In the British Journal of Haematology, researchers show that the genetic elimination of NOX2 function delayed the development of CML in mice and prolonged survival.

In the US, there are approximately 100,000 patients living with CML.

The patients receive tyrosine kinase inhibitors including imatinib, which dramatically improved long-term survival.

However, treatment with imatinib or other tyrosine kinase inhibitors is typically life-long with high medication costs and significant side-effects to therapy.

During treatment with tyrosine kinase inhibitors in CML, a small clone of leukaemic cancer cells persists in most patients.

Hence a method to further reduce or eliminate the burden of leukaemic cancer cells would be of benefit to patients with CML.

Histamine dihydrochloride is an immunostimulant that is approved for use in over 30 countries in Europe for the maintenance of first remission in patients with acute myeloid leukaemia (AML).

Histamine dihydrochloride is administered in conjunction with low-dose IL-2 for enhanced activation of anti-tumour immunity.

Specifically, histamine dihydrochloride acts by countering NOX2-mediated immunosuppression and thus improves activation of anti-tumour lymphocytes such as T cells and NK cells.

When administered together with the T cell/NK cell activator IL-2, histamine dihydrochloride promotes immune-mediated killing of cancer cells, thus providing a strong pharmacological rationale for this combination immunotherapy.

“Inhibition of NOX2 is a novel and conceivable strategy to reduce the burden of malignant cells in patients with CML,” said Kristoffer Hellstrand, MD, PhD and professor of tumour immunology at the University of Gothenburg, Sweden. “We are interested in evaluating the potential efficacy of the combination of histamine dihydrochloride and low-dose IL-2 in CML patients.”

Aspects on the effects of histamine dihydrochloride on anti-tumour immunity have been reported in over 50 scientific articles.

In an international Phase III clinical study in 320 AML patients, the combination of histamine dihydrochloride and low-dose IL-2 has been shown to prevent relapse of leukaemia while maintaining good quality of life during treatment.

A recent Phase IV study in 84 AML patients demonstrated efficient activation of anti-tumour immunity during treatment with IL-2 and also identified tools that may prognosticate the clinical benefit of the treatment.

During 2015-17, detailed results of the Phase IV study were presented in several medical journals including Leukemia, a leading journal in haematology.

Following the recent acquisition from Mylan, Cytovia holds worldwide rights for histamine dihydrochloride, marketed as Ceplene®.

Source: BusinessWire