MGC Pharma has received formal notification of the acceptance of its patent application for its self-nanoemulsifying drug delivery system by the Slovenian Intellectual Property Office (SIPO).
The successful patent application of European-based biopharma company MGC Pharma for the Self-Nano Emulsifying Cannabinoids-Ionic Complex Concentrate Drug Delivery System (SNEDDS) now gives the Company priority to file subsequent patent applications for the product in other jurisdictions and Intellectual Property (IP) agencies.
MGC Pharma anticipates that the patent for its novel SNEDDS formulation will be issued within the coming 12 months.
The application sets out the formulation of the SNEDDS, as well as the method of manufacture and its capacity for enhancing stability, solubility and bioavailability of drugs that are designed for multiple neurological therapeutic applications.
Traditionally, cannabidiol (CBD) has been administered in either oil- or alcohol-based formulations which vary greatly in bioavailability. MGC Pharma’s SNEDDS enables the administration of higher concentrations of CBD, at 100-200 milligrams per ML, needed for the treatment of neurological conditions at increased bioavailability.
The molecule emulsifies immediately at the oral mucosa epithelium, resulting in instant bio-trade into the blood plasma.
The SNEDDS is based on the Type IV (oil-free) nanotechnology which guarantees a globular molecule size below 50 nanometres in order to pass through the Blood Brain Barrier for the treatment of neurological diseases, and is based on an “Ionic Complex” that greatly increases solubility and bioavailability of the Active Pharmaceutical Ingredient (API).
MGC Pharma is looking to implement this delivery system in its CannEpilTM and CogniCannTM products, both of which are going through the clinical development process, including clinical trials.
CBD as a neurological treatment
CBD has demonstrated beneficial effects in clinical studies and has been found to have antioxidative, anti-inflammatory, and neuroprotective properties. It has also become a supplemental therapy for a number of neurological conditions including multiple sclerosis, neurodegenerative disorders (such as Parkinson’s disease, Huntington’s disease, Tourette’s syndrome and Alzheimer’s disease), epilepsy, chronic pain, neuralgia and various psychiatric disorders.
Roby Zomer, co-founder and managing director of MGC Pharma, commented: “The acceptance of this patent could be transformational for patients who need treatment and therapeutic relief from neurological diseases. The new IP will not only improve MGC Pharma’s current formulations, including our phytocannabinoid-based drugs CannEpilTM and CogniCannTM, but potentially provide more affordable medicines for patients as a result of the more efficient use of resources in formulations.
“The submission to SIPO provides MGC Pharma with the right to file further applications in multiple jurisdictions and treat people and patients suffering from these conditions on a global scale.”
Oxford Cannabinoid Technologies secures drug development agreements
The agreements follow its post-IPO review after its £16.5m fundraise and admission to the main market on LSE in May this year.
UK pharmaceutical company Oxford Cannabinoid Technologies has secured two commercial agreements that will contribute to the development of its lead compound and other drug development programmes.
Focused on developing a portfolio of cannabinoid-based prescription medicines approved by medicines regulatory agencies which target the pain market, the company has secured agreements with life sciences consultancy Voisin Consulting SARL and Evotec SE subsidiary Aptuit (Verona) SRL.
The agreements follow its recent post-IPO review after its £16.5m fundraise and admission to the main market on the London Stock Exchange earlier in May this year.
Drug development programmes
Oxford Cannabinoid Technologies struck a deal with Voisin, which has over 200 professionals in the UK, US and India with expertise in medical devices, cannabinoids, neurological disorders and addictions, in June this year, which will support and advise the company on its regulatory strategy and roadmap for its drug development programmes in the US, UK and Europe.
This will include First Time in Human clinical trials for its lead compound OCT461201 – a selective cannabinoid receptor type 2 agonist which has initial indications in post-herpetic neuralgia and visceral pain caused by irritable bowel syndrome (IBS). The trials are expected to commence in 2022.
The deal with Aptuit (Verona) SRL, subsidiary of Evotec SE, a fully integrated drug discovery and development company based in Germany, with a market capitalisation of approximately €5.7bn, will provide access to Evotec’s technology platform to further accelerate the development of OCT461201 towards phase 1 clinical trials.
These trials will be aimed at demonstrating the compound’s safety and tolerability by utilising its INDiGO programme, which is an integrated drug development process for expediting early drug candidates to the clinical trial stage.
This is scheduled to run for approximately 12 months and will provide manufacturing, safety and toxicology packages for regulatory submissions to the UK’s Medicines & Healthcare products Regulatory Agency (MHRA) and in the US, The Food & Drug Administration (FDA).
Dr John Lucas, Oxford Cannabinoid Technologies CEO, said: “I am delighted with the company’s progress across all fronts. The board agrees that we are off to a great operational start as a public company with the two partnership agreements signed recently, and we remain firmly on schedule to deliver the drug development timeline set out in our prospectus dated 17 May 2021.
“The Group will continue to develop its drug pipeline and its proprietary, unique library of cannabinoid derivative compounds. Furthermore, we have visibility over a number of exciting developments and a clear path to growth. By utilising a range of inputs, the Group is creating a drug development portfolio that is intended to maximise the therapeutic potential of cannabinoids, long-term market value and market exclusivity across its activities.”
Supply chains urged to use authentication to protect cannabis products
The IHMA says counterfeit cannabis is an alarming development that sees criminals taking advantage of people in desperate need of products.
International trade body, the International Hologram Manufacturers Association (IHMA), is urging supply chains to protect legitimate cannabis products and packaging with authentication technologies after it was revealed that sales of counterfeit cannabis were on the rise.
The IHMA has emphasised that the sale of counterfeit cannabis highlights the critical need for regulated cannabis products used for pain relief, relaxation and sleeping disorders, to be fully protected and secured from the threat of criminal counterfeiters. It is now urging supply chains to use authentication technologies to protect their products.
The call follows a recent report from WediNos, a Welsh harm reduction project that analyses samples of drugs provided by the public and other participating organisations, warned of an increase in sales of synthetic cannabinoids that are being mis-sold as cannabis in the UK, posing a significant health risk to the general public.
Reducing threats to public health
An analysis of 37 samples in the UK which were believed to be THC e-liquids used in vapes found that only 26% contained THC or cannabis, while 57% contained some form of synthetic cannabinoid, and further reports have shown that cannabis edibles being sold via social media have been hospitalising UK school children.
The IHMA says that counterfeit cannabis is an alarming development that sees criminals taking advantage of people who might be in desperate need of products during the pandemic, and is now urging supply chains to review how they tackle this threat by looking at the use of authentication technologies.
Dr Paul Dunn, chair of the IHMA, said: “The rise in fake drugs is a huge global problem and cannabis counterfeits are no different. However, holograms are effective weapons in the battle to combat criminals.
“They provide a flexible, quick to deploy visual authentication device that can bolster supply chains, helping manufacturers, regulatory authorities, international law enforcement and border customs improve their anti-counterfeiting plans.”
Packaging for cannabis products must comply with stringent regulatory requirements, and the IHMA warns that in the next few years, as the race to improve production and bring down costs in the face of growing demand for legalised cannabis-derived treatments opens new opportunities for consumer goods and pharmaceuticals, the need for authentication of products will become even more critical.
“The use of track and trace programmes featuring security devices and integrated QR codes are particularly helpful in proving the authenticity of cannabis products and packaging. This can be very reassuring for all involved as well as consumers, confirming products are genuine and safe to use,” added Dunn.
Patent for THC as Alzheimer’s treatment granted to India Globalization
India Globalization hopes the formula could provide relief for the potential 50 million people across the globe which are expected to be impacted by Alzheimer’s disease by 2030
The United States Patent and Trademark Office has issued a patent to India Globalization Capital Inc. for the treatment of Alzheimer’s disease using THC.
India Globalization, which develops cannabinoid-based therapies for indications such as Alzheimer’s disease and pain, has been issued the patent, entitled ‘Ultra-Low dose THC as a potential therapeutic and prophylactic agent for Alzheimer’s Disease‘, for the treatment.
The company, which hopes that its formula could help to provide relief for the potential 50 million people across the globe which are expected to be impacted by Alzheimer’s disease by 2030, entered into an exclusive license agreement with the University of South Florida with respect to the patent application and the associated research conducted on Alzheimer’s disease.
THC clinical trials
The original application was initiated by the University of South Florida and filed on 1 August, 2016.
The granted patent relates to India Globalization’s proprietary formulation, IGC-AD1, which is the subject of the company’s placebo-controlled Multiple Ascending Dose (MAD) Phase 1 clinical trial to establish the safety and tolerability of the formula that uses THC on patients suffering from Alzheimer’s disease.
The trial aims to obtain United States Food and Drug Administration (FDA) approval.
The company recently announced the completion of Cohort 3 in the trial. For Cohort 1, the company administered one dose of IGC-AD1 per day, in Cohort 2 the doses were increased to two per day, and the treatment will be increased to three doses for this final Cohort 3.
Participants have been monitored daily for safety, and for particular behavioural changes using the Neuropsychiatric Inventory scale. The Phase 1 trial is currently anticipated to conclude by September 2021 and the Data and Safety Monitoring Committee (DSMC) for the clinical trial will review the data from Cohort 3. India Globalization will report its findings from all three Cohorts to the FDA.
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