randomized trial. Every participant will get medical cannabis treatments alongside their standard cancer treatments. Schloss and Teo want to determine to what extent medical cannabis can aid and assist those standard treatments.

Schloss says participants will consume small doses of cannabis oil at night before bed. The 2 mL dose should not contain so much THC that patients have trouble sleeping or wake up groggy the next day. BioCeuticals will the supply the researchers with a cannabis oil it has manufactured specifically for this glioblastoma study.


Recruitment for the clinical trial will begin in two weeks. Those interested or who know someone interested in participating in the historic clinical trial can email trials@endeavour.edu.au or call (07) 3253 9582.
 

momofthegoons

Vapor Accessory Addict
Staff member
Proof That Cannabis Needs to Be Part of Your Treatment Protocol for Breast Cancer

These studies tell us that cannabis is effective in reducing tumor growth, size, and metastasis for breast cancer.

Breast cancer is the most common, and is now the second leading cause of cancer death in American women (lung cancer is number one). Metastasis is the big killer, responsible for approximately 90% of breast cancer-related deaths. This disease requires treatment using additional alternative therapies that have increased efficacy and low toxicity.


Image Credit: Guschen Kova

Studies suggest that regulation issues within the endocannabinoid system may trigger cancer by fostering the body conditions that allow mutated cells to proliferate and migrate. Cannabinoid receptors CB1 (central) and CB2 (peripheral) have been shown to be over-expressed in tumor cells (compared with normal cells) for various types of cancers, especially breast and liver cancers.


Image Credit: Sutterstock

Synthetic Cannabinoids and Breast Cancer
Given that breast cancer tumors have more CB2 receptors than healthy tissue does, a team of researchers set out to find out if cannabinioids could be used to stop the tumor growth. The study used a synthetic CB2 agonist (a chemical that binds to the receptor and activates it). THC, found in the cannabis plant, is natural agonist of the CB2 (and CB1) receptors.

Mice treated with the synthetic CB2 agonist saw 40-50% reduction in tumor growth and 65-80% reduction in metastasis. Additionally, when the cancerous mice were also treated with a CB2 antagonist (a chemical that prevents receptor activation), these benefits were reversed. This tells us that endocannabinoid receptors are involved in modulation of tumor growth and metastasis.



Image Credit: CAPJAH

Patients (91%) with the HER-2 mutation (ErbB2-positive tumors) over express CB2 receptor. HER-2 is a very aggressive form of breast cancer, compared to other forms. Fortunately, both THC (phytocannabinoid) and the synthetic CB2 agonist reduced tumor growth, tumor number, and the amount/severity of metastases in animal models for HER-2.

Cannabinoids also have a modulatory effect on triple negative breast cancer cells (cancer cells that lack HER-2/ErbB2, estrogen and/or progesterone receptors).

Interestingly, COX-2 is an inflammatory enzyme that is expressed in 40% of human cases for invasive breast cancer. This enzyme promotes metastasis. Studies have shown that a cannabinoid called cannabidiolic acid (CBDa) is a selective COX-2 inhibitor. This means that CBDa is able to inhibit COX-2 by down-regulating and also through the suppression of genes that are positively involved in the metastasis of cancer cells.


Image Credit: Shutterstock

Cannabinoids exert their anti-cancer effects by binding to CB1 and CB2 receptors. Since these anti-tumorigenic effects are dependent on the cell line or tumor type, the endocannabinoid system provides a targeted treatment of cancer by demonstrating selective action on tumor cells while not affecting normal cells.

Stathmin and Tau Protein Regulation
Microtubule Associated Proteins (MAPs) stathmin and tau are the key proteins in cancer metastasis. Both interact with microtubules (responsible for forming cytoplasm, the living matter of all cells) to regulate their function.


Image Credit: ESB Professionals

Stathmin, a phosphoprotein, can be used to measure and predict the aggressiveness in many cancers, including endometrial and breast. High stathmin levels in a primary tumor is an identifier of high risk for recurrent disease in patients and also predicts a poor overall survival rate, along with a less robust response to chemotherapy. When stathmin and tau expression levels were measured in breast cancer cells, the analysis showed that the ratio of high tau: stathmin is prognostic for improved survival in breast cancer patients.


Image Credit: Danaan

A Cannabis sativa extract effectively reduces tau and stathmin gene expression in cancer cells, and it significantly decreases the migration of cancers cell lines. Growing evidence indicates that tau can provide a selective advantage during metastasis in cancer patients. Since this protein contributes to the metastatic efficiency of breast tumor cells, anti-tau drugs may potentially inhibit tumor metastasis.

This indicates that cannabis-based medicines are effective adjunctive treatment in cancer patients.
 

deep_meditation

Well-Known Member
Good appt with one member of my neurooncology team.

She attend a medical marijuana conference in Colorado either this year or last! I think that’s awesome. The conference was for medical professionals.

And, even better, I’ll have one of my last scans this year. I’ve finally reached a milestone.
 

Shredder

Dogs like me
Good appt with one member of my neurooncology team.

She attend a medical marijuana conference in Colorado either this year or last! I think that’s awesome. The conference was for medical professionals.

And, even better, I’ll have one of my last scans this year. I’ve finally reached a milestone.
Great news! Sounds like you have a very component team, and that's huge.
 

momofthegoons

Vapor Accessory Addict
Staff member
THC VERSUS BREAST CANCER
Comparing the antitumoral activity of single-molecule tetrahydrocannabinol and whole plant cannabis oil

BY ALEX ANDIA ON MARCH 18, 2019

This CA 15-3 test is used to monitor certain types of cancer, like breast cancer.

It’s no secret that many cancer patients are using cannabis to help manage pain, fatigue, nausea, and other side effects of chemotherapy. Less well known is the fact that extensive preclinical research shows that plant cannabinoids – most notably, tetrahydrocannabinol (THC) and cannabidiol (CBD) - produce antitumor responses in various animal models of cancer.

The vast majority of this preclinical research has examined the anticancer activity of pure compounds, mainly THC isolates. But medical cannabis patients aren’t using pure, single-molecule THC to battle cancer. Instead, they are consuming whole plant cannabis oil extracts that include hundreds of compounds, many of which also have therapeutic properties. These artisanal cannabis oil preparations are available in licensed dispensaries in states where medical cannabis is legal and elsewhere via the unregulated black market.

Thus far, however, few rigorous studies have analyzed the effects of whole plant cannabis extracts. So a team of Spanish researchers, led by Cristina Sanchez at Complutense University in Madrid, decided to compare the efficacy of pure THC isolates and THC-rich oil extracts in a series of preclinical experiments that focused on breast cancer. (The oil extracts were provided by Aunt Zelda’s, a California-based medical cannabis producer.) The researchers also investigated the effects of pure THC and an artisanal THC-rich oil formulation when each was combined with standard chemotherapy drugs.

Their findings were reported in a 2018 article - “Appraising the ‘Entourage Effect’: Antitumor action of a pure cannabinoid versus a botanical drug preparation in preclinical models of breast cancer” - which was published in the journal Biochemical Pharmacology. The phrase “entourage effect” in this context refers to the full-spectrum synergistic interplay between numerous cannabis compounds - cannabinoids, terpenes and flavonoids - that impart a therapeutic impact that’s greater than the sum of the plant’s individual components.

Spoiler alert: Both THC and the artisanal THC-rich oil were shown to have antitumoral properties, but the oil worked better than the THC isolate for three different breast cancer subtypes.

TRICKY TO TREAT
It is estimated that one in eight women will develop breast cancer. Breast cancer is tricky to treat because there are few biomarkers that signal when someone has the disease, and many patients show or develop resistance to current therapies. Moreover, several specific types of breast cancer respond poorly to modern treatment. These difficulties underscore the importance of exploring new treatments for breast cancer.

Two biomarkers frequently used to diagnose breast cancer are hormonal receptors (the estrogen receptor and progesterone receptor) and the HER2 oncogene (a gene which can transform a normal cell into a tumor cell). But a more aggressive malignancy, known as “triple-negative breast cancer,” doesn’t express hormonal receptors or the HER2 oncogene. No targeted therapy exists for triple-negative breast cancer, so patients are treated with harsh chemotherapies that indiscriminately kill proliferating cells, whether cancerous or not.

These three types of cancer - hormone-sensitive, HER2, and triple-negative - were used as models for “Appraising the entourage effect.”

In all models of breast cancer studied, in vitro as well as in vivo, the whole plant extract was significantly more effective at producing anticancer effects than single-molecule THC. These results were largely consistent for type of cancer and type of model. Researchers tested the compounds in cell cultures (petri dishes) and in rodent models (mice).

THC & HORMONE-SENSITIVE BREAST CANCER
In the case of hormone-sensitive breast cancer cells, whole plant extract was found to be 15-25% more potent than THC alone. In live-animal models single molecule THC exhibited no significant antitumor response, unlike the whole plant extract, which had a pronounced antitumor effect. Testing on lab animals is a necessary step towards establishing the efficacy of a specific clinical treatment.

When the cannabinoid preparations were added to tamoxifen, a standard chemotherapy drug, in a cell plate, the combined therapy was about 20-25% more effective than chemotherapy alone. But these results were not replicated in live-animal trials. Importantly, the cannabinoids also did not negatively impact the efficacy of the chemotherapy. This suggests that at the very least using cannabis as an add-on treatment to deal with common side effects of chemotherapy, like nausea and appetite loss, won’t impede chemotherapy’s ability to destroy cancer cells.

In hormone-sensitive breast cancer, it appears that THC produces effects via interaction with the CB2cannabinoid receptor. CB2 receptor activation has received significant attention because of its potential to treat diseases while avoiding the “high” mediated by the CB1 cannabinoid receptor, which THC also activates. When THC binds to CB1, it causes the swimmy-headed feelings of intoxication associated with cannabis consumption.

THC & HER2-POSITIVE BREAST CANCER
Whole plant extract was found to be significantly more potent than THC for HER2-positive breast cancer cells. Both single-molecule THC and whole plant extract showed antitumor effects when the experiment was replicated in mice. Additionally, both THC and the whole plant extract amplified the anticancer effects of lapatinib, the standard chemotherapy drug for HER2 breast cancer.

As with hormone-sensitive breast cancer, THC’s antitumoral effect in HER2-positive breast cancer experiments was shown to be mediated by the CB2 cannabinoid receptor. Published in the Proceedings of the National Academy of Science, a subsequent report by Cristina Sanchez and other Spanish scientists noted that HER2 and CB2 receptors are often found in the same exact place on cells.

CB2 actually conjoins with HER2 - forming what is called a dimer - and this dimerization is associated with poor treatment outcome for breast cancer. The PNAS report shed new light on THC’s anticancer mechanism of action: When THC binds to the CB2 receptor, it breaks up the CB2-HER2 dimer, triggering a chain reaction of signals that culminates in tumor regression.

THC & TRIPLE-NEGATIVE BREAST CANCER
Triple-negative, the breast cancer subtype with the worst prognosis, does not generally respond well to chemotherapy. But the Spanish group found that THC and THC-rich cannabis oil both offer some hope in improving treatment outcomes for this highly aggressive cancer. Again, the whole plant extract was found to be more effective than THC alone in decreasing the viability of cancer cells in vitro as well as in mouse model studies.

There are several other examples where a combination of plant cannabinoids and standard chemotherapy agents have produced a heightened antitumoral response that exceeded the potency of either therapy alone. A phase 2 clinical trial tested the strength of Sativex, an equal THC and CBD mixture, combined with temozolomide, the “gold-standard” chemo for brain cancer, and the results were positive.

Cancer patients are often treated with several single-compound drugs in an effort to create a treatment that can hit multiple targets. “Although current medicine is mostly based on the use of pure compounds that have single targets,” the Spanish scientists write, “it is increasingly obvious that for diseases as complex as cancer, multi-target approaches could conceivably be more effective.”

The results of the Spanish study, along with compelling data from other researchers, suggest a promising future for whole plant cannabis oil extracts and multitarget cancer therapies. But the Western medical system and its typical drug development procedures are not conducive to the approval of complex botanical preparations as multitarget medicaments - in part because elucidating a precise mechanism of action when numerous compounds are involved is much more difficult than studying a single-molecule pharmaceutical that’s geared toward a single, primary outcome.

THE TAKEAWAY
The fact that both the THC isolate and the whole plant cannabis extract were shown to be effective at reducing tumor viability is truly groundbreaking and should be an impetus for advancing the development of nontoxic, cannabinoid-based treatments for breast cancer.

Cannabinoid therapies are particularly promising for tumor-producing cancers given that “no overtly cannabis-resistant tumors have been described so far,” according to the Spanish researchers. “Considering how different cancer subtypes are, and the fact that the viability of non-transformed cells is not affected by cannabinoids at the concentrations they kill tumor cells, it is tempting to speculate that these compounds tackle essential, as yet unidentified, cellular functions that all cancer cells share, and that are absent in their non-cancerous counterparts.”

The Spanish breast cancer study underscores the importance of the entourage effect by demonstrating that full spectrum artisanal cannabis oil extract with numerous components is more effective than pure THC.* “[A]lthough the pharmacology of cannabis drug preparation extracts is obviously more complex to study,” the researchers acknowledge, “this therapeutic approach has the potential to produce better therapeutic responses than pure cannabinoids.”

The Spanish scientists emphasize that the whole plant cannabis drug preparation “did not, in any case, diminish the antitumor efficacy of any of the standard treatments.” That’s good news for cancer patients who use cannabis to manage the adverse side effects of chemo. Cannabis is very likely a safe add-on therapy for treating pain and nausea and for appetite stimulation. And it may also increase the efficacy of standard chemotherapy treatments, which means that chemo could be more effective - requiring lower and less toxic doses - when used in combination with cannabis.

Alex Andia, who holds his PhD in Chemistry, teaches Organic Chemistry at the City University of New York - City College. He is also the brains behind Chemical Makeup, a non-profit dedicated to promoting the queer voice in science.

Copyright, Project CBD. May not be reprinted without permission.

FOOTNOTE
*An interesting finding from the Spanish breast canceer study pertains to the not fully understood role of terpenes, the aromatic compounds that give cannabis its distinctive smell. The scientists created a “terpene cocktail” composed of the 5 most prominent terpenes in the full-spectrum cannabis oil extract: beta-caryophyllene, alpha-humulene, nerolidol, linalool, and beta-pinene. When added to the THC isolate, however, this terpene cocktail failed to increase the antitumoral efficacy of the single-molecule cannabinoid. This could mean that mixing a few terpenes with pure THC does not adequately recreate the qualities of a full-spectrum cannabis oil extract. Or it could be that other compounds in the oil extract are responsible for enhancing THC’s anticancer impact. The authors note that the whole plant cannabis oil extract used in the study also contained measurable amounts of cannabigerol (CBG) and tetrahydrocannabinolic acid (THCA - the ‘raw’ form of THC that won’t get you high). CBG has demonstrated effectiveness against colon cancer in preclinical models, and THCA is known to interact with a PPAR (nuclear) receptor that mediates apoptosis (cell death) in cancer cell lines. A combination of all these compounds may be required to achieve the antitumoral response observed in the Spanish breast cancer study.

REFERENCES
  • Blasco-Benito S, Moreno E, Seijo-Vila M, Tundidor I, Andradas C, Caffarel MM, Caro-Villalobos M, Uriguen L, Diez-Alarcia R, Moreno-Bueno G, Hernandez L, Manso L, Homar-Ruano P, McCormick PJ, Bibic L, Bernado-Morales C, Arribas J, Canals M, Casado V, Canela EI, Guzman M, Perez-Gomez E, Sanchez C. Therapeutic targeting of HER2-CB2R heteromers in HER2-positive breast cancer. Proc Natl Acad Sci U S A. 2019 Feb 26;116(9):3863-3872. doi: 10.1073/pnas.1815034116.
  • Blasco-Benito, S.; Seijo-Vila, M.; Caro-Villalobos, M.; Tundidor, I.; Andradas, C.; Garcia-Taboada, E.; Wade, J.; Smith, S.; Guzman, M.; Perez-Gomez, E.; Gordon, M.; Sanchez, C. Appraising the “Entourage Effect”: Antitumor Action of a Pure Cannabinoid versus a Botanical Drug Preparation in Preclinical Models of Breast Cancer. Biochem. Pharma. 2018, 157, 285.
  • Bray, F.; Ferlay, J.; Soerjomataram, I.; Siegel, R. L.; Torre, L. A.; Jemal, A. Cancer Statistics, 2018. Ca-Cancer J. Clin. 2018, 68, 394.
  • Caffarel, M. M.; Andradas, E.; Perez-Gomez, M.; Guzman, M.; Sanchez, C. Cannabinoids: a New Hope for Breast Cancer Therapy? Cancer Treat. Rev. 2012, 38, 911.
  • Campos, A. C.; Fogaca, M. V.; Sacarante, F. F.; Joca, S. R. L.; Sales, A. J.; Gomes, F. V.; Sonego, A. B.; Rodrigues, N. S.; Galve-Roperh, I.; Guimaraes, F. S. Plastic and Neuroprotective Mechanisms Involved in the Therapeutic Effects of Cannabidiol in Psychiatric Disorders. Front. Pharmacol. 2017, 8, 269.
  • ElSohly, M.; Waseem, G. Handbook of Cannabis, Oxford University Press, Oxford, United Kingdom, 2014, pp. 3.
  • Harbeck, N.; Gnant, M. Breast Cancer, Lancet, 2017, 389, 1134.14
  • Ligresti, A.; De Petrocellis, L.; Di Marzo, V. From Phytocannabinoids to Cannabinoid Receptors and Endocannabinoids: Pleiotropic Physiological and Pathological Roles Through Complex Pharmacology. Physiol. Rev. 2016, 96, 1593.
  • Ligresti, A.; Moriello, A. S. K.; Starowicz, I.; Matias, S. P.; De Petrocellis, L.; Laezza, C.; Portella, G.; Bifulco, M.; Di Marzo, V. Antitumor Activity of Plant Cannabinoids with Emphasis of the Effect of Cannabidiol on Human Breast Carcinoma. J. Pharmacol. Exp. Ther. 2006, 318, 1375.
  • McPartland, J. M.; Russo, E. B. Handbook of Cannabis, Oxford University Press, Oxford, United Kingdom, 2014, pp. 280.
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  • Russo, E. B. Beyond Cannabis: Plants and the Endocannabinoid System. Trends in Pharmcol. Sci. 2016, 37, 594.
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Revision date:
Mar 18, 2019
 

deep_meditation

Well-Known Member
That is fabulous news deep_meditation. Time for you to celebrate life and do something special for yourself. :smile: Got anything on that bucket list that you want to do?

Thanks so much! I appreciate the kind words.

This year will be really busy. I’ll probably try to take a short trip this summer. I’m debating between Montreal, San Francisco (Barbary Coast) is on the list, or possibly Vancouver Canada.. Just a long weekend or something like that.

Next year I hope to be able to go overseas somewhere.
 

momofthegoons

Vapor Accessory Addict
Staff member
FDA Approves Cannabis For Brain Cancer Treatment


Insys Therapeutics announced that the United States Food and Drug Administration had granted orphan drug designation to its proprietary cannabidiol product for the treatment of glioma. (A glioma is a type of tumor that starts in the brain or spine.)

To be granted orphan drug designation, the pharmaceutical must generally be intended to treat a disease that affects less than 200,000 people, although there are exceptions. Companies can apply for ODD through an FDA application. Part of this application includes a discussion of the scientific rationale for why the drug could benefit the intended disease. Acceptable evidence includes in vitro studies, preclinical animal testing, and any relevant human experience. If the rationale is not strong enough, then the FDA would reasonably deny the application.

Orphan Drug Designation for CBD
The fact that the FDA has granted ODD to a CBD product for treating glioma is remarkably important. It means the United States government believes the scientific evidence is strong enough to justify directly treating brain cancer in humans with a cannabinoid. They would have simply denied the application if there were no tangible merits, but such approval expressly implies real therapeutic potential.

This progress is impressively significant, but there is still much to be desired.
First, cannabinoids work best when used together, so a CBD-only treatment will probably yield poorer results than a formula with CBD, THC, and the dozens of other cannabinoids. It is also likely that the CBD being used by Insys is synthetic. While organic whole-plant, full-spectrum cannabis extracts are best, the FDA approval for CBD alone is still a major step.

The scientific and anecdotal evidence supporting glioma treatment with cannabis is quite strong. Dr. Manuel Guzman from Spain is well known for his study showing how THC induces programmed cell death in glioma cells. CBDhas also been shown to kill multiple types of glioma cell lines, in addition to inhibiting migration, proliferation, growth, invasion, and angiogenesis. With such powerful properties, it’s no surprise that anecdotal evidence is supportive.

Sophie Ryan, an optic pathway glioma patient, has been featured in the journal O’Shaughnessy’s, with documentation supporting amazing anticancer effects of cannabinoids (THC & CBD) against her tumor. While she was also on chemotherapy, the traditional treatment was only expected to stabilize the tumor, not shrink it. Another observational study in the same journal documents an optic pathway glioma reducing more than 95% in 16 months; in this case, cannabis oil was the sole treatment. (Editors note: Sophie is only 2 years old. Yes, a two year old cannabis patient.)



For years, many other people have reported amazing success against brain cancers with cannabis oil. It is undeniable that this is working, at least in some cases. Given this reality, cannabis extracts should be made available to any brain cancer patient who desires it, and clinical testing should begin immediately to optimize cannabis treatment.

UPDATE: It is important to note that Insys is also evaluating the potential use of pharmaceutical CBD in several additional indications, including: adult epilepsy; chemotherapy-induced peripheral neuropathy; and addiction in cocaine, amphetamines and opioids.
 

momofthegoons

Vapor Accessory Addict
Staff member
Chemo Kills Healthy Cells But THC Kills Cancer Cells Only

THC kills cancer cells by causing mitochondria to stop making energy.
There is a lot of new and old research surrounding cannabis and cancer treatment. And, perhaps just as significant, the medical community is now willing to listen to cancer patients describe how well cannabis treats their symptoms. There may be additional benefit to using cannabis during cancer treatment because THC kills cancer cells. Studies in the lab and animal models show THC to be an effective assassin.

More and more studies back up these patient anecdotal reports to demonstrate that CBD and THC (among other cannabinoids, terpenes, and flavonoids yet to be fully discovered) are critical in the fight against cancer. THC helps the immune system find cancer cells and encourages apoptosis, while CBD helps slow or even prevent metastasis.

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Research Has Known THC Kills Cancer Cells For 40 Years
With funding and cannabis scheduling the way it is, cancer and cannabis research hasn’t been as prolific in North America as it has been overseas. But this is beginning to change.


Following the release of preliminary data, like the Virginia Study, published in 1975, the American government shut down funding into cannabis-cancer research for twenty years. It wasn’t until the 1990s that the US National Toxicology Program rediscovered the positive impact of cannabis on cancer.

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Unfortunately, funding opportunities for cannabis research remain limited. There are many suggested reasons for this, but most cannabis advocates believe that Big Pharma financial incentives to key figures in the government influence funding and research for medicine. Permission is still required for all cannabis research, and as political commentators like John Oliver explain, that can take years. Once permission is gained, it can still take another several years for the study to be complete.

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THC Kills Cancer Cells Via Ceramide Pathways
How?

Well, this goes back to the endocannabinoid system, and the CB1/CB2 receptors. These cannabinoid receptors are triggered by phytocannabinoids found in cannabis. There is a theory being tossed about research circles that disease comes from a deficiency in endocannabinoids. If this is the case, it makes sense that cannabis is able to treat a wide variety of conditions.

CB1 receptors are concentrated in the nervous system, including the brain; CB2 receptors are found throughout the body organs and as part of the immune system.

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When THC binds to the CB1 or CB2 receptors (on a cancer cell) it causes the increased production of ceramide, a type of lipid commonly found in skin care products. It is the ceramide that drives cell death. A healthy cell will not increase ceramide in response to THC, but a diseased cell will.

Watch this time-lapse video of THC killing cancer cells but leaving healthy cells alone. This 30 seconds has been condensed from 20 hours.


As ceramide increases, it makes the mitochondria more permeable to cyctochrome (an important protein in energy production). Cytochrome leaves the mitochondria and the cell can no longer make energy = death.

We are only at the very beginning of understanding how these mechanisms work; how cannabis works to kill cancer. What we do know, at this time, is that cannabis is a ruthless killer of cancer cells, but always leaves healthy cells alone.
 

momofthegoons

Vapor Accessory Addict
Staff member
Medical cannabinoids and brain tumours – Interview with Dr Wai Liu

Dr Wai Liu is a Senior Research Fellow at St George’s, University of London, who has been investigating medical cannabinoids and their potential anticancer properties.

Dr Liu led a small research group at St Bartholomew’s Hospital investigating the anticancer properties in 2001. Anecdotal evidence presented to him suggested that cannabis could improve the responses to some therapies in patients with cancer. This led to more research studying the anticancer effects of cannabidiol (better known as CBD) in a variety of cancer types used both alone and in combination with other treatment modalities.

According to the research at St George’s, cannabinoids – the active chemicals in cannabis – have been confirmed to contain anticancer properties and are the most beneficial when combined with chemotherapy drugs.

I caught up with Dr Liu at event on medical cannabinoids and brain tumours in London, organised by our Member Charity brainstrust, and asked him a few questions so we could bring some more useful information to our community on this topical subject.

Does the research point towards CBD needing THC (tetrahydrocannabinol – the psychoactive constituent of cannabis) element in order to be effective for brain tumours?

Dr Liu: This is not so clear. There is no doubt that in the lab, THC has anticancer action. In a similar way, CBD has too. Using the two together seems to result in good activity, but the level of action is not necessarily synergistic, thus I suspect the two compounds do not actually require each other to work effectively.

You suggested in your research that it will never be the case of CBD alone - brain tumour trials need to allow for multiple agents in combination (such as chemotherapy drugs) ... which is so hard to design in terms of a trial. Is that correct?

Dr Liu: Depending on the questions asked, combination trials can be relatively straightforward. For example, if you test only two drugs – the arms of the trials may be something like Drug A without CBD and Drug A with CBD.


What clinical trials are currently taking place, any plans linked to brain tumours?


Dr Liu: Very few – an up-to-date list will be on the Clinical Trials website.

Are clinicians prescribing CBD as part of the treatment for brain tumours? What are the barriers for brain tumour patients accessing CBD?

Dr Liu: Some clinicians are prescribing CBD, but this would not be on the NHS and so would be quite expensive. Apart from this way, it can be difficult to get official CBD from doctors.

The fundamental barrier for patients is the lack of full clinical trials confirming activity in patients. Without this ‘badge’, clinicians will rarely prescribe something that has no official clinical value. Once the trials in the UK are completed, depending upon results, access will almost certainly improve.

We know that some clinicians are advocating for medical cannabinoids to be prescribed as a standard for brain tumour patients to treat headaches and seizures, as well any cancer-related side effects – are there plans to expand guidelines so patients can readily access medical cannabinoids?

Dr Liu: Not sure; but it seems sensible that a drug that can help should be made available to patients that could benefit from using it. I understand there has to be legislation to ensure safety, but time is of the essence!

We thank Dr Liu for his time and answering my questions.

The research priorities at our Centres of Excellence are based on finding ways to innovate new curative treatments for brain tumours which will likely have the best outcomes for patients.

We are not currently funding any research into cannabinoids but recognise that the use of these for the management of brain tumours is an important topic and we will continue to closely monitor the ongoing developments in this area, including contributing to governmental Inquiries and consultations where possible.

 

deep_meditation

Well-Known Member
Going in for an annual scan on Tuesday. Thankfully no more three or six month scans. I’ll see two oncologists this week one surgical and one medical/hematologist. Not looking forward to these appointments this time around (not that I ever am) as I’m basically symptomatic. In my case that means pain or exhaustion or both. Could just be a temporary thing. Hoping that’s the case.
 

felvapes

Well-Known Member
Going in for an annual scan on Tuesday. Thankfully no more three or six month scans. I’ll see two oncologists this week one surgical and one medical/hematologist. Not looking forward to these appointments this time around (not that I ever am) as I’m basically symptomatic. In my case that means pain or exhaustion or both. Could just be a temporary thing. Hoping that’s the case.
I hope you grt some good news and some sort of relief this week
My friend has just been going through a heap of scans and a recent treatment again too
Thoughts with you
 

deep_meditation

Well-Known Member
I hope you grt some good news and some sort of relief this week
My friend has just been going through a heap of scans and a recent treatment again too
Thoughts with you
Thanks! I’m hanging in there. I have so much going on now that I’m a bit more wound up than usual. Life is moving ahead in a good way and I don’t need another setback. Hope your friend is doing well.
 

Shredder

Dogs like me
Going in for an annual scan on Tuesday. Thankfully no more three or six month scans. I’ll see two oncologists this week one surgical and one medical/hematologist. Not looking forward to these appointments this time around (not that I ever am) as I’m basically symptomatic. In my case that means pain or exhaustion or both. Could just be a temporary thing. Hoping that’s the case.
Good luck Tuesday!
 

momofthegoons

Vapor Accessory Addict
Staff member
With a history of illness it's hard to not think the worst when going in for a check up. I've personally felt that I was symptomatic prior to one so I can sympathize. In my case, everything was fine and as soon as I heard that diagnosis (in most cases) I felt better. I wish the same for you @deep_meditation . Please let us know how it goes.
 

deep_meditation

Well-Known Member
With a history of illness it's hard to not think the worst when going in for a check up. I've personally felt that I was symptomatic prior to one so I can sympathize. In my case, everything was fine and as soon as I heard that diagnosis (in most cases) I felt better. I wish the same for you @deep_meditation . Please let us know how it goes.

Thanks, I appreciate the kind words. :)
 

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