Tilray Announces Support Of Two New Clinical Research Studies In Australia And Canada

CANADA: Tilray, Inc., a global leader in cannabis research and production, today announced its support of two new clinical studies: a pilot study led by Murdoch Children’s Research Institute (MCRI) in Melbourne, to evaluate the feasibility and acceptability of a larger randomized placebo-controlled trial of cannabis extract as a form of treatment for reducing Severe Behavioral Problems (SBP) in pediatric patients with Intellectual Disabilities (ID); and a study with McGill University Health Centre’s Division of Infectious Diseases and Chronic Viral Illness, to examine the effectiveness of medical cannabis on immune activation in People Living with HIV.
 
Tilray_Logo“Tilray is at the forefront of clinical research in the medical cannabis field and we’re very proud to support two groundbreaking studies that have potential to identify more indications in which medical cannabis can benefit patients in-need,” says Philippe Lucas, VP of Global Patient Research and Access, Tilray. “We are committed to advancing cannabinoid-based science to further understand the potential benefits of medical cannabis as a treatment option among these critical patient populations. There is a serious need for more clinical data in our field, and we are proud to support research like this around the world.”
 
Murdoch Children’s Research Institute in Australia:  

Over 50,000 youth in Australia today have Intellectual Disability with Severe Behavioral Problems such as irritability, aggression, and self-injury. Anti-psychotic and other psychotropic medications are prescribed for half of these patients in Australia, despite limited evidence for their efficacy and a high risk of serious side-effects, including weight gain, metabolic syndrome and extrapyramidal movement disorders. Polypharmacy and off-label prescribing are common in these patients, and drugs are sometimes added to treat side effects. Novel interventions are urgently needed for this highly vulnerable patient group.
 
The American Academy of Pediatrics and the Royal Australasian College of Physicians have highlighted the need for further research into the therapeutic uses of cannabinoids in youth. There is intense interest from parents and physicians in medical cannabis as a treatment for SBP in youth with ID. Research to date suggests that CBD and other cannabis extracts, have had fewer reported side-effects than anti-psychotic medications; however, there is currently insufficient evidence to inform its use in treating SBP. MCRI is among the first institutions to conduct research specifically testing the effectiveness of CBD on patients with intellectual disabilities to reduce severe behavioral problems.  
 
“We are committed to increasing the scientific understanding of cannabinoid-based medicine as treatment for pediatric patients with intellectual disability and associated severe behavioral problems through this study.” says Associate Professor Daryl Efron, senior researcher at MCRI and pediatrician.
 
The single site, double-blind, parallel group, randomized, placebo-controlled pilot study of 10 participants, compares CBD with a placebo in reducing Severe Behavioral Problems in pediatric patients aged eight to 16 years of age with Intellectual Disability. Participants are randomized 1:1 to receive either Tilray C100 oral solution or the placebo.
 
Tilray supplied the medical cannabis products used for this trial, which were successfully exported from Tilray’s Good Manufacturing Practices (GMP) certified facility in Nanaimo, British, Columbia, Canada to Australia in early 2019, with the trial commencing shortly thereafter.
 
The results from this trial are expected to be published by 2020.

MediPharm Labs Signs Agreement With AusCann For Cannabis Oil Export To Australia

CANADA: MediPharm Labs, a leader in specialized, research-driven cannabis extraction, distillation, purification and cannabinoid isolation, is pleased to announce that its wholly-owned subsidiary, MediPharm Labs Inc. (“MediPharm Labs” or the “Company”), has entered into its first definitive international sales agreement, dated February 20, 2019, with AusCann Group Holdings Ltd. (“AusCann”) to supply private label purified, pharmaceutical grade cannabis oil concentrates, or resin, from MediPharm Labs’ own inventory of oil for export to Australia. AusCann will use MediPharm Labs’ concentrates to manufacture hard-shell cannabinoid capsules to address the medical patient demand and critical need for precision and consistency of dose in cannabinoid medicines.

“MediPharm Labs has quickly established a global reputation as the go-to producer of high quality, pharmaceutical grade cannabis concentrates at commercial scale. We are thrilled to have been selected by AusCann as a supplier of choice for their medical products and clinical trials,” said Patrick McCutcheon, Chief Executive Officer of MediPharm Labs. “As the first extraction-only LP to begin exporting to Australia, this agreement marks an important milestone that accelerates our expectations for future growth. Looking ahead, we expect to begin supplying additional international markets to build our robust global distribution platform.”

“MediPharm Labs’ significant market share combined with proprietary methodology ensures reliable supply of pharma-grade cannabinoid extracts and AusCann’s continued ability to develop and deliver quality cannabinoid medicines for distribution in Australia,” said Dr. Paul MacLeman, Interim CEO of AusCann. “Critical to our process is repeatability in manufacturing, reliable dosing, and purity assurance. MediPharm Labs’ concentrates will form an important foundation to our products that will allow delivery of effective, trusted and safe medicines for the treatment of chronic pain.”

This marks the Company’s first international export agreement and establishes MediPharm Labs as the first extraction-only licensed producer in Canada to commence exporting pharmaceutical grade cannabis oil to Australia. To date, MediPharm Labs has completed 5 private label sales agreement since receiving its sales license in November 2018. The first export of cannabis concentrate is expected be completed in the coming months, subject to regulatory requirements. The agreement has a two-year term. The Company expects to continue expanding its international distribution of its proprietary cannabis concentrate products for resale globally on a private label basis for medical markets. Initially this demand will be serviced from its wholly-owned, leading facility in Canada, and once its Australian laboratory, now under construction, is fully licensed and operational, Australia and Asia-Pacific demand can be addressed regionally.

Study: Long-Term Cannabis Use Not Associated With Changes In Brain Morphology

AUSTRALIA: The use of cannabis, even long-term, is not associated with changes in the cortical surface of the brain, according to data published in the journal European Neuropsychopharmacology.

A team of investigators from Australia and the Netherlands assessed the relationship between cannabis use and brain morphology in a cohort of 261 subjects (141 cannabis users and 120 controls). Researchers reported “no significant effects on cortical surface morphology” that could be attributable to subjects’ cannabis use, dependence, or age of initiation.

Authors concluded, “Our lack of finding in a well-powered study suggests that cortical surface morphology may be less associated with cannabis use than previously assumed.”

The findings are consistent with other recent brain imaging studies – such as those herehere, and here – and are largely inconsistent with those of a well-publicized 2014 study purporting that even causal cannabis exposure was linked to changes in the brain in young people.


For more information, contact Paul Armentano, NORML Deputy Director, at: paul@norml.org. Full text of the study, “Cortical surface morphology in long-term cannabis users: A multi-site MRI study,” appears in European Neuropsychopharmacology. Further information is available from the NORML fact-sheet, “Marijuana Exposure and Cognitive Performance.”

Canadian Cannabis Companies Seeking Higher Stakes in Australian Market

CANADA: As investor excitement continues to climb in Canada over the upcoming legalization of cannabis on July 1, 2018, major Canadian companies are already setting their sights on the next big legal cannabis market-Australia.

Big players in the Canadian cannabis space already have started to stake claims “Down Under” where medical cannabis is beginning to take hold.  Notable companies include Aurora Cannabis (TSX: ACB), Canopy Growth Inc. (TSX: WEED) (OTC: TWMJF), CannTrust Holdings Inc. (CSE: TRST) (OTC: CNTTF), MedReleaf Corp. (TSX: LEAF) (OTC: MEDFF), and MYM Nutraceuticals Inc. (CSE: MYM) (OTC: MYMMF).

Australian consumers are already undergoing a very quick renaissance into the cannabis market, with several developments happening in the past few months.

After Australia’s federal decision that low-THC hemp seeds were fit for human consumption, almost instantly hemp beer and other related products hit the market.

Australian-listed companies are already starting to see major gains, as the country’s first corporate cannabis production is set to begin in 2018.

Stock prices on several Australian companies are beginning to take off, as the reality of Australia as a viable cannabis market for years to come, sets in.

Tilray Completes First Bulk Medical Cannabis Export To Australia Under New Regulations

CANADA: Tilray, a global leader in medical cannabis research and production, today announced it has completed its first import of medical cannabis products into Australia under the country’s new import regulations. The products were produced at Tilray’s federally licensed, GMP-certified facility in Canada and can be dispensed to any patient with a valid prescription.

“We are proud to be able to offer Australian patients in need access to high quality, pharmaceutical-grade medical cannabis products in accordance with quality standards mandated by the Australian government,” said Brendan Kennedy, Tilray President. “We commend the Australian government on its recent steps to legalize and regulate medical cannabis as well as to ensure patient access.”

With the bulk shipment of Tilray products now warehoused in Australia, Tilray can serve patients as soon as they become authorized to receive medical cannabis under Australian regulations. Importing in bulk reduces costs and ensures Tilray can provide products faster to patients in need. Tilray is currently providing oils containing tetrahydrocannabinol (THC) and/or cannabidiol (CBD) in Australia. The company plans to introduce capsules containing THC and/or CBD in the coming months.

Earlier this year, Tilray announced that it had successfully exported medical cannabis products to the state of Victoria for 29 children with severe epilepsy, who became the first patients in the state to legally access medical cannabis. Currently, Tilray is able to supply medical cannabis products to authorized patients in every Australian state and territory. Tilray also serves authorized patients in New Zealand, North America, Latin America, and the European Union.

Tilray became the first medical cannabis producer in North America to be GMP certified in December 2016. GMP certification is the most rigorous standard that manufacturers of medical products must meet in their production processes, and it provides regulators and health care providers in countries new to medical cannabis with certainty that Tilray products are the safe and smart choice.

GMP certification is enabling Tilray to expand international distribution of its products for commercial, clinical research, and compassionate access purposes. In 2016, Tilray made history by becoming the first company to legally export medical cannabis products from North America to Australia and the European Union.

Tilray is also committed to advancing the science and safety of medical cannabis products by supporting clinical research. 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. Tilray supports additional clinical trials focused on pediatric epilepsy at SickKids Hospital in Canada and post-traumatic stress disorder at the University of British Columbia in Canada.

Australia To Lift Ban On Medical Cannabis

AUSTRALIA: The Australian government has announced plans to allow cannabis to be legally grown for medical and scientific purposes.

Under current laws, marijuana is classified as an illegal drug, and while penalties vary from state to state, people who grow, use, possess or sell it can be fined or sent to prison.

In a statement Saturday, the government said the Narcotics Drugs Act 1967  would be amended to allow the drug to be grown locally, without breaching the country’s international obligations as a signatory to the Single Convention on Narcotic Drugs 1961.

“This Government is incredibly sympathetic to the suffering of those Australians with debilitating illnesses and we want to enable access to the most effective medical treatments available,” Health Minister Sussan Ley said in a statement.

Geoffrey Edelsten Will Sell Medical Marijuana

AUSTRALIA:  Maverick medico Geoffrey Edelsten has teamed up with a colleague in Canada who he claims holds a licence to grow Cannabis in Nevada and the two plan to buy a range of marijuana dispensaries in the US.

Spotting a looming lucrative market, Edelsten, who was deregistered as a doctor in 1988, also plans to open cannabis stores in Australia when laws permit him to.

“They are extremely popular and very successful as a business,” he said.

“I notice that other states here in Australia are having investigations to see whether it should be made legal and I think it will be. The medical benefits are unarguable now and very well-known.

 

Australia Next To Legalise Medical Marijuana In August

AUSTRALIA:  Australia could be the next nation to legalise medical marijuana as senators from all the major political parties are set to endorse a bill giving cannabis the green light.

Led by Greens Leader Richard Di Natale​, a committee made up of Coalition, Labor and cross-bench senators will strongly recommend that Parliament pass the bill to set up a medical marijuana regulator.

The Regulator of Medicinal Cannabis Bill would effectively make the federal government responsible for overseeing the production, distribution and use of the drug Down Under.

After conducting public hearings around the country and attracting almost 200 public submissions, the committee is due to deliver its report on August 10.

 

Seizure-Plagued-Teen In Coma Approved For Cannabis Treatment On ‘Compassionate Grounds’

AUSTRALIA:  A Nelson teenager in an induced coma has been granted the one-off use of cannabis treatment to help his condition after the Government approved the drug on “compassionate grounds”.

Today, Associate Minister of Health Hon Peter Dunne granted the use of Elixinol, a cannabidiol (CBD) product from the United States, to be administered by doctors treating Alex Renton in Wellington Hospital.

The 19-year-old has been in the hospital’s intensive care unit since April with a condition causing him to suffer repeated seizures.

The Capital and Coast District Health Board asked the Ministry of Health to approve the use of medical marijuana after all other treatment options had failed.

 

Medical Marijuana Company To List On ASX

AUSTRALIA:  In the United States, it is known as the dot bong boom. And although in Australia cannabis does not – yet – flow as freely, the first medical marijuana company is about to list on the Australian Securities Exchange.

Perth-based PhytoTech Medical will lodge its disclosure document in late November, with the aim of raising $5 million through 25 million shares at 20¢ each. The float will be fully underwritten by BBY.

At its helm is Ross Smith, 51, who rode the highs and lows of the dotcom boom and who has a long and colourful history with both marijuana and sharemarket floats. Mr Smith, Israeli-based, smoked and sold cannabis as a teenager and young man, and was convicted and fined $15,000 for possessing and cultivating marijuana in 1989.

Although listed on the Australian Securities Exchange, PhytoTech will use marijuana grown in California and Uruguay to develop medical products in Israel. These will then be sold in Israel, Europe, the US and Canada.