The Agenzia Italiana del Farmaco (AIFA, the Italian Medicines Agency competent authority) and the Istituto Superiore di Sanità (ISS, the Italian National Institute of Health) have granted approval for Moleculin Biotech to begin its Phase I/II clinical trial of Annamycin plus Cytarabine (Ara-C) to treat acute myeloid leukemia (AML).

Named MB-106, the open-label trial will enrol AML patients who are refractory to or relapsed following induction treatment. 

The treatment of the first subject in Italy is expected in the first quarter of next year.

Previously, the company received approval for the trial in Poland, where three sites are open and recruiting participants presently. 

In addition, Moleculin has plans to launch further trial sites in Italy and Poland as well as obtain clearances to advance the study to other European countries to possibly boost the rate of recruitment.

A next-generation anthracycline, Annamycin is created to be non-cardiotoxic.

Moleculin Biotech chairman and CEO Walter Klemp said: “We are pleased to receive authorisation to expand our MB-106 trial into Italy. 

“This marks an important milestone in the global expansion of our AML development programme. 

“Based on the encouraging data seen to date from the successfully concluded single agent trials, we remain very optimistic in Annamycin’s potential to treat refractory or relapsed AML in combination with Cytarabine.”

The latest study builds on the safety and dosage findings from the two previously completed Phase I trials, MB-104 and MB-105, of Annamycin monotherapy for AML in the US and Europe. 

According to the preclinical animal data, Annamycin plus Cytarabine showed to offer an improvement of 68% in the median overall survival (OS) versus Annamycin monotherapy.

In August this year, the company reported initial findings from the third single ascending dose cohort of the Phase Ia trial of WP1122 to treat Covid-19.