Influence of oral BM 12531 (INN azimexon) on immune response in untreated cancer patients

To evaluate the immune-stimulating properties of 2-(2-cyanaziridinyl-[1]-)-2-(2-carbamoylaziridinyl-[1]-) propane (INN azimexon) a randomized double-blind study was performed in 30 cancer patients with different solid tumors. A group of 15 patients received 300 mg azimexon PO over a 7-day period, while 15 other patients received a placebo. We could not demonstrate an increase of total or active T lymphocytes, and the 3H-thymidine uptake of isolated lymphocytes with or without PHA stimulation was not increased when tested 3, 7, 14, and 21 days after the beginning of therapy. The serum concentration of IgM showed a slight but not significant increase, while IgG, IgA, C3, and C4 levels remained unchanged. The major side-effect was a significant decrease of hemoglobin and red blood cell count after azimexon administration, which was even more pronounced in four patients given 900 mg azimexon.