Study: CBD-Dominant Cannabis Oil Safe And Effective In Autistic Patients

ISRAEL: The administration of plant-derived cannabis extracts is effective and well-tolerated in patients diagnosed with autism spectrum disorders (ASD), according to data published in the journal Scientific Reports.

Israeli investigators assessed the safety and efficacy of the daily administration of CBD-enriched cannabis oil (consisting of 30 percent CBD and 1.5 percent THC) in a cohort of 188 patients with ASD. Of those patients who continued treatment for six months and provided feedback to researchers, over 90 percent reported some level of symptomatic improvement — including reductions in restlessness, seizures, and rage attacks. Approximately one-third of respondents reported a reduction in their intake of other medications.

Authors concluded: “Cannabis as a treatment for autism spectrum disorders patients appears to be well-tolerated, safe and seemingly effective option to relieve symptoms, mainly: seizures, tics, depression, restlessness and rage attacks. … [W]e believe that double blind placebo-controlled trials are crucial for a better understanding of the cannabis effect on ASD patients.”

The results are consistent with those of a prior Israeli study which concluded that the daily administration of CBD-dominant extracts was associated with “overall improvement in behavior, anxiety, and communication” in autism patients.


For more information, contact Paul Armentano, NORML Deputy Director, at: paul@norml.org. Full text of the study, “Real life experience of medical cannabis treatment in autism: Analysis of safety and efficacy,” appears in Scientific Reports.

 

New Study: Children With Autism See Improvement After Treatment With Tikun Olam High-CBD, Low-THC Medical Cannabis

NEW YORK: Children with Autism Spectrum Disorder (ASD) see a “significant” improvement in symptoms and less reliance on other medications after treatment with Tikun Olam’s Avidekel™ medical cannabis, as confirmed by a new study published in Scientific Reports.

The two-year study, “Real Life Experience Of Medical Cannabis Treatment In Autism: Analysis Of Safety And Efficacy,” followed 188 children (average age: 13) diagnosed with ASD. The patients were treated with Tikun Olam’s high-CBD, low-THC medical cannabis strains, which have been specifically cultivated and shown to provide symptom relief for ASD and related conditions with minimal psychoactive effect.

At the study’s outset, the most common patient symptoms were restlessness (90.4%), rage attacks (79.8%), and agitation (78.7%). After six months of daily cannabis treatment at Tikun Olam clinics in Israel, 80.1% of patients reported improvement of their symptoms, with 30.1% reporting “significant” improvement. Other key findings include:

  • Of 27 patients who had epilepsy, 24 reported improved or disappearance of symptoms;
  • 34% of patients decreased other medications; and
  • 20% of patients stopped using antipsychotic medication.

“Autism is a leading condition of concern worldwide, so this study couldn’t have come at a better time,” says Dr. Annabelle Manalo, PhD, Tikun Olam’s Science Director. “The data shows that autism patients can improve their overall quality of life utilizing a high CBD strain, and most importantly, that young users can safely and effectively benefit from medical cannabis.”

“With this study, cannabis is shown to be an effective choice for parents looking for the safest and most neuroprotective treatment.”

Side effects to cannabis treatment were minimal, with the most common at six months reported as restlessness (6.6%), sleepiness (3.2%), psychoactive effect (3.2%).

FSD Pharma Announces Launch of IBS Clinical Study

CANADA: FSD Pharma has announced the launch of a pilot clinical study in Pittsburgh, Pennsylvania, by its strategic R&D partner, SciCann Therapeutics. The study is designed to test the safety and efficacy of SciCann’s proprietary “Steady Stomach” cannabidiol (CBD) combination product for the treatment of irritable bowel syndrome (IBS) patients. This study follows the previously reported efficacy results from a preclinical study in rodent models which demonstrated a three-fold increased efficacy in lowering abdominal inflammation levels with the advanced combination product as compared to CBD alone.

The double-blind, randomized, placebo-controlled study will enroll 20 patients in a cross-over design to comply with the highest standards of rigorous scientific validity and certification demands of international medical regulatory authorities.

Under the terms of FSD’s strategic agreement with SciCann, the Company holds exclusive manufacturing and distribution rights for the “Steady Stomach” product in Canada.

The study’s principal investigator is Dr. Bryan Doner of Compassionate Care Certifications Centers in Pittsburgh, Pennsylvania and the CRO is Affinity Bio Partners, led by CEO Dr. Christina DiArcangelo Puller.

Dr. Raza Bokhari, CEO of FSD Pharma, stated, “This innovative clinical study aims to demonstrate the safety and efficacy of this easy-to-administer, side-effect-free therapy for a very common disease. Although rarely spoken about, IBS causes suffering to many patients around the world by dramatically reducing quality of life. The launch of this study marks another important milestone for FSD on its way to becoming a leading supplier of superior and differentiated medical, cannabis-based therapies for patients. Together with our partner SciCann, FSD is working tirelessly towards the development of novel and disruptive cannabinoid-based therapies for the world’s most under-treated diseases and irritable bowel syndrome is high on our list of target indications.”

Dr. Zohar Koren, co-founder and CEO of SciCann Therapeutics, stated, “The prevalence of irritable bowel syndrome is estimated at 10-15 percent of the global population. This is an under-diagnosed, hard-to-treat condition that causes an estimated cost to society of over US$21 billion annually in direct medical expenses and indirect costs associated with loss of productivity1. Based on our research, we believe that our proprietary “Steady Stomach” CBD combination product can serve as a new treatment standard to improve the lives of patients. We are looking forward to reporting on the results of this clinical study. ”

Tilray Gets DEA OK To Import Medical Cannabis Study Drug For Clinical Trial At University Of California San Diego Center For Medicinal Cannabis Research

CANADA: Tilray has announced that the U.S. Drug Enforcement Administration (DEA) has granted approval to import a cannabinoid study drug into the United States from Canada for a clinical trial at the University of California San Diego (UC San Diego) Center for Medicinal Cannabis Research (CMCR) examining its safety, tolerability and efficacy for Essential Tremor (ET).

Agreement represents major milestone recognizing medical cannabis as a conventional medicine for patients in need

Tilray is providing a cannabinoid formulation for the trial in capsule form, which will allow researchers to test an investigational drug product containing two active ingredients extracted from the cannabis plant, cannabidiol (CBD) and tetrahydrocannabinol (THC). Dr. Fatta Nahab, a board-certified neurologist and director of the Functional Imaging of Neurodegenerative Disorders Lab at the UC San Diego Health’s Movement Disorder Center, will serve as the principal investigator for the study. It is expected to begin in early 2019 with financial support from Tilray and the International Essential Tremor Foundation.

“Tilray is proud to support this crucial research,” says Dr. Catherine Jacobson, Director of Clinical Research at Tilray. “If this study can identify cannabinoids as a potential treatment for patients suffering from essential tremor, we can conduct further research and potentially provide alternative effective methods of relief for the high numbers of patients with ET.”

Essential Tremor is a neurological movement disorder characterized by involuntary and rhythmic shaking. ET has extremely high prevalence rates; 0.4% of the general population suffer from ET, and that figure rises to 4.6% to 6.3% among those 65 and older. Essential Tremor can have a significant impact on a patient’s quality of life, causing embarrassment, social withdrawal, disability, and loss of occupation. Many patients do not experience relief with the current drugs on the market or find the side-effects of these drugs to be unbearable.

Clinical Trial: Use Of Herbal Cannabis Safe And Effective In Cancer Patients

ISRAEL: Cannabis administration is associated with the subjective improvement of symptoms in patients with cancer, according to clinical data published in the European Journal of Internal Medicine.

Israeli researchers assessed the safety and efficacy of cannabis in a cohort of over 1,200 cancer patients over a period of six months. Ninety-six percent of patients “reported an improvement in their condition.” Symptomatic improvements included: relief from nausea and vomiting (91 percent), improved sleep (86 percent), decreased anxiety (84 percent), and pain relief (over 50 percent). Nearly half of respondents reported either decreasing or eliminating their use of opioids during the treatment period.

Authors concluded, “Cannabis as a palliative treatment for cancer patients seems to be a well-tolerated, effective, and safe option to help patients cope with the malignancy related symptoms.”

An estimated 30,000 Israeli patients are approved to use medical cannabis, which was legalized by the Ministry of Health in 2007.


For more information, contact Paul Armentano, NORML Deputy Director, at: paul@norml.org. Full text of the study, “Prospective analysis of safety and efficacy of medical cannabis in a large unselected population of patients with cancer,” appears in the European Journal of Internal Medicine.

Intec Pharma Reports Clinical Results From Phase I Trial of Accordion Pill For Cannabinoid Therapies

ISRAEL: Intec Pharma, a clinical stage biopharmaceutical company focused on developing drugs based on its proprietary Accordion Pill platform technology, announced the results from a Phase I clinical trial of AP-CBD/THC, its Accordion Pill platform with cannabidiol (CBD) and tetrahydrocannabinol (THC), the two primary cannabinoids contained in Cannabis sativa.

“We’re excited about these encouraging results from our Phase 1 study of AP-CBD/THC as it shows the Accordion Pill platform is well suited to safely deliver CBD and THC with significant improvements in exposure compared with Sativex,” said Nadav Navon, Ph.D., Chief Operating Officer of Intec Pharma. “We are particularly pleased to see the reduction in THC metabolite, which tells us that the AP-CBD/THC avoided some of the hepatic first-pass metabolism of THC.”

The Phase I trial was a single-center, single-dose, randomized, three-way crossover study to compare the pharmacokinetics, safety and tolerability of two formulations of AP-CBD/THC with Sativex in 21 normal healthy volunteers. Sativex is a commercially available oral buccal spray containing CBD and THC[1].

The study results showed that AP-CBD/THC had significant improvements in exposure of CBD (290% – 330%) and THC (25% – 50%) compared with Sativex. The median time of peak concentration was 2-3 times longer than Sativex and absorption was significantly higher. Importantly, the formation of THC metabolites were meaningfully reduced (>25%) and AP-CBD/THC was found to be safe and well tolerated with no serious adverse events reported.

“This study further affirms the value of our Accordion Pill platform as a safe and effective drug delivery platform,” said Jeffrey A. Meckler, Chief Executive Officer of Intec Pharma. “We plan to review these data in the coming weeks to determine the next steps in developing our AP-CBD/THC program and plan to announce the next steps in the clinical development of this exciting program by year end.”

The Cannabis sativa plant is used for the treatment of chronic pain and a variety of other indications. Previous clinical studies conducted using the whole plant or specific extracts generated evidence of the cannabis analgesic activity. Furthermore, extracts containing known amounts of the active plant driven compounds (mainly THC and CBD) or diverse synthetic THC derivatives are thought to be promising treatments for painful conditions that do not respond properly to currently available treatments, such as chronic, neuropathic and inflammatory pain[2],[3].

AP-CBD/THC holds the potential to address several major drawbacks of current methods of use and treatment with cannabis and cannabinoids, such as short duration of effect, delayed onset, variability of exposure, variability of the administered dose and adverse events that correlate with peak levels. AP-CBD/THC is designed to extend the absorption phase of CBD and THC, resulting in more consistent levels for an improved therapeutic effect.

The cannabis market has significant commercial potential and is projected to represent approximately 10% of the specialty pharmaceutical market over the next five years, or a market of at least $20 billion[4]. According to Global Data, in 2016 the global low back pain drug market was $6.2 billion and the global Fibromyalgia drug market was $1.8 billion.

Tilray Announces Support For Clinical Trial Examining Cannabis And Chronic Lung Disease

CANADA: Tilray, a global leader in medical cannabis research and production, today announced a partnership with the Research Institute of the McGill University Health Centre (RI-MUHC) in Montreal, one of the world’s premier public academic and research institutions, to study the effects of vaporized cannabis on symptoms associated with chronic obstructive pulmonary disease (COPD).

The Phase II trial will study the efficacy of medical cannabis on breathlessness, and exercise tolerance in symptomatic patients with advanced COPD. Patients with COPD suffer from chronic, progressive lung diseases that obstruct airflow and can cause irreversible lung damage without intervention. The pathophysiological hallmarks of COPD include expiratory flow limitation; pulmonary gas trapping and lung hyperinflation; gas exchange abnormalities; and mucus hypersecretion. These pathophysiological hallmarks are linked to breathlessness, loss of autonomy, and a diminished quality of life. Patients with COPD also often avoid exercise, leading to psychological co-morbidities, such as anxiety and depression, and a decrease in overall health.

COPD is a leading cause of morbidity, mortality, and socioeconomic burden in Canada and around the world. Estimates suggest that approximately 17% of Canadian adults over the age of 40 suffer from COPD. Symptom management is critical for COPD patients to ensure that their condition remains stable and their quality of life is maintained. Nonetheless, an estimated 45-90% of adults with advanced COPD suffer from chronic and disabling physical activity-related breathlessness, despite optimal treatment of their underlying lung disease with existing and approved pharmacotherapies (e.g., bronchodilators, corticosteroids). There is a critical need to develop more effective therapies for COPD.

The research team led by Drs. Dennis Jensen and Jean Bourbeau will conduct the trial at the McConnell Centre for Innovative Medicine of the RI-MUHC. “Adjunct therapies targeted to relieve breathlessness and improved exercise tolerance are needed to enhance health outcomes for adults with advanced COPD, and medical cannabis is a potential therapy of interest,” said Dr. Jensen. Patient recruitment for the trial, which will involve 20 participants, is already underway, and the trial is expected to conclude later this year.

“Tilray is proud to support this important research,” said Dr. Catherine Jacobson, Director of Clinical Research at Tilray. “If we find that vaporized cannabis is safe, well-tolerated, and effective, we can conduct further research to help people with COPD and other medical conditions manage their symptoms effectively.”

Tilray is committed to advancing the science and safety of medical cannabis products by supporting clinical research. The COPD trial is one of several research efforts underway. In Canada, Tilray supports additional clinical trials focused on pediatric epilepsy at SickKids Hospital and post-traumatic stress disorder at the University of British Columbia. In Australia, Tilray has partnered with the University of Sydney and New South Wales Government to study medical cannabis as a treatment for symptoms of chemotherapy-induced nausea and vomiting.

About Tilray

Tilray is a global leader in medical cannabis research and production dedicated to advancing the science, efficacy and safety of cannabinoid medicine for patients with a diverse range of conditions. The company operates one of the largest and most sophisticated federally licensed medical cannabis cultivation facilities in the world, offering a range of products to patients, pharmacies and researchers in Canada, Australia, the European Union and the Americas.

Review Identifies 140 Controlled Clinical Trials Related to Cannabis

GERMANY: Scientists have conducted over 140 controlled clinical trials since 1975 assessing the safety and efficacy of either whole-plant cannabis or specific cannabinoids, according to a literature review published in the journal Critical Reviews in Plant Sciences.

A pair of German researchers identified 140 clinical trials involving an estimated 8,000 participants. Of these, the largest body of literature focuses on the use of cannabis or cannabinoids for the treatment of chronic or neuropathic pain. Authors identified 35 controlled studies, involving 2,046 subjects, assessing the use of marijuana or cannabinoids in pain management. In January, the National Academy of Sciences acknowledged that “conclusive or substantial evidence” exists for cannabis’ efficacy in patients suffering from chronic pain.

Cannabinoids have also been well studied as anti-emetic agents and as appetite stimulants. Researchers identified 43 trials evaluating marijuana or its components for these purposes, involving a total of 2,498 patients. They identified an additional 14 trials examining the role of cannabis or cannabis-derived extracts for the treatment of multiple sclerosis.

Researchers also identified several additional trials evaluating the use of cannabis or cannabinoids for a number of other diseases, including Crohn’s disease, Tourette’s syndrome, Parkinson’s disease, glaucoma, and epilepsy.

A 2014 study published in the Journal of the American Medical Association reported that pharmaceutical drugs typically gain FDA approval on the basis of one or two pivotal clinical trials.

 

Medical Marijuana NY-Based Biotech Company Enters Clinical Trials

NEW YORK:  AXIM Biotechnologies, Inc., a world leader in cannabinoid research and development, has entered clinical trials on treating irritable bowel syndrome (IBS) with the Company’s CanChew Plus cannabidiol (CBD) gum at Wageningen University in the Netherlands.

Human Clinical Trials Detail Include:

  • Controlled-release hemp oil CBD chewing gum and matching placebo gums will be tested for the clinical studies
  • The amount of the hemp oil CBD gum is set at 50mg of CBD per serving
  • Per the trial protocol patients can use up to 6 chewing gums a day to control their stomach cramps, bloating, pain and other symptom
  • The main study outcome is perceived pain reduction. Furthermore, the study will record general relief and change in stool frequenc

The clinical trial will include a group of 40 patients, age 18-65, diagnosed with IBS according to ROME III criteria to determine the effectiveness of CanChew Plus in alleviating IBS symptoms

“The clinical trial at Wageningen University is the first of its kind to treat IBS symptoms by cannabinoid-containing chewing gum, and we look forward to sharing updates from the trial with you,” added Anastassov.

 “With positive outcome from the IBS clinical trial, we will be ready to proceed immediately with further trials on our pharmaceutical grade CanChew Rx products to treat inflammatory bowel disease (IBD); Ulcerative colitis and Crohn’s disease. We are committed to finding research-based cannabinoid

The Arthritis Society Canada Funds More Medical Cannabis Research Amid Legalization Speculation

New clinical trial will study use of oral cannabinoids for fibromyalgia pain

CANADA: The Arthritis Society has announced the winner of its latest research grant for the study of medical cannabis and arthritis. McGill University’s Dr. Mark Ware, who has garnered a worldwide reputation as a leader in pain research, will lead a trial examining the use of oral cannabinoids for fibromyalgia — a disease that inflicts chronic pain on some 520,000 Canadians, most of them women1.

The study was selected from among several proposals submitted by Canadian researchers to receive the three-year grant, following an extensive peer review process by an impartial volunteer panel of cross-disciplinary medical and scientific experts as well as arthritis health consumers.

This is the second medical cannabis research project The Arthritis Society has funded in the past 18 months: in 2015, Dr. Jason McDougall was awarded a similar three-year grant to study the impact of medical cannabis on arthritis pain and disease management.

“These investments are about leading by example,” says Arthritis Society president and CEO Janet Yale. “Patients and physicians both need to be able to make informed decisions about whether cannabis has a place in the individual’s treatment plan. With these commitments, The Arthritis Society is doing its part to help fill some of the critical knowledge gaps around medical cannabis, but we can’t do it alone. There’s no reason for the government to wait until new legislation is in place to start addressing the need for research identified by their own task force. That’s why we continue to call on the federal government to make a firm commitment in the 2017 budget to fund $25 million in medical cannabis research over the next five years.”

Impact of fibromyalgia

Fibromyalgia is a chronic disease that affects the central nervous system, delivering widespread pain throughout the body. Pain can vary in location and intensity on a daily or even hourly basis, and can come with a host of other symptoms such as fatigue, sleep difficulties, lack of concentration and memory, mood swings, gastrointestinal problems and heightened sensitivity to touch and pressure.

Many fibromyalgia patients have reported that cannabis has positive effects on pain and symptom management, but this has not yet been confirmed in large-scale clinical trials. This study will be used to help educate patients and health professionals regarding the possible risks and benefits of oral cannabis in fibromyalgia therapy.

“This disease has a tremendous impact on a person’s life,” Dr. Ware explains, “but to date we haven’t really had any good treatment options to offer. Opioids and NSAIDs for pain management are often ineffective for fibromyalgia pain, or can have serious negative side effects — especially when used for prolonged periods. We hope to identify whether oral cannabinoids can offer the person with fibromyalgia hope for relief from their symptoms, and help restore their quality of life. We are grateful for the support of The Arthritis Society for this important project.”

New regulatory framework

The announcement comes just days after the report of the federal task force on legalization and regulation of marijuana was made public. That report echoes the priorities expressed by The Arthritis Society and other patient advocacy groups about ensuring that the new regulatory regime addresses patient concerns, with a priority on access, affordability and the vital need for more research. Earlier this fall, The Arthritis Society led a joint submission to the task force by patient advocates, and followed it up by co-facilitating a meeting where task force members heard directly from patients who use medical cannabis. The government is expected to issue new legislation as early as Spring 2017.

Two thirds of people who use cannabis for medical purposes are doing so to help cope with the pain, fatigue and other symptoms of arthritis.

“In the rush to legalize cannabis for recreational use, we need to be careful that the needs of people who rely on cannabis for medical purposes aren’t forgotten,” says Yale. “We will be watching closely to ensure that the new regulations put patients’ needs first.”