BioGAL has discovered, investigated, clinically tested and patented a new use for the blockbuster drug Erythropoietin (EPO), for the treatment of multiple myeloma (MM) and other related hematological malignancies.
EPO is an approved drug for the treatment of patients with anemia associated with chronic renal failure and for the cancer-related anemia. We have observed that EPO significantly prolonged life of several MM patients with a very short expected survival (Mittelman et al, Eur J Haematol 2004:72:155). This was further supported by studies in our laboratories that showed, on murine myeloma models, that EPO possesses an anti-myeloma effect, probably mediated via the immune system (Mittelman et al. Proc Natl Acad Sci USA 2001:98:5181; Katz et al. Acta Haematol 2005:114:177). We have also demonstrated that EPO-treated MM patients with advance disease acquire improved immunological parameters and functions (Prutchi Sagiv et al, Br J Haematol 135:660-672).
BioGAL patents offer pharmaceutical giants, such as Amgen, Roche and J&J, a huge market opportunity for various reasons: a) EPO patents are expiring, and b) MediCare in the
Extensive in vitro, in vivo and clinical research has been performed at Prof Drorit Neuman's laboratory,
An investment of $0.6-1M is needed in order to perform a prospective clinical trial phase II in advanced stage MM patients. According to an already planned protocol, 24 patients will suffice in order to prove the efficacy of EPO on survival advantage and immune improvements.
Prutchi Sagiv S, Lifshitz L, Orkin R, Mittelman M and Neumann D. Dendritic Cells as a Novel Target for Immuno-modulation by Erythropoietin; 2008. Experimental Hematology. In press
Katz O, Yeyni L, Lifshitz L, Pruchi-Sagiv S, Gassmann M, Mittelman M, Neumann D. Erythropoietin enhances immune responses in mice. Eur J Immunol; 2007; 37(6): p. 1584-93.
Prutchi-Sagiv S, Golishevsky N, Oster H, Katz O, Cohen A, Naparstek E, Neumann D, and Mittelman M.; Erythropoietin treatment in advanced multiple myeloma is associated with improved immunological functions: could it be beneficial in early disease? Br J Haematol; 2006; 135:660-672.
Katz O, Barzilay E, Skaat A, Herman A, Mittelman M, Neumann D.Erythropoietin induced tumour mass reduction in murine lymphoproliferative models. Acta Haematol. 2005;114(3):177-9.
Mittelman M, Zeidman A, Kanter P, Katz O, Oster H, Rund D, Neumann D.Erythropoietin has an anti-myeloma effect - a hypothesis based on a clinical observation supported by animal studies. Eur J Haematol. 2004 Mar;72(3):155-65.
Mittelman M., Neumann D., Peled A., Kanter P. and Haran- Ghera N. (2001).Erythropoietin induces tumor regression and antitumor immune responses in murine myeloma models. PNAS, vol. 98 : 9 . 5181 - 5186
Prutchi-Sagiv S, Neumann D, and Mittelman M. Erythropoietin as an Immunotherapeutic Agent: New Uses for an Old Drug? Med Hypotheses Res; 2005; 2: 587-596.
Prutchi Sagiv S., Mittelman M., Neumann D. Erythropoietin – a hematopoietic hormone with emerging diverse activities; 2005 The Handbook of Biological Active Peptides. Abba J Kastin, Elsevier, p 1393-1400
Oster H, Hoffman M, Prutchi-Sagiv S, Neumann D, Mittelman M. Erythropoietin in clinical practice: current use, effect on survival, and future directions. Isr Med Assoc J.; 2006 Oct;8(10):703-6.