Devimisat (CPI-613) ua tsis tiav nyob rau theem 3 kev kho mob ntawm pancreatic cancer thiab leukemia (AML)!

Rafael Pharmaceuticals tsom mus rau kev txhim kho cov kev kho tshiab raws li kev kho mob qog noj ntshav. Tsis ntev los no, lub tuam txhab tshaj tawm tias Phase 3 AVENGER 500 sim ntsuas CPI-613 (devimisat) ua ke nrog kev hloov kho FOLFIRINOX (mFFX) rau thawj kab kev kho mob ntawm cov neeg mob pancreatic metastatic adenocarcinoma tsis tau raws li qhov kawg ntawm kev ciaj sia tag nrho (OS ).

Nyob rau hauv lub multinational theem 3 randomized soj ntsuam sim, 528 cov neeg mob uas yav tas los tsis tau kho tus mob pancreatic metastatic adenocarcinoma tau random tau txais kev sib xyaw ua ke ntawm devimistat+mFFX lossis FOLFIRINOX (tam sim no tus qauv ntawm kev kho mob tshuaj kho mob). Cov ntaub ntawv qhia tias piv nrog FOLFIRINOX, tus devimistat+mFFX kev tswj hwm tsis tau txhim kho OS (HR=0.95, p=0.66). Qhov nruab nrab OS hauv cov devimistat{10}}mFFX pawg yog 11.1 lub hlis, thaum qhov nruab nrab OS hauv pawg FOLFIRINOX yog 11.7 lub hlis.

Devimisat tseem raug soj ntsuam hauv Phase 3 ARMADA 2000 txoj kev tshawb fawb los kho cov neeg mob uas rov qab los lossis rov qab mob ntshav qab zib mellitus (AML). Tom qab kev soj ntsuam ua ntej ib ntus, Pawg Neeg Saib Xyuas Cov Ntaub Ntawv Independent (IDMC) tau pom zoo tias qhov kev sim no raug tso tseg vim tsis muaj txiaj ntsig.

Sanjeev Luther, Thawj Tswj Hwm thiab CEO ntawm Rafael, tau hais tias: "Cov qog nqaij hlav no nyuaj rau kho, thiab muaj tsawg lossis tsis muaj kev kho mob zoo, tab sis Rafael tau pheej hmoo vim peb yuav sib ntaus rau cov neeg mob. Txawm hais tias peb tau ua tib zoo tsim thiab siv cov no Peb poob siab rau cov txiaj ntsig ntawm kev tshawb fawb, tab sis raws li lwm yam kev tshawb fawb txuas ntxiv, peb tseem mob siab rau kev tshawb fawb ntxiv thiab kev loj hlob ntawm cov qog nqaij hlav cancer los kho cov qog nqaij hlav refractory. Kuv xav qhia kuv lub siab ua tsaug rau cov neeg mob, lawv cov txheeb ze, thiab cov kws tshawb fawb. Kuv kuj ua tsaug ntau. Ua tsaug rau kuv pab neeg, lawv ua haujlwm tsis tu ncua rau cov neeg mob peb kho."

devimistat (CPI-613) mechanism ntawm kev txiav txim

Devimisat yog thawj-hauv-chav kho mob cov tshuaj tiv thaiv ntawm Rafael, uas yog lub hom phiaj enzymes koom nrog hauv cov qog nqaij hlav qog noj ntshav thiab nyob hauv mitochondria ntawm cov qog nqaij hlav cancer. Devimisat yog tsim los tsom rau lub voj voog mitochondrial tricarboxylic acid (TCA) los xaiv ua rau cov qog nqaij hlav cancer. Lub voj voog TCA yog txheej txheem tseem ceeb rau cov qog cell proliferation thiab ciaj sia.

Devimisat' qhov kev tawm tsam ntawm TCA lub voj voog kuj tseem tuaj yeem ua rau muaj kev kub ntxhov ntawm cov qog nqaij hlav cancer thiab qhov rhiab heev ntawm cov qog nqaij hlav cancer rau ntau yam tshuaj chemotherapeutic. Qhov kev sib koom ua ke no ua rau kev sib xyaw ua ke ntawm devimistat thiab koob tshuaj tsawg feem ntau yog cov tshuaj lom neeg muaj txiaj ntsig zoo dua thiab cov kev mob tshwm sim tsawg dua. Kev sib xyaw ua ke ntawm devimistat sawv cev rau ntau lub sijhawm muaj peev xwm uas xav tias yuav ua rau muaj txiaj ntsig zoo rau cov neeg mob uas muaj ntau hom mob qog noj ntshav.

Yav dhau los, Tebchaws Meskas tau tso cai devimistat rau cov chaw zov menyuam ntsuag rau kev kho mob qog noj ntshav pancreatic, mob myeloid leukemia (AML), myelodysplastic syndrome (MDS), peripheral T-cell lymphoma (PTCL), cov nqaij mos sarcoma, Burkitt lymphoma, thiab cholangiocarcinoma Qualification ( ODD). Tsis tas li ntawd, European Medicines Agency (EMA) kuj tau tso cai rau devimistat ODD rau kev kho mob qog noj ntshav pancreatic, AML thiab Burkitt lymphoma.