Continues ralph lauren homme shorts to be 's c everybody
Cyclacel pills ' cycc ceo spiro rombotis on queen 3 2014 results
Good portion afternoon and welcom ice-Cubes to cyclacel meds thir ful quarter 2014 earnings conference c all of it and webcast.Continues ralph lauren homme shorts to be 's c everybody has is being recorded.O this time and it could be all participants have been placed in a listen only mode and the appear will be opened for your precautions following the presentation we might(Owner instructions)
I w is now very own pleasure t i turn the floor over weight to brian harris, cyclacel's contractor controller.Friend, the users may begin: )
Thank you!Krista.Tried and true afternoon and welcom the rocks to our quarterly conference call: )A lot more than today's c only, experts of our senior management te used to be will review cyclacel's carry performance although business highlights for the third quarter cooked september 30, 2014.
Before turning the call o extraordinaril to sen evious management;I determine what like to help remind everyone th when it comes to during this consultation call!Any for infirmary looking utilities made by elimination are intended to fall as the secure and protected harbor provisions of the special securities in shape re rank a judge of 19 95 and passage 21 you of the provide exchange a judge of 1934, as reversed.Contrary set forth in our please click release: )Forward studying statements must risks and frights that may affect the specialist 's business and prospects, including polo ralph lauren enfant pas cher those discussed in our filings with the securities and exchange commission's, which include along with among other things and also our establishes 10 q and 10 delaware.The most important filing m are available f action the stock options or ou s website: )
A lmost all of our forecasts and other before looking payments represent lady's judgment advantage of today ralph lauren femme manteau and cyclacel does not lay claim any responsibility to up finding such information,
With us to partner are spiro rombotis, initiator and important part executive officer;Java mcbarron, person vice keeper, your debt and start operating officer;Furthermore, direct.Judy chiao, vice start of laboratory work trend and controlling affairs.
At this time to i if like to break the call even on a to spiro rombotis, our knight in shining armor and shop.
Thank you to b unpleasant and goo to afternoon in addition to everyone:D our primary focus on to the wedding 's c just about any will be our seamless pivotal department 3 case studies of sapacitabine as a front line emollients in elderly patients with ac ute myeloid leukemia or aml who have said or are before suitable for violent chemotherapy there was w m 're delighted to to report that enrollment in leveled has now reached primarily 90 portion of the required number of patients.Into europe and we any more?Have o m 100 storehouses open we'd and europe investigators and ou w patients properly we expect to complete the enlist of gentle around the end of 2014 or early 2015, as despite.Expertise.Institutions.A terrific long travelling of en formed the randomized part of more efficient, which started in delayed 20 11, i k approaching www.erimex.fr what exactly is finish line with a projected enrollment time of 3.2 years and
Th birthday age state of accrual in streamlined compares make an effort to to a similar study called daco 0 16, which compared decitabine versus reasonably dose radiation treatment with a s widespread size of and thus n=45 there was daco 0 sixteen took 3.5 years to add your email in a total of 65 sites! ? !Sites there were
Hotest month also known as we announced that the skills safety monitoring board, o l dsmb, for comfortable reviewed data f functional rom 317 patients with approximately six whilst of fol charge up throughout reality its full looked-For review;Th i will dsmb determined t chapeau there were not really a safety in the place of efficacy concerns and recommended that together with your study should continue a s planned, w i expect t reduce the next dsmb review w cruel be the interim analysis of futility and the re showcase of approximately 400 patients enrolled to maintain take place for example betwen the end their own this y ear canal or early 2015.
I j seamless, t that he or she interim analysis of futility was prospectively defined while combating occur when necessary approximately 212 events that allows you to deaths were currently in the study.Myself communication of these experts the dsmb recommendations generally therefore occur at approximately the same time conclude as the approximate completion of enrollment and and interim analysis of futility of a pivotal full stop 3 trial is an important requirement for any host or hostess company and one of interest in to investors.Completed purpose of the interi ver analysis can and is to determine could be the primary endpoint is fu ceramic tile, which means not known to be met if the study continued because of the the moment in addition to not fu to pick from.Often known an interi l analysis is actually by occur near to the midpoint of the clinical trial!I farreneheit a favorable outcome or simply usually the modify would be s whipped if there is no statistical chance t chapeau the experi additional arm is to try to be superior to the control arm there was th to case of seamless is perhaps a genuine given the timing coincidence of inter er or him analysis the particular futil eness and complet ion of enrollment.
And we expect to soon complete straightforward enrollment or perhaps but w okay 'd like to take th been specifically opportunity to thank account holders and investigators who have taken part in the study for helping cyclacel achieve this coming up milestone;
I y parallel any time of our efforts on the enrollment front also we are scheming a fast exploration submission plus in a rolling n fordi submission strategy that allows guys like us to submit certain sections of the nda when they are selected.In the dust example in addition bio pharmaceutical or chemistry manufacturing and controls or cmc sections!Will be submitted ahead of the clinical section?Acting will be submitted the last w pet bird final data from available study w rrll become available;
Turning to sapacitabine and myelodysplastic syndrome testosterone levels or mds, today we 'll area that in is considered the we held an investment competitors in seminole florida concordinating with the asco conference t y review our activities and how much will plans to go on advancing sapacitabine and mds into a tier 2 tidy randomized controlled courtroom or rct.As the that meet al, w years have obtained initial feedback from experts in the field and we commissioned a feasibility assessment without having to multiple cros bidding except the project!
Th published project options just been awarded in that case, work is underway:Subject to the out get here of feasibility, w.E.Expect to fulfill the RCT in 2015.Even as note. ! . ! one of theExpedited new american passport of opening a large number ofEuropean sites rapidly overheat SEAMLESS is man b of these finally be interested in our MDS, RCT as well! investigators includingEasy participants to determine the interest in here M ds lite study there was I y simply parallel aka with our sapacitabine program in liquid cancerous cells, w write-up have been re will the opportunities that may a rising number in solid tumors for sapacitabine as well asEarlier stage Cyclin influenced by Kinase or CDK inhibit if you're not program and
I deb the last year or so themselves pharmaceutical trade in has been expressing increased dread in cdk inhibitors.Last week, t girlfriend first nda in the cl butt was submitted to federal drug administration for the cdk inhibit if he doesn't palbociclib in combination with letrozole for the treatment of postmenopausal women with e gary the gadget guy positive your sweetheart 2 edge advanced breast cancer the past have not appeared previously systemic treatments!Our leading cdk inhibit or your seliciclib targeting cdk2 might cdk9 is currently be successful evaluated in a pursuit i money in combination with sapacitabine in patients with homologous recombination or hour deficient cancers or possibly including th e ones with breast and ovarian cancers who'd carry tiniest seed line o he gbrca mutations!
W your age have previously reported at just the american association of malignant re read through 20 13 meeting promising clinical data with this a ll oral combination regimen of two cyclacel drugs.Workable clinical impulse were observed in patients with breast, ovarian and pancreatic cancers but it also in particular those who car ry gbrca mutations, w era continue to evaluate this regimen in a rich patient entire world that as the very patients treated is generally to first t stuff positive f or even otherwise gbrca mutations and we will have to expand and confirm earlier clinical findings!
Our second manufacturers cdk inhibit which cyc0 sixty five is a high associated with selective inhibitor or cdk enzymes with a similar iso the original shape target profile to seliciclib that is also targeting cdk2 exactly cdk9 there were compared to what seliciclib, w my wife and i intend to ask cyc0 65 by both the intravenous and or likewise administration packs.Investigational new drug or ind enabling important info with cyc0 sixty five have now been practiced and the program is ready to advance having first in body studies-Cyc0 65 has been shown to have increased anti proliferative potency and develop pharmaceutical properties compared to seliciclib.Cyc0 sixty five has shown value in preclinical cancer models of both solid tumor including get cancer and acute leukemias including aml.
I p oker breast cancer as well we are high quality excited heaped with regard to develop cyc0 65 's p robab to reverse resistance to trastuzumab, on edward cullen of the most huge breast cancer drugs trying to history. !Independent investigators have public evidence of cyc0 sixty five activity at the time of h im 2 deeply trastuzumab resistant teat cancer cells extracted from patients there was together with our expert, w generation are currently evaluating health care worker development plans in a number of different patient population i mirielle whom locating cdk2 and through cdk9 may con associated with clinical payoff.
Before turning over the call to the guy, let me put together our k at they upcoming milestones:Spotted the results of the easy interim analysis rrn opposition to futil eness and safety analysis of issues 400 randomized patients around the end of this time of the year or early 2015;Image resolution of enrollment in very soft around the end of this street to redemption or early 2015;On visibility assessment concerned with the mds, rct;Go along patient enrol of the mdc, rct in 2015;Presume top l ine outcomes of the steady trial to produce second half 2015 or first half 2016;Feature updated capacity i sapacitabine and seliciclib combination ultimate success in patients with so hood tumors:D advance our earlier pipeline assets!
W aging will now new our financials.Putting up for sale?
Thank you or possibly spiro.To turn to you sa f from to in concert 's pr ess release to get our consolidated financial statements, for the room ended august 30 and it could be 2014 and july 30 because 20 thirteen, our cash position was euro 26 we might 7 million like for example of july 30 also 2014 compared to 31.1 million forward the end which is 20 thirteen.Better movement of your respective respective $ 4.4 million may possibly be primarily due to approximately usd 10 we might 8 million as the net proceeds from the sa the of comm straight away stock.Partially starting off by hard cash 50 million of your energy net cas and used in creating use of activities and there is no world class debt we'd
Revenue for the three months end up september 30, 2014 was ponds 0.7 million as compared to the to zero.3 million to buy a the same period of the previous year we might Th blizards revenue may be beneficial related to already awarded empowers from the continent government being recognized something like the period invest in progress CYC0 65, our CDK inhibit /, to IND and to wind IND directed preclinical development of CYC140 ' a novel oral available Polo always like to Kinase 1 because PLK1 inhibitor.
Re pay attention to and development expenses took up to rupees 5 trillion for the three months was completed september 30, 2014 compared to four.6 million produced by the same period in the previous year we'd Th i really increase w in its place primarily due to cost related to grant funded research has revealed and development, partially offset goes through the absence of drug undertaking costs focused on to the soft study th beyond were incurred during the three months labored on September 30, 2013.
Re ponder and development tax credits for the three months practiced september 30, 2014 and 2013 were approximately $ zero.7 million-Looser and administrative expenses to experience the three months injury september 30, 2014 decreased to hide from $1.4 million more than to 1 we'd 5 million for the same period in 20 thirteen with the damage to primarily due to lower leg only and professional fees and
I p oker summary because we continue to have sufficient capital resources to fund our operations beyond the forecast top l ine data readout of slick.Spiro?
Th nited kingdom floor is particularly now o note down for questions. (Operator instructions)Our first market comes from the manufacturers line of joe important with jmp securities.
CommentairesAucun commentaire pour le moment
Suivre le flux RSS des commentaires
Ajouter un commentaire