Achieve Life Sciences, Inc.
Q1 2013 Earnings Call Transcript

Published: 3 May 2013

[Operator:]

Good afternoon, ladies and gentlemen, and welcome to the OncoGenex Update on Clinical Development Programs and Discussion of First Quarter 2013 Financial Results Conference Call. My name is Charlotte and at this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time. (Operator Instructions). At this time, I would like to turn the call over to Susan Specht, Director of Investor Relations with OncoGenex Pharmaceuticals. Please go ahead.

[Susan Specht:]

Thank you. And thanks everyone for joining us. With me today from OncoGenex are Scott Cormack, Chief Executive Officer and Susan Wyrick, Principal Accounting Officer. Also, on the call are Cindy Jacobs, Chief Medical Officer and Jaime Welch, VP of Marketing & Corporate Communications. Before we begin, I’d like to remind everyone that today’s conference call contains forward-looking statements based on current expectations. These statements are only predictions and actual results may vary materially from those projected. Please refer to OncoGenex documents filed with the SEC concerning factors that could affect the company copies of which are available on the website. I’ll now turn the call over to Scott, who will provide an update on our two clinical-stage product candidates, custirsen and OGX-427.

[Scott Cormack:]

Thanks Susan. Good afternoon and thank you for joining us. I’d like to begin today’s call by providing a brief update on the custirsen development program. In the fourth quarter of 2012 we announced the completion of patient enrollment in SYNERGY, our Phase 3 primary registration trial for custirsen. We are pleased to announce that the SYNERGY trial is continuing as planned per the recommendation of an independent Data Monitoring Committee, who have completed the second and last futility analyses per protocol. The planned efficacy interim analysis has not yet occurred. As sponsors both OncoGenex and Teva remained blinded to all analyses and data results. As a reminder, SYNERGY is designed to evaluate a survival benefit of custirsen when added to the first-line chemotherapy docetaxel in men with metastatic castrate-resistant prostate cancer or CRPC. Custirsen has received fast track designation and the SYNERGY trial is under an SPA agreement with the FDA. As previously discussed the expected timing of final results for SYNERGY is based on a pre-specified number of death events that we project to occur in the fourth quarter of 2013. We continued to expect data results to be announced in the first half of 2014. Patient enrollment continues in the two additional Phase 3 trials of custirsen, AFFINITY and ENSPIRIT. AFFINITY will evaluate the potential survival benefit of custirsen in combination with Jevtana or cabazitaxel. A second-line chemotherapy in approximately 630 men with CRPC and is currently enrolling patients throughout North America, Europe, Russia and Australia. Meanwhile, ENSPIRIT will evaluate the potential survival benefit of combining custirsen with docetaxel as second-line chemotherapy in approximately 1,100 patients with advanced or metastatic non-small cell lung cancer who have progressed after first-line chemotherapy have failed. Custirsen is also received Fast Track designation from the FDA in the patient population being evaluated in the ENSPIRIT trial. In addition to the continued progress of our custirsen trials, we are excited about the momentum we are gaining for the OGX-427 ORCA program. ORCA, which stands for ongoing studies evaluating treatment resistance in cancer, encompasses clinical trials evaluating the addition of OGX-427 to commonly used anti-cancer therapies in multiple tumor types. Currently, the ORCA program is comprised of five Phase 2 trials intending to treat more than 700 patients, who are suffering from common and difficult to treat cancers including the advanced bladder, lung, pancreatic, and prostate. Given the robustness of the program and flurry of recent announcements and initiations. I’d like to now turn the call over to our Chief Medical Officer, Dr. Cindy Jacobs to review the ORCA trails we have announced to-date. Cindy?

[Cindy Jacobs:]

Thanks, Scott. Beginning with bladder cancer, we have two trails that are currently enrolling patients. The Borealis-1 trial is the company-sponsored, randomized, placebo-controlled Phase 2 trial evaluating OGX-427 in combination with first-line chemotherapy gemcitabine and cisplatin in approximately 180 patients with metastatic bladder cancer. This trial is being conducted in North America and Europe and is expected to complete patient accrual in the second half of this year. Leading GU cancer experts, Dr. Kim Belmont from the Dana-Farber Cancer Institute; Dr. Dan Petrylak from Yale University; and Dr. Bernie Eigl from the British Columbia Cancer Agency are the primary investigators on the trial. Additionally in bladder cancer, the Borealis-2 trial is an investigator-sponsored, randomized Phase 2 trial evaluating OGX-427 in combination with docetaxel in approximately 200 patients with advanced or metastatic bladder cancer who have disease progression following first-line platinum-based chemotherapy. Earlier this week, we announced that Borealis-2 is open for enrollment. The trial is being conducted at approximately 35 from the U.S. and is sponsored by the Hoosier Oncology Group. Dr. Noah Hahn from the Indiana University Simon Cancer Center, Dr. Toni Choueiri from the Dana-Farber Cancer institute; and Dr. Jonathan Rosenberg from Memorial Sloan-Kettering Cancer Center are the primary investigators on the trial. Moving on to lung cancer, we’ve recently announced plan for the Spruce trial. Spruce is an investigator-sponsored, randomized, placebo-controlled Phase 2 trial evaluating OGX-427 with carboplatin and pemetrexed in approximately 155 patients with previously untreated, advanced, non-squamous, non-small cell lung cancer. Spruce is being sponsored by the Sarah Cannon Research Institute or SCRI and Dr. David Siegel, Director of the Lung Cancer Research Program is the primary investigator of the trial. We expect patient enrollment for Spruce to begin in the middle of this year. Just yesterday, we announced our plans to initiate the Rainier trial in pancreatic cancer. Rainier is an investigator-sponsored, randomized, placebo-control Phase 2 trial evaluating OGX-427 in combination with ABRAXANE and gemcitabine in approximately 130 patients from previously untreated metastatic pancreatic cancer. The trial is also being sponsored by SCRI and is expected to begin patient enrollment in the middle of this year. Dr. Andrew Ko from University of California San Francisco and Dr. Johanna Bendell from SCRI will serve as the primary investigators on the trial. And finally prostate cancer. Building upon previously reported preliminary data of OGX-427 and CRPC, we announced initiation of the Pacific trial in December of 2012. Pacific is an investigator-sponsored, randomized, Phase 2 trial evaluating OGX-427 in approximately 80 men with CRPC, who are experiencing rising PSA, while receiving Zytiga. The trial is being managed by the Hoosier Oncology Group and is currently enrolling patients. Dr. Kim Chi from the British Columbia Cancer Agency, Dr. Christopher Sweeney from the Dana-Farber Cancer Institute and Dr. Noah Hahn are the primary investigators on this study. I’ll now turn the call back to you Scott.

[Scott Cormack:]

Hi, Sandy. As you can see we have made significant progress in establishing an extensive development program for OGX-427. We have partnered with leading oncology experts and institutions to assist with the design and execution of trials and will provide us with the opportunity to explore the implications of heat shock protein 27 or Hsp27, in cancer progression and treatment resistance and the immense potential of OGX-427. The initiation of multiple investigator sponsored Phase 2 trials across tumor types, represents a significant inflection point in the creation of value for OGX-427 for which we currently retain all commercialization rights. I’d like to remind everyone, that these trials and future trials may be initiated this year are part of the ORCA program are accounted for in our cash guidance, and we remain confident in our cash position will sustain us into 2015 well pass the synergy data readout. At this time, I’ll turn the call over to Susan Wyrick, who will provide an overview of the first quarter financial results. Susan?

[Susan Wyrick:]

Thanks, Scott. We ended the first quarter of 2013 with approximately $64.6 million in cash, cash equivalents and short-term investments. We continue to expect that these funds combine with reimbursements due from Teva under our collaboration agreement, will be sufficient to fund our operations into 2015. Revenue for the first quarter of 2013, increased to $5.1 million compared with $1.3 million because of prior year quarter. The increase was due to higher revenue earns to our collaboration with Teva largely resulting from clinical development activity associated with the affinity trial. Total operating expenses for the first quarter of 2013 increased the $13.4 million compared with $6.8 million in 2012. The increase was primarily due to higher clinical trial expenses associated with patient enrollment in the AFFINITY and Borealis-1 trial, higher costs directly associated with efforts to increase patient enrollment, increased head count to support our clinical development activity and stock-based compensation. Net loss for the first quarter of 2013 was $6.7 million or $0.46 per diluted common share, compared with $6.9 million or $0.67 per diluted common share for the prior year quarter. The net loss in the first quarter of 2013 included a non-cash gain on revaluation of our warrant liability of $1.4 million. The net loss in the first quarter of 2012 included non-cash loss on revaluation of our warrant liability of $1.4 million. Before completing our financial review, I’d like to reiterate guidance for 2013. Net cash requirements are expected to be in a range of $40 million to $50 million, reflecting AFFINITY costs, which are reimbursed by Teva quarterly in arrears and completion of patient enrollment in Borealis-1. Year-end cash, cash equivalents and investments are expected to be in the range of $25 million to $35 million. This estimated year-end cash balance does not reflect the fourth quarter receivable from Teva. We continue to expect that this cash and receivable will be sufficient to fund our operations into 2015. Our cash burn will be reduced in 2014, compared with 2013 because the company sponsored Borealis-1 trial is expected to incur the majority of its cost in 2013. Further, the investigator-sponsored OGX-427 Phase 2 trials are substantially less capital intensive. This concludes the prepared financial results discussion. I will now turn the call back over to Scott for closing remarks.

[Scott Cormack:]

Thank you, Susan. In conclusion we’ve had a fantastic to 2013. With Synergy passed its last futility analysis, we now turned our focus to enrolling the additional Phase 3 trials of custirsen while eagerly anticipating the final results of our primary registration trial. For our unpartnered product candidate OGX-427, there are now a total of six randomized Phase 2 trials ongoing. The ORCA program has regionally expanded to encompass five of these Phase 2 trials in four tumor types, all of which are a direct use of proceeds from the March 2012 financing and are fully accounted for in our guidance. We continue to execute against our data development program goals while demonstrating capital efficiency. We’re conducting three Phase 3 trials with custirsen and a total of six randomized Phase 2 trials with OGX-427. All this is being accomplished while retaining cash into 2015. Thank you, again for joining us. And I will now turn the call back over to the operator to open the line for questions. Operator?

[Operator:]

Certainly. (Operator Instructions). Our first question comes from the line of Katherine Xu from William Blair. Your line is now open and you may proceed with your question.

[Philippa Flint:]

Hi, good afternoon, everyone. This is Phil in for Katherine. Thanks for taking my question. Scott, just a quick question on the ENSPIRIT study. Could you just give us an update how things are going in terms of recruitment? How the sites are doing. I know there is a lot of competition in that space and just trying to find those patients for the study. And then second question related to, have you guys disclosed when the first futility analysis would occur for the study?

[Scott Cormack:]

Hi, Phil. Thanks for the questions. The ENSPIRIT enrollment as you probably know from previous discussions, we tend not to give moment-by-moment accrual numbers for any of the trial. So, we can’t give too much more detail on that. The trial has been open to a number of centers now and is clearly no. And on your second question, sorry, I missed the second part of that.

[Philippa Flint:]

Yeah. Just regarding potential futility analysis, I know you guys have too big into that study. Have you provided any timeframe when the first one might occur?

[Scott Cormack:]

Yeah. No, sorry. We haven’t given any guidance on those items.

[Philippa Flint:]

Okay. And then back to – I know you can’t provide exact numbers and obviously with the enrollment. But just to get a sense that everything is going well, obviously this space is pretty high in the light of, I guess, studies are being run on top of docetaxel, they are not second line on non-small cell. I’m just trying to get a sense that you feel comfortable with the recruitment timelines?

[Scott Cormack:]

Yeah. We continue to be comfortable with the accrual and it matching what we had plotted out for the trial. So, I think those expectations are being matched to the internal expectations.

[Philippa Flint:]

Great, great. Thank you so much for the question.

[Scott Cormack:]

Thanks a lot Phil.

[Operator:]

Thank you. (Operator Instructions) Our next question comes from the line of David Nierengarten from Wedbush Securities. Your line is now open and you may proceed with your question.

[David Nierengarten:]

I always know you call on me when there’s a pause pronouncing my name.

[Scott Cormack:]

Hi, David.

[David Nierengarten:]

Hi there. Could you remind us quickly on the Pacific Trial. You’re dosing 427 end patients while on Zytiga with a rising PSA. What are the goals again on that treatment and what are these subsequent, kind of what are the subsequent treatments allowed that would be a – kind of – what’s your idea, what’s your victory for 427 in that setting? Thanks.

[Scott Cormack:]

Right. Okay. So I’ll turn the details over to Cindy in a second, but just to reiterate basically what we’re doing of this study, we’re taking patients, CRBC patients that are on Zytiga that have rising PSAs but not other manifestations of progression. Randomizing the patients at that point such that half the group would continue on Zytiga while the other half receives Zytiga plus OGX-427. And the overall goal is to test the theory that 427 is implicated in treatment resistance. If we inhibit Hsp27 with OGX-427, then the intent would be to basically delay the full on test of treatment resistance and progression. So I’ll turn over to Cindy, who can give you some of the details on the primary endpoint and some of the statistics that surround that hypothesis.

[Cindy Jacobs:]

Sure. First of all on the treatment – on that, we’ve seen OGX-427 the dosing is typical to our trials where there is a loading dose period of 600 milligrams for three loading dose infusions, and then weekly 1,000 milligrams thereafter. The primary objective is really looking at a progression-free survival rate at a milestone days 60 assessment, which is approximately 8 weeks out. And so, what we’re looking at is then, these patients who have a rising PSA is basically stopping that PSA rising this then would further determine PSA progression as well as looking at preventing other radiographic and objective progression as well. Does that answer your question?

[David Nierengarten:]

Does the PSA have to stop rising or does it have to decline?

[Cindy Jacobs:]

It has to stop rising. So basically what happens, stop rising to the point where then it would reevaluated progression as progressions with PSA rising per standard criteria for PSA rising rate.

[David Nierengarten:]

Okay, all right. Thanks.

[Scott Cormack:]

Thanks.

[Operator:]

Thank you. And our next question comes from the line of Chad Messer from Needham & Company. Your line is now open and you may proceed with your question,

[Chad Messer:]

Hi. Thanks for taking my question. When I look at your two different programs, the custirsen and 427, obviously some similarities in the two drugs and that they both have a chaperone-type or they both go after a chaperone-type protein that cancers used to sort of evade – develop resistance to various treatments. And then you look at the two programs, there is some overlap with the prostate in the lung. But then some differences where you diverge 427, bladder, now adding pancreatic with custirsen, one time there was a breast, but that nothing is being pursued there. Can you kind of go through the reasoning between where you’re – why and where you’re looking the same and where you’re looking different. Is it mechanistic? Is it driven by data seen in Phase 1? Is it partly or mainly just sort of strategic? What’s driving – how do you think differently about the possibilities and the opportunities for the two different programs?

[Scott Cormack:]

Right. Thanks a lot for the question, Chad. That’s a good one to spend some time on. So, OGX-427 and custirsen are different in a number of ways. The first and foremost is, they are targeting different molecular targets. And they do operate by slightly different mechanisms, although they do operate at their basic level as chaperone molecules. Their clients are different and there are some similarities, if you kind of get into the depth of the mechanism of action, which we don’t have to go into today’s call. But where we get into the selection of potential indications is we will always generally follow the data that is there. So, to the extent that we know the expression profile in humans for these various targets in the context of the development or treatment resistance that will certainly guide our thinking. Then we turn to preclinical data and look after each strengths of the evidence that is there for each one of the product candidates. Then we get into some more strategic discussions. For example, what is the landscape looking like what are the opportunities that way. In the case of lung cancer, I think you had alluded to the differences in lung cancer for the two programs. We’ve elected to go forward with OGX-427 and the frontline setting with pemetrexed. Whereas with custirsen and with docetaxel and both of those are data driven. 427 is data with pemetrexed, we see that is an emerging trend towards treatment for frontline disease. In the case of custirsen, we had obviously a lot of data for custirsen with docetaxel and most notably obviously the evidence that we had for prostate cancer that took us into the Phase 3, but we got a good safety base. So, we could probably also have generated data with custirsen with pemetrexed, but that data was not yet in house. So, some of that background is giving us the direction. And then as we think to the forward plans, we take an overview generally of the, what we think drugs into development might look like. The opportunities for not only executing successful Phase 2 and Phase 3 strategies, but also what the landscape may shift to on the commercial front. And that lend us to an interesting discussion for things like bladder cancer. In the case of bladder cancer, unfortunately for these patients, we have not seen advancements for new therapies for decades. And so when we look at that landscape, we say okay, we’ve got nice expression data, that preclinical data is supportive, and there is a market, a true market need where we don’t see our landscape is going to shift for us if we direct that way. Because it’s an obviously it’s history has now been well established for in the late phases of clinical development in both prostate and lung cancer and while we continue to do pre-clinical work, we are really focusing on the getting the drug across the line with respect to approval at this point. So, hopefully that gives you a pretty good overlay of kind of how we walk through the different opportunities if we see for the drugs there are fairly deepen and broad opportunities for both, where we could go into various solid tumors probably liquids as well. And then there is a basically an array of data sets and opportunities that we evaluate as we choose the indications.

[Chad Messer:]

Thanks for that added information.

[Scott Cormack:]

Right. Thanks, Chad.

[Operator:]

Thank you. (Operator Instructions) Our next question comes from the line of Stephen Willey from Stifel. Your line is now open, and you may proceed with your question.

[Stephen Willey:]

Yeah, guys, good afternoon. Thanks for taking the question. I guess maybe a little bit of a follow-up to Chad’s question. I know that as you kind of look at the ORCA program, you have 427 in combo with a variety of different chemo backbones, gem, tax, platinum and I’m just wondering, I know you just kind of inferred some of these decisions are competitive in nature in terms of how you view the landscape. I’m just wondering if there is any data at this point to suggest that one mechanism on the chemo side would be more amenable to combo with 427 or if you’re just kind of agnostic to the chemo backbone at this point.

[Scott Cormack:]

Yeah. I think we’re quite agnostic at this point actually Stephen. Again, we have to turn to the history on the pre-clinical data front and I think what we’re looking at is to the extent that the particular chemo is more effective in a disease setting we tend to follow that that way. I don’t think there is a clear delineation that to say that 427 is better with taxanes versus platinums or anything like that. There is not that clear demarcation. So, I think right now the data would suggest that if the chemo agent or any other therapeutic class, we’re not just receptive to chemos, are effective in the treatment of the disease, then we have opportunities to combine in the data we suggest we’re able to augment that by the deferring of development of treatment resistance.

[Stephen Willey:]

And then I know you just mentioned liquid tumors. Is that something what you guys are considering at this point?

[Scott Cormack:]

Yeah, we look at liquids. I think it’s fair to say most of the dataset that we have access to is generated out of Dr. Martin Gleave’s facility at the prostate center in Vancouver in general and that facility has tissues pretty much in the solid tumor realms, most of the data that we have to evaluate is in solid tumors. I don’t think that is – should it be right to say that there is restriction or no opportunity in liquids. It’s just we have more data in solids and that’s tend to and because we follow datasets as a primary guide for our strategy development. We tend to follow that dataset which takes us into the solids.

[Stephen Willey:]

Okay. And we see more trials initiated under the ORCA program throughout the remainder of the year or just kind of it for now?

[Scott Cormack:]

Yeah. We remain I would say probably best stated as being opportunistic on where we could take the ORCA program in further development. I think we have now executed everything that we have had on our IR slides to date with Rainier being the last on the pancreatic side. And I think it’s an important statement to make sure people fully realize that as we are looking at these programs, we have put forward a budget that allows us to do a number of different program trials that allows us to get into the 2015 timeline. To the extent that we add any other trials are still going to be maintaining that objective because the last thing we want to do is shorten the life expectancy of the corporation from a runway perspective to do additional trials. So, everything that we have and would continue to execute on is still within the confines of that general strategy. I think that’s an important note. So, if we go forward, if somebody came to us and said we’ve got an opportunity to go into a different disease or a different indication setting and it’s accompanied by grant dollars or something that provides a different leverage, it would make sense to go there because that cost to do so would be remarkably inexpensive for us and provide additional diversity.

[Stephen Willey:]

Okay. And then in the pancreatic study you just announced, I know that OS is the primary endpoint and I think OS is the primary endpoint to a few of these trials and from a powering perspective, they’re not all that large from patient numbers. So, I’m just kind of wondering how do you guys deal with the data that comes in, in terms of – go decisions in terms of – in terms of going forward. So, kind of just which one of these things where you’ll know it when you see it?

[Scott Cormack:]

Right. Yeah. So, no, these are statistically designed and I’ll turn some of the detail back over to Cindy for some discussion on specifics. But, generally what we’re trying to do is, establish what we believe to be the critical endpoint to make an informed decision to go into future Phase 3 trails. So, for most of the diseases that we’re dealing with overall survival is the approvable endpoint. So, we want to be able to evaluate that endpoint in the context of these studies. And that way, we have an informed knowledge base to say go forward or not. Now, I think what you’re touching on it’s a slightly different issue. Let’s say, we design a trail that has a target hazard ratio of say 0.65, which is a pretty material change in the reduction and the rate of death. That is not to say that if you don’t see a 0.65 that’s a failure. That’s actually not correct. What we’re trying to do is, see a separation in the curve that informs rate of development. So, I would actually say that, on a general occurrence if you look at oncology trails, you want to be between 15% to 20% or better improvement in survival. And if you are seeing that in a randomized controlled study, that’s generally going to be good evidence to go into further studies on the Phase 3. So, while you name this a statistical endpoint on the Phase 2. It still gives you very important information for the design of the Phase 3 that would still be a success. And I think that’s a great distinction because this is a shift in strategy and probably guiding marketplace when you’re trying to do Phase 2 trials based on survival endpoints. Because they’re really not powered like a Phase 3 where you’re talking about 800 to 1,000 patients. So, they may end up being not statistically significant. But they give you the critical information for a future go no go decision. I think that’s a critical understanding as we think about the reveal on these trails in the future not just for us but for others in the industry.

[Stephen Willey:]

Okay and then just lastly, will you be communicating the completion of the interim analysis from SYNERGY or is that just kind of something that we should expect to kind of get in passing or in terms of an update on the next call or subsequent call?

[Scott Cormack:]

We’re still having those discussions with Teva and we’ll give some further update as the year unfolds. I think the important point for this particular call is to note that we have in fact cleared both of the futility analysis that we’re preplanned in the SYNERGY trial for custirsen. So, those are now behind us. And I think that’s an important claim for the development of custirsen as we think about things that could derail the program having those behind us I think is an important event for us. Stephen, I just – I wanted to return back to your previous conversation on hazard ratio and targets that I wanted to turn back to Cindy to make sure you have the specifics on I think it was the range of trials.

[Stephen Willey:]

Yes.

[Scott Cormack:]

If we can go back and add to that question for you that would be great.

[Cindy Jacobs:]

Sure. Just in general, what we’re doing with these ORCA investigator-sponsored studies is first of all they have to be randomized and controlled. Survival is primarily the endpoint. And although they are pilot Phase 2 trial for – we aim for these trials have 80% to 90% power to show a difference in the hazard ratio between 0.6 to 0.7 and usually had a one-sided significant level between from 0.05 to 0.1. And that these types of trials would give us enough trend. Certainly, it would have to be a quiet significant hazard ratio like 0.6-0.65 and then some case 0.7 to have a statistically significant finding, but that does not prevent us from using that data, let’s say if it’s 0.75 to then appropriately know how to adequately power and design a Phase 3 that obviously to show a statistically significant difference that 0.75 would be about right to the patient.

[Stephen Willey:]

Okay. And that’s powered off of the ABRAXANE Phase 3 results, right, and not the Phase 2, I know there was a fairly large disconnect between the two.

[Cindy Jacobs:]

Right for the Rainier trial, we are looking at the ABRAXANE Phase 3 data.

[Stephen Willey:]

Okay. Thank you.

[Scott Cormack:]

And again I just want to reiterate to the discussion that we just had with Steve and I think it is an important point to make that in our development cycle, we are raising the bar with respect to what we are doing in this clinical trials to do randomized, controlled Phase 2 trials to get to the clear answer. It is important for the design and ultimate registration of this product candidate.

[Operator:]

Thank you. Our next question comes from the line of Rene Shen from Leerink Swann. Your line is now open. And you may proceed with your question.

[Rene Shen:]

Hi, Thanks so much for taking my question. I just wanted to follow-up on the CRPC studies you’re running. First of all, why is OGX-427 being dosed with prednisone in these studies? I understand for the Zytiga study – for the Pacific study, Zytiga dosed prednisone, but the chemo and IE study was also dosed with prednisone and is that true of the other ORCA studies as well? And then just what sort of end point are you thinking for Phase 3 registration study in prostate cancer? Is PFS going to be sufficient in this study or how do we think about the past forward after the Pacific study result? Thank you.

[Scott Cormack:]

Okay. So – thanks again for the question Rene and welcome to the call. And so, first to deal with your question on prednisone utilization in the CRPC studies for 427. The requirement for prednisone is not a necessity. In the other trials under the ORCA, we don’t have prednisone unless it’s required generally with the drug that we’re combining with, which would be the case for example in things like docetaxel and so on. The trial that you’re specifically mentioning in 427 with prednisone versus prednisone alone in the patients prior to chemotherapy, the question I think is why would we include prednisone then? The main reason is because prednisone is an active control and the prednisone does effect patient’s progression and is effective treatment in about 25% to 30% of patients. You can see that in the results that we have revealed that were presented it has – there is about 20% some response rate in prednisone alone patients and I think that’s an important thing to know. We didn’t want to go into this patient population with no control whatsoever that would not be an appropriate control. The other thing I think to note is that at that time that this trial was initiated, other agents that have recently entered into the market and the pre-chemo marketplace were not available. There may have been utilized, but they were not available from label perspective. So, we wanted to generate data with something that was being utilized that was affair out of control. But it is again just go back to your key point. It’s not required in combination of 427. That’s not into factor inclusion criteria for the utilization of OGX-427.

[Cindy Jacobs:]

I think just to add others in the trial design as many of these patients were already on prednisone. So, we have the problem of having patients come on that would or would not have been on prednisone – standardize that all patients would have prednisone and then add it to 427 for those randomized patients.

[Scott Cormack:]

Right.

[Rene Shen:]

So at least we would be able to in a small study have more control over the data that everybody had prednisone.

[Scott Cormack:]

Right. And then just turning to the next study Pacific, we have Zytiga plus prednisone versus that and the addition of OGX-427 in a comparison. Prednisone is included as you alluded to there because it is required with Zytiga. So, again, its conclusion is really determined because of the Zytiga addition rather than the 427 addition. With regards to your discussion on PFS for CRPC, I think it’s still a bit of reach to suggest that PFS is likely an approvable endpoint in CRPC. I think we’re still dealing with OS, notwithstanding some of the recent things that happened with drugs that are in this space. But I think unless you have OS already demonstrated in this disease setting, maybe for an expansion of your label claim, PFS may be appropriate. But I think it’s a hard one as your primary endpoint. As to our future plans, I think where we stand is we obviously need to see the results of the Zytiga study, see the final revelation of the trial that we refer to in combination with prednisone in the pre-chemo setting and probably the context of a bunch of these other studies to basically take a look of continuum of the dataset we see across four different tumor types and opportunities that may evolve particularly with the shift in landscape and then we will have information to say here is our topics and again be driven by data and opportunity. And then, we’ll be able to design and evaluate our Phase 3 opportunities from that perspective, so probably a little bit early to call at this point given the dataset that we have available in CRPC.

[Rene Shen:]

Great. Thank you so much.

[Scott Cormack:]

Thanks a lot, Rene.

[Operator:]

Thank you. I’m not showing any further questions at this time. I would like to turn the call back over to CEO, Scott Cormack, for closing remarks.

[Scott Cormack:]

Great. Thank you very much for all the questions on this call. It’s been a very engaging discussion that we’ve had in this quarter. And again, just to reiterate that we are very pleased to pass these utility assessments for custirsen. Looking forward, to the final data results as we continue that development program and again to reiterate our enthusiasm for the OGX-427 program as we continue to execute on six randomized Phase 2s across four different tumor types. Thank you very much and we look forward to the future update.

[Operator:]

Ladies and gentlemen, thanks you for participating in today’s conference. This does conclude the program and you may all disconnect. Everyone have a great day.