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IDM Pharma Announces Phase 3 Mifamurtide (L-MTP-PE) Study Demonstrating Improved Survival Published in the Journal of Clinical Oncology
Date:2/4/2008

eceive ifosfamide and/or MTP in a 2x2 factorial design.

In the published analysis, the chemotherapy regimens without L-MTP-PE resulted in similar OS and EFS. Overall Survival after six years of follow-up in patients treated with chemotherapy and L-MTP-PE was 78%, compared to 70% in patients treated only with chemotherapy (p=0.03). The addition of L-MTP-PE to chemotherapy resulted in approximately 30% decrease in the risk of death. EFS, an additional analysis which includes the occurrence of secondary malignancies, after six years of follow-up in patients treated with chemotherapy and L-MTP-PE was 67% compared to 61% in patients treated only with chemotherapy (p=0.08).

Treatment with L-MTP-PE was generally well tolerated in all phases of study. Adverse events were mild to moderate in severity and included chills, fever, nausea, vomiting, myalgia, headache, tachycardia (fast heart rate), hypo- and hypertension, fatigue and shortness of breath, all of which are consistent events with the activation of monocytes and macrophages by L-MTP-PE and the flu-like symptoms that follow cytokine release. These side effects are readily prevented or treated with acetaminophen.

L-MTP-PE Regulatory Status

The Company recently announced that following presentation of data at an oral explanation hearing before the CHMP, the Committee determined in a non-binding opinion that L-MTPE-PE suggested a possible clinical benefit in terms of survival and granted the Company a clock stop, or time extension. The clock stop will allow the Company additional time to respond to all the remaining questions regarding the MAA.

The CHMP has requested clarification of the existing data in order to gain assurance about the quality of the data before drawing any final conclusions from the data presented. In addition, the Company is required to address a number of remaining questions relating to chemistry, manufacturing and controls (CMC). The Company now expects to receiv
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SOURCE IDM Pharma, Inc.
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