MGC Pharmaceuticals Ltd (ASX, LSE: MXC, ‘MGC Pharma’ or ‘the Company’), a European based bio-pharma company specialising in the production and development of phytomedicines, is pleased to advise that senior MGC Pharma executive directors, Roby Zomer and Brett Mitchell, are currently in the USA to meet with AMC Holding Inc. (AMC) and other US stakeholders 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.
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 GraftBioTM 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.
- CimetrATM 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 GraftBioTM 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. CimetrATM 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: CimetrATM 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.”