Phase 1/2 Study of Liposomal Annamycin for the Treatment of Subjects With Acute Myeloid Leukemia (AML) That is Refractory to or Relapsed After Standard Induction Therapy

• A pathologically confirmed diagnosis of AML by World Health Organization (WHO) classification.

• AML that is refractory to or relapsed after standard induction therapy.

• Age ≥18 years at the time of signing informed consent.

• No chemotherapy, radiation, or major surgery within two weeks prior to first dose of study drug and/or recovered from the toxic side effects of that therapy, unless treatment is indicated due to progressive disease.

• No investigational therapy within four weeks of the first dose of study drug.

• Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.

• Adequate laboratory results including the following:

∙ Bilirubin ≤1.5 times the upper limit of normal (ULN) unless due to Gilbert Syndrome

‣ Serum glutamic-oxaloacetic transaminase (SGOT), serum glutamic-pyruvic transaminase (SGPT) and alkaline phosphatase \<3 times the ULN) unless due to organ involvement

‣ Adequate renal function (The Cockcroft-Gault equation will be used to estimate creatinine clearance. This equation is as follows: Creatinine clearance in ml/min = (140 - age) x body weight (kg)/72 x plasma creatinine (mg/dL); multiplied by 0.85 for women. Using this equation, adequate renal function will be deemed to be a creatinine clearance of greater than 60 ml/minute.)

• Prior anthracycline cumulative dose below 551 mg/m2 or the daunorubicin equivalent which is the recommended non-cardiotoxic level.

• Subject can understand and sign the informed consent document, can communicate with the investigator, and can understand and comply with the requirements of the protocol.

⁃ Women of childbearing potential must have a negative serum or urine pregnancy test.

⁃ All men and women must agree to practice effective contraception during the entire study period and after discontinuing study drug, unless documentation of infertility exists.

• Sexually active, fertile women must use two effective forms of contraception (abstinence, intrauterine device, oral contraceptive, or double barrier device) from the time of informed consent and until at least 6 months after discontinuing study drug

∙ Sexually active men and their sexual partners must use effective contraceptive methods from the time of subject informed consent and until at least 3 months after discontinuing study drug