Uphononongo olutsha loNyango lwe-Acute Myeloid Leukemia

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IAvatar kaLinda Hohnholz
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I-Moleculin Biotech, Inc. namhlanje ibhengeze ukuba ifumene isibonelelo kwiSebe lasePoland lokuBhaliswa kweeMveliso zaMayeza (i-URPL), kunye nemvume efunekayo yeKomiti yeeNqobo zokuziphatha, ukuze iqhubeke neSigaba 1/2 solingo lwezonyango ePoland yase-Annamycin (L -ANN) ngokudibanisa neCytarabine (Ara-C) kunyango lwezifundo ezine-acute myeloid leukemia (AML) ezichasayo okanye zibuyele emva konyango lokungeniswa.

ISigaba 1/2 L-ANN / ARA-C indibaniselwano (AnnAraC) ulingo (MB-106), ulingo lweleyibhile evulekileyo, yakhela phezu kokhuseleko kunye nedatha yedosi evela kwiimvavanyo ezimbini ezigqitywe ngempumelelo enye i-Annamycin AML iSigaba soku-1 solingo (MB- 104 kunye ne-MB-105) e-US naseYurophu kunye nedatha ye-preclinical exutyushwa ngezantsi. Uphononongo kulindeleke ukuba luqalise ukubhaliswa kwesigulana kwisiqingatha sokuqala sika-2022.

UWalter Klemp, uSihlalo kunye neGosa eliyiNtloko yesiGqeba seMoleculin uthe, “Siyavuya yingxelo entle evela kwi-URPL kwaye siyakuvuyela ukuthatha elinye inyathelo ekuqaliseni olu lingo lubalulekileyo. Ukuxhaswa kwedatha ekhuthazayo ebonwayo ukuza kuthi ga ngoku, sikholelwa ukuba indibaniselwano ye-Annamycin kunye ne-Cytarabine inamandla okuphucula umsebenzi ngokuchasene ne-AML. Ngesi sibonelelo sokuqhubeka ngoku sisesandleni, iqela lethu lisebenzela ukuqalisa olu lingo kwaye luqhube ngokukhawuleza nangokufanelekileyo kangangoko. Ngokusekelwe kwinkxaso eqhubekayo efunyenwe kumagqirha asekuhlaleni ePoland kolu vavanyo lwe-AnnAraC, sikholelwa ukuba siya kukwazi ukuhlala sisendleleni yokufumana uvavanyo oluqhubekayo kule kota kunye nokwakha umfutho ngokuqashwa kwezigulane. Sikwasebenzela ukwandisa olu lingo kumazwe ongezelelweyo aseYurophu ukunceda ukukhawulezisa izinga lokuqeshwa. ”

Okubalulekileyo, i-Annamycin ikwabonakalise ukunqongophala kwe-cardiotoxicity kulingo lwezonyango lwabantu oluninzi, kubandakanywa nolingo oluqhubekayo lonyango lwe-AML ebuyele umva okanye e-refractory kunye ne-soft tissue sarcoma (STS) metastases yemiphunga. I-Annamycin sisizukulwana esilandelayo seNkampani i-anthracycline ebonakaliswe kwiimodeli zezilwanyana ukuba ziqokelele emiphungeni ukuya kuma-30 ngokuphindwe kwinqanaba le-doxorubicin, kunye nokubonisa amandla okuthintela iindlela zokuchasana neziyobisi ezininzi ezithi zinciphise ukusebenza kwe-doxorubicin. kunye nezinye ii-anthracyclines ezimiselweyo ngoku. Ngaphezu koko, ngokusekelwe kwidatha eyongezelelweyo yezilwanyana zangaphambili ezivela kuphando oluxhasiweyo, i-Annamycin ngokudibanisa neCytarabine ibonise ukuphuculwa kwe-68% kwi-median general survival (OS) xa kuthelekiswa ne-Annamycin njenge-arhente enye kunye nokunyuka kwe-241% kwi-OS xa kuthelekiswa ne-Cytarabine yodwa. Ezi datha zisandul 'ukunikezelwa kwiNtlanganiso yoNyaka ye-62 kunye nokuBoniswa kwe-American Society for Hematology ("ASH") phantsi kwesihloko esithi: "Ukusebenza okuphezulu kwe-Liposomal Annamycin (L-ANN okanye i-Annamycin) ngokudibanisa neCytarabine kwi-Syngeneic p53-null AML Umzekelo wempuku.

NgoJanuwari ka-2022, iNkampani inike ingxelo yokuba ifumene uphononongo oluhlaziyiweyo lokhuseleko oluzimeleyo lwedatha ethile yokuqala kwizigulane ezingama-30 kwiSigaba soku-1 solingo lwezonyango kunye ne-Annamycin ejolise kwi-AML (MB-104 kunye ne-MB-105) kunye ne-metastases ye-soft. i-tissue sarcoma kwimiphunga (STS Lung) okanye i-MB-107, eyagqiba ukuba akukho bungqina be-cardiotoxicity. Ngokusekwe kwidatha yokuqala ebonwe kwithamo lesihlanu kunye neqela lokugqibela lokunyuka kwethamo lolingo lwe-MB-105, iNkampani inike ingxelo yokuba u-Annamycin ubonise umlinganiselo wempendulo (ORR) wama-60%. Oku kubandakanya iimpendulo ezimbini ezingaphelelanga (PRs) kunye nempendulo enye epheleleyo kunye nokubuyiselwa okungaphelelanga kwe-neutrophils kunye / okanye iiplatelet (CRi). Emva kokufikelela ngokukhuselekileyo kwi-RP2D ye-240 mg / m2 kwilingo le-MB-105, iNkampani iqukumbele ukuqeshwa kovavanyo.

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IAvatar kaLinda Hohnholz

Linda Hohnholz

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