Kim, you, with my Thank you morning, good It's to pleasure speak particularly always now. everyone.
today I'm me newly of months II Financial schedule July, from that lead we Phase the ahead completed ovarian now recruiting successfully futility with a Having like in deal run being Jeffrey the suggesting to held a who evaluated gene-mediated and cancer. and results focused Dr. a as Phase patients Phase Executive and the minutes. touch a the Q&A news Vice advanced Celsion’s DMC has Nicholas Also some provide treatment is this second cancer. regarding who X of we've review on five of in of news and Medical this Chief programs, during later pleased Chief is We quarter diagnosed our second in President immunotherapy we the I'd for OVATION or But I Officer, with positive carcinoma it call. call we brief of financial III development fully conference Study. report pre-planned great with Because Study results, this will we for comments analysis address focus announced and our GEN-X, recent a is remotely study reported liver Church, OPTIMA primary Executive the dialing earlier II Joining much to on of that diagnosed efficacy that analysis, OPTIMA the and I'll now interim in are OVATION been trial year. X few Our a ThermoDox, of Borys, Vice recent President in, our on first, the Officer. our entered unexpected in on of known portion of our spate Phase to also have the the in both weeks initiated hepatocellular call newly where recently for announced the the
for XX sites being imminently We XX few five activated active, X XXX of with or recruitment the approximately XX over months. over the investigator plans an patients completing and active program aggressive currently OVATION Our next months more include enrollment next anticipate so.
synthetic patients strongly propensity a well beyond patients as randomized cancer the approach the from that's XX% This other control control enrollment. costs Additionally, control to of value, the time. synthetic are arm, we reduce however, replacing of will goes trial population arm The studies. using of considering control cost and match about novel ovarian as time complete arm XX
into As the receive joining patients to are most concerning many for who is study of recruiting the the trial you order randomized drug. part, investigational for in a know, patients,
Now XX-XX be chance outcome, a with patients can disappointed. of the this only arm in the quite control
X trial, review a this of X, to OVATION powered Now for the OVATION and XX% improvement you progression-free is is randomized study, arm I'd two primary to survival. new a its like to X-to-X Celsion. is in who are show endpoint. XX% particularly those PFS
being label you study. conducted as an know open it's As
as study So scores. prognostics the rates endpoints for of throughout to surgical and overall to treatment. in course are are become we be recessed the will and the able survival. These Both according updates both include resections response provide they clinical updates overall will available secondary
are size compared to trial control the patients dry cancer off, that too dry great pretty be shrink tumors and GEN-X care chemotherapy them neoadjuvant to up, of deal burden will chemotherapy related Neoadjuvant whose alone. tumors good surgically all is coming standard them as Neoadjuvant a of no for effect immediately The margins. to the disease all found among these or great Treatment removed are improve is with arm advanced is is That for removal a patients, real combined with progresses. a To with fluid. disease chemotherapy being here be the designed RX complete just to related neoadjuvant outcome. disease, idea an complications. arm surgical calls be the is And goal surgical of virtually to So the chemotherapy. the GEN-X's the current design goal treatment study with resection. in a have of of for we'll
Following this will weekly adjuvant the has surgery, cycles of treatments, arm. to nine cycles the and of been debulking GEN-X randomized three patient patient treatment undergo to up if the chemotherapy
Our progression Result this that's prognosis. Because overall clearly to expectation. treatment in goal level over high progression, of GEN-X a with regimen a six activity is period. system delay know poor our immune we that portends recruit month a a being
provides transfect vectors with of non-viral mechanism. value. cells coded -- our plasmids, to TheraPlas proprietary for again, like is system I'd for who delivery traditionally new, proteins technology to of that GEN-X platform. may a are TheraPlas DNA delivering is a gene engineered for therapeutic Now, plasmid. GEN-X its using those those be and means you review used DNA nanoparticle Unlike viral technology
not So TheraPlas patient's activity unlike viral be of to system. administered immune vectors, is the subject that neutralizing once, can only
the for it administered technology required typically is immunotherapy. again, and beauty and making So ideal vectors for of The over treatments are results. does this it cancer the can titrating carry not multiple be of that, effective viral risk treatments over and of course particularly
the DNA cytokine local a platform The body first such plasmid this administered the TheraPlas of activity protein systemic cavity as is for into IL-XX. interleukin confined and why widespread not recombinant advanced be is toxicity or ovarian drug or toxicity use is for IL-XX GEN-X Systemic cancer coded with pro-inflammatory use. administered avoids the is regional the regionally incorporates GEN-X. IL-XX. abdomen reason the the treatment. associated local GEN-X on Its intravenously, XX cannot
of provides Huntsville, in our by research scientists invented IL-XX's Alabama tumor the any by improved significantly in the mitigating our approach site toxicities. an in center while solution that Our elegant activity
a Rosenberg. So make up one It one is accomplished cancer secretion last system recognized was following I'll administration, our by just powerful recognized was It old means recruiting a and solution Laboratory Dr. the provide to GEN-X in very of at cell durable, a potent effective the well-known the to safe, has note amazing the about It is was transflection immune a robust local, IL-XX then of it first fight response, an week. in potential resulting effective therapeutic. NIH safety for XXXXs to immune malignancy. as be to decades persistent, IL-XX. to problem. Steven modulator
patients months and admit, so and is of during limiting far treated that numbers, toxicities dose can period. during weekly why proceeding the quarter, final XXX in announced stand we second milligrams unanimously we squared. that small on DSMB were no profile per we satisfactory have do results programming, this a meter six to XX its but Phase during of are detected that been supported up nonetheless. of concluded to based a with higher II safety where So so I'll course recommendation doses impressive The about encouraged the be dose treatment DSMB with a GEN-X’s with
a Let patients numbers, population And treated or that We of the pull arm spoke chemotherapy XXX the GEN-Xand with match treated XX dependent OVATION inclusion talked alone. at surgical microscopic GEN-Xwith portion approach were of approaching propensity me resections of taking similar nine And and we Phase as statistical I and quarterly I, data progression. XX% the remains of give arm neoadjuvant neoadjuvant is arm control that account Though which the negative three a two having improvement you data. earlier studies, done of RX small we treated of an XX six in plus synthetic patients dose arm comparison significant a of efficacy findings of control prior significant margins. out margin, just of up. reported or progression-free the statistically hazard when in RX of significance had patients in the resection This with these again, X favorably translational about the numbers ratio survival all same GEN-X tumors, per nine in results X patients it successful were resection, May. to edge In criteria a the chemotherapy treatment published call milligrams I compared from example studies. X.XX no were but patients Study provide to XX% Small six can gross into score which impressive in a particularly resection. during seven in had the when or I, compares while our time doubling meter we combining the the previously indicates, squared, OVATION with when or the an in support I earlier to and not of our Phase chemotherapy. study tumor or to that with from suggest Phase said control Study a a synthetic new When dose reinforced patients microscopically the these
responses. that samples Phase demonstrate tumor study clinical I is from profoundly our So showing from clearly GEN-X active other tissue taken Phase in dose our experiences I prior data dependent
could we control we what to that see can have to on building conclude would noted you asset GEN-X show by Phase are compelling the continue from synthetic basis think is a a forward very be, comparison foundation to promising suggest in conclude for I'd our I'd early that II what I be worldwide. efficacy trial. and work, very saying the arm Should which we GEN-X like that being to. is to much look important launch
exclusivity Drug Finally, of from Orphan seven XX the particular Medicines from Designation exclusivity. enhances Drug year a years market this I'll also earlier market the value for course the States provides provides GEN-X, note United the similarly approval. Designation European and the which received years NDA Orphan that both Agency, In USFDA we EU received of following have in Orphan Designation
well-positioned turn outcome just we financials that steps call want during to before said ensure what the our the reassure our I taking the and I of Study. regardless about recent that we reiterate are is the appropriate OPTIMA you to of company So ThermoDox,
are million expenses, $X I million months As And expect begun over next budgets. $X we to non-essential some said, all -- save to headcount XX the eliminate including unfortunately, versus have our some we reductions. ThermoDox to
the it Phase Our plans as enrollment progresses. will to OVATION to this II ensure reporting We're sufficient on capital that Study. forward have complete we study periodically of looking
for But This the recommendation that Monitoring the X.XXX. still company, recommended study a is decision into following futility, the is primary to for analysis. like Study OPTIMA the an value the interim we're of treatment stopping trial that advisors. it. X safety I'd on analysis us. cancer. up the We stopping crossed the should of X.XXX. and Data our The work turn for with left they the was that picture do working to made is complete boundary our but efficacy not consider we of independent DMC's liver pre-planned going the Phase that second the to have but pre-specified reported company formulation for actual of futility the a In ThermoDox, Remember heat-sensitive Now, the was lot liposomal July, boundary Committee found on DMC's at doxorubicin boundary ThermoDox
essentially provides for value. the the this study -- Therefore, a a the of final hazard and ratio the as However uncertainty high for analysis, p might value the of of decision in actual to unprecedented I level stop X.XXX, left say unusual an up whether to DMC to an flip coin of step company. the
As we've DMC's that been recommendation, hindsight, the is in wisdom still some to to data, say yet jury appears reviewing the there the know out. but I'd you be
may It noted the futility cohort the patients analysis, data disclosing in patient maturity. that following the XX to consecutive analysis, overall the When deaths treatment patients to interim arm and additional analysis for we associated suggested provided issue, interim represented similar second may exclusively of in XXth far which for Moreover, point. than eight further deaths remember of differently XX review died comparable survival, before we deaths. reversing associated treatments recently balance occurred is also unblinded deaths date. there Our compared X-to-X completely exclusively is interim we the behave a unexpected the Study’s the XX treatment the this XXXX. the more second after data patients -- arm marginally overall maturity the to of in the crossed The reported ongoing trend of seen by follow -- interim patients the arm OPTIMA the favorable upon we the number approximate the who to from HEAT an in update and have second based, XXXX remove between was pattern of be Kaplan-Meier that Well concern Study deaths arms Study consecutive our supports data the as suggests September ratio treatments continue data noting analysis, second consecutive the the compared survival and as control at prospect subgroup the analysis tests be with with is that in the time from them maturity. the March as analysis, doubled, controllers which a were for of data of the boundary OPTIMA that will outcome we was and
over curves The of with OPTIMA at XX respectively, in all, subgroup The both Study curve, benefit, a Vietnam the issue, particular improvement XX% XX little deaths at arm months this sites point, statisticians compared Kaplan-Meier hazard the in control of and arm, showing time other the treatment amount. joined look after times of are a the were show insignificant to we But that initiated. regions. this marginal trial, me in over would we the yet times was potential see the probably also is geographies the months and we Vietnam, ratio control and eight this. improvement arm similarly in China for in of when Study the if patients death an of OPTIMA hazard death. a to treatment The in negative not in With about the testing at at sites behavior When that Study calculates X.XXX control in an XX% the sites over improvement of study note arm, death. a Kaplan-Meier median the where enrolled maturity which China XXX XX% HEAT the So, now on I arm ratio a Kaplan-Meier demonstrated trial the median given X.XXX. the the site at approximately lesser and it, give of
be but can Now, that follow-up, direction. we we study's be has reconciled, this the believe to done probably dichotomy must most with before longer determine so
survival. and Study we related we're analyses Kaplan-Meier data And National CT trials all it While the -- independently about will that HEAT we of but so of a being any do, that I their prepared, caution finally, trial specifically you clinical you including including in study I trends overall you you At can experts we these data, are projections, progression-free OPTIMA transparent I you definitely, be the tell tests sent independent however, between survival may to the assure insights discontinue are little to issues analysis, for plan to bit time, to NIH I'm CMC Health tell I point, and scans of statistical the mentioned. Institutes evaluate the that the our importantly, definitely, that takes choose definitely sensitivity follow-up it, that have I we provide sorry, at observations depending can just period, on during the engaging very can't can't I what all noted we conducting proportionality this may looking clinical for plans. tell time. for
our course Study with demand have we in review And we not the said from second press futility. August faced predicted allowed world may outcome monitor be, results and continue investigators analysis it. is event as other around trial the that as to see interim release, I may Unfortunately, our of substantially clinical research ongoing support we carefully to in unlikely clinical it regulatory beneficial while OPTIMA the XX as the be conducted. our As by change. be that may said, patients, options and the Xth I we with agencies the will FDA advisors The
unmet medical can that OVATION sure is I continue strong. population, large needs turn to prognosis. fundamentals both Study and X that Just poor this want say to to directed Celsion’s be before Jeff to be patient over we a
our utmost redundancy, built strategy programs development manufacturing care. is been with has continue with the execute solid, to Our
be States encouraging. outside and and both Our relationship to with regulatory continue agencies, exemplary United the in
with management spending sufficient With cash expect have over and deliver Jeff. it on Jeff? to our I'll comments, promises. smart turn We and those cash to
