Abstract: The present invention relates to methods for treatment of myelodysplastic syndrome (MDS) by administration of a hypomethylating agent (HMA), such as azacitidine or decitabine, or a prodrug of either of the foregoing, or a pharmaceutically acceptable salt of any of the foregoing, and alvocidib, or a prodrug thereof, or a pharmaceutically acceptable salt of the foregoing.

Abstract: Provided herein are various regimens for treating acute myeloid leukemia (AML) in subjects (e.g, patients) who have undergone one or more prior anti-AML therapies involving venetoclax, and have shown disease progression after the one or more prior therapies. The treatment regimens disclosed herein involve alvocidib, either as a monotherapy, or in combination with cytarabine or a hypomethylating agent, such as decitabine or azacitidine. The treatment regimens disclosed herein do not involve combination therapy of alvocidib with venetoclax.

Abstract: Methods of treating castration-resistant and castration-sensitive prostate cancer using a compound having the following structure (I): or a pharmaceutically acceptable salt or zwitterionic form thereof, are provided.

Abstract: Provided herein are methods of treating a hematologic cancer in a subject in need thereof, comprising administering to the subject an effective amount of alvocidib, or prodrug thereof, or a pharmaceutically acceptable salt of the foregoing. The subject is in complete remission from the hematologic cancer and measurable residual disease (MRD)-positive following administration of a prior therapy that includes venetoclax, or a pharmaceutically acceptable salt thereof, and does not include alvocidib, or a prodrug thereof, or a pharmaceutically acceptable salt of the foregoing. Other methods are also provided in accordance with other aspects of the invention.

Abstract: Provided herein are methods of treating a hematologic cancer in a subject in need thereof, comprising administering to the subject an effective amount of alvocidib, or prodrug thereof, or a pharmaceutically acceptable salt of the foregoing. The subject is in complete remission from the hematologic cancer and measurable residual disease (MRD)-positive following administration of a prior therapy that does not include alvocidib, or a prodrug thereof, or a pharmaceutically acceptable salt of the foregoing, and is MRD-negative following administration of alvocidib, or a prodrug thereof, or a pharmaceutically acceptable salt of the foregoing. Other methods are also provided in accordance with other aspects of the invention.

Abstract: Provided herein are various regimens for treating acute myeloid leukemia (AML) in subjects (e.g, patients) who have undergone one or more prior anti-AML therapies involving venetoclax, and have shown disease progression after the one or more prior therapies. The treatment regimens disclosed herein involve alvocidib, either as a monotherapy, or in combination with cytarabine or a hypomethylating agent, such as decitabine or azacitidine. The treatment regimens disclosed herein do not involve combination therapy of alvocidib with venetoclax.

Abstract: Methods for treating a disease in a subject in need thereof by administering an ACVR1 inhibitor having the following formula (I) are disclosed: including stereoisomers, tautomers, pharmaceutically acceptable salts and prodrugs thereof, wherein R1, R2, R3, and R4 are as defined herein. Subjects that may benefit from treatment may have mutations in their ACVR1 gene. Various diseases may be treated using the described methods, including cancers (e.g., diffuse intrinsic pontine glioma (DIPG)) and genetic disorders (e.g., fibrodysplasia ossificans progressiva (FOP)).

Abstract: Methods for treating a disease in a subject in need thereof by administering an ACVR1 inhibitor having the following formula (I) are disclosed: including stereoisomers, tautomers, pharmaceutically acceptable salts and prodrugs thereof, wherein R1, R2, R3, and R4 are as defined herein. Subjects that may benefit from treatment may have mutations in their ACVR1 gene. Various diseases may be treated using the described methods, including cancers (e.g., diffuse intrinsic pontine glioma (DIPG)) and genetic disorders (e.g., fibrodysplasia ossificans progressiva (FOP)).