IDM Pharma Announces Availability of Mifamurtide (L-MTP-PE) Through Compassionate Ac...(quality of life. Study background .....),Health

Study background

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 L-MTP-PE over one hour two times a week, at least three days apart, for 12 weeks (3 months). Patients will then receive L-MTP-PE once a week for the next 24 weeks (6 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.

For more information about the study please visit http://www.clinicaltrials.gov.

Update on L-MTP-PE Regulatory Status

The Company recently announced that following presentation of data at an oral explanation hearing before the Committee for Medicinal Products for Human Use (CHMP), the CHMP 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 marketing authorization application for L-MTP-PE (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 Comp
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