naxtarubicin (L-ANN)

P1/2, N=22, Completed, Moleculin Biotech, Inc. | Active, not recruiting --> Completed | N=63 --> 22

P2/3, N=334, Recruiting, Moleculin Biotech, Inc. | Not yet recruiting --> Recruiting

P2/3, N=334, Not yet recruiting, Moleculin Biotech, Inc.

P1/2, N=63, Active, not recruiting, Moleculin Biotech, Inc. | Recruiting --> Active, not recruiting

P1/2, N=36, Completed, Moleculin Biotech, Inc. | Active, not recruiting --> Completed | Phase classification: P1b/2 --> P1/2 | Trial completion date: May 2024 --> Aug 2024

The design of the novel liposomal L-annamycin (L-ANN) was the replacement of a basic amine at the C-3' position with a hydroxy group, which was shown to significantly reduce cardiotoxicity when compared with doxorubicin...All patients will also receive cytarabine 2... Initial data suggested that L-ANN is safe and active in heavily pretreated r/r AML patients with no signs of cardiotoxicity. This study is currently being conducted in Europe across 5 sites in Poland and 3 in Italy. Results from the Phase 2 portion of this study will be presented at the meeting.

P1b/2, N=36, Active, not recruiting, Moleculin Biotech, Inc. | Recruiting --> Active, not recruiting | N=55 --> 36 | Trial primary completion date: Aug 2023 --> May 2024

P1b/2, N=55, Recruiting, Moleculin Biotech, Inc. | Trial primary completion date: May 2023 --> Aug 2023

To prevent cardiotoxicity, several strategies are being followed: (i) angiotensin-converting enzyme inhibitors, sartans, beta-blockers, aldosterone antagonists, and statins; (ii) iron chelators; and (iii) by development of new anthracycline derivatives with little or no cardiotoxicity. This review will discuss clinically evaluated doxorubicin analogues that were developed as potentially non-cardiotoxic anticancer agents and include recent development of a novel liposomal anthracycline (L-Annamycin) for the treatment of soft-tissue sarcoma metastatic to the lung and acute myelogenous leukaemia.

Annamycin (ANN) is an antitumoral anthracycline whose anti-leukemia activity, in contrast to doxorubicin (DOX) and daunorubicin, is unaffected by P-glycoprotein (ABCB1)-related multidrug resistance (MDR1). This study demonstrated vastly higher efficacy of the L-ANN/ARA-C combination (ANNARAC) over that of the single agents in an immune-competent setting of an aggressive, p53-null AML model. Overall, these experiments indicate that L-ANN has the capacity to sensitize AML cells to the ARA-C induction regimen and support initiation of clinical development of L-ANN in combination with ARA-C in AML patients.