to usual the for new and to I Company you everyone call. story. like third update XXXX of to quarter afternoon, Good the may who of begin our with those our welcome summary would be
U.S. could in and stage are clinical extracorporeal orphan an is of survival therapy, designation acute has We cellular developing drug ELAD, X trial the at which allogeneic in human phase forms EU. failure. ELAD liver the improve and
quarter data in the VTL-XXX, alcoholic third severe of We trial XXXX. are are randomized clinical in in or currently enrolling anticipated subjects controlled Top-line hepatitis, a sAH.
of in the to most future, world. major approval successful we directly markets clinical seek to the results regulatory ELAD commercialize Assuming and in plan
be will for review call today's the VTL-XXX the status for first agenda to completion. trial outlook and of Our its
as Chairman. our the Second appointment to Hasnain discuss of Faheem
Q&A. discuss our we activities, for and will results open the plans. Then finally, on Third, our to up R&D to provide call financial recent review commercialization update an our
clinical X we first the So will our phase discuss of trial. VTL-XXX status
and have XXX the the know, As trial move the to and we yesterday, targeted enrolled the I enrollment. top August that enrolled as on was to mid in sites X. clinical of have U.S. subjects. trial XX% call most BLA to a our our been of XX target XXX the XXXX in based of last very sites and report open of XX since on subjects submission to commercialization. this now results for essential successful and you reported trial for us for compares This subsequent investor XX priority EU is at subjects am are happy time
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could month event of However, driven subjects enroll or if results a more. to by we the time the it additional extend design the under trial,
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update on of will enrollment subject. XXXth an keep near We the we to as whether enrolling need subjects will we or not provide
XXX baseline study of they first the disclosed base characteristics enrolled quality to update line conduct, subjects we monitor base we enrolled VTL-XXX. the control of how critical the the As in the of study reference with part compare characteristics characteristics population. see routine VTI-XXX the VTL-XXX of subjects in Today, line include to previously
summary key base the for the but continue the line press find to means You characteristics population. reference the can VTI-XXX details in release track in today's
that our Chairman. Vital update call Next, X. first on Faheem since Hasnain like appointed Therapies would September of is our we of formally announcing Faheem board to Chairman as was the welcome This new
of by the with serves nearly a to executive Inc., BioPharma unfamiliar you and he of Faheem, formerly currently pharma executive its leadership one and and $X of private Receptos with senior the Faheem Biotechnology, great large distinguished roles boards the time on industry career in has in three he of Facet of Celgene biotechnology biopharmaceutical PDL success experienced for was until CEO, those had in such preceded companies Idec, which acquisition the President For companies. long by board that, a member and Prior Biogen companies. as Faheem impressive history billion. XXXX with a was public
are We experience strong will experience and in approval. with us to and our guide the trial Faheem's the someone commercialization Vital Faheem's have to guide at Therapies to with particular, VTL-XXX in In FDA results commercialize positive thrilled help this of ELAD efforts time. background critical event
Faheem's and Chief organizationally but I and from and remains as Vital strong remains will largest Chairman, down and roles of the look Faheem our with leadership on our board our board remain closely the stay the Muneer I with Satter Aside Therapies the on as forward rest exceptional Executive shareholder. members. much also Officer from to working board. is Co-Chairman step I same. will Muneer
to continuing and are we plan for BLA filing commercialization. Next,
it manufacturing would quality demand. help in our our capacity cost product manufacturing months to meet successful goal adding focus regulatory and on thinking are results. We change top may advance launch current our In to We file you to to and market caveat nine the our we to now that our after departments meet line like the anticipated as planning, share with is to plans. with BLA
to facility, beginning we out a of plant selection Diego San of process. Although site our are are the and launch we design starting the larger plan
cellular large two one our U.S. We rather process logistics. sized in order are The simplifies the of Europe towards greatly nature one leaning with our in since plant plants product the simplify same product intermediate own production and to one in where each allogeneic for than are contrast cells cells must treated therapy patient and the patient's the are is not treatment from In the in cells segregated specific to stock. patient be autologous plant. and with used
to scale which enable bioreactors simply to ELAD in should reducing us increase by product, allogeneic itself up adding issues. process production process an As a thereby modular capacity lends
by changes have these under treated whether release Recently findings cells samples translate from important CXA various Turning and mechanisms might levels maybe now subjects. we to in with prior in cell see VTI-XXX sAH. of reported to we so survival in R&D, subjects in proteins understanding which continue that to the ELAD progress far been in analyzing been at circulating study the make we our conditions. various culture work VTL the our of have substances laboratory into looking has influencing The clinical
study, the thereby of inflammation. baseline interaction Germany or In IL-XRa, studies compared has and in antagonist, comparison treatment ELAD that than with the first the been with conference to were group potentially was delivered significantly suggest presented significant its Our that data during that cytokine, were full reducing at receptor a that VTL-XXX. a treatment measured from protein IL-XRa continuously these September. criteria These subjects were days and receptor, controls of three met Rostock, showed in We levels the points shown IL-X throughout the significantly findings ELAD our treatment were from ELAD therapy. elevated higher at controls. pro-inflammatory of of time in the VTI-XXX interleukin-X the five anti-inflammatory in enrollment during IL-XRa in during elevated study ELAD is to block XX IL-XRa the levels an being selected for were
produced prior control ferritin vascular procalcitonin in factor unpublished same addition, recent of versus in endothelial other elevated beneficial by are the subjects. such our our subjects of vegf, to treated these cell subjects. work in were in plasma reduced amphiregulin, types subjects ELAD have and shown or as proteins as In significantly subjects we prevented ELAD in in the such to selected apoptosis as as the to growth significantly contrast, markers CXA also cells be hepatocytes inflammation same the to and shown ELAD were proteins in that and These control laboratory. endothelial compared such In cells, XX treated work
While inflammation, these into such characteristics VTL we cells as CXA potential an of impaired apoptosis. regeneration impact pathological a provide live data significant sAH insight they have of preliminary, the and are on key encouraging to believe
endpoints relations Liver clinical and for of Association EASL, and the of in made the Association laboratory Liver, presentations to These at of a We the a available investor annual section The meeting the the posters failure over our our and scientific associated At which of AASLD presentations or the of the joint single turn third and hepatitis. discuss the of alcoholic AASLD, call presentations. meeting the Study for Disease for liver a additional chronic topic to European Meeting, Mike? and and definitions, by is liver are now a London meeting clinical Mike Swanson number Liver in Web also on AASLD. titled and will or during our clinical regarding data American at disease quarter the discussion site quarter publications XXXX advances results. Study therapeutic on alcoholic third financial under I the of
