Achieve Life Sciences Inc (ACHV) 2013 Q1 法說會逐字稿

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, Investor Relations with OncoGenex Pharmaceuticals. Please go ahead.

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 and 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. So please refer to OncoGenex's 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.

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 III primary registration trial for custirsen. We are pleased to announce that the SYNERGY trial is continuing as planned, per the recommendations of an independent data monitoring committee who have completed the second and last futility analyses per protocol. The planned efficacy interim analyses have not yet occurred. As sponsors, both OncoGenex and Teva remain blinded to all analyses and data results.

As a reminder, SYNERGY is designed to evaluate a survival benefit for 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 study is under an SPA agreement with 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 continue to expect data results to be announced in the first half of 2014.

Patient enrollment continues in the two additional Phase III trials of custirsen -- AFFINITY and ENSPIRIT. AFFINITY will evaluate the potential survival benefit of custirsen in combination with Jevtana, or cabazitaxel, as 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 has failed. Custirsen has 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 II trials intending to treat more than 700 patients who are suffering from common and difficult-to-treat cancers, including 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 trials we have announced to date.

Cindy?

Thanks, Scott.

Beginning with bladder cancer, we have two trials that are currently enrolling patients. The Borealis-1 trial is a company-sponsored, randomized, placebo-controlled, Phase II 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 expert, Dr. (inaudible) [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 II 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 30 sites in the US and is sponsored by the Hoosier Oncology Group. Dr. Noah Hahn from 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 recently announced plans for the Spruce Trial. Spruce is an investigator-sponsored, randomized, placebo-controlled Phase (inaudible) 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 Spigel, 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-controlled Phase II trial evaluating OGX-427 in combination with abraxane and gemcitabine in approximately 130 patients with previously-untreated metastatic pancreatic cancer. This trial is also being sponsored by SCRI and is expected to begin patient enrollment in the middle of this year. Dr. Andrew Ko from the 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 in CRPC, we announced initiation of the Pacific Trial in December of 2012. Pacific is an investigator-sponsored, randomized Phase II trial evaluating OGX-427 in approximately 80 men with CRPC who are experiencing a 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 the study.

I'll now turn the call back to you, Scott.

Thanks, Cindy.

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 in institutions to assist with the design and execution of trials that will provide us with the opportunity explore the implications of heat shock protein 27, or HSP 27, in cancer progression and treatment resistance, and the immense potential of OGX-427.

The initiation of multiple investigator-sponsored Phase II 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 that may be initiated this year are part of the ORCA program, are accounted for in our cash guidance, and we remain confident that our cash position will sustain us in 2015, well past 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)

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, combined 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 for the prior-year quarter. The increase was due to higher revenue earned through 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 to $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 trials; higher costs directly associated with efforts to increase patient enrollment; increased headcount to support our clinical development activities; 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 a 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 the 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 costs in 2013. Further, the investigator-sponsored OGX-427 Phase II 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?

Thank you, Susan. In conclusion, we've had a fantastic start to 2013. With SYNERGY past its last futility analyses, we now turn our focus to enrolling the additional Phase III 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 6 randomized Phase II trials ongoing. The ORCA program has recently expanded to encompass 5 of these Phase II trials in 4 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 stated development program goals which demonstrating capital efficiency. We are conducting 3 Phase III trials with custirsen and a total of 6 randomized Phase II trials with OGX-427. All of 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 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.

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's a lot of competition in that space in just trying to find those patients for the study. And then a second question related to -- have you guys disclosed when the first futility analysis would occur for the study?

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 trials, so we can't give too much more detail on that. The trial has been open to a number of centers now and is accruing though. And on your second question -- sorry I missed the second part of that.

Oh yes. Just regarding potential futility analysis. I know you guys have (inaudible) baked into that study. Have you provided any timeframe when the first one might occur?

Yes. No. Sorry. We haven't given any guidance on those either.

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 hot and a lot of, I guess, studies are being run on top of docetaxel there in that second-line non-small cell. I'm just trying to get a sense that you feel comfortable with the recruitment timelines.

Yes. 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.

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

Thanks a lot, Phil.

Thank you. (OPERATOR INSTRUCTIONS.) Our next question comes from the line of -- one moment. 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.

I always know you're calling on me when there's a pause pronouncing my name.

Hi, David.

The -- hi there. Could you remind us quickly on the Pacific Trial, you're dosing 427 in patients while on Zytiga with a rising PSA. What are the goals again on that treatment and what are the subsequent -- kind of what are the subsequent treatments allowed? What would be a -- kind of a -- what's your ideal -- what's a victory for 427 in that setting? Thanks.

Right. Okay. So I'll turn the details over to Cindy in a second, but just to reiterate basically what we're doing with this study, we're taking patients -- CRPC 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 HSP 27 with OGX-427, then the intent would be to basically delay the full onset 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.

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

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

It has to stop rising. So basically, it would have to stop rising to the point where then it would be re-evaluated with progression with PSA rising per the standard criteria for PSA rising rates.

Okay. Alright. Thanks.

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.

Hi. Thanks for taking my question. When I look at your two different programs -- custirsen and 427 -- obviously some similarities in the two drugs in that they both have a chaperone-type -- or they both go after a chaperone-type protein that cancers use to sort of evade -- develop resistance to various treatments. And then you look at the two programs -- there's some overlap with the prostate and the lung -- but then some differences where you diverge 427, bladder, now adding pancreatic -- with custirsen I guess at one time there was a breast, but that nothing's 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 I? 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?

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. Obviously, 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 to 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 of treatment or resistance, that will certainly guide our thinking. Then we turn to preclinical data and look at the strength 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 in the front-line setting with (inaudible), whereas with custirsen we went with docetaxel. And both of those are data-driven. 427 -- there's data with pemetrexed and we see that as an emerging trend towards treatment for front-line 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 III. But we've 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 in development might look like, the opportunities for not only executing successful Phase II and Phase III strategies, but also what the landscape may shift to on the commercial front. And that lends 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. The preclinical data is supportive. And there is a market -- a true market need where we don't see a landscape that is going to shift for us." So we direct that way. Custirsen -- obviously its history has now been well-established. We're in the late phases of clinical development in both prostate and lung cancer. And while we continue to do preclinical 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 that we see for the drugs. There are fairly deepened and broad opportunities for both where we could go into various solid tumors -- probably liquids as well -- and then there's a -- basically an array of data sets and opportunities that we evaluate as we choose the indications.

Thanks for that added information.

Great. Thanks, Chad.

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.

Hi, 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, platinums -- and I'm just wondering -- I know you just kind of inferred that some of these decisions are competitive in nature in terms of how you view the landscape, but I'm just wondering if there's 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.

Yes. I think we're quite agnostic at this point actually, Stephen. The -- again, we have to turn to the history on the preclinical data front, and I think what we're looking at is, to the extent that a particular chemo is more effective in a disease setting, we tend to follow that pathway. But I don't think there's a clear delineation to say that 427 is better with taxanes versus platinums or anything like that. There's 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 restricted to chemos -- are effective in the treatment of the disease, then we have an opportunity to combine and the data would suggest we're able to augment that by the deferring of development of treatment resistance.

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

Yes. We look at liquids. I think it's fair to say most of the data set that we have access to is generated out of Dr. Martin Gleave's facility at the Prostate Center at Vancouver General, and that facility has tissues pretty much in the solid tumor realm. So most of the data that we have to evaluate is in solid tumors. I don't think that is -- should be read to say that there's a restriction or no opportunity in liquids. It's just we have more data in solids. And that's -- and because we follow data sets in -- as a primary guide for our strategy development, we tend to follow that data set which takes us into the solids.

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

Yes. 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've 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 that 2015 timeline. To the extent that we add any other trials, we're 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, if would make sense to go there because the cost to do so would be remarkably inexpensive for us and provide additional diversity.

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 patients numbers. So I'm just kind of wondering how do you guys deal with the data that comes in in terms of your (inaudible) decisions in terms of going forward? So kind of just one of these things where you'll know it when you see it?

Yes. So no, there -- these are all 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 III trials. So for most of the diseases that we're dealing with, overall survival is the approval endpoint. So we want to be able to evaluate that endpoint in the context of these studies. That way, we have an informed knowledge base to say go forward or not. Now I think what you're touching on is a slightly different issue. Let's say we design a trial that has a target hazard ratio of, say, 0.65, which is a pretty material change in the reduction in the rate of death. That is not to say that if you don't see a 0.65, it's a failure. That's actually not correct. What we're trying to do is see a separation in the curve that informs later development. So I would actually say that, on a general occurrence, if you look at oncology trials, you want to be between a 15% and 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 III. So while you may miss, say, a statistical endpoint on the Phase II, it still gives you very important information for the design of the Phase III that would 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 II trials based on survival endpoints because they're really not powered like a Phase III where you're talking about 800 or 1,000 patients. So they may end up being not statistically significant, but they give you the critical information for a [go no or go] decision. I think that's a critical understanding as we think about the reveal on these trials in the future, not just for us but for others in the industry.

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?

Yes. We're still having those discussions with Teva and we'll give some further updates 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 analyses that were preplanned in the SYNERGY trial for custirsen, so those are now behind us. And I think that's an important point 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. Then I wanted to turn back to Cindy to make sure you had the specifics on -- I think it was the Rainier Trial.

Yes.

So if we can go back and answer that question for you, that'd be great.

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 II trials, we aim for these trials to have 80% to 90% power to show a difference in the hazard ratio between 0.6 to 0.7 and usually at a one-sided significance level between -- or from 0.05 to 0.1. And that -- these type of trials would give us enough trend. Certainly it would have to be a quite significant hazard ratio, like a 0.6, 0.65 and, in some cases, 0.7 to have a statistically significant finding, but that does not prevent us then from using that data. Let's say it says 0.75, to then appropriately know how to adequately power and design a Phase III to obviously to show a statistically significant difference at 0.75 would be 1,000 patients.

And that's powered off of the abraxane Phase III results -- right? -- and not the Phase II.

Yes. Yes.

I know there was a fairly large disconnect between the two.

Right. But for the Rainier trial, we are looking at the abraxane Phase III data.

Okay. Thank you (inaudible).

And again, 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're doing in these clinical trials to do randomized controlled Phase II trials to get to the clear answer. It is important for the design and ultimate registration of these product candidates.

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.

Hi. Thanks so much for taking my question. 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 is dosed with prednisone, but the chemo-naïve study was also dosed with prednisone. And is that true of the other ORCA studies as well? And then just what sort of endpoint are you thinking of for a Phase III registration study in prostate cancer? Is PFS going to be sufficient in this setting or how do we think about the path forward after the Pacific study reads out? Thank you.

Okay. So thanks again for the question, Rene, and welcome to the call. So on -- 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 were 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. The prednisone is -- does affect patient 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 at ESMO, there's about a 20-some percent response rate in prednisone-alone patients. And I think that's an important thing to note. 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 the time that this trial was initiated, other agents that have recently entered into the market in the pre-chemo marketplace were not available. They may have been utilized but they were not available from an on-label perspective, so we wanted to generate data with something that was being utilized that was a fair, active control. But it is -- again, just to go back to your key point, it's not required in combination with 427. That's not a de facto inclusion criteria for the utilization of OGX-427.

I think I'll just add that (inaudible) in the trial design and many of these patients were already on prednisone. So we had the problem of having patients come on that would or would not have been on prednisone. So we'd standardize that all patients would have prednisone and then added the 427 for those randomized patients.

Right.

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

Right. And then just turning to the next study, Pacific, we have Zytiga plus prednisone versus that and the addition of OGX-427 in the comparison. Prednisone is included, as you alluded to there, because it is required with Zytiga. So again, its inclusion is really determined because of the Zytiga addition rather than that 427 addition. With regards to your discussion on PFS for CRPC, I think it's still a bit of a 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 have happened with drugs that are in the space. But I think, unless you have OS already demonstrated in this disease setting, maybe for an expansion of your label plan, 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 at the continuum of the data set we see across four different tumor types and opportunities that may evolve, particularly with the shifting landscape. And then we will have information to say, "Here's our top picks" and, again, be driven by data and opportunity and then we'll be able to design and evaluate our Phase III opportunities from that perspective. So probably a little bit early to call at this point, given the data set that we have available in CRPC.

Great. Thank you so much.

Thanks a lot, Rene.

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

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're very pleased to have passed the futility 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 6 randomized Phase IIs across 4 different tumor types. Thank you very much and we look forward to future updates.

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