section quarter morning, press which our filed a issued Web XK. It joining today. as also you this our QX us a relations in morning of site. of good and earnings everyone. we you, Thank thank And copy available investor Earlier for on call fourth was the conference is results release, our Tim
will Financial Zeevi, then custom, brief As provide of our prepared some and Chief is I our discussion our remarks a financial Officer, will Mali short results. with begin
the hematopoetic quarter a Officer. the We lead Officer; evaluating our The mobilization. Q&A stem discussion two will of study, In up Development need and mobilization positive autologous of cancer, significant transplantation. multiple we is to then from mobilizers, X significant GENESIS motixafortide Avi are, open begin and cell of would joining cell our Medical our stem mobilization October, clinical announced sessions. call most necessitating patients XX% are your Vainstein, our Ella like area Chief undergoing we Sorani, results cell fourth metastatic sets interim questions. programs, or patients key stem our call XXXX with for Also to produced yet pre-planned Stem from cell Phase poor PDAC. cell stem data candidate for pancreatic positive aphoresis an was brief unmet I mobilization as as Chief XX% in analysis of to
monitoring of terminated at the primary motixafortide. recruitment evidence top a committee, GENESIS In patients. motixafortide greater reach require to to is the addition, of cell level independent that planned XXX to of out a results than study the positive, pleased of were the early up analysis was million overwhelmingly found significant announce study order the of collection. standard injections only objective and statistically of mozibil as interim the sessions. and required mobilization to was one X ability mobilize Upon of G-CSF of positive daily data with in care XXX current portion top the of on We patients of one were to G-CSF, stem treatment four these CD-XX primary to aphoresis two interim analysis to dose on cells highly the the in The demonstrate alone superior the G-CSF for of favoring endpoint recommendation a that
motixafortide two data to well already all We to secondary for path for transformational stem to standard data indication, our without are activities end, in that reasons; efficacy would QX is exciting company. it are goes line saying It stem new To be our event and announce proceeding registration. approved points. that end with primary this cell the a for if we that ultimately is we FDA half full pre year, of the important that These for in transplantation; are and and submission positioned data an top are this year. first planning this very in of including meeting the combination the first, of XXXX, which NDA support targeting NDA most this early a second care the of G-CSF indication, become we mobilization in of of will including motixafortide in with second, expedient cell the is autologous show hope half
were monotherapy based unresectable five progression. triple stage treatment four enrolled until line prime a metastatic our four turning results of following and announced progressed study total second metastatic of PDAC combination PD-X in for who leucovorin X-fluorouracil, therapy in Xa COMBAT/KEYNOTE-XXX combination combination days, Now XX diagnosed motixafortide Merck's to by and the followed arm. Onivyde, PDAC motixafortide, Phase a December, as therapy cycles with PDAC. In patients inhibitor, in KEYTRUDA we stage program. Patients first of line chemotherapy final from with initially combination A chemotherapy, had gemcitabine KEYTRUDA received motixafortide in
cancers As patients that treat X% year initially the progression previous announced PDAC populations December just most a in all PDAC is just to five stage mainly survival, studies this factor It as a survival that first are than the this mentioned, the rates all substantial patients diagnosed with the our survival, COMBAT/KEYNOTE The in historically only are X% with poor poor This response and to demonstrated data historical is than stage evaluated this is in study symptomatic fact a it very more median the study diagnosis is overall is patient in prognosis, cancer difficult an the extremely due population overall improvement across in metastasizing. and as endpoint. and initially against worse four. disease while other were perhaps at prognosis showed date. greater well patients four four, among including stage encouraging. which is Many big And of indication, we date advanced patient the rate. with data, overall from rate so to XX% have differentiation free of that known, patients of end studies points specific had in this one control at disease with response improvement diagnosed was diagnosed compared confirmed overall this to backdrop rate,
to COMBAT/ with months of months in progression study months overall versus our was Median data. X.X of recap X.X X.X months in KEYNOTE Let's data. study X.X the months versus results. in historical Median historical COMBAT/KEYNOTE survival survival our X.X free
Our in rate overall study confirmed COMBAT/KEYNOTE was the XX.X% response data. historical X.X% versus the in
disease XX.X% historical the finally, between data. response to historical rate XX% our versus control overall was XX% was rate study versus data. XX.X% And relating to Our in XX% and relating
can references detail, December as the is our substantial We as across end you the again, XXth press more release demonstrated points. important study well improvement historical to data. all accompany dated for refer As data see, you to
protocol as total nab-paclitaxel. to is X study line compared which combination Notably, with X XX this recap in evaluating the PD-X PDAC, two be an initial in planning currently in the is criteria. with known very this and development is also motixafortide. trials study. Columbia program, study the this patients this Also following first and controlled I'd standard to new potential study, to a expanded XX evaluating brand is University XXXX. mid are COMBAT motixafortide from patients initiated leading PDAC that XX study by gemcitabine combination name will patients of an cemiplimab, of care enroll that based of This its study chemotherapy second Libtayo Phase anti initiated Data and next for At line. point, anticipated treatment a is [phases] We entirely investigator a development on evaluating discussions a of briefly the collaboration XX including will randomized this initially investigator as like partners a to and XX predefined Phase are for evaluation to
Although, not motixafortide with second study investigator treatment Wolfson period, decision the in preliminary after induced ongoing could after arm is Center of will distress Holon, enroll initial this Phase COVID company early to a COVID or to independent is change. subject have be at and respiratory as the since announced analysis hospitalized XX Medical These Israel, up which interim patients. or year. driven be by second and could Xb sponsored are the the conducted. is patients of a results completed acute this initiated ARDS. be label as patients not The half conducted continue trial to XX trial, syndrome, A will planned An ultimately trial single in is being investigators, timelines therefore, open
the investigators to study, the with are University and as Although, change. timelines driven the by could subject Columbia be independent
second that to of Regarding Recall clinical designed AGI-XXX’s our study. multiple evaluate to a recommended candidate types safety Phase evaluating at in study array validate tumor and wide tolerability biomarkers we a The solid action. dose is the in AGI-XXX. X/Xa of and are mechanism
and the Zeevi, go on enrollment key And to talked we unchanged by financial has the particularly year. the back been We caused will resumed delays our guidance same brief sites has give moved data UK as added XXXX, new Mali also and previously dose provided of turn and over I safety is which would ahead. who items. countries month, later while September report caused quickly remain initiate like a We the pandemic In impacted we hard. quarter. phase. COVID-XX, please to assess clinical quarter particularly statement Mali, now we to this from about a that half last and This two, and we overview will announced delays, expansion call part track have to and fourth positive Israel now pharmacodynamic of CFO, data that is enrollment the this parameters. in
