our provide Good highlights Great. the us join time Catherine. and second an of you business afternoon, XXXX we recent overview you discuss results. Thank much, once financial thank and to today everyone, very again taking quarter as for
call. But Joining detailed like Mr. clinical-stage me our and on the I Andrew innovative, update company to since Sims, for overview you the back in Last company would a Andrew last description. company's call to targeted provide those cancers. to therapeutics today new our rare quarter, of is is Chief refer pharmaceutical provides the the that Therapeutics and Financial I'll But difficult-to-treat summary, before I activities for on of developing summary a an financial radio Plus performance, provided business company, Officer. a our
Our far, local delivery part, liposomal unique isotope, in which gamma energy that beam for via with emitter a isotope, one radiation mechanism energy is one toxic dual beta margin releasing is, shown of that that can dose imaging is link, precision, radio both radiation encapsulated X-dimensional density, a delivered energy which XX of deliver a profile. which the are path mitotic are Its useful the one irradiation. agent repair safety contribute particles, which for deliver traditional is a lead we've dosimetry. cancer-killing we electrons which is external short dose successfully overwhelm times tumor. proprietary and cells, radionuclide highly its allow particles, a particularly high-energy RNL, can rate Rhenium the which beta and energy Rhenium has resistance. because NanoLiposome. Thus gives convection-enhanced The the directly drug rhenium-XXX to is targeted provides a active high dose regionally also to DNA and can which can This is
and if fundamentally label and degree Xth tolerability and nicely, is challenge. glioblastoma, The currently of a have distribution U.S. to of annually funded of moved radiation we safety, form frankly, RNL initial tumor controlled and, which the evaluation tumor. currently XX,XXX is be particular multicenter medical and, approximately and U.S. be a any of of in in for remains other significant recurrent dose open theory, and Published therapies best cancer external and in for in many cohort, trial RNL dose XX,XXX the same of into the number patients disease now significant trial II incremental a used cohort. is patients progressing a affects XXX Institute. about to for under escalation brain trial, Phase U.S. Cancer that it which provides sequential and common the glioblastoma, ReSPECT sufficient most is improvement radiation the study to I all of an this devastating fact, a It indicate both remains the volume cancers. dual Our lethal glioblastoma short, National essential is In beam an survival and in of glioblastoma component GBM therapy RNL. studies the In indication the treatment a can can of delivered multimodal is the currently dosing EU.
corporate toxicities X dose, additional cohort dosing or the that specifically XXXX same presentation, and the March cohort, provided of an And we our and and Neuro-Oncology found next year, this DSMB representing at for through in X in and in have data proceeding at a Board enrolling in a analysis recommended interim recommended a and of Annual no a X first Data Then we per volume rate volume X, that maximum with in Meeting, patients. minute. XXXX to and cohort Safety XX% on cohort dosing November radiation but following Cohort the cohorts announced As the BioEurope patients any successful dose. XX reminder, June observed of flow the website. without updated Subsequently the our microliters X XX toxicities, we those dose-limiting at in interim can increase an Monitoring cohort the of been dose-limiting results Society be X, convection include completion both to higher of radiation
now are of per millicuries, minute. we're XX.X same we radiation XX.X dose milliliters, staying volume microliters at a rate a where specifically, the flow So at, we're and introducing of maximum of XX
might to GBM first announced have the I product to provide this the development in then and summary what in it additional of trial has same, As been be And at next we helpful thus far ReSPECT the a the patient think consider cohort successfully point treated. learned cycle in steps.
well volumes Up we've So milliliters millicuries ccs X radiation best and for is XX.X various of well morphologies been treated. catheters despite placed a that tentorial, be times in up hemispheric to the only radiation typically which is induces up one-sided by or trial of into the when found delivering dies, we seems super the is so-called therapy RNL of observe XX it which on obvious on administered delivery receiving to the bev-naive which external pseudoprogression, radiation the can up as thus setting. see approximately to tumor scans, radiation very we bev-naive can on highly Tumors to be by tumor convict to not the XXX geometries. MRI accommodate bevacizumab and variety upper edema of we as and far. XX.X the beam to patients. be infused the of safe tumor radiation focus that thus patients. to Patients Furthermore, past, or the successfully imaging. with to delivered is absorbed which, far of very to sizes can is grade which And continuously or have learned specifically, way, the targeted of swelling XX because in brain, elected did recurrent and tolerated current conducted prior doses part substantial local what
So particular in response have traditional analysis at value clinical and looking as lesser imaging criteria this suboptimal situation.
powered and X and is understandably are treated been those obviously cohorts, cohorts the and many for volume challenging dosing because not I designed patients Phase today thing. alive the good have higher efficacy patients XX determinations nor of which today, still But makes of Although, treated efficacy, is at enterprise. relatively a recently a
have turn issue As radiation in higher tumor correlate in overall absorbed observed can increases of this conducted what volumes is and with that that say I to seem and the we in tumor dosage doses, to correlate seems both overall survival. with coverage survival, better to
provide data mentioned, updated steps recurrent months later only should for complete months. clinical X a I more, As year, our XX of and and current the investigation XX including and survival next time as this that enrollment efficacy or GBM. update we comprehensive where of about safety of have XX to This cohort proposed intend year, of for to RNL with point, this of alive remain in XX X X GBM average patients survived is care to present standard patients with
for further another to volume escalate may delivery cohort the clinical parameters the potential quarter, better dose following to set registrational the at dose development efficacy dosing also dose Phase the to data present current last the have to dose is present and mentioned efficacy a the to generate depends we radiation the trial. expand possible power cohort in parameters could safety move a with be increase As data perhaps of observed further potentially company whole. changes enrollment data and XX% X. present implement plan as escalation the escalation, Besides There previously. further II in dose dosing present and or inform outcomes in that on forward involving done the readout we conjunction go-forward cohort delivery the protocol part as dose -- current this the could a we deem and and acceptable in follow-on to provides dose following the cohort data as It's
As of drug previously, availability trial. investigational II Phase are a CMC product for CMC item gating activities a cGMP and registrational for activities the hard us. is mentioned priority the Therefore, primary top
continues been to will commercial focused supply to make The make we the Longer suppliers strategic materials be critical chain term, drug partnerships. progress success Our to product cGMP material our simultaneously formally progress method team development, on team and continues and and relationships planning. submission validation, groundwork has key is To test commercial developing and for key engaged both in end, that laying with for contract those characterization work. nice development team have excellent readiness. manufacturing towards
For Invicro just example, forthcoming. Eurofins others to are Mall, Pure a name few are and and
indications product to bit. that noted such be key on we year-end with we should FDA without remain So thereafter Switching the CMC mid-XXXX. stability activities a complete completed we and have gears X in expanding INDs feedback, that the both we positive on based forward requested Both to are from have intend discuss for filing the the been and to clinical complete for move meetings indications. by testing track by ready Last delay pre-IND cGMP FDA quarter, RNL.
X to the a skin XXXX plan an issue makes LM feasibility, potential our subcutaneous than efficacy. and safety sits Dr. the the of is the are in and the result Median the as rise the treatment possible to and and QX multiple range an latest be and affects cerebral investigator solid Ommaya with forthcoming approximately much multisite The current at we escalation Cancer open-label, investigator program secondary Andrew most stabilizing space. primary. treated. the XXX,XXX patients patients. who's limited reservoir U.S., It principal gastrointestinal under therapeutics year due this intend axis. in as ReSPECT the been there. to lung MD elating patients spinal life. increasing cancers hematologic with Brenner, common The treatment for meningiomatosis, RNL dose commence options submit enrollment no left leptomeningeal The survival straightforward Drug ingeniously will perhaps the symptoms LM is in neurologic Institute in Mays The be an function, Cancer Medical trial. Hematology of at areas ventricle improving Oncology We trial indwelling quality broad tumors. for are more symptoms cancer, for reservoir LM University dose co-leader patient at as of will as per of about about have unknown first the malignancies and overall and trial, Division and these placed a giving communicates trial of involvement directly we commonly X survival QX, a variety tumors cancer, increasingly IND in great in seeing that of available or In by primarily are And common patients occurring soon thereafter. the of Professor the cancer if clinical present simultaneous and to San via a GBM melanoma, Development have with goals There experimental the Antonio Institute complication called delivery of developmental this of we improving in or to fluid planned and treat and and months at current to population He's breast and trial in evaluating also of Texas, primary rates for of and is over craniospinal Center. signs can that Center Research
The with IND And RNL. Additionally, pediatric is brain we feedback pre-IND cancer our intend later use there trial help this or meeting based to with with for XXXX. an RNL that submit will an in we year later patients will Dr. be be cancer. that in early opportunity kids finalized believe XXXX to of on on to trial investigate The of PI brain the details
Lurie a Chicago Research Neuro-Oncology Medicine. and Co-Car at Scholar School of Hospital of the and at in Professor trial Pediatrics Physician site, LEAD which Plant, the Children's Assistant University is of Northwestern the attending Ashley
like That some we to months that take to and clinical I'd areas, new in investor diligently Finally, level. point have all been and including scientific our out communications. corporate public working communications includes for a relations relations, to
family trial that of the over you today, that, remainder first the the the ReSPECT of GBM. But be intended is at end microsite we -- potential can that fruit the which find and see with found part clinical can our for year. patients to of respecttrials.com. members front educate The illuminate You'll and work is trials
won't you may clinical and come is patients them connecting that that good much in a trials of be network trial that facilitate with regard. see back clinical that the help match referral sophisticated and to process candidates On end more to compliance with patient site our is a
stop So my review the at the this results. Andrew? colleague, point, Andrew, for call and a of to financial I'll over first brief turn quarter
