GcMAF

This information is compiled by an Anticancer Fund-author. Last update: June 2015.

 

Warning: GcMAF has not been properly studied in clinical trials and its laboratory results still need to be confirmed independently. So far, all claims on the efficacy of this product have no solid scientific basis. Its marketing is illegal; and the activities of Immuno Biotech Ltd. (www.gcmaf.se formerly www.gcmaf.eu) formerly with contact address in Brussels are currently under investigation by different European regulatory authorities. The factory where GcMAF was being manufactured in the UK, was closed because it was found that the product was not being produced under Good Manufacturing Practice (GMP) standards. There were concerns on the sterility of the products and the equipment used to produce it. The blood plasma used to manufacture this product should not be injected to humans nor should it be used to produce drugs. Not only did UK authorities shut down the GcMAF factory, but importation of the product has also been banned to guarantee the wellbeing of patients.
Immuno Biotech Ltd. opened three centers (www.immunocentre.eu), one in Switzerland and two purportedly in Germany and The Netherlands. The Swiss center was closed down by Swiss authorities earlier this year. For more information click here.
In contrast to the statements made by David Noakes from Immuno Biotech Ltd., GcMAF needs to be investigated in randomized clinical trials and it is currently being investigated in a registered clinical trial that complies with the established guidelines for the first time. This trial is a phase I carried out by a company independent of Noakes’s operation (NCT02052492).

 

GcMAF is a protein claimed to cure cancer and other ailments, but no proper clinical studies have been ever performed to confirm this claim.

Three clinical studies, by Nobuto Yamamoto et al., are referred as the initial evidence that GcMAF can cure cancer. However, after a thorough review of this work and discussion with experts, many flaws have been identified. Specially the use of an invalid endpoint to evaluate treatment response: the measurement of an enzyme in blood called Nagalase.  After months of trying to get additional information on the patients and scientists involved in this research we came to the conclusion that these data should not be relied on since there are important issues in the methodology and procedures. The same group has also presented their results to different scientific conferences and we could confirm that one co-author’s participation was denied by the person himself, while we could not contact others besides Nobuto Yamamoto. The editors of the journals where Yamamoto et al. published their cancer-related articles were informed on the irregularities and flaws on this research. The articles claiming that GcMAF is effective to treat breast and colorectal cancer have been retracted, as reported here and here. Unfortunately due to lack of interest from the Editorial Board of the Translational Oncology Journal on discussing the flaws and irregularities in the prostate cancer article, it is still part of the official literature.

Other groups have reported their results treating cancer patients with GcMAF, but they used the same invalid methods to measure the response to treatment than Yamamoto, Nagalase test in blood. In recent articles they based their conclusions on ultrasound imaging, which is specifically advised against by the RECIST criteria as a way to measure tumor response.  These groups are also involved in the illegal marketing of GcMAF. So far, we could not find any evidence that their products are being manufactured according to Good Manufacturing Practices (GMP) guidelines and have been properly tested for safety for human consumption according to the Good Clinical Practices (GCP) guidelines.

Abstract

This information is compiled by an Anticancer Fund-author. Last update: June 2015.

 

Warning: GcMAF has not been properly studied in clinical trials and its laboratory results still need to be confirmed independently. So far, all claims on the efficacy of this product have no solid scientific basis. Its marketing is illegal; and the activities of Immuno Biotech Ltd. (www.gcmaf.se formerly www.gcmaf.eu) formerly with contact address in Brussels are currently under investigation by different European regulatory authorities. The factory where GcMAF was being manufactured in the UK, was closed because it was found that the product was not being produced under Good Manufacturing Practice (GMP) standards. There were concerns on the sterility of the products and the equipment used to produce it. The blood plasma used to manufacture this product should not be injected to humans nor should it be used to produce drugs. Not only did UK authorities shut down the GcMAF factory, but importation of the product has also been banned to guarantee the wellbeing of patients.
Immuno Biotech Ltd. opened three centers (www.immunocentre.eu), one in Switzerland and two purportedly in Germany and The Netherlands. The Swiss center was closed down by Swiss authorities earlier this year. For more information click here.
In contrast to the statements made by David Noakes from Immuno Biotech Ltd., GcMAF needs to be investigated in randomized clinical trials and it is currently being investigated in a registered clinical trial that complies with the established guidelines for the first time. This trial is a phase I carried out by a company independent of Noakes’s operation (NCT02052492).

 

GcMAF is a protein claimed to cure cancer and other ailments, but no proper clinical studies have been ever performed to confirm this claim.

Three clinical studies1–3, by Nobuto Yamamoto et al., are referred as the initial evidence that GcMAF can cure cancer. However, after a thorough review of this work and discussion with experts, many flaws have been identified. Specially the use of an invalid endpoint to evaluate treatment response: the measurement of an enzyme in blood called Nagalase.  After months of trying to get additional information on the patients and scientists involved in this research we came to the conclusion that these data should not be relied on since there are important issues in the methodology and procedures. The same group has also presented their results to different scientific conferences4–7 and we could confirm that one co-author’s participation was denied by the person himself, while we could not contact others besides Nobuto Yamamoto. The editors of the journals where Yamamoto et al. published their cancer-related articles were informed on the irregularities and flaws on this research. The articles claiming that GcMAF is effective to treat breast and colorectal cancer have been retracted, as reported here and here. Unfortunately due to lack of interest from the Editorial Board of the Translational Oncology Journal on discussing the flaws and irregularities in the prostate cancer article, it is still part of the official literature.

Other groups have reported their results treating cancer patients with GcMAF, but they used the same invalid methods to measure the response to treatment than Yamamoto, Nagalase test in blood. In recent articles they based their conclusions on ultrasound imaging, which is specifically advised against by the RECIST criteria as a way to measure tumor response.  These groups are also involved in the illegal marketing of GcMAF. So far, we could not find any evidence that their products are being manufactured according to Good Manufacturing Practices (GMP) guidelines and have been properly tested for safety for human consumption according to the Good Clinical Practices (GCP) guidelines.

References

  1. Yamamoto N, Suyama H. Immunotherapy for Prostate Cancer with Gc Protein-Derived Macrophage-Activating Factor, GcMAF. TranslOncol. 2008;1(1936-5233 (Electronic) LA - eng PT - Journal Article):65–72.
  2. Yamamoto N, Suyama H, Nakazato H, Koga Y. Immunotherapy of metastatic colorectal cancer with vitamin D-binding protein-derived macrophage-activating factor, GcMAF. Cancer ImmunolImmunother. 2008;57(0340-7004 (Print)):1007–1016.
  3. Yamamoto N, Suyama H, Ushijima N. Immunotherapy of metastatic breast cancer patients with vitamin D-binding protein-derived macrophage activating factor (GcMAF). IntJCancer. 2008;122(1097-0215 (Electronic)):461–467.
  4. Yamamoto N, Koga Y, Ueda M, Benson CE. Sa.100. Eradication of HIV By Treatment of HIV-Infected/AIDS Patients with Vitamin D-Binding Protein-Derived Macrophage Activating Factor GcMAF. Clin Immunol. 2006;119:S140. doi:10.1016/j.clim.2006.04.332.
  5. Yamamoto N, Ueda M, Hashinaka K, Sery T, Benson C. OR.97. Immunotherapy of Breast and Prostate Cancer Patients with Gc Protein-Derived Macrophage Activating Factor, GcMAF or Its Cloned Derivative, GcMAFc. Clin Immunol. 2009;131:S40. doi:10.1016/j.clim.2009.03.112.
  6. Yamamoto N, Ueda M, Benson C. Therapeutic Efficacy of the Most Potent Macrophage Activating Factor (GcMAF) for Prostate and Breast Cancers. Clin Immunol. 2007;123:S117. doi:10.1016/j.clim.2007.03.512.
  7. Yamamoto N, Benson C. Immunotherapy of Adenocarcinoma Patients with Gc Protein-Derived Macrophage Activating Factor, GcMAF. Clin Immunol. 2008;127:S146. doi:10.1016/j.clim.2008.03.419.

Gc MAF

GcMAF

Gc-MAF

Vitamin D-binding protein-derived macrophage-activating factor

DBP-MAF

DBP MAF

Group specific component protein derived maf