Phytomedicine company MGC Pharmaceuticals has received approval for a dose finding study of its CimetraA formula for COVID-19.
European-based MGC Pharma, a bio-pharma company developing and supplying affordable standardised phytocannabinoid derived medicines, has received approval from the Israeli Ministry of Health for a dosing study for its proprietary treatment for the effects of COVID-19, CimetrA – a nanoparticle micellar formulation consisting of curcumin and boswellia.
The study, which will recruit 240 patients into the Study in sites located in Israel, South Africa, the USA, and Russia, will determine the most effective dosage of the treatment, incorporate a full safety and pharmacovigilance profile, and an extensive pharmacokinetic profile to outline the registration and administrative process of approval for sale and use.
Additionally, it will further examine the anti-inflammatory and immune-modulatory effects the medicine through cytokine level monitoring.
Patients will continue to be observed for a 28 day follow up period in order to ensure that data is not impacted by the effects of either long or post-COVID and results will be submitted to the health authorities of Israel, the USA, South Africa, and Russia.
Co-founder and managing director of MGC Pharma, Roby Zomer, commented: “This latest dosage study is the latest step as we move closer to being in a position to apply for marketing authorisation for CimetrA in territories across the globe.
“We believe that CimetrA will prove to be a vitally important drug in the treatment of COVID-19 going forward, and look forward to sharing the results of the study in due course, along with further steps towards providing COVID-19 patients and Governments across the world a cost effective treatment to fast track patient recovery and minimise the massive cost burden of long term hospitalisation.”
The results of the study will enable MGC Pharma to determine the most effective dosage of CimetrA for treating the symptoms of COVID-19 including cytokine storms and the results will be used to provide additional evidence to regulatory authorities around the world about CimetrA’s efficacy.
New agreement to fund Phase II trials for cannabis glaucoma treatment
Emerald Health Therapeutics has signed an agreement with Skye Bioscience.
A new agreement between Emerald Health Therapeutics and Skye Bioscience will enable Phase II studies exploring the use of Skye’s proprietary synthetic cannabinoid-derivative therapeutic initially targeting glaucoma.
Glaucoma is the globe’s leading cause of irreversible blindness – affecting nearly 80 million people across the globe – and has no cure.
Skye Bioscience‘s lead programme, SBI-100 Ophthalmic Emulsion, is focused on treating glaucoma. SBI-100 OE is designed to improve the ocular solubility and permeability of a cannabinoid receptor-type 1 agonist.
So far, preclinical studies have demonstrated that topical application of the nanoemulsion results in enhanced therapeutic efficacy and duration of response, allowing for a potentially once-a-day application to the eye. The results showed superior lowering of intraocular pressure, a key risk factor in disease progression.
Under the new agreement, which would see Skye acquire all of the issued and outstanding shares of Emerald in a share-for-share-transaction, Skye expects to have funding for a Phase II study which is expected to begin in the fourth quarter of 2022, following a Phase I study beginning in the second quarter of 2022.
Chair of the Skye’s special committee and president, CEO and board member of Invectys, Inc., Praveen Tyle, Ph.D., commented: “Skye’s proposed acquisition of Emerald stands to strengthen its balance sheet and ability to advance its well-positioned technology and development platform that has generated promising preclinical data in the past year and a half.
“Despite the constraints of Covid on all facets of the life science industry, Skye has completed the preclinical preparation necessary to launch its first-in-human study of its lead drug, SBI-100 OE, in the second quarter of 2022.
“We expect regulatory approval to start our Phase I study and begin enrolling patients shortly. The transaction with Emerald is expected to provide funding into 2023 and, importantly, for our planned Phase II study starting in the fourth quarter of 2022.
“The shortcomings of today’s glaucoma drugs are significant for patients. Today we are focused on clinically validating what could potentially be an advantageous new class of therapeutic drug for glaucoma.
“With this in mind, we are actively designing a Phase II efficacy study to deliver potentially meaningful data, yet optimised to minimise time and cost. We believe we can see preliminary data from this study in 2023, and the nature of this data could be transformational from a validation and value creation perspective.
“Securing the capital to achieve these goals is vital. We believe that acquiring Emerald and its cash and non-cash assets would provide a more favourable capital cost for our shareholders compared to other alternatives in light of current investment market conditions.
“In addition, Emerald possesses a research and development facility in the greater Vancouver area licensed to undertake cannabinoid-related research under applicable Canadian law, which could be beneficial to Skye as we continue to progress our R&D efforts.”
Chair of the board’s Special Committee of Emerald Health Therapeutics, Bobby Rai, commented: “We are excited to present this opportunity with Skye to our shareholders. Since announcing the strategic pivot of Emerald last November, we have been working to wind down our past operations, monetise our non-cash assets, and apply our capital to a new investment opportunity. We have searched for a company with differentiated positioning and a pedigree of expertise and experience. We believe we have found it in Skye Bioscience.
“Emerald has always recognised the therapeutic potential of cannabinoids based on our experience with the body’s endocannabinoid system and its modulating and balancing activities in the body. We also recognise that the goal to clinically and commercially capitalise on the potential therapeutic benefits of cannabinoid-derived drugs may benefit from advanced technology and drug products with mechanisms of action or formulations enhanced to realise effects superior to not only natural cannabinoids but to existing approved classes of drugs and those under development.
“The beauty of this situation is that the underlying cannabinoid that Skye is working with has previously been shown through prior third-party research to have promising potential. And Skye’s recent preclinical work has shown improved delivery of the underlying cannabinoid to the back of the eye and notable effects in reducing intraocular pressure, which is a key risk factor of glaucoma.
“Skye Bioscience has proprietary technology, R&D initiatives to expand its therapeutic capabilities, a strong focus on IP, along with a management team, board, and advisory board with many decades of experience in pharmaceutical drug development and clinical practice, notably in ophthalmology and in fundamental cannabinoid research. This company is uniquely positioned to capitalise on the substantially untapped opportunities represented by the intersection of cannabinoids with modern science and traditional drug development.
“We believe this is an excellent opportunity for Emerald shareholders to potentially benefit from a new class of cannabinoid-derivative drug candidates.”
Apollon Formularies purchases four patents from Aion Therapeutic
Apollon Formularies has announced the acquisition of four patents previously owned by AI Pharmaceuticals, covering a number of treatments for cancers and inflammation using cannabis and mushroom compositions.
Apollon Formularies plc, a UK based international pharmaceutical company has acquired intellectual property from AI Pharmaceuticals Ltd, a wholly-owned Jamaican subsidiary of Aion in what Apollon is calling a “win-win” for both companies. Under the terms of the Agreement, Apollon will acquire four patents and all associated supporting data including the pre-clinical testing results from BIOENSIS.
The patents include: ‘Compositions and Methods for Treatment of Cancers’, ‘Compositions and Methods for Treatment of Inflammation, ‘Methods for Treatment of Human Cancers using Mushroom Compositions’ and ‘Methods for Treatment of Human Cancers using Cannabis Compositions’.
In a statement, Stephen Barnhill, MD, Chairman and CEO of Apollon Formularies said: “This intellectual property acquisition is a win-win for both companies. Apollon’s Jamaican affiliate, Apollon Formularies Jamaica Limited, has Cannabis Licensing Authority (CLA) issued medical cannabis licenses for processing, retail therapeutic sales, and research and development which allows performing human clinical trials with approval of the Ministry of Health (MOH) and cultivation. Apollon’s CLA licenses also currently allow the export of these products from Jamaica to countries globally allowing legal import.
Dr. Barnhill is also the Executive Chairman of Aion and serves as a director and executive officer of AI Pharmaceuticals.
Apollon, which is trading on the Aquis Stock Exchange, has purchased the patents from Aion via a cash payment of £95,957.18 and the issuing of 4,348,679 ordinary shares in the company. These shares will be subject to a complete trading restriction for a period of six months from the date of the stock transfer. After the six month restriction period, twenty percent of such stock will become eligible for trading and an additional twenty percent will be tradable at the end of each following three-month period, with all trading restrictions being fully removed at the end of eighteen months.
In addition to the cash payment and Apollon shares, Apollon will pay to Aion a royalty fee of four percent of Net Revenues on all products produced and sold globally that are derived from or based on the purchased intellectual property assets. The royalty fee shall be due from Apollon on a quarterly basis after the first commercial product sales.
“Apollon has a state-of-the art, high volume processing and manufacturing facility in Jamaica allowing production of these products. Apollon intends to immediately make these medical cannabis and medicinal mushroom products available at Apollon’s International Cancer and Chronic Pain Institute in Kingston, Jamaica and at our CLA-licensed dispensary in Negril, Jamaica, as well as initiating human clinical trials to validate the successful results seen in the pre-clinical testing.”
AI Pharmaceuticals and Apollon Formularies Jamaica announced in May last year that the two companies had made arrangements for the testing of their respective formulations and products independently and jointly. BIOENSIS, an independent pre-clinical predictive pharmaceutical testing laboratory, previously evaluated the effect of mushroom and cannabis formulations on multiple cancer cell lines in 3D cell cultures.
New partnership aims to transform global phytomedicine sector
HempStreet and MGC Pharmaceuticals have teamed up to increase access to phytopharmaceutical medicines for patients.
India’s first medical cannabis “research to retail” venture, HempStreet, and Europe’s biopharma and phytomedicine specialist, MGC Pharmaceuticals, have entered into a partnership that will see the pair combine research and development as well as distribution strengths to improve quality of life.
UK-based MGC Pharma has been working on polyherbal formulations based on cannabis and other phytopharmaceuticals. Through this new partnership MGC Pharma will leverage HempStreet’s extensive distribution reach and key institutional partnerships to bring Indian patients access to its medicines.
The partnership will also help to accelerate HempStreet’s upcoming venture, the transdermal delivery technology for cannabinoids, to launch in markets beyond Asia with the help of MGC Pharma’s distribution network in Australia, UK, Brazil and Ireland.
Co-founder of HempStreet, Abhishek Mohan, commented: “We are very excited to work with Roby and the team at MGC Pharma, bringing cutting-edge, scientifically-validated phytopharmaceutical medicines to tackle mass ailments in India and beyond.
“In particular, CimetrA, which has shown a 100 per cent success rate in Phase II clinical trials in India, will be an important product just on account of the fact that an estimated 15 million individuals are experiencing some sort of post-Covid-19/Long-Covid symptoms.”
MGC Pharma has stated that CimetrA – made of artemisinin, curcumin, and boswellia serrata – is effective in arresting cytokine storms associated with Covid-19. There are currently over 15 million individuals, approximately 30 per cent of all Covid-19 recoverees in India, said to be experiencing some form of post- or long-Covid related symptoms.
Co-founder, MGC Pharma, Roby Zomer, added: “Entry into significant global markets such as India is paramount to MGC Pharma’s agenda, advancing phytomedicine adoption globally.
“India has a long-established and government-supported Ayurvedic healthcare system, and working with HempStreet to facilitate access to our proprietary phytomedicines such as CimetrA and CannEpil and the new formulations on the pipeline, is crucial to gaining a foothold in this market.”
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