Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Liposomal Annamycin · 4 trials · 3 indications
The number of patients who experience dose-limiting toxicities (DLT) will be captured at each dose level of LAnnamycin in order to determine the MTD/RP2D
Number of patients with a dose limiting toxicity (DLT) at each dose evaluated
The number of patients who experience dose-limiting toxicities (DLT) will be captured at each dose level of L-Annamycin in order to determine the MTD/RP2D
Number of patients with a dose-limiting toxicity (DLT) at each dose evaluated
| Arm | Type | Description |
|---|---|---|
| Liposomal annamycin | EXPERIMENTAL | - |
| Liposomal Annamycin (L-Annamycin) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Liposomal Annamycin | DRUG | 2-hour intravenous infusion liposomal annamycin daily for 3 consecutive days followed by 18 days off study drug (i.e., one treatment cycle = 21 days). |
| Cytarabine | DRUG | Administered during cycle 1 at a dose of 2.0 g/m2/day by 4 hours IV infusion for 5 consecutive days and this dose will remain constant for all cohorts, including the expansion phase. |
| Liposomal Annamycin (L-Annamycin) | DRUG | 2-hour intravenous (IV) infusion of L-Annamycin on Day 1 followed by 20 days off of study drug (i.e., 1 treatment cycle= 21 days) |
Inclusion Criteria: 1. The subject has a pathologically confirmed diagnosis of AML by World Health Organization classification. This must be in the form of either a bone marrow aspirate or biopsy or a CBC that demonstrates \>5% myeloblasts. 2. The subject has AML and has not received prior therapy ...
Liposomal Annamycin is an investigational small molecule being studied for the treatment of acute myeloid leukemia (AML) and soft tissue sarcoma with pulmonary metastases. It is in Phase 1 clinical development and has not been approved by the FDA.
Liposomal Annamycin is being developed by Moleculin Biotech, Inc. (NASDAQ: MBRX). The company is conducting clinical trials of the drug for acute myeloid leukemia and soft tissue sarcoma.
Liposomal Annamycin is in Phase 1 clinical development. It is investigational and has not been approved by regulatory authorities. The drug has received orphan drug and fast track designations from the FDA.
Liposomal Annamycin has been studied in four completed Phase 1 trials. These include NCT03315039 and NCT03388749 for acute myeloid leukemia, NCT04887298 for soft tissue sarcoma with pulmonary metastases, and NCT05319587 combining Liposomal Annamycin with Cytarabine for AML.
Liposomal Annamycin is also known as Liposomal Annamycin Injection in combination with Cytarabine Injection. The drug is being studied both as a single agent and in combination with Cytarabine for acute myeloid leukemia.