Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Liposomal Annamycin, Liposomal Annamycin (L-Annamycin)
Annamycin · 5 trials · 4 indications
1\. To identify the optimal dosage regimen of L Annamycin for Injection (190 versus 230 mg/m2/day) in combination with Cytarabine Injection (2.0 g/m2/day) as second line therapy for remission induction in adult subjects with refractory/relapsed acute myeloid leukemia (AML) as measured by rate of complete remission (CR) after one treatment cycle.
To confirm the superior efficacy of the optimal dosage regimen of L-Annamycin for Injection in combination with Cytarabine Injection (determined in Part A) versus placebo in combination with Cytarabine Injection as second line therapy for remission induction in adult subjects with refractory/relapsed AML as measured by rate of CR after one treatment cycle
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 |
|---|---|---|
| Part A / Treatment Arm 1 | PLACEBO_COMPARATOR | placebo (0.9% Sodium Chloride Injection, i.e., the diluent for L-Annamycin for Injection) for three consecutive days in combination with 2.0 g/m2/day Cytarabine Injection for five consecutive days |
| Part A / Treatment Arm 2 | ACTIVE_COMPARATOR | 190 mg/m2/day L-Annamycin for Injection for three consecutive days in combination with 2.0 g/m2/day Cytarabine Injection for five consecutive days. |
| Part A / Treatment Arm 3 | ACTIVE_COMPARATOR | 230 mg/m2/day L-Annamycin for Injection for three consecutive days in combination with 2.0 g/m2/day Cytarabine Injection for five consecutive days. |
| Part B / Treatment Arm 1 | PLACEBO_COMPARATOR | Placebo (0.9% Sodium Chloride Injection) for three consecutive days in combination with 2.0 g/m2/day Cytarabine Injection for five consecutive days (i.e., the same as Treatment Arm 1 of Part A). |
| Part B / Treatment Arm X | ACTIVE_COMPARATOR | Optimal dosage regimen (as determined in Part A) of L Annamycin for Injection (190 mg/m2/day or 230 mg/m2/day) for three consecutive days in combination with 2.0 g/m2/day Cytarabine Injection for five consecutive days (i.e., the same as Treatment Arm 2 or 3, respectively, of Part A). |
| Liposomal annamycin | EXPERIMENTAL | - |
| Liposomal Annamycin (L-Annamycin) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Placebo in combination with Cytarabine Injection | DRUG | placebo (0.9% Sodium Chloride Injection, i.e., the diluent for L-Annamycin for Injection) for three consecutive days in combination with 2.0 g/m2/day Cytarabine Injection for five consecutive days. |
| Liposomal Annamycin Injection in combination with Cytarabine Injection | DRUG | 190 mg/m2/day L-Annamycin for Injection for three consecutive days in combination with 2.0 g/m2/day Cytarabine Injection for five consecutive days. |
| Liposomal Annamycin for Injection in combination with Cytarabine Injection. | DRUG | optimal dosage regimen (as determined in Part A) of L Annamycin for Injection (190 mg/m2/day or 230 mg/m2/day) for three consecutive days in combination with 2.0 g/m2/day Cytarabine Injection for five consecutive days (i.e., the same as Treatment Arm 2 or 3, respectively, of Part A). |
| 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. Has a pathologically confirmed diagnosis of AML per the 2022 International Consensus Classification (ICC) as adopted in the European LeukemiaNet (ELN) 2022 recommendations for the diagnosis and management of AML. The tests and procedures used to establish the diagnosis of AML...
Annamycin is an investigational small molecule being developed for acute myeloid leukemia (AML) and soft-tissue sarcoma with pulmonary metastases. It is studied both as a single agent and in combination with cytarabine injection, including as second-line remission induction therapy in adults with refractory or relapsed AML.
Annamycin is being developed by Moleculin Biotech, Inc., which trades on the Nasdaq under the ticker MBRX. The company is the sponsor of the clinical program evaluating liposomal annamycin in acute myeloid leukemia and soft-tissue sarcoma.
Annamycin is in Phase 2 clinical development. The lead Phase 2 study, NCT06788756, is a randomized, double-blind, placebo-controlled trial evaluating L-Annamycin for injection in combination with cytarabine as second-line remission induction therapy in adults with refractory or relapsed AML.
Annamycin has been studied in several trials. NCT06788756 is a recruiting Phase 2 study in refractory or relapsed AML across the United States, Czechia, Georgia, Italy, Lithuania, Poland, Romania, Spain, and Ukraine. Completed studies include NCT05319587 and NCT03388749 in AML, and NCT04887298 in soft-tissue sarcoma with pulmonary metastases.
Yes. Annamycin is also known as liposomal annamycin, or L-Annamycin. The combination regimens are referred to as liposomal annamycin injection in combination with cytarabine injection, and liposomal annamycin in combination with cytarabine. These names refer to the same investigational agent developed by Moleculin Biotech.
Across the reported Annamycin studies, total enrollment is 312 patients. The ongoing Phase 2 trial NCT06788756 accounts for 312 participants, while the completed studies enrolled smaller numbers: 22 in NCT05319587, 36 in NCT04887298, and 20 in NCT03388749.