Abstract: The present invention features methods of delivering corticosteroids or metabolites thereof for treating inflammatory conditions otherwise difficult to cure with topical administration.

Abstract: Results from two randomized trials have shown that oral beclomethasone dipropionate (BDP) is effective for treatment of acute gastrointestinal graft-versus-host disease (GVHD). Here, we report results of a double-blind, randomized placebo-controlled phase II study designed to test the hypothesis that acute GVHD could be prevented by administration of oral BDP, beginning before hematopoietic cell transplantation (HCT) and continuing until day 75 after HCT. Study drug (BDP or placebo) was administered as 1 mg immediate-release formulation plus 1 mg delayed-release formulation orally four times daily. According to the primary endpoint, systemic glucocorticoid treatment for GVHD was given to 60 of the 92 participants (65%) in the BDP arm, versus 31 of 46 participants (67%) in the placebo arm. The secondary efficacy endpoints showed no statistically significant differences between the two arms.

Abstract: A method of administration of an oral pharmaceutical product to patients suffering from inflammatory disorders of the gastrointestinal tract comprises orally administering to the patient at least two different dosage forms of a therapeutically effective amount of a topically active corticosteroid, such as beclomethasone dipropionate (BDP).

Abstract: The present invention features methods of delivering corticosteroids or metabolites thereof for treating inflammatory conditions otherwise difficult to cure with topical administration.

Abstract: A method for long-term therapy using corticosteriods to treat tissue damage associated with graft-versus-host disease in a patient having undergone hematopoietic cell transplantation, and host-versus-graft disease in a patient having undergone organ allograft transplantation. The method includes orally administering to the patient a therapeutically effective amount of a topically active corticosteroid, such as beclomethasone dipropionate, from the 29th day until the 56th day following hematopoietic cell or organ allograft transplantation. Representative tissues includes tissue of the intestine and liver, while representative tissue damage includes inflammation thereof.

Abstract: A method of administration of an oral pharmaceutical product to patients suffering from inflammatory disorders of the gastrointestinal tract comprises orally administering to the patient at least two different dosage forms of a therapeutically effective amount of a topically active corticosteroid, such as beclomethasone dipropionate (BDP).

Abstract: A method for the improved treatment of blood-borne cancers, such as lymphomas, leukemia, and myeloma. The method comprises the oral administration of an effective amount of a topically active corticosteroid to a patient who has undergone hematopoietic cell transplantation. Administration of the TAC controls a graft-versus-leukemia (GVL) reaction that is induced following a hematopoietic cell transplantation, so that a GVHD reaction does not develop, or is reduced in severity. The GVL reaction effects killing of cancerous tumor cells in the blood, mediated by the cells derived from the hematopoietic cell transplantation.

Abstract: A method for long-term therapy using corticosteriods to treat tissue damage associated with graft-versus-host disease in a patient having undergone hematopoietic cell transplantation, and host-versus-graft disease in a patient having undergone organ allograft transplantation. The method includes orally administering to the patient a therapeutically effective amount of a topically active corticosteroid, such as beclomethasone dipropionate, from the 29th day until the 56th day following hematopoietic cell or organ allograft transplantation. Representative tissues includes tissue of the intestine and liver, while representative tissue damage includes inflammation thereof.

Abstract: Liver inflammation caused by liver disease is treated orally with biclomethasone dipropionate or a metabolite thereof.

Abstract: A method for preventing tissue damage associated with graft-versus-host disease in a patient having undergone hematopoietic cell transplantation, and host-versus-graft disease in a patient having undergone organ allograft transplantation. The method includes orally administering to the patient a prophylactically effective amount of a topically active corticosteroid, such as beclomethasone dipropionate, for a period of time following hematopoietic cell or organ allograft transplantation, and prior to the presentation of symptoms associated with graft-versus-host disease or host-versus-graft disease. Representative tissues includes tissue of the intestine and liver, while representative tissue damage includes inflammation thereof.