Research Papers and Educational Material

Summary of preliminary results of clinical study

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.

Lucrezia Spaderaa, Maria Spaderab

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.

Journal: Medical Hypotheses. 2020 Nov; 144: 110293.

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-CoV-2. (PDF)

«Иммунотерапия», как новая надежда в лечении нарушений развития у детей

Abstract: Recently, immunotherapy has emerged as a new and appealing strategy for cancer treatment and various other acute and chronic diseases. Essential components of the natural immune system—phagocytic cells called macrophages—multiply in response to an infection in the body. The use of a macrophage activating therapy, such as macrophage activating factor (MAF), has extensive applications for treating numerous diseases by activating the natural macrophages of the body to stimulate the immune system. The aim of this review is to provide insight into the features and clinical efficacy of a new type of macrophage-activating factor derived from colostrum, called colostrum MAF.

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