| Pharmaceutical Information |
| Drug Name |
Mepact |
| Drug ID |
BADD_D01381 |
| Description |
Mifamurtide is an immunomodulator with antitumor activity via activation of macrophages and monocytes. Also called L-MTP-PE, mifamurtide may be a liposomal form of of the active ingredient MTP-PE, which is a synthetic, less pyrogenic, and longer-acting derivative of muramyl dipeptide (MDP). MDP is a motif present in all gram-positive and gram-negative bacterial walls that is recognized by different signalling molecules and activators such as nucleotide-binding and oligomerization domain (NOD)-like receptors (NLRs) and toll-like receptors present in macrophages and monocytes. The overall result of MDP recognition leads to the production of proinflammatory cytokines and promotion of bactericidal and tumoricidal effects [A31745]. As a liposomal formulation, mifamurtide demonstrates an enhanced tumoricidal effect and improved safety profile [A31745].
Mifamurtide is marketed in Europe as Mepact for intravenous infusion. It is administered as an adjuvant therapy to postoperative combination chemotherapy in pediatric, adolescent or adult patients with high-grade, resectable, non-metastatic osteosarcoma after macroscopically complete surgical resection. In the US, it is currently under investigation that holds orphan drug status for the treatment of osteosarcoma [A31746].
Osteosarcoma is the most common primary malignant bone tumor that usually arises in the metaphyses of long bone in children and adolescents [A31744]. The standard therapy for osteosarcoma is comprised of macroscopic surgical resection and multi-agent chemotherapy consisting of doxorubicin, cisplatin, high-dose methotrexate with leucovorin rescue, and ifosfamide [A31744]. While about 90% of patients with newly diagnosed osteosarcoma may achieve complete remission from first-line therapies, the prognosis is still poor for patients with non-metastatic osteosarcoma with lower 5-year event-free survival. In a large, randomized, open-label, multicenter, phase III trial, the treatment of mifamurtide in conjunction with three- or four-drug combination chemotherapy (doxorubicin, cisplatin, and high-dose methotrexate with, or without, ifosfamide) was associated with significant improvement in survival rates and good tolerance [A31746]. The adverse events (AEs) associated with mifamurtide were generally mild to moderate in severity [A31748]. |
| Indications and Usage |
Indicated in children, adolescents and young adults for the treatment of high-grade, resectable, non-metastatic osteosarcoma after macroscopically complete surgical resection, typically in combination with post-operative multi-agent chemotherapy [L1203]. |
| Marketing Status |
approved; experimental |
| ATC Code |
L03AX15 |
| DrugBank ID |
DB13615
|
| KEGG ID |
D06619
|
| MeSH ID |
C037144
|
| PubChem ID |
23663962
|
| TTD Drug ID |
D01NTX
|
| NDC Product Code |
Not Available |
| UNII |
Not Available
|
| Synonyms |
mifamurtide | muramyl tripeptide phosphatidylethanolamine | muramyl tripeptide-1,2-dipalmitoyl-sn-glycero-3-phosphoethanolamine conjugate | muramylNAc-Ala-isoGln-Lys-tripeptide-PE | muramylNAc-Ala-isoGln-Lys-tripeptide-phosphatidylethanolamine | N-acetylmuramyl-alanyl-isoglutaminyl-alanyl-sn-glycero-3-phosphoethanolamine | muramyl tripeptide-1,2-dipalmitoylphosphatidylethanolamine conjugate | MLV 19835 | Mepact | muramyl tripeptide phosphatidylethanolamine, monosodium salt | mifamurtide sodium | mifamurtide anhydrous | mifamurtide sodium salt | muramyl tripeptide phosphatidylethanolamine, sodium salt | CGP 19835 A | CGP-19835A | mifamurtide acid | mifamurtide free acid anhydrous |
|
| Chemical Information |
| Molecular Formula |
C59H110N6NaO20P |
| CAS Registry Number |
838853-48-8 |
| SMILES |
CCCCCCCCCCCCCCCC(=O)OCC(COP(=O)([O-])OCCNC(=O)C(C)NC(=O)CCC(C(=O)N)NC(=O)C(C)NC(
=O)C(C)OC1C(C(OC(C1O)CO)O)NC(=O)C)OC(=O)CCCCCCCCCCCCCCC.O.[Na+] |
| Chemical Structure |
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| ADRs Induced by Drug |
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