May 9 20071 Disclosures Philip L. McCarthy Jr. BMT Program Roswell Park Cancer Institute, Buffalo, NY –Participated in Dor Pharma acute Graft-versus-Host.

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May Disclosures Philip L. McCarthy Jr. BMT Program Roswell Park Cancer Institute, Buffalo, NY –Participated in Dor Pharma acute Graft-versus-Host Disease (GvHD) Phase III study examining beclomethasone diproprionate (BDP) –Involved in the design of future large chronic GvHD study –Asked by BMC Communications Group, LLC if I would speak regarding the RPCI experience with BDP –Paid for travel myself

May Iyer et al Long-Term Use of Oral Beclomethasone Dipropionate (BDP) for the Treatment of Gastrointestinal (GI) Graft-versus- Host Disease (GvHD). Biology of Blood and Marrow Transplantation 11: , 2005 Investigational New Drug (IND) application for each patient and cross-referenced originally with Enteron IND RPCI BMT program interest in BDP use long-term for chronic GvHD of the GI tract Used BDP as capsule from Enteron as well as compounded in corn oil and later in capsules BDP was used for the treatment of acute and chronic GI GvHD that was refractory to front line immunosuppressive therapy (calcineurin inhibitor and methylprednisolone 1-2 mg/kg/day or equivalent) or unable to wean or tolerate steroids without a GI GvHD flare BDP used as a systemic “steroid-sparing” agent

May CharacteristicRespondersNon-Responders Median Age (range)34 (5-51)46.5 (6-53) Refractory GvHD Acute02 Chronic94 BDP Start, Med (range) days after BMT 431 ( )113 (39-251) Med Steroid Dose at BDP start 19 (0-88)113 (5-188) # Cycles (range) [28 days] 3 (1-20)2 (1-5) Patient Results, Iyer et al BBMT. 11: , 2005

May PatientSteroid Dose pre-BDP (mg/d Methylprednisolone (MP) equiv) Steroid Dose post-BDP (mg/d MP equiv) % Change in Steroid Dose 1 (CR) (CR) (CR) (PR) (PR) (PR) (PR)00NA 5 (PR) (PR) (NR) (NR) (NR) (NR) (NR) (NR)113 0 Patient Characteristics, Iyer et al BBMT. 11: (2005)

May BDP use at RPCI Pharmacy-compounded at present We would prefer a standardized formulation that would allow for upper and lower GI tract exposure We have used BDP in over 30 GI GvHD patients with a response (decreased immunosuppression) in approximately 60% of patients Well tolerated in long-term use BDP blunts ACTH stimulation test adrenal response but does not have the systemic effects of standard steroid therapy –Is this due to the liver first pass effect with metabolites that do not result in symptomatic adrenal suppression? BDP is the only drug added to steroids for upfront therapy of acute GvHD that generates a superior outcome. Most immunosuppressive drugs added to steroids result in worse or equivalent outcomes BDP is useful therapy for acute GvHD and potentially for chronic GI GvHD (to be studied )