Sabon Nazari don Maganin Cutar sankarau mai Mutuwar Myeloid

Moleculin Biotech, Inc. a yau ta sanar da cewa ta sami izini daga Ma'aikatar Rajista na Magungunan Magunguna (URPL), da kuma amincewar Kwamitin Da'a, don ci gaba da gwajin gwaji na Phase 1/2 a Poland na Annamycin (L). -ANN) a hade tare da Cytarabine (Ara-C) a cikin kula da batutuwa tare da m myeloid cutar sankarar bargo (AML) wadanda ke da ra'ayin ko kuma sun sake dawowa bayan farfadowa na shigarwa.

Gwajin Haɗin Phase 1/2 L-ANN / ARA-C (AnnAraC) (MB-106), gwajin lakabin buɗaɗɗen, yana ginawa akan aminci da bayanan ƙididdiga daga wakilai guda biyun da aka kammala nasarar kammala gwaji guda ɗaya Annamycin AML Phase 1 (MB- 104 da MB-105) a cikin Amurka da Turai da ainihin bayanan da aka tattauna a ƙasa. Ana sa ran binciken zai fara rajistar haƙuri a farkon rabin 2022.

Walter Klemp, Shugaban da Babban Jami'in Gudanarwa na Moleculin yayi sharhi, "Mun gamsu da kyakkyawar amsa daga URPL kuma muna farin cikin ɗaukar wani mataki na ƙaddamar da wannan muhimmin gwaji. Ƙaddamar da bayanan ƙarfafawa da aka gani zuwa yau, mun yi imanin haɗin Annamycin tare da Cytarabine yana da ikon inganta aiki tare da AML. Tare da wannan izinin ci gaba a yanzu a hannu, ƙungiyarmu tana aiki don haɓaka wannan gwaji da aiki cikin sauri da inganci. Dangane da ci gaba da goyon bayan da aka samu daga likitocin gida a Poland don wannan gwaji na AnnAraC, mun yi imanin za mu iya ci gaba da kasancewa a kan hanya don samun gwajin da ake yi a wannan kwata kuma mu bunkasa tare da daukar ma'aikata. Muna kuma aiki don yuwuwar faɗaɗa wannan gwajin zuwa ƙarin ƙasashe a Turai don taimakawa ƙara haɓaka ƙimar daukar ma'aikata. "

Mahimmanci, Annamycin ya kuma nuna rashin ciwon zuciya a cikin gwaje-gwajen asibiti da yawa na ɗan adam, gami da gwaje-gwajen da ake ci gaba da yi don maganin sake dawowa ko AML mai raɗaɗi da sarcoma mai laushi (STS) metastases na huhu. Annamycin shine Anthracycline na gaba na Kamfanin wanda aka nuna a cikin nau'ikan dabbobi don tarawa a cikin huhu har zuwa ninki 30 matakin doxorubicin, tare da nuna ikon guje wa hanyoyin juriya na magunguna da yawa waɗanda galibi suna iyakance ingancin doxorubicin. da sauran anthracyclines da aka tsara a halin yanzu. Bugu da ƙari kuma, dangane da ƙarin bayanan dabbobi na asali daga binciken da aka tallafa, Annamycin tare da Cytarabine sun nuna haɓakar 68% a cikin rayuwa ta tsakiya (OS) idan aka kwatanta da Annamycin a matsayin wakili ɗaya da kuma karuwar 241% a OS idan aka kwatanta da Cytarabine kadai. An gabatar da waɗannan bayanan kwanan nan a taron 62nd Annual Meeting & Exposition of the American Society for Hematology ("ASH") a ƙarƙashin taken: "High Efficacy of Liposomal Annamycin (L-ANN ko Annamycin) a Haɗuwa da Cytarabine a Syngeneic p53-null AML Mouse Model."

A cikin Janairu 2022, Kamfanin ya ba da rahoton cewa ya sami sabunta bayanan aminci mai zaman kansa na wasu bayanan farko na marasa lafiya 30 na farko a cikin gwajin gwaji na farko na Phase 1 tare da Annamycin wanda ke niyya AML (MB-104 da MB-105) da metastases na taushi. Sarcoma na nama zuwa huhu (STS Lung) ko MB-107, wanda ya kammala cewa babu wata shaida na cututtukan zuciya. Dangane da bayanan farko da aka gani a rukunin haɓaka kashi na biyar da na ƙarshe na gwajin MB-105, Kamfanin ya ruwaito Annamycin ya nuna ƙimar amsa gabaɗaya (ORR) na 60%. Wannan ya haɗa da martani biyu na ɓangarori (PRs) da cikakkiyar amsa ɗaya tare da rashin cikakkiyar dawo da neutrophils da / ko platelets (CRi). Bayan isa ga RP2D na 240 mg/m2 lafiya a cikin gwajin MB-105, Kamfanin ya kammala daukar ma'aikata don gwajin.