ANTG
Australian Natural Therapeutics Group (ANTG) has been given approval to ship its locally cultivated dried flower product to New Zealand.
The Eve CBD flower will be distributed by Nubu Pharmaceuticals in a deal ANTG CEO Matthew Cantelo described as a landmark for both countries.
He said: “This agreement is not only a historic first for New Zealand, but beneficial for the Australian industry as a whole.
“Our Kiwi neighbours will have access to the highest quality Australian flower while their home-grown cultivation industry starts producing.”
Nubu Pharmaceuticals co-founder and CEO Mark Dye added: “Being the first company to legally sell cannabis in New Zealand is beyond exciting.
“I am excited for the patients – they have been calling out for this for decades.
ANTG Eve dried flower is for preparation as a tea for oral consumption only, comprising 10mg/g total THC and 125mg/g total CBD.
Avecho Biotechnology
Avecho Biotechnology has released the results of a Phase I human clinical trial characterising the absorption profile of CBD from its proprietary soft-gel capsule.
The primary objective of the study of 16 healthy volunteers was to determine the single dose pharmacokinetics (PK) of cannabidiol absorbed from a 75mg and 150mg oral dose of the product. The doses align with those specified by the Therapeutic Goods Administration (TGA) when it announced the down-scheduling of CBD late last year.
Avecho said both doses showed attractive delivery profiles that would be appropriate for investigation in a range of clinical indications. All PK parameters were well characterised, with the data forming an integral component of future regulatory submissions to the TGA or US Food and Drug Administration.
Both doses were well tolerated with no adverse events of concern related to the study medication.
CEO Dr Paul Gavin said: We now understand the absorption profile from both doses of our proprietary CBD soft-gel in humans. The results are exciting and show that the delivery profiles from both doses could support utility across a range of potential indications, whether they require once per day, or twice per day, dosing.”
Canopy Growth/Spectrum Therapeutics
Canopy Growth, via its medical channel Spectrum Therapeutics, has added two original strains – Tweed Bakerstreet and Tweed Penelope – into the Australian market.
Both its Spectrum Therapeutics and Tweed-branded medicinal cannabis flower products are manufactured under Good Manufacturing Practices and are fully compliant with TGO100 inhalation medicine standards.
They are available to patients under the Special Access Scheme.
Zelira Therapeutics/Levin Health
Zelira Therapeutics has secured ethics approval for a Phase 2a clinical trial assessing the efficacy of its ZTL-106 cannabinoid formulation in treating sports-related chronic pain in retired professional and amateur athletes.
The randomised, double-blind, placebo-controlled clinical trial at La Trobe University’s Sport and Exercise Medicine Research Centre in Melbourne is sponsored by Levin Health and managed by Zelira.
It will be led by sports medicine expert Professor Peter Brukner and is expected to start in April 2022 with 114 patients
Levin Health managing director Mark Brayshaw said: “To the best of our knowledge, this trial will be the first of its type globally in terms of evaluating the efficacy of medicinal cannabis in the treatment of chronic, non-cancer pain under strict controlled conditions.”
Last month, Levin announced a new sports advisory board featuring basketball champion Lauren Jackson, Australian Football League coach Alastair Clarkson, and jockey Damien Oliver.
Neurotech International
Preclinical studies of Neurotech International’s NTI164 novel cannabis strain show it can improve the efficacy of prednisone at low doses.
Prednisone belongs to the Corticosteroid class of drugs and is used to treat conditions including autoimmune and neurological disorders, rheumatoid arthritis, and multiple sclerosis. While extremely effective, when taken in high doses, it can cause adverse effects such as glaucoma, cataracts, high blood sugar, increased risk of infection and osteoporosis.
Neurotech found that when NTI164 was paired with prednisone (at low doses), significant anti-inflammatory synergistic activity was observed.
The company said reducing the prednisone dose while achieving increased efficacy (compared to prednisone alone) could overcome many of its adverse side effects.
Neurotech non-executive director Professor Emeritus Allan Cripps added: “The synergistic suppression of the inflammatory response with combined prednisone and NTI164 treatment in the preclinical in-vitro studies is a very exciting finding. Clearly, we are seeing the applications of the ‘entourage effect’ of our full spectrum cannabis strains.”
Epsilon Healthcare
Epsilon Healthcare has gone into a trading halt ahead of a capital raise. The halt will remain in place until Thursday (December 9), when full details are due to be released.
Epsilon recently extended its agreement with The Valens Company to January 31 2022 to allow additional time to settle the deal.
The arrangement would allow Valens access to Epsilon’s GMP facility in Southport in return for a licence to use Valens’ intellectual property in operating the facility, with Valens funding all future operational and capital expenditure.
Creso Pharma
Creso Pharma’s wholly owned Canadian subsidiary Mernova Medicinal has generated A$666k in revenue in the current the quarter, adding to a total A$3.16 million divisional revenue year to date.
Group revenue for Creso Pharma in the current quarter now sits at A$1.48 million – an increase of around 28% on the previous quarter.
Mernova managing director Jack Yu said: “Mernova has achieved strong sales during October and November, and we anticipate that this will continue during the remainder of the quarter.”
“We have a number of potential purchase orders from provincial partners in the pipeline and expect these to materialise and underpin further revenue increases.”
The company said the revenue growth comes after changes to growing and harvesting processes led to an increase in THC content in its products, fuelling customer demand.
