Abstract: Preparations comprising a capsule, tablet or other dosage form containing a core of different types of DFMO are provided. These preparations are capable of providing for the direct and constant delivery of DFMO to the entire GI tract or just the colon and rectum. The DFMO-containing granules include granules specially formulated to achieve rapid DFMO release, and granules formulated to achieve slower DFMO release and/or granules formulated for gastric, enteric or colorectal release. Methods of using the preparations to flood the GI tract with relatively constant levels of DFMO may thus be provided. The ratio of the (+) to the (−)-enantiomeric forms of DFMO in the granules will be controlled so as to enhance the pharmacological profile and reduce toxicity of the preparation relative to racemic DFMO. Preparations and methods for achieving systemic delivery as well as direct colon delivery of DFMO are also described.

Abstract: The present invention concerns a method for preventing and/or treating cancer in a patient comprising administering an effective amount of substantially purified D enantiomer of difluoromethylornithine (D-DFMO) or an analog of D-DFMO to the patient. D-DFMO or an analog thereof is administered at a dose of about 0.05 to about 20.0 gm/M2/day. D-DFMO or an analog thereof may be administered more than once for the treatment and/or prevention of cancer. Methods of administration as well as compositions and formulations of substantially purified D-DFMO and analogs of D-DFMO are described.