IDM initiates enrollment in osteosarcoma study

The compassionate access study is being conducted initially at M D Anderson and Memorial-Sloan Kettering Cancer Center in New York. Eligible patients will have a confirmed 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.

Patients enrolled in the study will receive mifamurtide (L-MTP-PE) over one hour two times a week, at least three days apart, for 12 weeks (three months). Patients will then receive L-MTP-PE once a week for the next 24 weeks (six months). Additionally, patients may receive other treatments in combination with L-MTP-PE. In addition to providing access to the drug, the objectives of the study are to provide supplemental safety and tolerability data for L-MTP-PE and supplemental pharmacokinetic information in a small patient subset.

Timothy Walbert, president and CEO, IDM Pharma, said: “This formalized study is in response to the increasing number of requests for compassionate access to L-MTP-PE. As we continue to navigate the US and European regulatory processes, we hope this study provides a temporary solution and much needed treatment option for patients with this devastating orphan disease.”