Pre-clinical trials aim to provide preliminary information into the efficacy, pharmacokinetics and safety of our cannabinoid-based medicines
Enhanced Distillate Capture and Dissolution Matrix (EDCDM) technology
Zelira has successfully developed and demonstrated enhanced dissolution of cannabinoids using its enhanced distillate capture and dissolution matrix (EDCDM)
Before this breakthrough technology was developed by Zelira cannabis manufacturers had difficulty in formulating and developing free flow solid oral dosage forms based on cannabinoid distillate. This is due to the non-uniformity of cannabinoid distillate and its separation from the powder bed. EDCDM technology, developed by Zelira, resolves this problem by creating the capacity to capture distillate in a unique and proprietary matrix. When combined with the cannabinoid distillate, it creates a free-flowing powder base for capsules and tablets.
Enhanced Distillate Capture and Dissolution Matrix (EDCDM)
This novel matrix absorbs the distillate into a nano porous silicate particle where the distillate is effectively trapped in the structure of the silicate rendering the powder bed dry. As a result, this prevents the distillate from separating from the powder bed during encapsulation and under the compression forces utilised in tableting thus opening new ways to develop pharmaceutical grade, cannabinoid-based medicines in solid oral dosage forms such as capsules and tablets.
CBD Encapsulation and Improved Oral Bioavailability
Sponsored by Zelira Therapeutics, researchers from Curtin University developed oral capsules containing cannabidiol (CBD) that enabled more CBD to penetrate the brain. The new capsulated form protects the CBD from oxidation and degradation by light which helps to extend product shelf-life. The findings support the development of CBD-based treatments for a range of neurological disorders including diabetes associated dementia, Alzheimer’s disease, multiple sclerosis and traumatic brain injuries.
The new capsulated form protects the CBD drug from oxidation and degradation by light which helps to extend product shelf-life. The findings could support the development of CBD-based treatments for a range of neurological disorders including diabetes associated dementia, Alzheimer’s disease, multiple sclerosis and traumatic brain injuries here.
- Majimbi M, Brook E, Galettis P, Eden E, Al-Salami H, Mooranian A, et al. (2021) Sodium alginate microencapsulation improves the short- term oral bioavailability of cannabidiol when administered with deoxycholic acid. PLoS ONE 16(1): e0243858
Around 15 – 20% of brain cancers in children is caused by medulloblastoma.1 It’s the most common form of brain tumour in children and also the most malignant.
Mortality from medulloblastoma remains significant and many survivors suffer from severe treatment-related effects of radiation and cytotoxic chemotherapy.
Zelira’s research collaboration has the potential to provide an alternative treatment option.
Research with Telethon Kids Institute, Western Australia
Working with researchers at Telethon Kids Institute at Perth Children’s Hospital, Zelira Therapeutics has demonstrated that synthetic and whole plant cannabinoids have some anti-cancer effects in paediatric brain cancer.
The program of work demonstrated that the cannabinoids do not interfere with medulloblastoma chemotherapies, cyclophosphamide and gemcitabine in vitro, and indeed induced apoptosis and inhibited the mTORC1 signalling pathway. These results pave the way to undertake clinical trials in this highly vulnerable paediatric population.
Pancreatic cancer is the 8th most common cancer in both men and women in Australia and the 12th most common cancer globally. 1
Research with Curtin University, Western Australia
In collaboration with the School of Biomedical Sciences, Curtin University, Zelira Therapeutics tested a range of the cannabinoids against a suite of in vitro pancreatic cancer models, as well as against human pancreatic cell cancer lines grown in the laboratory.
The aim of this work was to test the impact of cannabinoids as stand-alone treatments, as well as in combination with existing pancreatic cancer chemotherapy drugs such as Abraxane and Gemcitabine.
The studies mirrored current human treatment protocols to generate relevant data for potential future human clinical trials.
Breast cancer is the most common cancer in women world-wide, with 2.3 billion women diagnosed in 2020.1 There are many different types of breast cancer with HER2 positive breast cancer making up around 20 – 30% of all breast cancers.2
Research with Complutense University, Spain
Sponsored by Zelira Therapeutics, researchers at the Complutense University in Spain completed a pre-clinical research program looking at cannabinoids as anti-breast cancer agents. From this work, Zelira was awarded a patent (AU2017346940A) for a novel prognostic biomarker for breast cancer entitled “Prognostic method and kits useful in said method”.
This patent details a method for detecting levels of expression of a novel receptor complex containing HER2 and CB2.
Initial Results have also been published in a paper which can be found here entitled “Therapeutic targeting of HER2-CB2R heteromers in Her2-positive breast cancer” in the Proceedings of the National Academy of Science.
- Engel R, Kaklamani V, HER2-positive breast cancer. Drugs 2007:67, 1329-1241
Diabetes related cognitive decline
The number of dementia sufferers is expected to almost double every 20 years, reaching 75 million people in 2030. In 2018, the global cost of dementia was estimated at more than US$1 trillion.1
This growing economic burden and population with unmet needs is an opportunity for Zelira Therapeutics to step in with effective alternative treatments.
Research with Curtin University, Western Australia
Working with researchers at the Curtin Health Innovation Research Institute, Curtin University, Zelira Therapeutics is examining the potential for cannabinoids to treat diabetes related cognitive decline.
One of the complications of diabetes is damage to blood vessels in the brain, which is associated with cognitive decline and can lead to dementia and other conditions. Zelira Therapeutics is testing its cannabinoid formulations on validated animal models of diabetic cognitive decline developed by Curtin University. This research is ongoing.