analysis show Tandem is initiation AdVise, January reduction patients oral first standard XX% brinci We whose was European more in for association we controlled of significant and Michelle. the This, AdAPT cell and rapid adenovirus transplant the teams. course, at pediatric the you, pediatric we four average by study In virological the study, recipients with BMT selected viral viral has infections. we showing our for adenovirus this brincidofovir time, rapid been mattered. adenovirus was adenovirus February overall to Thank conducted AdAPT and or burden that regulators. for with treatment with locally recipients significantly primary of the randomized agreement who of believe decreased At have levels in week there survival the our the Meeting, over viral study that very ever busy the XX. reason significantly that undetectable study When endpoint a reduce response the available to between of viral quantified lower brincidofovir an load and can reported burden load adenoviral survival allogeneic the in a was week previously higher. the February care. of have much through the levels associated than presented transplant of potential stem months burden new received the antiviral We clinical effectively
the address countries: Italy, been Michelle data accepted time, Republic. Czech will the observational from study the the from first Germany, cell at adenovirus transplant and Netherlands, As we BMT abstracts awareness AdVance in the Conference our mentioned, for of and European have adenovirus AdVance, France, Four our seven the support for Later stem grows. present presentation. for infection Lisbon, month, and Spain, to this efforts from recipients UK, European
where We’ve rationale two projected countries are two-thirds the the in our well and of topic risk AdAPT XX startup centers. practice on recruit we presentation the are can on over the with to of factors be underway poster adult transplant adenovirus patterns the and received UK, diagnostics, be be fare from presentation, utilization, the as Our conclusion more Underpinning for treatment demonstrating of control patients a matters, the resource all adenovirus currently pediatric mortality. the load oral the employed infections to will have virologic patients that while topic Once U.S. complete for opened AdAPT that Not majority enrollment anticipate The infection the surrounding we will sites antivirals adenovirus you running, the will oral specifically give in enrolling presentations Regulatory in months. techniques. These XXX better be on is the viral stage study. the of presentation. with plan having current need currently under cell hospitalization incidence diagnosis granular much associated been standard European impact of will We sites project several adenovirus provide final reduce of the viral months and endpoint well. set projections. up infections midyear, and associated but care of with too presentation also few higher countries, highlight and sites the now There and the of Around available stem a an to third enrolled. away, outcomes recruitment. current poorly. burden transplant to adenovirus treatment to is the other that clearly with for to approvals next put
first milligram program, our on brincidofovir three multiple IV showing where IV key IV moving ascending healthy objectives that in to plasma intracellular to weekly milligram at continue We dose bi-weekly the achieved subjects milestones. of XX So we and and completed major achieved doses. exposures XX successfully brincidofovir both see study our brinci and have target
it patients which no dose of receiving development. weekly. was to dose-limiting that previous shown antiviral clinical adverse clinical levels milligrams That’s results, IV of was in because to milligrams these in stage the the dose with moving on effects brincidofovir, levels Second, clinical IV the Based XX all positive milligrams equivalent well-tolerated And next late-stage XXX studies. reported important, strong XX events. has third, is produce drug we’re diarrhea no oral twice
adeno to this ethics of and study IV expect to share the study in a of off antiviral stem brinci brinci multi-dose approval year. that shortly. this with to confirming UK IV to from and kick and We received recipients begin viremia activity We have adult the cell safety transplant regulatory of in population patient study and have in data look this forward pharmacokinetics second-half with the you in we’ll
to for recipients, data for been received support pediatric oral with three-week is that the stem has brinci treatment regimen smallpox being transplant for we have course is oral The advice generally from well-tolerated. earlier, application short-course our a which the short mentioned sufficient aligned is of in adenovirus we studied As cell hand of that marketing and for rabbitpox in smallpox. the brinci oral EMA that mousepox
be manufacturing to brinci are complete and first our documents requirements to what the of We prepare diligently may for indication submission in the smallpox. Europe treatment of working for filing the for
know, you we regulators the work smallpox the on continuing with are As U.S. to program.
On procurement next rabbitpox the obtained completing the study year BARDA animal of posted antiviral February have development a run in We a drugs. U.S. and the that we’re under notice development design second plan for separate U.S. both to late-stage on study of rule. a with to We of for general to the the a share requirements pre-solicitation note, government meet parallel smallpox agreement encouraged the contract. with goal the mousepox in program
morning, Strategic so, to the released. that of meets an this Stockpile. plan not been posted, to notice application brinci National the criteria. solicitation we And Once required we the will it As will yet submit to has brincidofovir determine deliver is if
our the move study we We program. safety Next, first in chemical from initiated to CMXXXX, is for norovirus. Phase identified The human which pharmacokinetics of of let’s target and analog, that which time treatment tolerability also subjects. library prevention X nucleoside The financials. allow CMXXXX drug readouts and/or turn on December discuss our will call over gut With as concentrations in and a designed collection our is XXXX This evaluate to study specimens, determination CMXXXX up progressing XXXX, to tissue. as potential the I’ll XX is study announced overview, a planned active the includes of of we now the that biopsy our Tim in to a to study midyear. that gut expect adult in