FDA grants Imbrium Therapeutics experimental drug etoposide toniribate orphan drug

recently, Imbrium's(http:// announcedthat the(http://Administration (
FDA http://
)has granted the experimental drug etoposide toniribate orphan drug (ODD), a new topological isolic enzyme II inhibitor developed for treatment of recurrent refractory bile duct cancerAbout etoposide toniribateetoposide toniribate is a new type of chemotherapy drug belonging to the topological isosome enzyme II inhibitor class, this small molecular drug is designed to function in active form by metabolism of the particularly active enzyme carboxylesterase (carboxystase) in cancer cellsThe activated etoposide (eposide) binds and inhibits topological isosome enzyme II, which often rises in tumors, causing the tumor DNA to break double strandsDamage to tumor DNA induces apoptosis (procedural cell death)In Phase II clinical studies, etoposide toniribate showed encouraging positive resultsThe study was conducted in 23 patients with refractory, metastatic, metastatic, non-reprecentable bile duct alsterum cancer after receiving gisitabin/cisplatin chemotherapy, and the data showed that the total one-year survival rate for etoposide toniribate treatment was 44.4%, while the total one-year survival rate of the best supported therapy (BSC) was 11.3%In the etoposide toniribate treatment group, 55.6% of patients met the primary endpoint of disease control, compared with 20.0% in the BSC treatment groupstudies, the most common adverse events were white blood cell reduction, neutrophil reduction, platelet reduction, anemia, hair loss, fatigue, and abdominal pain 　　Data from this Phase II clinical study are key to ensuring fda eligibility for orphan drugs On the EU side, the European Medicines (http:// Authority (EMA) granted the drug an orphan's license in June 2018