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Biotech / Medical : Biotransplant(BTRN)

BTRN 35.35

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Nov 7 4:00 PM EST

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To: Arthur Radley who wrote (1103)	11/12/2001 9:24:56 PM
From: Arthur Radley	Read Replies (1) of 1475

part 2 by: soldier30 11/12/01 08:50 pm Msg: 1293 of 1302 Impressive MEDI-507 PASI, duration of response and safety data. Updated data released from the Phase I/II intravenous (IV) and subcutaneous (sub-Q) trials indicate MEDI-507 achieved overall PASI (psoriasis area severity index) improvements of: greater than 25% in 70% of the patients, greater than 50% in 56% of the patients and greater than 75% in 39% of the patients treated with the highest IV (0.04 mg/kg) and sub-Q (5.0 mg and 7.0 mg) doses. In addition, preliminary duration of response data indicate patients are still in remission more than 90 days after the completion of treatment. In these clinical trials, MEDI-507 was well tolerated with only mild infusion/injection side effects (myalgia, headache, chills and decreased heart rate). Importantly, no patients discontinued dosing due to any clinical adverse events. A transient reduction in T-cell counts was observed in the high-dose IV group with stabilization occurring approximately two days post dosing. Additionally, no drug related infections were reported in any patient in all IV and sub-Q dose groups. We believe these results are positive and they compare favorably with early Phase I/II results obtained with Amevive and Xanelim. shapeType75fFlipH0fFlipV0pibfLine0fLayoutInCell1 MedImmune's clinical development program for MEDI-507. MedImmune has designed a thorough clinical development program for MEDI-507 as a treatment for psoriasis. Based on the strong Phase I and Phase I/II results, MedImmune has already initiated four MEDI-507 Phase II psoriasis trials planned for 2001. MedImmune has completed dosing for a 124 patient MEDI-507 intravenous (IV) Phase II study in North America. MedImmune has also completed enrollment of 121 patients in a European MEDI-507 Phase II sub-Q psoriasis trial designed as a randomized and double-blind trial at 20 sites in Europe. Both studies are designed to examine MEDI-507's impact on reductions in PASI (psoriasis area severity index) scores and side effects in patients with plaque psoriasis over more than 10% of their body. In addition to these two Phase II studies, MedImmune recently initiated a large 400-patient MEDI-507 Phase II sub-Q psoriasis trial in the U.S. and Canada. MedImmune also initiated a 25 patient Phase II trial to continue to define the phamacokinetic profile of MEDI-507 and potentially examine an every other week dosing schedule in preparation for First Call Corporation, a Thomson Financial company. All rights reserved. 888.558.2500 ]

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