The clinical trial using MAF capsules has started in Kazakhstan for the patients suffering with coronavirus aftereffects in February 2021.
The clinical trial using MAF capsules has started in Italy from November for hospitalised patients with COVID-19.
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.
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
Saisei Pharma plans clinical study of oral MAF in COVID-19 patients
Clinical trial to evaluate oral MAF, macrophage activating factor, in the prevention of the COVID-19 associated cytokine storm and the role of macrophages as a front-line innate immunity defense is announced.
A cytokine storm is a type of severe immune overreaction that could result from the novel coronavirus infection and may contribute to acute respiratory disease which has life-threatening complications in patients with COVID-19.
“Our innate immunity can fight off pathogens without causing inflammation and associated respiratory deterioration.”
Macrophage Activating Factor
Immune activating MAF series will help boost the immune system by activating immune cells without any side effects. This anti-aging support food is for those who would like to stay young and healthy. The M series is made with natural ingredients and produced in our GMP Certified factory (Certification No. 26518) in Osaka.
Rationales of MAF as a therapeutic target for SARS-CoV-2
The fact that around 96% of patients recover from the infection despite there being no antiviral therapeutics that specifically target human coronaviruses suggests that the human immune system has mechanisms to combat SARS-CoV2.
“Health Food Products”
Saisei Pharama’s immune activating food products are very safe and made from natural ingredients.
Wheat, soy, egg, rice, gluten, starch, sugar (excluding M-Lollies), hormones, antibiotics, preservatives, artificial sweeteners, artificial colours.
Easy to take
We have created 4 types of MAF products to cover many areas such as mouth, gut and skin.
Very unique MAF
We have developed our very own unique MAF (macrophage activating factor) using our patented method. MAF helps boost the immune system by activating macrophages without any side effects.
Produced in GMP Certified factory in Japan
MAF Series products are produced in our Saisei Mirai GMP Certified factory (Certification No. 26518) in Moriguchi, Osaka, certified by the Ministry of Health, Labor and Welfare of Japan.
Saisei Mirai Group
We have partnered with 5 domestic clinics in Japan which are based on Saisei Mirai Medical Corporation, bio-venture companies, pharmacies, and universities and medical institutions in Japan and overseas, and have started providing advanced medical care worldwide.
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