XXXX. the everyone our for XX, quarter like third ended welcome to Thank September I'd to you, Susan. call
both development. which clinical drugs, of as in from made the are CG-XXX in we well drugs the these in as hematology from and small development. another quarter, are X Mechanistically, development on the I molecules our quite one X During other progress and Phase hematology market group of distinct APTO-XXX, significant
questions. developments, clinical other as today's On the well status you both on corporate up open review financials, the we and we'll date then our to of programs will bring your call, quarterly as to call
CG-XXX, inhibitor only wild-type CG-XXX, Let's highly just upon mutant not it no potently BTK drug first-in-class cells update which This and noncovalent rely signaling agent all oral, driver forms development. oncogenic kinases. of like XXX, and survival. other for is under start inhibits pathways with commercialized potent or BTK and our cancer or the and suppresses our of simultaneously FLTX multiple FLTX,
well particular mutation we XXX as to or that FLTX inhibitor rely the much compensatory For FLTX mutation-agnostic those kinases Rather you is refer XXX be inhibitor. of mutant a engaging of it's new Aptose, or just XXX because BTK treat just not directed forms on who the multiple typical designed of your than at only FLTX/BTK than driver may the as one mutation at to to more overall target, BTK. drivers, CXXS diseases of multiple pathways. is as ITD
related kinases, mutations and viewed They of known Importantly, class in with the typically represents render targets is of new establish of our truly occur the mutation-agnostic the clusters designed resistant This multicenter, recommended as avoids yet suppress that to clinical B-cell key our safety, of the XXX XXX that assess the dose. XXX cells with agents. Certainly, entirely II patient. quarter highlights and third responses a to agent and was trial drugs. and trial and of preliminary dose-escalation first cancers the of Phase pharmacokinetics targets CLL AML to other it continues initiation cells of open-label, tolerability, efficacy Phase dosing pharmacodynamic can I in the toxicity. such an be the precision that associated the
of XXX CLL, As heavily XXX pretreated lymphocytic or oral or with daily. patient BID leukemia starting in of dosing milligrams chronic dose initiated twice in we announced at July, we the
You to XXX which only milligrams each in testing levels. administer patient we may clinical unless necessitate unexpected required of XXX at were recall milligrams calls our those BID, effects to titration XXX dose protocol one and levels, accelerated additional side trial an the at for that first X
in We're pleased this program. to report significant progress
Our one on currently lowest one on considered moved to dosage, disease patient. level in and X, at XXX has dose, patient dose is the status. we CLL level the patient XX-day is Because to stable cycle in dose the milligrams X of also required dose first requires XXX, have improvement only who BID continuing placed treatment was completed complication, only XX-day cycle, ECOG shown then first was which dose fifth that the without is
to second pretreated was milligrams XXX increase X. increase the dose Most This in has and treatment of initial XX-day lymphocytosis, also their also patient CLL. BID, defined lymphocytes, observed cycle third completed cycle. patient cycle has an currently Our blood and continued in heavily continuing XX-day interesting, throughout the is cycle as first peripheral is has during
This sign active of progression, CLL because lymphocytosis tissue into lymphoid the promote is when from considered clinical CLL inhibitors hallmark an with cells generally a BTK of is disease BTK active bloodstream. lymphocytosis While inhibitor. is the treated in response of patients, the being peripheral exfiltration
observation the lymphocytosis very for this good patient. is So news of
FDG-PET/CT very observed X regions, key cycle the activity, abdomen or patient, we hypermetabolic In for said patient. in This tumor way, the this nodes, decreases the with good we in is Across news index an too another decreases this burden. addition, scan. at end particularly in pelvis and of performed
tumor formal reduction it we a burden. Although and response to see this patients, reach thrilled takes in CLL are for typically a to patient lymphocytosis months in the
on drug-related well model far. fifth tolerated adverse serious or And of So were for safety observed, with the that their their continuing SAEs, study XXXX patients been two to both patients patient are conducted patient and October first dosing XXX been observations has dosing on these of review currently end showed, third suppression observed. and at data the Two, and three, one, a thus cycle. currently cycle events, second the on far, tolerability thus toxicities no summarize no has
clinical lymphocytes, described blood tumor foci scan. hypermetabolic to increase burden or Regarding dose evidence and one, CLL a BTK; by second classically response patient new index of on observed, a a multiple across in in in inhibition no FDG-PET/CT the and two, assessed as scheduled nodes the reduction lymphocytosis, we peripheral the response level, of robust as first at
the Regarding state with the dose-related end properties week the observed such by XXX well-behaved the of was dosing. that X pharmacokinetic profile PK patients, we of first of steady and first achieved
dose-related serum We cohorts. higher-dose levels patients, these we as by achieved see are gratified to and the to hope in continued exposures dose-escalate exposure we
request to review protocol, the XX-day X milligrams CSRC, this dose cycle our before at data their we are next able to XXX to represents of dose. clinical cohort of from we their BID dose dose, Review patients patients made had dosage we have doses per can next X, a level, will XXX-milligram of Indeed, enrollment continue that After cohort. such clear currently tolerated or XX-day attending we need if and that may patients on on the Committee, successfully a trial of to are successfully dosing the of by XXX XXX the dose BID. and milligrams Now let's patient continues dose we move the and recommended to higher well milligrams been discussion to XXX drug dose-escalate Also, already BID, the of the the and this their increase to dose next milligrams. X Safety physicians third XXX so on and to complete the lower be eager now the and date. proceed unanimously At level. currently X are that This enrolling for the screening design, X Clinical first two patients
per ascending CLL with dose. XXX Once three three patients dose, and of with be patients including followed that been relapsed at or milligrams up select recommended expansion milligrams with cancers, XXX patients non-Hodgkin's their an refractory B-cell by the MTD recommended patients intent as All cohorts the XXX dose XXX, in each going enrolled XXX our -- for Phase selected II that well, Phase to safe to be BID will at at biologically may or II and has phase and active treatment lymphoma. dose
patients for board. with enrolling U.S. on to additional sites scheduled we open come the As and sites of have study today, XX screening for
the specific the malignancy enrolling more on information B-cell and sites patients, clinical please trial For visit clintrials.gov.
let's the AML CG-XXX. Now study with discuss proposed
to I also Aptose plans XXX FDA mentioned, include to allowance that a or seek from move separate into previously AML refractory relapsed As trial. the patient populations in Phase
and patients As would a relapsed we do dose refractory population and clinical a to that chose ill first to likely wish not initiate this with we benefit. Therefore, the dose therapeutic not acutely to able patients. safety of subtherapeutic are From have patients to provide we should the patient collect clinical reminder, immediately data. malignancy be that identify we and result B-cell such to in benefit a AML trial likelihood deliver and believe data, PK dose the AML
For in have patients high to the agents to other referred population medical and having refractory inhibitors target patients or Moreover, patients, to gatekeeper AML unmet to relapsed view with plan and that trial intended patients distinct tyrosine wild-type as planned XXX IDHX AML mutation from initially resistant mutations other kinase Indeed, genotypes. We focus patients domains FLTX a who on or FLTX have the having needs. include typically as that we having other or are AML status. within ITD molecule as FLTX. we the relevant patients, IDHX AML the include well wish mutations in as venetoclax FLTX-positive we FLTX of those to FLTX or
our trial. for are with well under We new this clinical preparation way protocol
AML Our to during the clin-ops the next protocol expect trial, to submit team the sites first we has FDA in the to of year. half busy for and the identifying been be position
trial. our can the rationale here for perhaps comment Joti, AML you on
