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Allos Therapeutics Inc. (NASDAQ:ALTH)

Q1 2008 Earnings Call

May 7, 2008 8:30 am ET

Executives

Derek Cole - VP, IR

Paul Berns - President and CEO

Pablo Cagnoni - SVP and CMO

Jim Caruso - EVP, CCO

David Clark - VP, Finance

Analysts

Mark Monane - Needham & Company

Jason Kantor - RBC

Charles Duncan - JMP

Operator

Welcome, ladies and gentlemen. I'll now hand the conference over to Mr. Derek Cole, Please go ahead, sir.

Derek Cole

Good morning and thank you for joining us on Allos Therapeutics' first quarter 2008 results conference call.

With me this morning are Paul Berns, President and CEO; Dr. Pablo Cagnoni, Chief Medical Officer; Jim Caruso, Chief Commercial Officer; and David Clark, Vice President of Finance.

Following this introduction, Paul will summarize the company's first quarter activities. Pablo will then provide an update on our clinical development program. Jim will provide a brief commercial planning update. And David will review the company's financial results for the first quarter of 2008. Paul will conclude with a review of our key 2008 objectives. We welcome your questions following Paul's remarks.

As a reminder, this conference call is being recorded and webcast. The call may be accessed live on our website and will be available in our event archives for the next several weeks.

Before we begin, please be advised that during the course of this call, we may make forward-looking statements concerning our company that are not historical facts. These forward-looking statements may include, but are not limited to, statements concerning our future financial performance, our future product development plans, timelines relating to our clinical trials, timelines for regulatory actions, the potential safety and efficacy of our product candidates, and our plans related to potential marketing and commercialization of PDX.

Such forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that may cause actual results to differ materially from those anticipated by the forward-looking statements. Additional information concerning these risks and uncertainties is contained in the Risk Factors section of the company's annual report on Form 10-K for the year ended December 31, 2007, and in the company's other periodic reports and filings with the Securities and Exchange Commission.

The company cautions investors not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to the Company on the date hereof, and the company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date hereof except as required by law.

I will now turn the call over to Paul.

Paul Berns

All right. Good morning and thank you, Derek. It's a pleasure to update you today on recent advancements in our PDX clinical development program and to share our perspective for the balance of the year.

Under Dr. Pablo Cagnoni's leadership of the clinical development organization, we recently completed patient enrollment in PROPEL trial and remain on track to report topline results before yearend. Following our review of the trial results, we intend to submit a new drug application for PDX for the treatment of patients with relapsed or refractory PTCL as expeditiously as possible.

Our commercial organization, led by Jim Caruso, continue to advance our commercial planning and preparation for the future potential launch of PDX should PROPEL produce positive results and we receive marketing authorization from the FDA. Beyond the PROPEL trial, we continue to evaluate PDX's clinical utility in hematologic malignancies in three additional clinical trials.

In January, we advanced PDX's development in solid tumors with the initiation of a Phase IIb study of PDX compared to erlotinib in second-line non-small cell lung cancer.

In summary, we are making important progress in executing our PDX product development and commercialization plan to evaluate the therapeutic potential of PDX in both hematologic malignancies and solid tumors.

With that, let me now turn the call over to Pablo to review the results of the status of our clinical development programs.

Pablo Cagnoni

Thank you, Paul, and good morning.

Allow me to begin by highlighting recent progress for our pivotal Phase II PROPEL trial. PROPEL is an international, multi-center, open-label, single-arm trial designed to evaluate the safety and efficacy of PDX in patients with relapsed or refractory PTCL. Patients receive 30 milligrams per meter squared of PDX once every week for six weeks followed by one week of rest per cycle of treatment.

The treatment regimen also includes vitamin B12 and folic acid supplementation. The primary endpoint of the trial is objective response rate, complete and partial response. Secondary endpoints include duration of response, progression-free survival and overall survival. All patients enrolled in the trial will continue to be followed for long-term survival. It is important to note that this is the largest prospective designed trial of a single agent in this patient population.

The PROPEL trial was initiated in August of 2006. In April of this year, we completed patient enrollment in the trial with more than 100 evaluable patients enrolled at 31 medical centers in the U.S., Canada and Europe. We look forward to reporting topline results in the PROPEL trial by the end of 2008. Following our review of the trial results, we intend to submit a new drug application for PDX for the treatment of patients with relapsed or refractory PTCL.

The PROPEL trial is being conducted under an agreement reached with the FDA under its Special Protocol Assessment or SPA process. This process allows for the FDA evaluation of a protocol intended to from the primary basis of an efficacy claim in support of a new drug application and provides an agreement that the trial design, including trial size, clinical endpoints and/or data analysis, are acceptable to the FDA. The response rate required to support FDA approval is not specified in the PROPEL trial protocol and will be subject to FDA review.

Outside of PROPEL, we are also evaluating the potential clinical utility of PDX in other hematologic malignancies and solid tumors. We are currently conducting three clinical trials in other hematologic malignancies, which we expect will provide further insight into the clinical and commercial potential of PDX in these indications. We look forward to providing updates on our development program as the year progresses.

At the 10th International Conference on Malignant Lymphoma in Lugano, Switzerland, in June, updates will be presented on our study of PDX in patients with relapsed or refractory cutaneous T-cell lymphoma and a PTCL subset of the Memorial Sloan-Kettering Phase I-II study of PDX in patients with non-Hodgkin's lymphoma and Hodgkin's disease.

We have also continued to advance or develop in the PDX and solid tumors. In January of this year, we initiated a Phase IIb randomized, multi-center study comparing PDX and erlotinib in patients with stage IIIb/IV non-small cell lung cancer who are or have been cigarette smokers and who have failed treatment with at least one prior platinum-based chemotherapy regimen.

The objective of the study is to compare the efficacy of PDX to that of erlotinib in this patient population, and the primary endpoint of the study is overall survival. Secondary endpoints include response rate and progression-free survival, both compared to erlotinib and the safety and tolerability of PDX. This study will seek to enroll approximately 160 patients and up to 50 investigative sites worldwide.

We believe this study will provide important data on the potential utility of PDX in a patient population that is not adequately served by currently approved treatments.

We continue to be encouraged by the progress of our PDX development program. Based on PDX's rational design for improved uptick in retention in malignant cells, we believe PDX's potential across multiple indications in both hematologic malignancies and solid tumors.

To conclude our clinical development update, RH1 is a novel, small molecule chemotherapeutic agent that we are evaluating in a Phase I open-label, multi-center dose escalation study in patients with advanced solid tumors or non-Hodgkin's lymphoma. We plan to enroll up to 60 evaluable patients in this study with the objective of determining the maximum tolerated dose, recommended Phase II dose and safety profile of RH1 in this population.

With that, I will now turn the call over to Jim who will provide an update on our commercial planning efforts.

Jim Caruso

Thank you, Pablo. Peripheral T-cell lymphomas or PTCLs account for approximately 10% to 15% of all cases of non-Hodgkin's lymphoma or NHL in the United States. According to the American Cancer Society, approximately 63,000 patients are expected to be diagnosed with NHL in the United States in 2008.

We estimate the current annual prevalence of PTCL at approximately 9,500 patients annually. There are currently no pharmaceutical agents approved for use in the treatment of either first line or relapsed or refractory PTCL. Patients with this disease are often treated with multi-agent chemotherapy regimens for which first-line treatment responses typically range from 50% to 70%.

In addition to the 30% to 50% of PTCL patients that do not respond to first-line treatment with multi-agent chemotherapy regimens, a significant number of first-line multi-agent chemotherapy responders relapse or become refractory after treatment, underscoring the need for new therapies to treat patients with aggressive T-cell lymphoma.

Based on PDX's unique mechanism of action, along with the clinical experience to date, we believe PDX has the potential to play a clinically meaningful role in the treatment of T-cell lymphoma patients.

We continue to be focused on detailed product development and commercialization planning and execution in preparation for the potential future launch of PDX for the treatment of patients with relapsed or refractory PTCL, a first-to-market opportunity for Allos.

Our goal is to build a high-performance oncology sales and marketing organization that will allow us to achieve an appropriate share of voice with key treatment decision makers and providers. We view the U.S. oncology market space as scalable with a significant number of PTCL patients treated at larger cancer centers and institutions.

We continue to advance key market research activities such as product brand name and positioning, market dynamics, customer segmentation as well as pricing adoption work. We are also driving key activities such as sales force sizing and optimization and are in the process of establishing our specialty distribution channel, as you'd expect, which we plan to have in place prior to the potential launch of PDX.

Outside the U.S., we continue to evaluate strategic partnership opportunities that we believe are in the best interest of our company, customers and shareholders. Importantly, Allos retains exclusive worldwide rights to PDX for all indications.

With that overview, I will now turn the call over to David Clark for our financial review.

David Clark

Thanks, Jim.

For the quarter ended March 31, 2008, we reported a net loss of $12 million or $0.18 per share. This compares to a net loss of $8.4 million or $0.14 per share for the first quarter of 2007. Our R&D expenses for the quarter ended March 31, 2008, were $6 million as compared to $3.3 million for the same period last year. This increase was primarily a result of our expanded clinical development program for PDX.

Our cash position as of March 31, 2008, was $50.5 million. For the quarter ended March 31, 2008, our cash use in operating activities was $9.3 million. We expect that our cash use in operations for fiscal year 2008 will be in the range of $42 million to $46 million, consistent with our previous guidance. So, based upon our product development plans, we believe that our current cash position is sufficient to fund operations through at least the first quarter of 2009.

Now, I'll turn the call back to Paul.

Paul Berns

Thank you, David. I would now like to take the opportunity to thank the patients and clinical investigators for their participation in the PROPEL trial and the role in helping evaluate a potential new therapy for the treatment of relapsed or refractory PTCL.

As I'm sure you can appreciate, we are excited by our progress so far in 2008, and we continue to focus on driving our PDX product development and commercialization plan with a clear emphasis on completing the PROPEL trial.

As Pablo indicated, we intend to report PROPEL topline results by the end of the year. And following our review of the trial results, we intend to submit a new drug application for PDX for the treatment of patients with relapsed or refractory PTCL as expeditiously as possible.

In addition to the PROPEL trial, we are committed to evaluating PDX for oncology use as a single agent and in combination with other therapies. We currently have six ongoing clinical trials involving PDX, including the PROPEL trial, evaluating the compound's potential clinical utility in hematologic malignancies and solid tumor indications. We intend to initiate a Phase II single-agent study of PDX in another solid tumor indication in the second quarter and additional Phase I studies of PDX by yearend.

We believe 2008 has the potential to be an exciting year for Allos. We look forward to keeping you apprised of our progress.

We would now like to turn the call over to the operator for your questions. Operator?

Question-and-Answer Session

Operator

(Operator Instructions)

The first question comes from Mr. Mark Monane. Please state your company name followed by your question.

Mark Monane - Needham & Company

Thank you. Good morning. It's Mark Monane from Needham & Company. Good morning from New York City.

Paul Berns

Good morning, Mark.

David Clark

Good morning.

Mark Monane - Needham & Company

Let's start with a PDX question, please. Since there is no approved agents for peripheral T-cell lymphoma, maybe you can comment on what's currently being used out there and if the current agents may have any affect on response to PDX in a second-line setting.

Paul Berns

Sure, Mark. I'll have both Jim and Pablo speak to that, of course. But as you are probably aware, in our prior conversations, it's clear that in this setting, they tend to use the B-cell therapies really in an off-label capacity to try to treat PTCL patients. Typically, you see them using various chemotherapeutic suites such as CHOP, sometimes ESHAP, for example, and using various components and mixing various components of those, that polypharmacy, if you will, to try to manage the patients.

As we are aware, there aren't any approved agents today. From our market research with clinicians, there is certainly a great unmet medical need that exists in the market for improved therapies not just in the second-line setting, but frankly even ultimately in the first-line setting as well. So, with that comment, I'll turn it over to Jim and then Pablo to add some additional color.

Jim Caruso

The only other thing that I would add to that, Mark, is that this clearly is an area of high unmet medical need regardless of the chemotherapeutic regimens that are being used. Oftentimes, as you know, these agents do not work in first-line settings. And unfortunately, when the do have some type of response, either a partial response or complete response, the patients relapse or refract in a relatively short period of time.

I think the only additional color I will add to that is now you're seeing more and more single-agent utilization and kind of the tertiary or fourth and fifth-line settings for the treatment of these patients onto single-agent ONTAK, Gemzar. You're seeing some FLUDORA use there as well.

So, it's interesting to see that as clinicians move into third, fourth, fifth-line settings, they are getting more aggressive with single-agent monotherapies that really have no documented history and a well-controlled study of having effectiveness for this patient population.

Pablo Cagnoni

Yes, the one comment I would add is when we look at the patients that are being enrolled in PROPEL, and I have to tell you, Mark, that there is a variety of regimens and the spectrum of different treatments that these patients received is pretty incredible. I mean everything from phototherapy and local radiation therapy and single-agent Targretin all the way through autotransplant and allotransplant.

So, I don't think there is a clear standard-of-care out there regardless of the fact that, obviously, there are no approved agents. But, even beyond that, there is no clear standard-of-care for these patients that have emerged over the last 25 years.

Regarding the second part of your question, we have not analyzed the data yet, obviously, to see whether prior therapy influences in a certain way potential for response to PDX. I don't expect that to be the case, but we haven't looked at that yet.

Mark Monane - Needham & Company

Okay. That was helpful. And then one more question on the marketing side. I know that Jim and Paul have extensive experience and Pablo too in this area. I mean there are relatively few drugs that are approved in both the solid tumor and liquid tumor indications. Can you comment on is there a model that you're using in terms of developing the marketing strategy for this drug?

Jim Caruso

This is a very unique agent. And you bring up a very good point. I mean there is a number of issues that we need to address as we think about the brand positioning for this compound. There is the rich history of MTX, which is very interesting compound and, to your point, has demonstrated a lot of utility over the years in solid tumors. I think, to this day, relative to head and neck, it has never been beaten head-to-head or an agent has never been demonstrated to have superiority relative to MTX, in that setting, in that head-and-neck setting. You look at the latter, it's a very effective compound there. It's been also used in combination chemotherapeutic suites on the hemalignancy side of the equation.

Getting back to your previous question, Mark, I think it's important to note that in our earlier work at 078 with Owen O'Connor et al at MSK in patients that were treated with MTX in combination chemotherapeutic suites and feel they responded to monotherapy PDX in that study as well. I think that's important to note, talking to the potential differentiation between this advanced and next-generation antifolate relative to MTX.

So, you have this fine line of taking advantage of the history of MTX, and then the fact that this is a different molecule in the sense that it was rationally designed to be a significant enhancement relative to ease of transport into the cell and then the polyglutamation to bulking up in the higher degrees of efficacy.

Getting back to your earlier point around this broad spectrum of activity and the fact that this may be a very atypical agent in having effectiveness in both the hematologic malignancies as well as solid tumors, you have to build out your brand plan over a five to seven-year period. So, it's not as if you're just planning for our initial indication for PTCL, that first-to-market opportunity, we think beyond that in terms of potential utilization of this compound across a broad range of oncology indications.

So, we're very excited about the opportunity that this presents and we have to be very judicious in terms of building that plan out.

Mark Monane - Needham & Company

I think that's great. Pablo, do you have any additional comments?

Paul Berns

The only thing I would add to that, Mark, is that Pablo and Jim, I think, and the team, I will tell you, have worked collaboratively hand-in-hand with their outside heal community leaders and advisors to Jim's comments and really taking a look at, as you would expect, as we build our product development commercialization plans, looking at the science of PDX, a differentiated product profile that we believe we have with PDX, understanding the history of antifolates, but prior to clinical utility with antifolates in both hemalignancies and solid tumors and then putting together from our own proprietary Allos view of business of really a prioritized business plan in developing PDX on a risk-adjusted basis and the way that we think about it both in the fields of liquid tumors and solid tumors, looking at all those inputs, so that's what the underlying science and biochemistry, that's certainly the clinical pharmacology of the drug, if you will, and the application of regulatory strategy and hopefully commercial strategy, looking at unmet medical needs. We'll be looking to differentiate and serve the patient population. That all factors in rather rigorously. It would be our proprietary business plan of our own priorities for development.

Mark Monane - Needham & Company

Thanks very much for the added information, and congratulations on completion of enrollment for the trial.

Paul Berns

We are very, very excited about that.

Mark Monane - Needham & Company

Thanks. Again.

Paul Berns

Thank you.

Operator

Thank you. Your next question comes from Mr. Jason Kantor. Please state your company name followed by your question.

Jason Kantor - RBC

Hi, it's Jason Kantor from RBC. A couple of questions. You talk about topline results by yearend, which is what you've always been guiding to. But could you give us a little more clarity on what you mean by that, since there isn't a comparative arm? It's not like you're going to say, you know, we met our primary endpoint. Are you going to actually give the response rate at the time? Is that what you mean by topline results?

Pablo Cagnoni

That's correct. We're going to provide results around the primary and secondary influence for the study as well as the patient characteristics before the end of the year.

Paul Berns

We plan on submitting this, obviously, data, as you would expect, with the investigators into a peer review setting. So, if you think of yearend, we are targeting ASH for that. And in that regard, Jason, our intentions are with the investigators to provide, as Pablo just mentioned, the appropriate rigor beyond a topline set of data that looks at primary, secondary endpoints, certainly looking at response rate and breaking out according to base location demographics and additional characteristics that make sense for the review.

Jason Kantor - RBC

So, is it possible you will have a late breaker at ASH? Is that at all useful?

Pablo Cagnoni

We intend to submit an abstract to the ASH meeting. We certainly think that the data from the PROPEL study will be of enough interest that we'll be giving a presentation. Obviously, the abstract we will be submitting will be a placeholder, but we fully expect that the data will be presented at ASH, yes.

Paul Berns

And it was clearly our intention, and we hope ASH will take it and review it as such.

Jason Kantor - RBC

Great, that would be terrific.

Paul Berns

Yes.

Jason Kantor - RBC

The Phase II that you said you were going to start in the second quarter in another solid tumor, would you describe this as sort of a small exploratory study or is this a refractory patient setting where you could potentially be looking at as a registrational Phase II in the same way the PDX?

Pablo Cagnoni

The study will be a Phase II study in a relapse or refractory population. Obviously, we intend to target a population that is currently underserved by current therapies, but the study design at this point is a smaller exploratory Phase II study in a relapse refractory setting.

Jason Kantor - RBC

Okay. Terrific. Thank you.

Paul Berns

Thank you, Jason.

Pablo Cagnoni

Thank you.

Operator

And your next question comes from Mr. Charles Duncan. Please state your company name followed by your question.

Charles Duncan - JMP

Hi, this is Charles with JMP. Congrats on a good quarter of progress, guys. Thanks for taking my question. My question is related to the patient characteristics enrolled, and I know that you haven't done a full analysis yet, Pablo, but could you perhaps characterize the number of patients enrolled in the PDX study versus the number that you needed for the 100 evaluable?

Pablo Cagnoni

We have not completed analysis yet, Charles. As I mentioned during the conference call, we have enrolled at least 100 evaluable patients. That's all I'm ready to disclose at this point.

Paul Berns

Well, I think it's fair to say, as you can imagine, Charles, you enroll the patients, and then this study, as we've said before, this histology review that qualifies the patients done by independent third party, it's a rigorous evaluation that determines their evaluability of those studies. And so that's still underway.

Charles Duncan - JMP

Okay. Jim mentioned that these patients have been exposed to a broad range of agents and modalities. With regard to that kind of general range of drugs that have been given, does that differ really much from kind of what MSK usually uses with their PTCL patients? I mean I know you can't be too rigorous on that, but do you think that that was reflective of the MSK experience?

Pablo Cagnoni

Yeah, I mean I would put it the other way around. I do think that the prior therapy in the patients enrolled in the MSK trial are roughly reflective of the way these patients are managed outside of MSK. You have to remember not all of the centers have participated in the PROPEL trial are large referral centers. So, while dependence of carriers have variability from center to center, roughly they are similar.

Charles Duncan - JMP

And their definitions of the types of patients that should be enrolled in the trial are probably very similar, correct?

Pablo Cagnoni

That's correct.

Charles Duncan - JMP

Okay. And then I know you're probably not going to give me this answer, but can you give me the current number of patients that are still on the drug from the study?

Paul Berns

You're right. I'm afraid we're not going to talk about that.

Charles Duncan - JMP

Okay. And then maybe moving over to Jim, can you fine point a little bit more the pricing logic or the key elements of your pricing strategy that you're thinking through in terms of both hem and then potentially solid tumor cancers?

Jim Caruso

Great question. In terms of pricing right now, obviously we're doing the necessary fielding of the pricing adoption and market research work. We are modeling a number of different scenarios. I will tell you that when you look at some of our market research patient intent to take the medication, clinician intent to treat with the medication and third-party payer intent to reimburse for the medication, move down only slightly or incrementally with increases in the cost of the compound, and so that level of elasticity is very, very good obviously.

Input that you look for are obviously going to be the quality of the data in terms of going into our pricing model, the quality of the data that comes from our PROPEL study, which would be very helpful. I think you also need to take a look at the fact that there are no labeled compounds in the space. And quite frankly, there is a real question around the durability of responses for those agents or chemotherapeutic treatment regimens that are currently used in the space. There is a significant high, unmet medical need there.

The team here led by Pablo has designed the largest prospectively designed study for single-agent therapy of PTCL ever. We believe it's a significant and robust database, and we'll be able to take advantage of that database to further position PDX relative to existing agents from an efficacy, an adverse event profile, as we move further downstream, which we think will also be able to differentiate the compound from existing available agents.

We believe relative to single agents, there is one compound that's a peptide that is currently in a registration trial. And we believe, just from a product profile perspective, as we welcome obviously all comers into that space because number one, it's good for patients; number two, it's market awareness. But we believe we have a very interesting compound here based on both preclinical and the previous work done at 0278 from both an adverse event profile and from an activity in this T-cell lymphoma world, if you will.

So, the net of all of that, you take a look at some of the pricing benchmarks in this space that are being used potentially in a single-agent setting, Ontak, their range for CTCL depending on dose and duration goes anywhere from about $75,000 to $220,000. You could look at other agents as benchmarks for CTCL. Targretin could be as high as north of $100,000. ARRANON in a T-ALL space, as low as 15. But based on duration, number of cycles, et cetera, you're north of $100,000.

You can take a look at Clolar for pediatric ALL, anywhere from $35,000, $40,000 to $220,000 or so on an annual basis. Other agents that you look to, Gleevec for CML could be as high as $100,000 a year.

So, you can take a look at CMV's niche spaces for the most part, where there are other agents indicated, these orphan drug status types of markets, there is pretty significant pricing. And so our expectation is that this is a premium-priced compound at the end of the day. We're going to test a pretty wide range of price points, and what I will share with you to date, increases in that price point have very little effect on the intent, as I opened with, to use, prescribe and reimburse.

Charles Duncan - JMP

Jim, do you think that discussion around drug prices perhaps over the course of the next four years could impact this, and will you be prepared with some pharmacoeconomic type information that you can share with folks or will it be obvious to everyone including reimbursement, if there is?

Jim Caruso

Well, if you take a look at some of the compounds that I originally mentioned, the pharmacoeconomic data is particularly valuable when you can measure it against mortality, durability of response, keeping patients alive. So, that's one element to look at. The other one is you can take a look at transplants. And although the data is all over the place there, but you can take a look at the price points there anywhere from for a transplant with allo up to $500,000, and although the data is limited, maybe the additional life expectancy there is 24 months or so.

And so, you could see that there have been significant investments into this patient population with limited success. To your point, demonstrating a response rate both from a CR and PR perspective, and let's also not forget the importance of stable disease here, the role that that plays as well in terms of extending and enhancing the life of the patient and then the durability of that over time, these are the types of things with any drug in any space you would look at.

Charles Duncan - JMP

Okay. Thanks for the added color.

Operator

(Operator Instructions)

Thank you, sir. We seem to have no further questions. Please continue.

Paul Berns

All right. Thank you, Operator. And to conclude this morning's call, we'd like to summarize our three key corporate operating principles. First, our focus on excellence and innovation in the development and execution of our clinical programs; second, proactively evaluating opportunities to grow our business through potential product acquisition, partnerships and other strategic initiatives; and third, lead with ethics and integrity to ensure quality business decisions that create value for our patients, employees and stockholders.

As always, we appreciate your participation and look forward to keeping you apprised of our progress in the months ahead. Have a good day.

Operator

Thank you, ladies and gentlemen. This concludes today's conference call. Thank you for participating. You may now disconnect.

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Source: Allos Therapeutics Inc. Q1 2008 Earnings Call Transcript
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