Q2 2020 Cyclacel Pharmaceuticals Inc Earnings Call
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Good afternoon, and welcome to the Cyclacel Pharmaceuticals second quarter 2020 results conference call and webcast. At this time all participants are under listen only mode. After today's call members have the financial community will have an opportunity to ask questions. If he would like to ask a question at that time.
Please press star one on your Touchtone phone if at any point. Your question has been answer to your neighbor move yourself from the Q by pressing the town key and publishing your question. We ask that you. Please pick up your handset to allow optimal sound quality. The company will also be accepting a limited number of questions submitted via email.
To that to the address IR at Cyclophilin Dot Com lastly, if at any point during the call you should require operator assistance. Please press Star Zero. Please note that today's call is being recorded I would now like to turn the conference over to the company.
Thanks.
Erica and good afternoon, everyone. Thanks for joining today's conference call to that's got Cyclacels financial results in business highlights for the second quarter ending June 30 up to 2020.
Before turning the call or would it management I would like to remind everyone that during this conference call forward looking statements made by management already tended to fall within the Safe Harbor provisions of the private Securities Litigation Reform Act of 1995 and section 20, Onee Other Securities Exchange Act of 1934 as amended.
As set forth in our press release forward looking statements involve risks and uncertainties that may affect the company's business and prospects, including those discussed in our filings with the FCC, which include among other things our forms 10-Q, and 10-K B filings are available from the FCC or our website.
All of our projections and other forward looking statements represent our judgment as of today, it's like a sell does not take any responsibility to update such information.
With us today, our Spiro Rombotis, President and Chief Executive Officer, Palmer, Barry Executive Vice President Finance, and Chief operating Officer, and Dr., Judy Chow, Vice President of clinical development and regulatory affairs.
Sure, we'll begin with an overview of our business strategy and accomplishments on cycle shells multiple clinical programs a poll provide financial highlights for the second quarter 2020, which will be followed by a QNX session.
This time I would like to turn the call over to spira.
Thank you John and thank you everyone for joining us today for our second quarter Twentytwenty business update call.
First and foremost we hope that all of you listening to our webcast, our safe and well.
The global pandemic continues to affect nearly all human activity and create uncertainty in every business sector.
It is becoming clearer to society that in order to emerge from the club at 19 crisis, we need to create novel Science based solutions and that pharmaceutical innovation will play a central role in this fight.
At Cyclacel, we take our corporate social responsibility very seriously, including protecting their health and safety OVARA employees. The patience, we serve and the communities, which we live and work.
We have maintained relevant protective measures and a following government orders within our employees, mostly working from home.
Today, we have worked closely with clinical trial sites to ensure adequacy of clinical supplies and compliance with relevant ft a guidance.
We have been advised by clinical investigators that they continue to screen and register a patients in our studies and remain on track with enrollment.
As an illustration we have enrolled a total of 86 patients in company sponsored studies with fiber Psych Lib Sapacitabine and see what see 140 as monotherapy and didn't combinations thus far.
At the same time, but you don't assume that circumstances, such as localized spikes or a second Serge will not make it more difficult for patients to remain on or join our studies.
Cancer patients faced increased risks in this environment, such as frequency of visits and translational research requirements.
Like other sponsors we are working without a collaborating investigators to address such matters you know trial design.
Second yourself business strategy is to build an innovative pipeline addressing the rising problem of cancer resistance.
We are studying the ability of our agents alone and been combinations with other drugs to improve anticancer effectiveness and treatment outcomes.
We're pleased to report continued progress it will briefly describe on todays call our plan for advancing our lead drug HUD recycling.
Based on current spending plans, we estimate that our cash and equivalents or $25.3 billion as of June 30, 2020 will provide a cash runway to the end of 20 to 22.
Well, let's review our lead development program.
FID recycling our novel CDK inhibitor targets, the syndicate, and nine isoforms, which act as key components of that beef to three pathway.
Activity against syndicate to results and reduction of sex and eat and again Cdknine introduced expression levels of Mcl one.
We were pleased to announce the publication in yellow S. One well that peer reviewed study or first like live by scientists from cyclists, though and the institute of cancer Research in London.
The findings from the V. strengthen the mechanistic rationale for FID recycling potential as an anti cancer therapy.
Including the benefits of inhibiting both the syndicate to and syndicated nine.
And elucidate the roles of second E Mcl, one and Mick over expression.
Furthermore, independent findings from Duke University reported at the ASCO Twentytwenty virtual scientific program corroborate the attractiveness of this dual targeting approach against syndicate to answer the canine.
Second MISO is evaluating federal cycling as a single agent in patients with solid tumors and in combination with other drugs in patients with came up the logical malignancies.
We're also preparing our planned phase one study ingenico logical cancers.
We will provide details on the progress of these studies later on but were first like to review the relevance of photos types mechanism. It.
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[noise] overexpression of cancer resistance proteins, such as Mcl one.
Or amplification of uncle proteins, such as cycling E.
Our associated with escape of cancer cells.
Mcl one is one of the 10, most frequently overexpressed cancer genes and as a member of the Bcl two protein family, including Bcl two beer fell one.
And Bcl XL.
These proteins act as pro survival mechanisms for cancer.
Second E F protein encoded by the C.C. and he gene is over expressed in several gen ecological cancers, including breast.
Endometrial slashing interline and ovarian.
Addiction to cycling E enables cancer cells to escape death after other cancer therapy.
Suppressing this proteins forces aberrant sells into apoptosis or programmed cell death.
Sector. So therapeutic strategy is to suppress the expression of such proteins and reactivate the apoptotic machinery, leading to cancer cell death.
Recent discoveries over the importance of Mcl, one have resulted in a race to bring to market medicines suppressing this protein.
We believe that Phedra cycling is a leader in this race.
Based on demonstration of desirable suppression of the protein in peripheral blood mononuclear cells.
And anti cancer activity as monotherapy in heavily pretreated patients with solid tumors.
Mcl one suppression what was observed in the majority of patients enrolled at the recommended phase two dose or RP two d. in part one of our 065 Dash Oh, one dose escalation study using a sparsely administered schedule.
We enrolled 26 patients who received from recycling as a single four hour infusion every three weeks.
Nearly all patients who achieved stable disease with tumor shrinkage had molecular markers relevant to the drugs mechanism, including Mcl, one cyclin E and or Mick amplification.
We have enrolled at further 23 patients in the ongoing part two of this study with a more frequent dosing schedule.
Oh, one hour infusion.
On days, one to eight and nine every three weeks.
Escalation in part to has reached the fourth dose level.
And additional patients have been enrolled to establish RP today.
As previously reported a patient at the fourth dose level with heavily pretreated mcl, one amplified endometrial cancer.
Achieved radio graphically confirmed partial response or PR after a month and a half one for recycling.
This patient is continuing on study after over a year on the same dose of and recycling.
After the last three staging shrinkage in her targets tumor lesions has improved to 83%.
Other patients achieved stable disease, including a patient was cyclin E amplified ovarian cancer with tumor shrinkage of 29%.
After four months well first like that monotherapy.
We have submitted data from part two of the study for publication at an upcoming oncology conference in late fall.
Well I lost called quarterly call. We described plans to further explore orford recycle it in a tissue agnostic precision medicine, driven study evaluating patients with gen ecological cancers.
The concept behind the study broadly follows the precedent setting approval of Pembrolizumab in microsatellite instability high or mismatched repair cancers.
This study is planned as an open label.
I don't know cohort study design with an initial sample size of 60 patients.
With each cohort and rolling 20, breast endometrial, slas, UTR, Ryan or ovarian cancer patients respectively.
Patients will receive phedra sacred monotherapy and subsequently combination therapy, depending on available options.
Preparation for the study are advancing in consultations with experts along with development of the study design.
In parallel we are selecting a vendor to provide genomic analysis for the biomarkers of interest Mcl, one second E and or Mick over expression.
Once the study has started another 2021, we expect enrollment to take approximately a year notwithstanding pandemic delays.
In addition to intravenous administration of fiber Psych Lib, we're evaluating an oral capsule formulation.
We have dose for patients to date and reach the second dose level.
Initial pharmacokinetic or PK data demonstrated a PK profile closely overlapping that of the Ivy administration with encouraging exposure levels at the equivalent dose.
In our human for logical Malignances program, we have opened two dose escalation studies to test the hypothesis that suppressing mcl, one and Bcl two can result in anti cancer activity against relapsed or refractory leukemias.
Mcl one plays a dominant role in A.M.L. and is supported by a preclinical evidence of synergy effect recycling and venetoclax in inducing apoptosis.
We're evaluating a fiber cyclists and venetoclax combination in patients with relapsed or refractory AML or Mds in the O six five das or three study.
And relapsed or refractory chronic lymphocytic leukemia or CLL in 065 Dash Oh too.
The primary endpoint of each study, it's a determination of RP, two d. and safety.
In 065 Dash Oh, three A.M.L. study anti leukemic activity consistent with the drugs mechanism has been reported in four out of 11 patients dose.
These heavily pretreated patients received a combination of oracle than ever clocks, and escalating doses of FID recycle it on a four hour infusion schedule. Once every two weeks.
Based on the observed activity and previous reported reductions of leukemic blasts in the peripheral blood of patients treated them lower doses with a combination we plan to evaluate additional more frequent dosing schedules.
In CLL Bcl two over expression is the main feature and Mcl, one isn't escape mechanism.
Leukemia cells, especially in the lymph nodes may stop responding to have another KLAX, followed by relapse orphan associated with Mcl one over expression.
Eradicating CLL in the midst nodes and achieving minimal residual disease or M. R. D. Negativity is an important treatment objective.
In Oh sick five does show to enrollment has been slow reflecting the long relapse free survival after frontline CLL therapies.
Given that eventually a large number of patients will relapse investigators have advised cyclacel to persist.
As an unmet medical need is emerging.
Five patients have been treated so far up to the fourth dose level.
Or 150 milligrams per meter squared.
The first two patients fail I have risen IV therapy, and one of the two also failed car T.
There were dosed once every two weeks with 64 milligrams per meter squared off I'd recycling.
And Venetoclax as per label post ramp for five and six cycles, respectively, which was well tolerated.
Both patients had continued shrinkage of their lymph nodes and one was MRT negative after five cycles on the combination.
A third patient now dosed at 85 milligrams per meter squared off and recycling also achieved MRT negativity after six cycles on the combination.
Both of these studies a part of our risk sharing alliance with the University of Texas, MD Anderson Cancer Center.
Whereby MD Anderson assume station costs for all studies, we provide investigational drugs and other limited support.
The MD Anderson Alliance also includes clinical trials with our two other programs Sapacitabine and see what see 140.
In our DNA damage response program sick said it do dash 11 were evaluating the safety and effectiveness over an oral combination of Cyclacels nucleoside analogs sapacitabine with another clocks in patients with relapsed or refractory AML or Mds.
This is a dose escalation study with 12 patients enrolled to date.
Two patients previously treated with combination therapy, including Hypomethylating agents have achieved five and six cycles of treatment respectively.
In addition, and the investigator sponsored trial or iced tea is enrolling at the Dana Farber Cancer Institute.
Evaluating a combination of Sapacitabine will elaborate.
So then it goes empowers, though in patients with BRCA mutant breast cancer.
Seven patients have been enrolled with one partial response and prolonged stable disease observed.
In a antibiotic program were evaluating see waze see what city, one 408 polo like kinase or be okay, one inhibitor, which lifecycle. It was discovered in house.
Six patients with advanced Leukemias have been recruited two 140 dash or won our first in human single agents dose escalation study.
No dose limiting toxicities have been observed thus far.
She wants to enforce it is a small molecule selective p., okay, one inhibitor that demonstrated potent and selective target inhibition and high activity in xenograft models of human cancers.
We have received interest from investigators to study see what's the one for zero in patients with solid tumors, which we're now evaluating.
Turning to our other I Estes were collaborating with an international cooperative group to evaluate fed recycling in Histologies, We're Mick overexpression is prevalent and it will provide updates. Once this study is open for enrollment.
Hey, good diversity November continuously evaluate the comparative what then show over our city gain hibbett, Ers, FID recycling and sell recycling for reducing runaway inflammation.
And subsequent lung injury in preclinical studies in plasma donated by patients with covered 19 disease.
We will report the findings of these studies Edinburgh once reported by the investigators.
In addition to other I Estes at Cedar Sinai Medical Center.
And they get a diversity of new castle are evaluating sell the cycling a first generation CDK inhibitor in patients with Cushings disease, and rheumatoid arthritis, respectively.
During the quarter, we continued to move out programs forward to multiple data outcomes over the next two years.
Our upcoming key milestones includes.
Report updated Phedra sacred phase, one safety and efficacy data with frequent Ivy dosing schedule in patients with advanced solid cancers.
[noise] report initial safety and PK data from Phase, one study or further sacred oral formulation.
Treat first patient in fiber sacred phase, one slas to precision medicine driven study.
Report initial data from fibrous likely been other clocks phase one study in relapsed or refractory AML and CLL.
Reports initial data from sea, let's see 140 phase one first in human study in relapsed or refractory leukemias.
Report initial data from Sapacitabine Venetoclax phase, one study in relapsed or refractory AML or Mds.
And report data from Phase one base last two sapacitabine on upper it I S. T in Brock our mutant metastatic breast cancer when reported by the investigators.
With capital on hand estimate it through the end of 20 to 22.
We have the resources to deliver key milestones in our clinical studies.
I will not like to turn to come over to Paul to review, our second quarter 2020 financials Paul.
Thank you Sarah.
As outlined in todays press release for the quarter ended June Thirtyth Twentytwenty.
Cash cash equivalents totaled $25.3 million.
Compared to 11.9 million as of December 31st 2019.
The increase of 13.4 million was primarily due to net proceeds of 18.3 million from an equity financing in April twentytwenty.
Net cash used in operating activities or $4.7 million.
We estimated cash resources as of June Thirtyth will fund currently planned programs through the end of Twentytwenty too.
Research and development expenses were 1.2 million for each of the three months ended June Thirtyth 2020 and 2019.
R&D expenses relating to the transcriptional regulation program fact recycling increased by approximately point 2 million for the three months ended June Thirtyth Twentytwenty as we continue progress progressed the clinical evaluation.
General and administrative expenses for the three months ended June Thirtyth Twentytwenty were 1.3 million compared to 1.2 million for the same period of the previous year.
Total other income net for the three months ended June Thirtyth Twentytwenty was $20000 compared <unk> point 2 million for the same period in the previous yeah.
The decrease of approximately point 2 million for the three months ended June Thirtyth Twentytwenty is primarily related to income received on an asset purchase agreement with them the Fisher scientific games.
United Kingdom R&D tax credits will point Threemillion for each of the three months ended June Thirtyth 2020, and 29 team.
Net loss for the three months ended June Thirtyth, Twentytwenty was 2.2 million compared to 1.8 million for the same period in 2019.
And following the April equity financing a common stock outstanding is 4.9 million shares.
Operator, we're now ready to take questions.
As a reminder, ladies and gentlemen, if you would like to asking question at this time simply press Star then the number one on your telephone.
Your question press the pound key.
Please standby.
Ross.
The question in queue.
Jonathan.
Roth capital partners.
Thank you Hello, guys I was curious what needs to be seen in the plasma test and the covered 19 program in order to enter clinical trial and when could that trial potentially start.
Thank you for your question, Jonathan first of all whatnot experts in either of our lives. Your inflammation. We are obviously, an oncology company, but we're learning from our collaborators and the Universal Edinburgh fast in the face of the pandemic. It appears that are there are several patient groups that could benefit to your core.
Question from an intervention that could put haps dampened the overactive inflammatory response that primary biomarker for this would be activated neutrophils.
This is a disease, where the patients do not have cancer, but just like in cancer when cells. They come up regulated and become over expressed the same thing on cars in covered 19 related viral pneumonia. The patients eventually after having a high level of overactive neutrophils go on to develop I could lung injury, which is often times not reversal.
The goal of the universe of Edinburgh studies is to compare fraud recycling, our newest a higher potency second generation CDK inhibitor with the first generation sounds like that molecule.
They have already tested and published several publications over the last decade whistle insight with showing can dampen the overact people talking about the response, but of course were quite keen to seek that are produced a data with the most important newer drug once studies done a they have proposed to us to run an exploratory medicines study, which.
I would look at a modest number of patients to demonstrate clinical benefit.
Thereafter, they belong to a UK wide consortium of hospitals, which is when all have recently discovered the utility of Vicsaly methods on in coffee 19 disease.
I think at this point, a little wait for them to come back with initially the ex vivo data from plasma donor patients and then discuss and this forum or subsequently when they will decide and if they will decide to go into clinical program in a small number of patients have demonstrated study.
Thanks.
Yeah My own my last question.
You mean M connect KLAX trial went from about six.
Well I updated Atlanta to 12, and enrollment and you added during the six with a one for you, but what kind of.
The size of factors that could trials and mail and yes as long as the CLL. They stayed at 11 in five respectively over the last several months.
Yeah I think this is probably a question for them to Judy show, but let me say isn't preamble that we're talking about is very different disease settings.
Hey, I'm out a with FID recyclable enroll very fast in fact run out of slots.
With 11 patients enrolled in record time, the supplement it looked like study took longer but essentially got to the same level.
In the case. So unfortunately this is a first in human study, where we ask you know patients who is probably close to the end of life to Altruistically offer.
Their participation into a study with an age and I've never before testing in human very different challenges for the spacious and make a decision not so by that explanation them yesterday to come in with her views.
We have video the line so.
Yes.
Can you hear me.
Yeah, because he gave me okay.
Well I think the unifying theme is that or three drugs SAP decitabine.
If I just think Glenn.
And see why see one for they are expected.
Do you have anti leukemic activity based on the mechanism of action.
And I think that current trials is really trying to define the safety those in the relapse refractory setting.
And hopefully that once that's done that we can move the.
The drug either single agent on combination upfront.
Okay. Thank you very much.
Thank you Jonathan.
Next question.
With Brookline capital market.
Hi, Thanks for taking my question so.
With regard to the precision medicine study ways talked about a study design developing.
Maybe you can talk a little bit about it all walks needs to be done before you can start depriving first quarter of 21.
Thank you for your question Kumar this is quite simply to interrogate the number of key opinion leaders.
You know three relevant types of women's cancers.
This is to ensure the weekend physically.
Role in this population this would be patients that would be in relapsed or refractory presumably to current disease standard of care.
They will be offered the clinical protocol with another single agent or possibly combination with standard of care and therefore, we need to understand what the current and more importantly emerging landscape is in each of these tumor types that are not necessarily a overlapping universities for example in ovarian cancer. The current standard of care would be most like.
Lee chemotherapy platinum for example, or a PARP inhibitor.
But many patients don't get offered PARP inhibitors, most likely because they don't have sensitivity to flatten them into first place.
A large number of these cases, we understand from clinician discussions have second the amplification.
This is the population will like to focus on.
In breast cancer as soon as population to be those that progress after people with hormonal therapy for the hormone receptor positive breast cancer together, we're sitting here for six inhibitor.
Why because we know in a large study published that I spoke last year, the Paloma three trial.
The only biological marker that showed starts a difference in terms of predicting for both resistance and sensitivity.
Two public sector therapy. The main syndicate for six inhibitor, where second amplification, which we know can be targeted buffered recycling. So we will have this discussion with coelce, which are now underway.
Simultaneously as we briefly mentioned in the prepared remarks, we are exploring different vendors to provide central laboratory testing for the biomarkers of interest.
This type of genomic profiling initially a baseline possibly also later is critical to understand the translational inside of this clinical study.
It's one thing about being able to say that patients achieved tumor shrinkage ideally partial response or even better.
In a different thing to say that it did this a mechanism. So we feel this is a very important part of our program.
Ultimately it all depends whether we see sufficient single agent activity to move forward in a precision medicine study or should we fall, possibly more more conservatively into a combination program with available standards of care. So we can demonstrate doubling or tripling activity as we have seen in many refractory cancers in recent months. So we think that.
This is eminently doable program between now and the beginning of next year. The first quarter of 2021 and will expand the maximum effort to achieve that go over the rest of 2020.
[noise] and being dumped off or interactions with the labor late.
What are your expectation and timing.
And also you talked about battle enrolled Maine and are taking about one year for the enrollment given that these are going to be different indications maybe.
Maybe you can probably due in part from you know what are your expectation in terms of retail which went off these trials might enrolled.
And that it can really fast comes out of the other.
Thank you Kumar, let me take the last part of your question of in Judy can discuss about interactions with regulatory authorities. So as far as time in an which over the three cohorts wouldn't go faster it seems to US and of course, that's our current judgment in May change tomorrow that the breast cancer program will go faster there are two reason.
Yes to suggest that one is the sheer size of patients.
Hormone receptor positive breast cancer is almost three quarters of all breast cancers observed in the United States approximately 80% of this patients will be offered at some point silicon for six inhibitor therapy in combination with hormonal therapy and the vast majority of those were still alive would relapse at the time that they show.
Progressive disease or lose sensitivity to the silica for six drug there could be tested for second amplification is I found to be secondly, amplified they would be possibly candidates for the study so given the tens of thousands of patients that would be available with this type of eligibility criteria will feel the breast is it likely want to go faster.
Let me ask Judy to step in and speak about the interaction with the FDA, it's such a program.
Well in deal that we have already safety data on five just like glut.
In the current phase one studies.
I think that's such a program as a phase one two study in solid tumors.
We're not be subjected to the scrutiny that the FDA typically require for interfacing human study now what I named by that is that the protocol, obviously, we need to be submitted to the FDIC, but there's no requirement for the way for FTC approval and before we move forward.
Hope that answers your question.
And maybe a one question based on the P.L. lowest spaipa surveyed you'll see our tested that the N.B.E. and.
I seem to have that Lady hi, inhibitory control.
It seems to be active there any thoughts on you know potentially testing in the NBC.
That's an excellent question again Kumar and perhaps the provocative one.
We are interested in triple negative breast cancer or TNBC as you suggest.
However at this point, we have not included a program. The reason is the rapid eager as our recent approval of Io immuno oncology drugs in this space. There is have a relevant finding it was published a month ago during ASCO 2020.
And that is a report from you CSF invest the California, San Francisco, combining Dennis acted and early generation Cdknine inhibitor with broad permit skews target profile together with Pembrolizumab, which of course, the most successful I owe a drug anti PD one drug we have today in our disposal.
The study was done in TNBC patients, but only those that have nickel modification.
You will recall that Nick is one of the markers of interest to cycle itself.
So you're obviously a month later from this announcement intensively studying these findings and trying to understand what this portends for fraud recycling, but we're certainly intend to discuss T.N.B.C. with relevant investigators as the opportunity develops but only as a second priority to what we have outlined which is.
Breast endometrial sounds good Ryan and ovarian or we have clinical signals for the drug as a single agent.
And maybe finally thumbs up close to 19 or maybe.
In terms of timing when can we get a next update on that.
Thank you.
You're welcome Kumar a this is a great question, we wish we knew the answer this is a program run by collaborating group. It is not our program we agreed to provide free drug and share our data. So we can facilitate their work, but they are the experts they have.
Very large group in the sensor for inflammation research at the University. They have been active it does feel for decades.
And we really are waiting for them to come back with the completion of the studies. They had initially difficulty accessing the loud and Scotland and thing it under locked down even though the southern part of the UK was allowed to go back to some level of normality, Scotland, a man of the locked out there since been able to go into the lab, but things have taken longer than they plan.
We hope that towards the end of the year, we'll have a better sense or whether it would be a clinical trial, but the first report what might have in the second half of this year will be the outcome of the comparative study of others like reimbursement Cellulosic. So the first job here is to show that Faade recycling has reproducible lowering of the overact, even fine with it.
Response as satisfied because doesn't hopefully with because it's hard to put more efficiently.
Clearly is not something but isn't our control, but we're very keen to find out.
Like again for all your questions.
Your final question is from <unk>.
Mr. Lee your line is open.
That's really your line.
Hello, Yes.
Yes. It can hear your nothing we can hear you Wednesday.
Hello.
Regarding the.
You mean.
Okay.
And again.
Yeah.
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Sure.
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No.
Yeah.
Yeah.
Sorry, the language that the crop that would you mind repeating the last part of your question.
Yeah.
Yes.
Okay.
Okay.
So we can hear you very well, but I.
I think the question you asked Wamsi was over the four of 11 patients the M.L. study.
That had a reduction in blasts and then we couldn't hear the second part.
[laughter].
Unfortunately, the Sun call it doesn't allow us, but I will ask a on the hope that I got the guest of your interest our last up to Chow Judy to come in if you go to explain the well we have seen and given the population of heavily pretreated relapse refractory patients what it port.
Fans for the future of address actually been ml over to your Judy.
Well thank you Phil.
I think it's encouraging to see that we have.
A decrease in trophoblast.
But I think that once the drug right now if those the every every every two weeks.
So I think that once the drought is removed.
The blast do retirement, so therefore.
I'd take is that we need to intensify the dosing schedule.
For example, instead of giving the every two weeks then maybe too far apart they we intent.
Pursued every week and hopefully that will.
Lead to more sustainable reduction in a blast not only in a painful bladder, but eventually in a bone marrow as well and I think that one has to take into consideration that did the patients currently enrolled in our studies are really very refractory Amy.
The these another phase three lapsation wincing pay central one went through five therapies and even more so these are really and rates have patience, but it's not it's encouraging to see a decrease in peripheral blast and I think our next and plant is to try to intensify the dose and schedule.
And we'll see if we can have more sustainable decrease in a pretty full blast as well and it's been males.
Okay.
Thank you Judy I don't know if you have heard the answer Wamsi.
Yes.
And then.
18.
Well.
Solid tumors.
Just wondering.
Hello.
In terms of.
Well, what treating a support or what.
I'm going to you on the phase one study.
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Meetings.
Thanks.
Right now.
Yeah.
Thank you for that question, let me clarify that Ah first of all the drug continues in a first in human study.
In MD Anderson cancer Center as part of our alliance with MD Anderson in refractory leukemia patients AML or Mds that program is ongoing the context of our interest in solid tumors arose from investigators.
Approaching cyclacel asking us whether we'll consider developing the drug also in sort of a tumors.
As we mentioned in her prepared remarks. This under consideration we have not yet given any detail what type of solid tumor what other relevant markets. What is the clinical setting, which we think that be okay. One inhibition can be relevant.
But there's certainly a lot of interest and the literature about the role of antibiotic agents without the liabilities of Taxanes and as you know there's an extensive pharmacological literature in this field, but vertical evidence that the okay inhibitors themselves could be active. So this is a field of current study and we hope to give more color on that topic.
In early 2021.
Got it and then.
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19.
Ladies.
And what your outlook or.
He room and.
Yeah.
And related to report.
That's a great question, but every sponsor is asked nowadays or at least the last several months and of course were no exception I think we can say that our experience over their pandemic over the last several months has been relatively light one well enrolling mostly in phase one studies very heavily pretreated patients.
Who is the expectation of survival with the exception of CLL is not very good we're talking about two weeks and months not years CLL patients take a long time to relapse, that's a different setting as we explained earlier so I have to say that in the early there's a pandemic, where we had primarily hot spots along the Atlantic and.
Under the Pacific Northwest Kosovo, United States have not had much of an impact.
Now I think that but then Nick is moving to other locations, including Houston, where MD Anderson is but no longer in Boston. So it's a bit of evolving picture, but one can say broadly speaking the we have not seen a slowdown for the reasons I described.
We mentioned before the patient and Dana Farber study the second part of our Phase one program.
It has been on federal sector mono therapy for over a year for her endometrial cancer, which is mcl one amplified for this patient a life has a very challenging proposition right now she lives and the perimeter or Boston has to commute into town to the south West side of the center city to receive a therapy for type.
Times every three weeks she sits in the chair at the inner Harbor for a one hour infusion, but it's clear that the single agent treatment has stabilized for disease and giving her a chance to hope for a better future. When she was referred for terminal care.
So one can say that covered 19 and risk of exposure is the least prefer concerns and stopping therapy would be extremely attractive option. If if if you'd have to be considered at all.
So for this reason so long as we are in this environment, where a patient survival is relatively short.
I think that we would have experienced significant decline in enrollment now once trying to 21 comes in and we began our phase one two study we expect this to be in a lot more centers. It will most likely require a multi center approach to enroll quickly as we have said about a year and this is an unpredictable and somewhat unknowable at this point.
We will certainly take into account emergence of hot spots or second surges across different parts of the country. Although we have spoken to international investigators. We've tried to focus on the United States for obvious reasons, we have a better understanding of the evolving nature of the pandemic. There. So every sponsor is facing those issues, but we think so far we have been spare.
The worse than have not had two other suspended any programs or slow them down.
Got it thanks for taking my questions.
Thank you once.
And.
Question.
<unk>.
Thank you operator, and thank you all for participating ANSAC myself second quarter 2020 earnings call.
We appreciate your support of our efforts to fulfill our strategy and realized stockholder value by demonstrating safety efficacy and cost effectiveness of our medicines.
We look forward to updating you on our progress and meeting some of you and upcoming conferences are the virtually hopefully in person.
Please stay safe and well and operator at this time you may end the call.
Ladies and gentlemen, this concludes today's conference call. Thank you for participating.
Yes.
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