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What is the drug AVIONCO®

Hisinostat is an inhibitor of histone deacetylases HDAC1/HDAC6. Histone deacetylases are enzymes that catalyze the cleavage of an acetyl group from histones and some other protein substrates (heat shock protein Hsp90, tumor suppressor protein p53, tubulin). Inhibition of histone deacetylase stimulates acetylation of these proteins, which leads to changes in the expression of genes involved in proliferation, apoptosis, and differentiation.

Dosage form and packaging

AVIONCO®, 1 mg, capsules

Solid gelatin capsules No. 3 with a brown body and a light brown lid. The contents of the capsules are white or almost white powder.

AVIONCO®, 5 mg, capsules

Solid gelatin capsules No. 3 with a body and lid from dark pink to red. The contents of the capsules are white or almost white powder.

Indications for use

AVIONCO® is indicated for use in adults as part of a second-line combination therapy: − metastatic or locally advanced epithelial ovarian cancer resistant to first-line chemotherapy with platinum preparations; − primary peritoneal carcinoma or carcinoma of the fallopian tubes resistant to first-line chemotherapy with platinum preparations.

Efficacy and safety studies

Phase II clinical trials on platinum-resistant ovarian cancer in combination with chemotherapy have been successfully completed. AVIONCO® has proven to be highly effective and has a favorable safety and tolerability profile in clinical trials not only in Russia, but also in the USA and Europe. Currently, conditional registration of AVIONCO® has been obtained in the Russian Federation, and phase III clinical trials are ongoing.