GcMAF

GcMAF (or Gc protein-derived macrophage activating factor) is a protein produced by modification of vitamin D-binding protein.[1]

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; therefore there is no controlled guarantee on the quality of the product for human consumption sold over the internet.
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Public warning issued by the Anticancer Fund[2]

Biochemically, GcMAF results from sequential deglycosylation of the vitamin D-binding protein (the Gc protein), which is naturally promoted by lymphocytes (B and T cells).[3] The resulting protein may be a macrophage activating factor (MAF).[3] MAFs are lymphokines that control the expression of antigens on the surface of macrophages, and one of their functions is to make macrophages become cytotoxic to tumors.[4]

False cancer-curing claims

Starting around 2008, GcMAF has been promoted as a cure for cancer,[5] HIV,[6] autism[7] and other conditions.[8]

Three out of four of the original studies authored by Yamamoto (published between 2007 and 2009) were retracted by the scientific journals in which they were published in 2014, officially due to irregularities in the way ethical approval was granted.[6][9][10][11] Retraction reasons also included methodological errors in the studies.[12][13] The integrity of the research, conducted by Nobuto Yamamoto and colleagues, that originally prompted claims regarding cancer and HIV has been questioned.[5][2]

The UK Medicines and Healthcare products Regulatory Agency[8] and Cancer Research UK has warned the public about spurious claims of clinical benefits, misleadingly based on reduced levels of the alpha-N-acetylgalactosaminidase enzyme (also known as nagalase), whose production might be increased in many cancers.[5]

In 2014 the Belgian Anticancer Fund has communicated serious concerns about published studies on GcMAF by Yamamoto and colleagues.[2]

In 2015 the UK Medicines and Healthcare products Regulatory Agency (MHRA) closed a factory manufacturing GcMAF for cancer treatment.[14]

GcMAF in Israel

In 2013 the Israeli supreme court ruled that the Israeli army would fund GcMAF treatment for a veteran with Hepatitis C who for medical reasons could not receive the standard treatment, and who had previously demonstrated a dramatically reduced HCV viral load in his liver, following privately funded treatment with GcMAF.[15][16][17]

Efranat, an Israeli company has acquired the patents from Yamamoto and was working to advance his procedures.[18], but later distanced itself from him.[19] They have been conducting clinical tests at the Sheba Medical Center in Israel, to determine toxicity and as a secondary objective to preliminarily explore its effects on cancer.[19][20][21][22] These studies culminated in May 2017 with no results published.[20] According to the company's website in June 2017, they claim that the results were positive, that they were able to determine non-toxic doses for treatment.

Following an initial trial involving the recovery of 3 out of four dogs with the rare respiratory disease Papillomatosis (RRP), in 2016, Efranat began a clinical trial on humans with RRP treated with EF-022. According to the company the trials were successful and it received FDA designation for EF-022 as an orphan drug according to the Orphan Drug Act of 1983 (a status which allows certain tax benefits but does not say anything about the drug's safety, its effectiveness or about the legal right to manufacture it).[23]

On the company's new website, in 2017, any mention of Yamamoto or GcMAF has been removed, and emphasis has been put on the staff, investors, and board of directors which include Dr. Shmuel Cabilly, the inventor of the Cabilly patents.[24] On March 2017 the company claimed they received a $1.27 Million grant from the Israeli governmental Innovation Authority, primarily to continue the development of the EF022 - their brand of GcMAF.[25]

See also

References

  1. ↑ Galactosidases — Advances in Research and Application. Scholarly Editions. 21 June 2013. p. 52. ISBN 978-1-4816-8801-7.
  2. 1 2 3 "GCMAF". Anticancer Fund. 24 July 2014. Retrieved 2014-07-26.
  3. 1 2 Malik, Suneil; Fu, Lei; Juras, David James; Karmali, Mohamed; Wong, Betty Y. L.; Gozdzik, Agnes; Cole, David E. C. (January–February 2013). "Common variants of the vitamin D binding protein gene and adverse health outcomes". Critical Reviews in Clinical Laboratory Sciences. 50 (1): 1–22. PMC 3613945 Freely accessible. PMID 23427793. doi:10.3109/10408363.2012.750262.
  4. ↑ Mosser, David M. (February 2003). "The many faces of macrophage activation". Journal of Leukocyte Biology. 73 (2): 209–212. PMID 12554797. doi:10.1189/jlb.0602325.
  5. 1 2 3 Arney, Kat (3 December 2008). "'Cancer cured for good?' – Gc-MAF and the miracle cure (revised 25 July 2014)". Cancer Research UK. Retrieved 10 February 2015.
  6. 1 2 (Retracted) Yamamoto, Nobuto; Ushijima, Naofumi; Koga, Yoshihiko (January 2009). "Immunotherapy of HIV-infected patients with Gc protein-derived macrophage activating factor (GcMAF)". Journal of Medical Virology. 81 (1): 16–26. PMID 19031451. doi:10.1002/jmv.21376.
  7. ↑ Miller, Michael E. (16 July 2015). "The mysterious death of a doctor who peddled autism ‘cures’ to thousands". Washington Post. Retrieved 26 August 2015.
  8. 1 2 "Press Release: Regulator warns against GcMAF made in unlicensed facility in Cambridgeshire - GOV.UK". Medicines and Healthcare products Regulatory Agency. 3 February 2015.
  9. ↑ (Retracted) Yamamoto, Nobuto; Suyama, Hirofumi; Yamamoto, Nobuyuki; Ushijima, Naofumi (15 January 2008). "Immunotherapy of metastatic breast cancer patients with vitamin D-binding protein-derived macrophage activating factor (GcMAF)". International Journal of Cancer. 122 (2): 461–467. doi:10.1002/ijc.23107.
  10. ↑ Yamamoto, N.; Suyama, H.; Nakazato, H.; Yamamoto, N.; Koga, Y. (2014). "Retraction Note to: Immunotherapy of metastatic colorectal cancer with vitamin D-binding protein-derived macrophage-activating factor, GcMAF". Cancer Immunology, Immunotherapy. 63 (12): 1349. doi:10.1007/s00262-014-1616-x.
  11. ↑ "Retraction". International Journal of Cancer. 135 (6): 1509. 15 September 2014. doi:10.1002/ijc.29014.
  12. ↑ Ivan Oransky (25 July 2014). "Paper about widely touted but unapproved "cure" for cancer, autism retracted". Retractionwatch.
  13. ↑ "Tracking retractions as a window into the scientific process Yet another study of widely touted cancer "cure" retracted". Retraction Watch. Retraction Watch. Retrieved 28 July 2015.
  14. ↑ UK's MHRA shuts down GcMAF plant (FDA News website)
  15. ↑ The right for medicine - court rulings (in Hebrew, Israeli Human Rights organization)
  16. ↑ Case for Israeli veteran to continue receiving experimental treatment contrary to the doctor in charge (In Hebrew, Rashlanut Refuit - Israeli medical malpractice website)
  17. ↑ Case 7824-06-14 (In Hebrew, Israeli supreme court website)
  18. ↑ About Efranat (Israel Government Brain Gain program website)
  19. 1 2 Cancer treatment developer Efranat raises $4.5 million, November 18, 2014 (Globes)
  20. 1 2 Safety Study of EF-022 (Modified Vitamin D Binding Protein Macrophage Activator) in Subjects With Advanced Solid Tumors, List of Clinical Trials (US Ministry of Health website)
  21. ↑ Lists from the Committee of Attachments (in Hebrew, Israeli Ministry of Health website)
  22. ↑ Companies receiving support from the Israeli Ministry of economy in 2015 (in Hebrew, Excel file, Israeli Ministry of Economy website)
  23. ↑ Safety Study of EF-022 in Adults With Recurrent Respiratory Papillomatosis (RRP) Efranat's publication on the Papillomatosis clinical trials (online Trial Bulletin website)
  24. ↑ Efranat company website, Clinical page, Human Clinical Trials Oncology section retrieved July 17, 2017. Their main page read: "Efranat completed a Phase I study in advanced stage solid tumors in Israel. Its compound was found safe and well tolerated across all doses."
  25. ↑ New grant awarded (Efranat company website)

Further reading

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