cannabidiol (CBD) / Claritas Pharma - LARVOL DELTA

An Open Label Study of Multiple Doses of Cannabidiol in the Prevention of Acute Graft-Versus-Host Disease (GVHD) (clinicaltrials.gov) - P2a; N=36; Active, not recruiting; Sponsor: Kalytera Therapeutics Israel, Ltd.; Recruiting ➔ Active, not recruiting; Trial completion date: Nov 2019 ➔ Dec 2022; Trial primary completion date: Oct 2019 ➔ Nov 2022

Clinical • Enrollment closed • Trial completion date • Trial primary completion date • Bone Marrow Transplantation • Graft versus Host Disease • Immunology • Myelodysplastic Syndrome • Transplantation

Claritas Announces Transfer of GVHD Program and Cancellation of Related Debt as Company Focuses on Nitric Oxide Therapeutics (GlobeNewswire) - "Claritas Pharmaceuticals...today announced that it has entered into an agreement (the 'Debt Forgiveness Agreement') with the former shareholders of Talent Biotechs Ltd. (the 'Talent Shareholders'), under which Claritas will transfer all assets of its program developing cannabidiol for the prevention and treatment of graft versus host disease (the 'GVHD Program') to the Talent Shareholders in exchange for forgiveness of debt and contingent liabilities."

Licensing / partnership • Graft versus Host Disease

Kalytera Therapeutics Inc. Completes Name Change to Claritas Pharmaceuticals, Inc. (Streetinsider.com) - "Kalytera Therapeutics, Inc....today announced that the Company has changed its name to Claritas Pharmaceuticals, Inc....All assets of the Company’s program developing cannabidiol for the prevention and treatment of graft versus host disease (the 'GVHD Program') in consideration for the release and discharge by the Former Shareholders of all obligations the Company and its subsidiaries have to such Former Shareholders."

Commercial • Graft versus Host Disease • Immunology

CBD for Pain and Joint Problems like Arthritis – Does it Work? - "Daniel Clauw advises that we use small amounts of CBD, as an isolated oil, and only at night. He then goes on to say that we should incrementally increase what we vape, eat, or ingest in terms of cannabidiol moving forward."

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What You Need To Know About Treating Joint Pain With Cannabis - "According to Dr. Daniel Clauw, a contributor to the guide, 'Right now, it (CBD) appears to be fairly safe and might help certain types of pain.'"

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Do Something About Your Asthma - "'It appears as though CBD is reasonably safe, and it could be effective in certain types of pain,' says Daniel Clauw, MD. Another factor he sayss is 'The greatest concern about CBD is knowing your source of CBD and ensuring that you're not consuming CBD that is somehow contaminated, either with THC or with a variety of other chemicals depending on how it has been manufactured as well as processed. Dr. Daniel Clauw...who actually helped develop the Arthritis Foundation guidelines says while CBD is certainly legal, it exists in a gray area."

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CBD oil for gout (Weedmaps) - "In an interview with Arthritis.org, Clauw shared some advice for using CBD oil alone (without THC) to treat different types of arthritis. Referring to the CBD oil treating knee osteoarthritis, he said: '...it appears as though it is very safe.' Clauw's guidelines for treatment include low doses of CBD in 5 to 10 milligrams twice daily and progressing to higher doses of 50 to 100 milligrams per day if needed. If symptoms persist, Clauw recommends trying a CBD product that contains a small amount of THC."

Interview

Arthritis Foundation Releases First CBD Guideline – Pain News Network - "'Millions of people in the U.S. are likely trying to use cannabinoids to treat pain, and many are doing this in ways that might cause more harm than good, especially when they use high doses of THC,' said Daniel Clauw, MD...who was one of the experts the foundation consulted....'It's important that the Arthritis Foundation has taken a stand on CBD,' Clauw said in a statement. 'Right now, it appears to be fairly safe and might help certain types of pain. It's far better to give this guidance, even if preliminary, because otherwise people will have no guidance whatsoever.'"

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Natural ways to reduce menstrual cramps - "Although more studies on CBD oil for menstrual pain are needed, Daniel Clauw, MD...tells us that it wouldn't surprise him if CBD oil helped ease period cramps, since 'it does act as a weak anti-inflammatory, not unlike nonsteroidal anti-inflammatory drugs, which are the most commonly used treatments for this type of pain.'"

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7 Amazing Methods People Are Utilizing Hempworx CBD Products - "Daniel Clauw, MD believes that cannabidiol may have real benefits for people. He cites a new clinical trial from pharmaceutical business Zynerba (for which Dr. Clauw has consulted) that found that the CBD-derived topical medication provided pain relief to patients afflicted by knee osteoarthritis....CBD seemingly have antibacterial properties, says Dr. Clauw, which is one particular reason the sweetness market has championed it as a fresh anti-aging ingredient in many skincare products and health spa therapies."

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Should you take cannabis supplement for pain relief? (Knowridge Science Report) - "So many people are turning to CBD as an alternative pain reliever, especially in light of the opioid crisis, that in a commentary published in Annals of Internal Medicine...Daniel Clauw...provided advice for clinicians on how to counsel their patients about CBD and cannabis use....Clauw recommends that people with chronic pain talk to their doctor about adding CBD to their treatment plan, and continue to use their prescribed medication."

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Stunning ways folks are utilizing CBD [Google translation] - "For pain relief Daniel Clauw, MD...believes that CBD might have real benefits for individuals living with chronic pain....Zynerba is no longer pursuing a version of that drug for osteoarthritis, says Dr. Clauw, and there are currently no normal recommendations for what dosage or formulation of CBD (in both oral or topical type) may work greatest for pain relief."

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The Pharmacokinetics and Pharmacodynamics of Oral and Vaporized Cannabidiol (clinicaltrials.gov) - P1; N=24; Recruiting; Sponsor: Johns Hopkins University; Not yet recruiting ➔ Recruiting

Enrollment open • Biosimilar

A Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P; CBD) as Adjunctive Treatment for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults (clinicaltrials.gov) - P3; N=120; Active, not recruiting; Sponsor: GW Research Ltd; Recruiting ➔ Active, not recruiting

Enrollment closed • Biosimilar • Epilepsy

Kalytera announces issuance of second patent covering the use of CBD in graft versus host disease (Businesswire) - "Kalytera Therapeutics...announced that the U.S. Patent and Trademark Office...issued U.S. Patent No. 9,956,182 with claims covering the use of cannabidiol...for the prevention and treatment of acute and chronic forms of graft versus host disease...market exclusivity for the use of CBD in GVHD through early 2034.”

Patent • Graft versus Host Disease • Immunology

Epidiolex and Drug Resistant Epilepsy in Children (clinicaltrials.gov) - P=N/A; N=N/A; Available; Sponsor: Georgia Regents University

New trial • Biosimilar • Epilepsy

Fixed or Self-Titrated Dosages of Sativex on Cannabis Users (clinicaltrials.gov) - P=N/A; N=10; Completed; Sponsor: Centre for Addiction and Mental Health; Active, not recruiting -> Completed

Trial completion • Biosimilar

A Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P; CBD) as Adjunctive Treatment for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults (clinicaltrials.gov) - P3; N=80; Active, not recruiting; Sponsor: GW Research Ltd; Recruiting ➔ Active, not recruiting

Enrollment closed • Biosimilar • Epilepsy

A Study of Tolerability and Efficacy of Cannabidiol on Tremor in Parkinson's Disease (clinicaltrials.gov) - P2; N=60; Not yet recruiting; Sponsor: University of Colorado, Denver

New P2 trial • Alzheimer's Disease • Biosimilar • Gene Therapies • Parkinson's Disease

The Effects of Cannabidiol and ∆-9-THC in Humans (clinicaltrials.gov) - P1; N=75; Recruiting; Sponsor: Yale University; N=36 -> 75

Enrollment change • Acute Coronary Syndrome • Biosimilar • Chronic Kidney Disease • Heart Failure

Treatment of Drug Resistant Epilepsy (clinicaltrials.gov) - P=N/A; N=N/A; Available; Sponsor: University of Florida

New trial • Biosimilar • Epilepsy

Characterization of the Analgesic Effect of CBD in Healthy, Normal Volunteers (clinicaltrials.gov) - P1/2; N=18; Active, not recruiting; Sponsor: New York State Psychiatric Institute; Trial primary completion date: Dec 2017 ➔ Dec 2018

Trial primary completion date • Biosimilar • CNS Disorders • Pain

DEA eases requirements for FDA-approved cannabis studies (American Pharmacists Association) - "DEA announced that it has eased some of the requirements that had been imposed on scientists conducting FDA-approved clinical trials on cannabidiol (CBD). Under the changes, which take effect immediately, researchers conducting CBD studies who realize they need more of the substance than originally approved for can now request a waiver, modify their protocol if approved, and continue their research without delay."

Regulatory • Graft versus Host Disease

Cannabidiol Oral Solution in Pediatric Subjects With Treatment- Resistant Seizure Disorders (clinicaltrials.gov) - P1/2; N=61; Completed; Sponsor: INSYS Therapeutics Inc; Recruiting ➔ Completed

Trial completion • Biosimilar • Epilepsy

Cannabidiol as an Intervention for Addictive Behaviors: A Systematic Review of the Evidence. (PubMed) - "A limited number of preclinical studies suggest that CBD may have therapeutic properties on opioid, cocaine, and psychostimulant addiction, and some preliminary data suggest that it may be beneficial in cannabis and tobacco addiction in humans. Further studies are clearly necessary to fully evaluate the potential of CBD as an intervention for addictive disorders."

Preclinical • Biosimilar