Clinical trial using MAF for hospitalized COVID-19 patients in Ukraine
In June 2020 we applied to the COVID-19 Scientific Technical Triage of the US FDA for the evaluation of the rationale to study the efficacy of MAF Capsules in COVID-19 treatment. The US FDA in PreIND 151946 meeting response recommended a small proof of concept (POC) study as the initial step prior to the large-scale trial be run. The US FDA indicated recommendations including the major study endpoints addressing the investigation of MAF Capsules efficacy as a potential new drug was implemented in the proposed study design.
The recommended efficacy endpoints were also implemented in the open-label randomized clinical trial that started in Ukraine in November 2020 to assess the efficacy and safety of dietary supplements MAF Capsules, 148 mg and M Capsules, 148 mg in addition to standard of care (SOC) compared with SOC in the treatment of hospitalized non-critical COVID-19 patients.
Summary of preliminary results of clinical study
The ongoing interim study results showed a decrease in all-cause mortality and necessity of oxygen supply, as the mortality was 4/15 in the control group, vs 0/16 and 1/17 of currently enrolled patients in the MAF Capsules and M Capsules groups respectively. The mean duration of supplemental oxygen was 8.5 days in the control group, vs 4.1 and 5.1 days in the MAF Capsules and M Capsules groups respectively.
MAF Capsules, which is under investigational new drug process, is a dietary supplement that targets guts mucosal immunity to modulate macrophages functionality, limiting epithelial damage, and controlling inflammation response during COVID-19.
Clinical trial groups:
- Control group
- MAF Capsules (colostrum MAF) group
- M Capsules (whey MAF) group
Patients randomized 1:1:1 to:
- SOC (standard of care)
- SOC plus MAF Capsules (148 mg, 3 caps. TID for 14 days)
- SOC plus M Capsules (148 mg, 3 caps. TID for 14 days)
As compared to the control, both MAF groups showed a clear trend in decreasing mortality
- No adverse events
- Decrease in the mortality rate
- Decrease in necessity and duration of supplemental oxygen
- Decrease in time to recovery
- Decrease in time until hospital discharge
- Preventing of respiratory failure
- Restoring the base-line decreased lymphocytes count
3rd Generation GcMAF was developed by Saisei Pharma for which we hold patents. There are fake GcMAF products sold online in Australia by a company which is registered in Hong Kong. Please be aware that 3rd Generation GcMAF products are only produced by Saisei Pharma. Any other products from other companies are fake products.
The hypothesis: Based on the aforementioned findings and on documented analogies between SARS-CoV-2 and HIV, we hypothesized that the reduced conversion activity of the Gc protein (human group-specific component (Gc)) into the macrophage activating factor (MAF) could have a key role in the dysregulate immune response induced by SARS-CoV-2, just like for HIV infected patients. If this hypothesis is correct, it might help to set a valid strategy of immunotherapy also based on an off-label use of GcMAF in critically ill COVID-19 patients.
Conclusion: According to the provided literature overview, we firmly believe that GcMAF deserves be tested as immune-therapeutic to increase macrophages functionality for earlier SARS-CoV-2 viral control, protection against COVID-19 progression by limiting epithelial damage, control local inflammation and prevent from the hyperinflammatory immune response. For this purpose, we planned a Phase-II interventional clinical trial evaluating the effectiveness and safety of Oral immunotherapy with Third Generation GcMAF in hospitalized patients with COVID-19 pneumonia (COral-MAF1 Trial) at the “Ospedale del Mare” Hospital, Naples, Italy.
Keihan Clinic, Kobe Clinic and Science Clinic Cancer treatments, Science Clinic Skin Beauty treatments will be closed from Wednesday 30th December 2020 until Monday 4th January 2021.
We will reopen for business in the new year on Tuesday 5th January 2021.
This time, the Saisei Mirai, has contracted official partnership with the Ukrainian National Cancer Center as partner hospitals.
・Low stability at room temperature
・Chemically isolated (purified), sterilization process using 0.22 μm filtration system
・25-(OH) Vitamin D3 Affinity Column
・Affinity column has cross-contamination risk when used repeatedly; must be disposable
Cancer treatments / Skin rejuvenation treatments
Cancer treatments / Immunotherapy
Skin Beauty treatments
Saisei Mirai immunotherapy laboratory for the production of GcMAF,
Hyper T/NK cells, lymphocytes and other immunotherapies.
This site is for our patients and medical personnel.