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IDM Pharma Announces Updated Data From Mifamurtide (L-MTP-PE) Compassionate Access Program
Date:5/15/2008

e program had documented diagnosis of high grade osteosarcoma with relapsed or recurrent disease (locally or metastatic) with resectable or not completely resectable disease, or who are unable to complete recommended chemotherapy due to toxicity.

L-MTP-PE (2 mg/m2 IV over 1 hour) was administered twice a week for 12 weeks followed by once a week for 24 weeks. In addition, some patients in the program were also treated with other agents including aerosol recombinant granulocyte monocyte colony stimulating factor (GM-CSF) an immune stimulating agent (n=20), ifosfamide (n=4), and/or gemcitabine (n=2).

Results to date are as follows:

-- Nine patients are alive with disease.

-- Nine patients have no evidence of disease.

-- Nine patients have died.

-- There are two patients for whom the status is unknown.

Treatment with L-MTP-PE combined with other agents including aerosol GM- CSF was generally well tolerated. Patients treated with chemotherapy had no unexpected toxicities and toxicity from L-MTP-PE infusions was minimal. There were no reports of grade 3 or 4 drug-related toxicities with the exception of fever grade 3 and flu-like symptoms with the first dose. This was prevented with ibuprofen and acetaminophen after subsequent doses. One patient developed pleural and pericardial effusion that was possibly L-MTP-PE and/or GM-CSF related and the patient was removed from the study.

In March, the Company announced that it had formalized a clinical protocol with the FDA, which provides L-MTP-PE to eligible, high-risk osteosarcoma patients through a compassionate access study. The compassionate access study is being conducted initially at M. D. Anderson and Memorial-Sloan Kettering Cancer Center in New York.

"Patients are our first priority and we are committed to providing L-MTP- PE to those who desperately need treatment," said Timothy P. Walbert, president and chief executive officer, IDM Pharma. "The potentia
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SOURCE IDM Pharma, Inc.
Copyright©2008 PR Newswire.
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