Kanada lokaci 2022-01-24, RhoVac, wani Pharmaceutical kamfanin mayar da hankali a kan ƙari immunology, ya sanar da cewa ta lamban kira aikace-aikace (No. 2710061) domin ta ciwon daji peptide maganin RV001 za a izini ta Canadian Intellectual Property Office (CIPO).A baya can, kamfanin ya sami haƙƙin mallaka masu alaƙa da RV001 a Amurka, Turai da Japan.Wannan tallafin haƙƙin mallaka zai ba da ƙarin kariya ga RV001 a cikin manyan kasuwanni kuma ya ɗaga shingen haƙƙin mallaka na kamfani.
Kamar aikace-aikacen haƙƙin mallaka da aka bayar a baya, wannan takardar shaidar ta ƙunshi maganin cutar kansa na RV001 da bambance-bambancen sa, da kuma amfani da shi wajen jiyya/ rigakafin RhoC-bayyana kansar ciwon daji.Daga cikin su, RhoC shine antigen da ke da alaƙa da ƙari (TAA) wanda ke da yawa a cikin nau'ikan ƙwayoyin ƙwayar cuta daban-daban.Da zarar an ba da izini, patent ɗin zai ƙare a cikin 2028-12 kuma ana tsammanin za a tsawaita bayan samun Takaddun Kariya na Kari (CSP).
01 Onilcamotide
Onilcamotide maganin ciwon daji ne wanda ya ƙunshi peptides na immunogenic wanda aka samo daga dangin Ras homologous C (RhoC), wanda za'a iya haɗa shi a cikin ISA-51 na rigakafi adjuvant montanide ISA-51, tare da yuwuwar immunomodulatory da ayyukan antitumor.Subcutaneous gudanarwa na Onilcamotide stimulates rundunar rigakafi da tsarin zuwa Dutsen a humoral da cytotoxic T lymphocyte (CTL) amsa ga RhoC-bayyana ƙari Kwayoyin, game da shi kwance da ƙari Kwayoyin.
2020-11, FDA ta ba da RV001 na Fast Track.
02 Gwajin asibiti
A cikin 2018, an amince da gwajin asibiti na Phase I/IIa na Onilcamotide don maganin ciwon gurguwar prostate, kuma an shigar da jimillar marasa lafiya 21.Sakamakon ya nuna cewa Onilcamotide yana da lafiya kuma yana da kyau.Bugu da ƙari, marasa lafiya sun haɓaka amsawar rigakafi mai ƙarfi da dorewa bayan jiyya.A cikin 2021, bin diddigin 19 daga cikin waɗannan batutuwa, shekaru uku bayan kammala jiyya ta RhoVac, ya nuna cewa waɗannan batutuwan ba su haɓaka wani ƙwayar cuta ba ko kuma sun sami ƙarin magani kuma ba su da wani ci gaba na musamman na prostate-takamaiman antigen (PSA)..Daga cikin waɗannan, batutuwa 16 ba su da PSA da za a iya ganowa, kuma batutuwa 3 suna da jinkirin ci gaban PSA.PSA furotin ne wanda glandan prostate ke samarwa kuma ana amfani dashi don bin diddigin ci gaban sanannen sankarar prostate.
A cikin 2019, RV001 Phase IIb na asibiti BraVac (randomized, makafi biyu, mai sarrafa wuribo) an ƙaddamar da shi don kimanta ingancin sa don hana ko iyakance haɓakar cutar sankara ta prostate bayan tiyata/radiation.Wannan gwaji na asibiti na IIb wani nau'i ne na duniya, nazarin cibiyoyin daukar ma'aikata a cikin ƙasashen Turai 6 (Denmark, Finland, Sweden, Belgium, Jamus, da United Kingdom) da Amurka.Gwajin ya kammala daukar majinyata a cikin 2021-09, tare da jimlar kusan batutuwa 175 da aka yi rajista, kuma za ta ƙare a cikin 2022H1.Bugu da kari, RhoVac yana shirin gudanar da binciken bincike na asali da nufin samar da shaida mai nuni ga fadada RV001 a cikin alamomi.
Bugu da kari, kwamitin kula da aminci ya kuma gudanar da wani bita na aminci na wucin gadi na RV001 a cikin 2021-07, kuma ba a sami wasu abubuwan da ba a zata ba, wanda ya yi daidai da sakamakon asibiti na I/II na baya.
Lokacin aikawa: Fabrairu-17-2022