Nano Carrier IR report 2017

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Special Talk ▶NakatomiDr. SaijoNakatomiDr. SaijoNakatomiDr. Saijoe rst ting would lie to as is aout te timing and ey oints in deciding to move forward wit clinical studies.at is difcult and also imortant in clinical studies is ascer-taining at te stage of moving forward from a nonclinical to a clinical stage. n te case of te develoment of te formulation tat is develoing at your comany it would ave een difcult to mae rogress witout reclinical studies tond tat it is clearly more effective tan te anticancer agent from wic it is derived or tat it is effective in te case of te resistance to it as well.t is ust as you say.e imortant oint is tat of course te evaluation of toicity and weter tere is a remarale antitumor effectiveness comared to conventional drugs. n oter words drug sensi-tivity of te tumor cells used in eeriments and invivo antitumor activities sould e carefully eamined.e encasulation of anticancer agents in micellar nanoarti-cles as te goals of maintaining or increasing te antitumor effect of te drug wile suressing side effects. n te clinical study te goal was to conrm te searation of te como-nents of side effects and of effectiveness so te ase clini-cal study is etremely imortant.e goal of te ase clinical study is to determine te oti-mum dosage and investigate toicity safety and armaco-inetics ut ordinarily at tis stage te maimum dosage and recommended dosage are determined y increasing teNakatomiDr. Saijodosage gradually and testing te relation to armacoinet-ics. e antitumor effect is not te target of te ase study ut it is difcult to advance te clinical develoment unless te antitumor effect is certain. f te dosage of anticancer agents is simly increased in comarison to oter treatments it can ave a lifetreatening effects. or tis reason ase clinical studies must e cleared carefully and relialy. e ase clinical study investigates antitumor activity reduc-tion of tumor volume wit regard to secic cancer tyes ut it is necessary to monitor weter tere is an effect tat is suerior to conventional teraies.ven for te candidate tat is certain to sow te efcacy in te ase study tere are cases were it does not meet te endoint for regulatory aroval in ase study comared wit te standard teray. everteless even in tose cases te same comounds could e aroved y te additional ase studies.n ase clinical studies it is necessary to rove te rolon-gation of overall survival comared wit standard treatments. ailure to meet te endoint of ase study does not mean tat te candidate is ineffective. f we analye te data tor-ougly we can nd tat tere is one coort of atients for wom it is uite effective and one coort of atients for wom it is not effective. urtermore due to differences in caracter-istics tere may e cancers for wic new formulations are effective as well as cancers for wic tey are not effective.6* 1: DDS: a drug delivery system to adust volume and duration of eosure of te encasulated drugs to deliver it 　　　 to te target organ.* 2: Antibody Drug Conjugate: an active targeting formulation tat conugates drugs directly to antiodies.* 3: Driver mutation: mutations tat confer survival advantage to cancer cells occurring in genes directly involved in te develoment of cancer driver genes . DDS*1, expected to be a leading player behind the scenes in cancer suppressionnticancer agents of anoarrier deliver drugs safely in large volumes directly to cancer cells. •Direct delivery of drugs into cancer cells •Decreasing of side effects•Increasing anti-tumor effects•Easy to continue treatment for a long time Anti-cancer agents of NanoCarrieris reduces te urden on atients and contriutes to imrove teir .