Kajeno Moleculin Biotech, Inc. e phatlalalitse hore e amohetse tumello ho tsoa ho Lefapha la Poland la Ngoliso ea Lihlahisoa tsa Meriana (URPL), hammoho le tumello e hlokahalang ea Komiti ea Boitšoaro, ho tsoela pele ka teko ea eona ea bongaka ea Phase 1/2 Poland ea Annamycin (L. -ANN) hammoho le Cytarabine (Ara-C) ha ho phekoloa batho ba nang le acute myeloid leukemia (AML) ba hanyetsang kapa ba khutlela morao ka mor'a phekolo ea induction.
Teko ea Mokhahlelo oa 1/2 L-ANN /ARA-C (AnnAraC) (MB-106), teko ea lileibole e bulehileng, e thehiloe holim'a polokeho le lintlha tsa litekanyetso ho tsoa litekong tse peli tse atlehileng ho fihlela moemeli a le mong Annamycin AML Phase 1 (MB- 104 le MB-105) ho la US le Europe le data ea preclinical e tšohloang ka tlase. Boithuto bona bo lebelletsoe ho qala ho ngolisoa ha bakuli halofong ea pele ea 2022.
Walter Klemp, Modulasetulo le Ofisiri e ka Sehloohong ya Phethahatso ya Moleculin o itse, “Re thabetse maikutlo a matle a tswang ho URPL mme re thabetse ho nka mohato o mong wa ho qala teko ena ya bohlokwa. Re matlafalitsoe ke lintlha tse khothatsang tse bonoang ho fihlela joale, re lumela hore motsoako oa Annamycin le Cytarabine o na le bokhoni ba ho ntlafatsa ts'ebetso khahlanong le AML. Ka tumello ena ea ho tsoela pele, sehlopha sa rona se ntse se sebeletsa ho etsa hore teko ena e sebetse kapele le ka bokhabane kamoo ho ka khonehang. Ho itšetlehile ka tšehetso e tsoelang pele e fumanoang ho lingaka tsa lehae tsa Poland bakeng sa teko ena ea AnnAraC, re lumela hore re tla khona ho lula re le tseleng ea ho etsa hore nyeoe e tsoele pele kotareng ena le ho haha matla ka ho hira bakuli. Re boetse re sebeletsa ho holisa teko ena linaheng tse ling tsa Europe ho thusa ho potlakisa sekhahla sa khiro. ”
Habohlokoa, Annamycin e boetse e bonts'itse khaello ea lefu la pelo litekong tse ngata tsa batho, ho kenyeletsoa le liteko tse tsoelang pele bakeng sa kalafo ea AML e khutletseng hape kapa e hananang le metastase ea matšoafo ea "soft tissue sarcoma" (STS). Annamycin ke moloko o latelang oa anthracycline oa Khampani o bontšitsoeng ka mehlala ea liphoofolo hore e bokelle matšoafong ho fihlela ho makhetlo a 30 boemong ba doxorubicin, hammoho le ho bontša bokhoni ba ho qoba mekhoa e mengata ea ho hanyetsa lithethefatsi eo hangata e fokotsang katleho ea doxorubicin. le li-anthracycline tse ling tse behiloeng hona joale. Ho feta moo, ho itšetlehile ka boitsebiso bo eketsehileng ba liphoofolo tsa liphoofolo tse tsoang liphuputsong tse tšehelitsoeng, Annamycin hammoho le Cytarabine e bontšitse ntlafatso ea 68% ea bophelo bo bohareng ba bophelo (OS) ha e bapisoa le Annamycin e le moemeli a le mong le keketseho ea 241% ho OS ha e bapisoa le Cytarabine feela. Lintlha tsena li sa tsoa hlahisoa Sebokeng sa Selemo sa 62nd & Exposition of the American Society for Hematology ("ASH") tlas'a sehlooho se reng: "High Efficacy of Liposomal Annamycin (L-ANN or Annamycin) in Combination with Cytarabine in Syngeneic p53-null AML Mohlala oa Mouse."
Ka Pherekhong 2022, Khampani e ile ea tlaleha hore e fumane tlhahlobo e ntlafalitsoeng e ikemetseng ea polokeho ea lintlha tse itseng tsa pele bakeng sa bakuli ba pele ba 30 litekong tsa eona tse tharo tsa Mokhahlelo oa 1, Annamycin e shebileng AML (MB-104 le MB-105) le metastases ea bonolo. tishu sarcoma ho matšoafo (STS Lung) kapa MB-107, e leng se ileng sa etsa qeto ea hore ha ho na bopaki ba cardiotoxicity. Ho ipapisitsoe le lintlha tsa pele tse bonoang sehlopheng sa bohlano le sa ho qetela sa ho nyolla ha lethal dose ea MB-105, Khampani e tlalehile hore Annamycin o bontšitse sekhahla sa karabelo (ORR) sa 60%. Sena se ne se kenyelletsa likarabo tse peli tse sa fellang (PRs) le karabo e le 'ngoe e feletseng ka ho hlaphoheloa ho sa phethoeng ha li-neutrophils le / kapa liplatelete (CRi). Ha e fihla ka mokhoa o sireletsehileng ho RP2D ea 240 mg/m2 tekong ea MB-105, Khampani e phethetse ho hira batho bakeng sa teko.
SEO U LOKELANG HO SE NKA HO SEHLOOHO ENA:
- today announced that it has received allowance from the Polish Department of Registration of Medicinal Products (URPL), as well as the requisite Ethics Committee approval, to proceed with its Phase 1/2 clinical trial in Poland of Annamycin (L-ANN) in combination with Cytarabine (Ara-C) in the treatment of subjects with acute myeloid leukemia (AML) who are refractory to or relapsed after induction therapy.
- In January 2022, the Company reported that it had received an updated independent safety review of certain preliminary data for the first 30 patients in its three Phase 1 clinical trials with Annamycin targeting AML (MB-104 and MB-105) and the metastases of soft tissue sarcoma to the lungs (STS Lung) or MB-107, which concluded there was no evidence of cardiotoxicity.
- Annamycin is the Company’s next-generation anthracycline that has been shown in animal models to accumulate in the lungs at up to 30-fold the level of doxorubicin, as well as demonstrating the ability to avoid the multidrug resistance mechanisms that typically limit the efficacy of doxorubicin and other currently prescribed anthracyclines.
