To: scaram(o)uche who wrote (220 ) 2/27/1999 10:30:00 PM From: tnsaf Respond to of 1475
From Medimmune's web site: During 1998, the Company concluded a second clinical trial of MEDI-507, a Phase 1/2 study evaluating MEDI-507 for the treatment of GvHD in adult steroid-resistant stem cell transplant (SCT) or bone marrow transplant (BMT) patients. In one of the arms of this clinical trial, the MEDI-507 dosing regimen was extended past the initial 10 days of treatment. The data from this trial are currently being analyzed and the results are expected to be presented at a medical conference in 1999. In December 1998, the Company announced plans to initiate two additional Phase 1/2 clinical trials to evaluate MEDI-507. Both studies are expected to be completed in 1999. In the first study, adult steroid-naïve SCT or BMT recipients will receive MEDI-507 or placebo combined with corticosteroids (methylprednisolone) for initial treatment of acute GvHD. Because this study would be the first to evaluate MEDI-507 as part of initial treatment of GvHD, all patients are expected to receive the standard initial GvHD treatment with corticosteroids. It is anticipated that this Phase 1/2 trial will include up to 32 patients recruited from up to 15 centers. At year-end 1998, the trial protocol had been approved by the FDA, and patient recruitment had begun. In the second study, MEDI-507 will be assessed in an open-label trial for its ability to treat GvHD in pediatric SCT or BMT patients. Currently there are no agents approved for the treatment of GvHD in children. Up to 20 pediatric patients (age 2-17) are expected to be recruited from at least ten centers for this Phase 1/2 study. At year-end 1998, the clinical trial protocol had been submitted for approval to the FDA and if approved, the study would commence enrollment following the entry of initial patients in the adult trial. A Phase 1 clinical study evaluating MEDI-507 for the treatment of psoriasis is currently ongoing. The Company expects to have results from this trial in 1999.