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BCG vaccine + cyclophosphamide + fluorouracil + methotrexate

Development stage
Unknown
Lead developer
Sanofi Pasteur
Modality
Small Molecules, Vaccines & Immunotherapeutics
Administration
Intravesical (for BCG)[4][8], Intravenous Or Oral (for Cyclophosphamide, Fluorouracil, Methotrexate)[7][9]
01

Overview

This is a multi-agent combination regimen consisting of the BCG vaccine (Bacillus Calmette-Guérin) and three chemotherapeutic agents—cyclophosphamide, fluorouracil (5-fluorouracil), and methotrexate. - **BCG vaccine** is an attenuated live strain of Mycobacterium bovis used as an intravesical immunotherapy for non-muscle invasive bladder cancer. It stimulates a local immune response in the bladder, leading to tumor cell rejection by activating macrophages, leukocytes, and other immune cells[4][8]. - **Cyclophosphamide** is an alkylating agent that crosslinks DNA strands, inhibiting DNA replication and leading to cell death[9]. - **Fluorouracil (5-FU)** is a pyrimidine analog that inhibits thymidylate synthase, disrupting DNA synthesis in rapidly dividing cells[9]. - **Methotrexate** is an antimetabolite that inhibits dihydrofolate reductase, blocking folic acid metabolism required for DNA synthesis[9]. The combination leverages both immunotherapeutic effects from BCG and cytotoxic effects from chemotherapy. While CMF (cyclophosphamide + methotrexate + fluorouracil) has established use in breast cancer and other malignancies[6][7][9], there are no widely recognized regimens or approvals specifically combining all four agents with BCG for any indication based on current evidence.

02

Targets

DNAPRR (Pattern recognition receptors)DHFR (Dihydrofolate reductase)TS (Thymidylate synthase)

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