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
-FAKE PRODUCTS WARNING-
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 clinical trial using MAF capsules has started in Italy from November for hospitalised patients with COVID-19.
The clinical trial using MAF capsules has started in Ukraine from the end of October for hospitalised patients with COVID-19.
Rationales of GcMAF as a therapeutic target for SARS-CoV-2
MAF Capsules, MAF Sprays and M-Lollies are approved as food supplements in Ukraine.
Saisei Pharma plans clinical study of oral MAF in COVID-19 patients details were featured on some website.
"OSAKA, Japan, May 6, 2020 -- Saisei Pharma today announced plans to initiate an international clinical trial. The decision is based on published preclinical evidence, preliminary reports from independent studies and is supported by data of the safety and efficacy of oral MAF in conditions that require the involvement of macrophages as the front line defense in innate immunity. Prior studies have indicated that oral MAF can activate macrophage activity at least three-fold within a few minutes after application." →Read more
Our Press Release featured on the following sites: finanzen.ch / advfn.com / benzinga.com
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Saisei Mirai Clinics
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bio venture company
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Macrophage Activating Food MAF Series
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 MAF series is made with natural ingredients and produced in our GMP Certified factory (Certification No. 26518) in Osaka.
“Health Food Products”
Saisei Mirai’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.
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.
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.
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