MGC Pharmaceuticals Ltd's, a European based bio-pharma company specialising in the production and development of phytomedicines, senior executive directors Roby Zomer and Brett Mitchell, are meeting with AMC Holding Inc. in the USA to further progress the initiation of critical US Clinical Trials for MGC Pharma products covered by the US Supply and Distribution Agreement signed by MGC Pharma and AMC in 2021.
Key highlights:
- MGC Pharma and AMC Holdings Inc. senior executives met with University of South Florida (USF) department heads to plan the commencement of a US Clinical Trial for CimetrA, supplied under the US Supply and Distribution Agreement executed in August 2021.
- The parties also advanced discussions regarding regulatory approvals for the use of MGC Pharma’s leading phyto-cannabinoid medicines CogniCann and CannEpil in the USA under existing early patient access schemes.
- The US Market Access and Distribution Agreement signed with minimum orders of US$24 million for MGC Pharma products over 3 years includes CimetrA, a plant-based Investigational Medicinal Product (IMP) currently in clinical trial phase, as a potential treatment for patients suffering from COVID-19.
- AMC Holdings is a Special Purpose Vehicle founded by experienced US healthcare professionals and former federal US government officials to facilitate the research and growth of Phyto-medicines in the USA.
- AMC is responsible for managing US-based clinical trials for MGC Pharma phytomedicines and for seeking US regulatory approvals including the FDA, for products which they intend to distribute in the US.
- AMC and MGC Pharma executives are currently working with University of South Florida’s Botanical Medicine Research and Education Consortium to conduct the first US-based clinical trial of CimetrA, now scheduled begin Q3 2022 following the Company’s submission of an application to the FDA as a materially advanced Investigational New Drug (IND).
MGC Pharma and AMC executives met in Tampa with the Deans of the University of South Florida’s (USF) Medical and Pharmacology School, and its Botanical Medicine Research and Education Consortium (BMER) on Thursday to confirm the timing, commitment, and logistics for MGC Pharma and AMC in undertaking clinical trials based at USF. MGC Pharma’s chairman of the board, Brett Mitchell with managing director and CEO, Roby Zomer held meetings at USF’s Morsani College of Medicine, to discuss the first US based Clinical Trial of CimetrA with BMER director Dr. Mark Kindy, Dean Kevin Sneed, PharmD, of USF’s Taneja School of Pharmacology and Dean Charles Lockwood, MD.
This US-based trial will add to the clinical research on CimetrA that has been carried out to date in Israel and India and will lay the foundation to achieve FDA regulatory approval for its sale and distribution in the USA as a medicine.
A Phase II double blind clinical trial in 2020 demonstrated the efficacy of the treatment for patients suffering from moderate COVID-19, with none of the patients in the treatment group requiring additional oxygen, mechanical ventilation, or admission to intensive care, in comparison with 23.4% of the placebo group requiring further assistance.
CimetrA is a natural medicine comprised of Boswellia and Curcumin which utilises Graft Polymer’s GraftBio self-nanoemulsifying drug delivery system (SNEDDS).
Existing trials and observations suggest that several things distinguish CimetrA as a treatment from current treatments:
- Ease of use: CimetrA can be self-administered as an oral spray.
- Efficacy of the delivery mechanism: the treatment is delivered to the oral mucosal cells, where it is most efficiently absorbed into the body in a highly concentrated form, without first being degraded by amino acids in the stomach or absorbed through the stomach lining.
- CimetrA is “variant agnostic”: it helps the body respond to the virus infection; it is not an anti-viral, which often have more efficacy against one variant than another.
- Graft Polymer's GraftBio SNEDDS delivery mechanism increases the bioavailability of the active ingredients delivered to cells.
- Many patients cannot or will not take existing medications owing to contraindications or the fact that they are not considered “high risk” enough to receive the treatment. CimetrA is targeting to fill that gap in the USA for healthcare providers and public health officials looking for a treatment between antivirals and infusion therapy versus “go home and let us know if you get worse.”
- Cost: CimetrA is selling overseas for a fraction of the cost of monoclonals and half the cost of antivirals.
MGC Pharma CEO and managing director, Roby Zomer, said: “We are excited to start the trials in collaboration with USF at the earliest opportunity this year, particularly with COVID-19 spikes and new variants emerging every few months. We are looking forward to working with our US distribution partners, AMC, to bring CimetrA to the US market, where we believe there is a real need, and expect the treatment to be well received.
"This is an important and exciting agreement for MGC Pharma, providing access to the largest healthcare market in the world, and we are look forward to working with AMC, utilising their expertise and network to widen patient access to MGC’s Phyto-medicine products.”
AMC’s general counsel, Brent Yessin, said: “We are fortunate to have the resources of a great research university like USF right here in Tampa and we look forward to working with Dr. Kindy and Dr. Sneed to get this trial underway so we can get approval for this medicine for use in our community, hopefully before the confluence of flu season and the next variant’s fall arrival.”