공시 • Dec 16
MGC Pharmaceuticals Limited Announces ArtemiC Phase II Clinical Trial Results
MGC Pharmaceuticals Ltd. announced the full results of its Phase II double-blind, placebo-controlled clinical trial for anti-inflammatory treatment ArtemiCTM, based on Swiss PharmaCan AG MyCell EnhancedTM delivery system technology (MyCellTM), on persons diagnosed with COVID-19, has successfully met all the Phase II primary and secondary endpoints and demonstrated to improve the clinical recovery of COVID-19 patients. The (Trial). Key Trial Results: The company has completed its Trial on ArtemiCTM on 50 infected patients across 3 independent hospital sites in Israel and India, 50 patients were recruited to the trial, 33 in the treatment group and 17 in the placebo group. The full results have demonstrated to improve the health status of COVID-19 patients delivering a NEWS score of less than or equal to 2. None of the patients in the treatment group required additional oxygen, mechanical ventilation or admission to intensive care where all of these events were reported in the placebo group. The average NEWS score of patients in the placebo group was 2.25 statistically significantly higher (p<0.04) than in the treatment group 0.5. Additionally, ArtemiCTM demonstrates the following distinct advantages. A full safety and efficacy profile with no drug-adverse events; the ability to prevent deterioration of COVID-19 patients and achieve faster clinical improvement; the ability to assist in reducing the pressure on the medical system and support coping with hospitalised patients; the ability to improve symptoms and pain associated with COVID-19; the versatility to be used in community as well as in hospitals; as the mechanism of action of ArtemiC TM is focused on the anti-inflammatory effect and prevention of cytokine storm, a wide spectrum of potential indications will be considered for future development. NEWS score determines the degree of illness of a patient and prompts critical care intervention. This was defined as a main tool for the estimation of COVID-19 patients clinical health status and improvement. In line with the interim results released on the 20th August 2020, the Trial met all the FDA requirements for a COVID-19 study including population diversity (age, medical history, and genetic diversity) and demonstrated a full safety profile with no drug related adverse events. This resulted due to ArtemiC TM and the Trial being focused on the immunomodulation specific for the prevention of cytokines storm, as opposed to other immunomodulators. These results also follow safety and toxicity testing completed on mice (refer ASX release 27 July 2020) and in line with FDA requirements for product registration requiring two types of rodents in pre-clinical trials, MGC Pharma completed an in vivo safety and toxicity pre-clinical study, including histology testing, on 24 rats. This included 4 groups with three 3 study drug dosages being 48ug, 96ug and 196ug per kg rat and a control group. The rats were observed and tested for clinical changes over seven days. This study included pathological examination of the organs: liver, heart, brain, spleen, spinal cord, sciatic nerve, kidney (L+R), lungs and tongue. The results concluded there were no pathological changes in all tested animal samples. Following the successful Phase II results, further development for ArtemiC TM will include immediate evaluation of a Phase III clinical study on COVID-19 and flu patients, and production in MGC EU GMP facilities as IMP under a new brand name. In addition, different indications related to inflammation and cytokine storm, will be considered as future development goals and include a wide range of diseases related to cytokine storm such as autoimmune diseases, inflammatory GI diseases, flu and chemotherapy patients. The Company is in a strong position to respond to a significant potential increase in the demand for ArtemiC TM in the immediate future as a supplement, and in the future as part of a Phase III study where the Company would look to develop ArtemiCTM as a pharmaceutical product and future development as an Investigational Medicinal Product (IMP). Regulatory approvals to commence the Phase III Clinical Trial will be progressed with Anvisa (Brazilian medical Authority), EU Novel Food authority and submissions are expected to be made in first quarter of 2021. The Company plans to develop and commence a Phase III Clinical Trial in the first half of 2021. The Phase III Clinical trial is anticipated to be an international multicentre study with up to 250 patients and expand its research to encompass a wide range of inflammatory indications for the use of ArtemiCTM as a treatment. These indications are related to cytokines storm as autoimmune diseases (rheumatoid arthritis, lupus), flu, chemotherapy patients and IBD could benefit from the mechanism of action ArtemiCTM, demonstrated in preclinical and clinical trials. Upon completion of a successful Phase III Clinical Trial the Company will seek registration of ArtemiCTM and commence production and sale as a supplement, through its existing production facilities and distribution networks. Successful results of Phase III will lead for a pre-IND meeting with FDA in order to initiate the registration process for ArtemiCTM as an IMP. The ArtemiCTM clinical study on COVID-19 patients is managed under GCP requirements and local Helsinki Committee approvals in 3 hospitals in Israel and 1 in India. The independent management of the study was performed by Dr Nadya Lisovoder, CEO of Galilee Clinical Bio Research, an external Clinical Research Organization (CRO), under all required regulatory conditions answering FDA requirements. Galilee-CBR is an independent Clinical Research Organisation located in Israel provides a full spectrum of clinical development phases I to IV in pharma and medical devices. Galilee- CBR is working with an Israeli Government for the bio medical research promotion in the hospital in Northern Israel. Certified Electronic Data Capture system (provided by Flask Data company, specializes in EDC systems for FDA and EMA clinical trials) was used for the data collection and 100% of the study data was monitored in order to ensure the data quality. Statistical analysis of the results was performed by an external and independent biostatistician, Dr. Nira Morag, a senior lecture in Tel Aviv University, Department of Biostatistics. Nira has more than 30 years of experience in biostatistics in pharma industry.