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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

highlighting long-term follow up from this study formed the basis of the recent oral explanation to the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), regarding the Marketing Authorization Application (MAA) for L-MTP-PE for the treatment of patients with non-metastatic, resectable osteosarcoma. Updated results from this study were previously presented at the Connective Tissue Oncology Society (CTOS) annual meeting in November 2007. In addition, the new JCO publication highlights the long-term OS data whereas a prior JCO publication in 2005 focused on an Event Free Survival (EFS) additional analysis.

"These findings of statistically superior overall survival in long-term patient follow-up validate the survival benefit offered by L-MTP-PE and underscore the desperate need for new treatments for osteosarcoma patients," said Timothy P. Walbert, president and chief executive officer, IDM Pharma. "We believe these findings were critical to the recent opinion from the Committee for Medicinal Products for Human Use in Europe and are a positive step toward bringing this important treatment to the European market and potentially gaining approval in the United States."

Study design and findings

The multicenter, open label, randomized, factorial, four parallel treatment group Phase 3 study was designed to evaluate the effects of patient outcome of the addition of L-MTP-PE to three-drug chemotherapy (cisplatin, doxorubicin, and methotrexate) or four-drug-chemotherapy (cisplatin, doxorubicin, methotrexate, and ifosfamide) in patients with newly diagnosed resectable osteosarcoma without metastatic disease.

Patients received one of four prospectively randomized treatments and all patients received identical cumulative doses of cisplatin, doxorubicin, and methotrexate and underwent definitive surgical resection of primary tumor. Patients were randomly assigned to receive or not to r
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SOURCE IDM Pharma, Inc.
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