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subset: commoncrawl


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Politics & Regulation Regulation Tax & Legal
The tax advantages of UCITS
UCITS funds are taxed more favourably than harshly treated offshore hedge funds in most European countries.
The investor pays tax according to their country of residence and the taxation of funds falls into three different systems:
1) Funds that are out of scope of income tax law by definition; or
2) Funds that are subject to tax but are exempt; or
3) Funds that are taxed but at very low levels
The investment fund structure is intended to offer a service to consumers, according to Georges Bock, partner and head of tax for KPMG in Luxembourg.
One of the advantages of putting money into a fund is


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Initial Report on Summary Judgment Practice Across Districts with Variations in Local Rules
Joe Cecil; George Cort
November 2, 2007, 17 pages
(Available On-line Only)
The Advisory Committee on Civil Rules asked the Federal Judicial Center to examine summary judgment practice across federal district courts as a means of assessing the potential impact of the proposed amendments to Rule 56. This initial report examined summary judgment practice in the 276,120 civil cases terminated in the federal district courts in Fiscal Year 2006. This unpublished research document is not restricted and may be distributed outside the federal judiciary.
Link or download
More in this Collection or Series:
Advisory Committee on Civil Rules
Unpublished Research
More on the Subject(s):
Fed. R. Civil P. 56
Federal Rules of Civil Procedure
Federal Rules of Practice and Procedure


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New management gets busy at Tessera Technologies (TSRA) which intends to refocus efforts on monetizing DigitalOptics technologies, including solutions for imaging and MEMS technologies.
"The changes announced today will enable the company to return its focus to its core IP business, will substantially reduce the company's operating costs, and provide the Company with a path to improved financial performance and profitability."
The company expects to take a charge of $50M-$55M, with about 75% of that amount coming in Q4 results. DOC-related operating expenses are expected to fall by about $17M and be fully realized by Q3 of this year.
CC at 8:30 ET
Shares are currently halted.


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Clinton Pushes Back Against GOP on Veterans' Health Issues
Clinton proposes improvements to veterans health care, services after her remarks criticized
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Temple Run episode 2 Tips and Strategies
- App name: Temple Run
- Developer: Imangi Studios
- Genre: Arcade
- Release: Aug 4, 2011
Let's play Temple Run on iOS. In this part of the walkthrough, you will learn more tips and tricks while playing the Temple Run game on the iPhone.
episode 2 Walkthrough
This page contains Temple Run video walkthroughs for iOS (iPhone/iPad) called "2 - marathon runner - - koopakungfu" and has been uploaded on KoopaKungFu official channel at May 4, 2013.
Still need help with this level? Here you can ask questions and discuss with other Temple Run users.
Hit like if this helped you!
Stuck on some levels in Temple Run? This walkthrough can help you finish the game.


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Getech is pleased to inform of its participation at: BAUMA 2016 fair, which is held from 11 to 17 April 2016 in Munich – at the The Peak of Excellence – Germany.Visit us in pavilion C2, stand 301. IFAT 2016 fair, which is held from 30 may … Continue to read
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the Gennaretti centrifuges
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Getech Revamping
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Tues 15th July 2008, 7.30pm start
Greetings everybody
Just giving the East Cheshire Harriers Black Knight Charge a plug. It is staged through Daisy Nook Country Park at Ashton Under Lyne. It is 6 mile offroad and consists mainly of track and trail, the start and finish is along the canal banking. It is a very demanding course with several short climbs,two years ago the weather was blazing hot, last year the course was like a mud bath and the river crossing had to be closed for safety reasons.
Registration is at ECH headquarters on Richmond st and the start is about a 15min jog so get there early, if you check out the club web site there is an entry form or enter on the night. www.eastcheshireharriers.co.uk .
Most important thing is the bar will be open after the race and there will be potatoe pie served what more do you need.
see you on the start line
Greeting Everbody
I have just been around the course, it is wet after all the rain we have had so off road shoes or fell would be advised.
I agree and what a good turnout over a hundred runners and the weather was great. I forgot how tough some of the climbs in the woods can be. Anyway thanks to all that made it a great night particularly the marshalls and backroom staff. see you next year.
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Runner's World is a publication of Hearst Magazines UK which is the trading name of The National Magazine Company Ltd, 72 Broadwick Street, London, W1F 9EP. Registered in England 112955. All rights reserved. Runner's World, Part of the Hearst UK wellbeing network
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There is one categorical position available on a competitive basis each year in the Pediatric Critical Care Fellowship.
You must apply through the Electronic Residency Application Service (ERAS).
The application and all supporting documentation must be submitted by Aug. 1 of the year preceding the appointment date. The academic year begins in July.


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Allos Therapeutics Inc. (NASDAQ:ALTH)
Q3 2008 Earnings Call
November 5, 2008 4:15 pm ET
Derek Cole – Vice President of Investor Relations
Paul Berns – President and Chief Executive Officer
Pablo Cagnoni – Chief Medical Officer
Jim Caruso – Chief Commercial Officer
David Clark – Vice President of Finance
Katherine Kim – Banc of America Securities
Lucy Lu – Citigroup
Mark Monane – Needham & Company
Thomas McGahren – Merrill Lynch
Jason Kantor – RBC Capital Markets
Welcome to the Allos Therapeutics' third quarter 2008 results conference call. (Operator Instructions). I would now like to turn the conference over to Derek Cole, Vice President of Investor Relations.
Derek Cole
Welcome to our third quarter 2008 results conference call. Joining us on today's call 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 third quarter activities. Pablo will then provide an update on our clinical development programs, Jim will provide a brief commercial planning update and David will review the company's third quarter financial results.
We welcome your questions following Paul's closing 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 the potential marketing and commercialization of pralatrexate.
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 factor 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
Good afternoon and thank all of you for joining us on today's conference call. It's certainly a pleasure to update you this afternoon on what was a very productive quarter for Allos. In clinical development organization led by Dr. Pablo Cagnoni continues to make important progress advancing the development of Pralatrexate in both hematologic malignancies and solid tumors. Our lead trial. PROPEL. is a pivotal Phase II trial of Pralatrexate in patients with relapsed or refractory peripheral T-cell lymphoma or PTCL.
Dr. Owen O'Connor, the principal investigator of the trial, is scheduled to report top line results from PROPEL in an oral presentation at the 50th Annual Meeting of the American Society of Hematology or ASH that will take place next month, December 6th through the 9th in San Francisco. Following our review of the trial results, we intend to submit a new drug application for Pralatrexate for the treatment of patients with relapsed or refractory PTCL as expeditiously as possible.
In addition to PROPEL top line data, three additional abstracts describing clinical and preclinical Pralatrexate studies have been accepted for poster presentations at ASH. Dr. Steven Horowitz, the study principal investigator, will present interim data from our ongoing Phase I/IIa open-label multi-center study of Pralatrexate and Jim [Sidabean] with vitamin B12 and folic acid supplementation in patients with relapsed or refractory non-Hodgkin's lymphoma or Hodgkin's disease.
Additionally, interim data from our Phase I open-label multi-center study of Pralatrexate with vitamin B12 and folic acid supplementation in patients with relapsed or refractory cutaneous T-cell lymphoma will be presented as well. If you recall in June of this year we reported encouraging interim data from the study and are pleased to be able to share additional interim data at the ASH meeting. Finally, data from our preclinical study of a combination of Pralatrexate and VELCADE will be presented.
Under the leadership of Jim Caruso our commercial organization continues to advance our commercial planning in preparation for the potential future launch of Pralatrexate, should we receive marketing authorization from the FDA.
In summary, we believe we are making important progress in executing our strategic business plans. We maintain worldwide rights to Pralatrexate for all indications and continue to advance the development of Pralatrexate in multiple hematologic malignancies and solid tumors.
I will now turn the call over to Pablo to review our clinical development programs.
Pablo Cagnoni
As we look forward to the presentation of top line results from our pivotal Phase II PROPEL trial in December at the ASH Annual Meeting, I would like to take this opportunity to review the PROPEL trial design and previously reported data. I will then review recent progress in our other clinical development programs before turning the call over to Jim.
As a reminder PROPEL is our pivotal Phase II international multi-center open-label single arm trial designed to evaluate the safety and efficacy of Pralatrexate in patients with relapsed or refractory PTCL.
Patients receive 30 milligrams per meter squared of Pralatrexate once every week for six weeks followed by one week of rest per cycle of treatment as well as vitamin B12 and folic acid supplementation. The primary endpoint of the trial is objective response rate either complete or partial response which will be assessed by central independent oncology review. Duration of response is the key secondary endpoint.
All patients involved in the trial will continue to be followed for long-term survival. Since we initiated the PROPEL trial in August of 2006, we have achieved the trial's clinical milestones either on time or ahead of schedule. In January, September and December of 2007 we announced in an independent data monitoring committee completed interim analysis of safety data from the first 10, 35 and 65 evaluable patients who completed at least one cycle of treatment with Pralatrexate respectively and recommended that the trial continue per the protocol at each analysis.
No major safety concerns were identified with the DMC. In September 2007 we announced the results of an interim analysis of patient response data exceeded the pre-specified threshold for continuation of the trial which required a minimum of four responses either complete or partial out of the first 35 evaluable patients as determined by independent oncology review.
In April of this year, we completed patient enrollments in the trial a full quarter ahead of schedule with more than 100 evaluable patients enrolled at 31 participating medical centers in the U.S., Canada and Europe.
In May, we reported interim response and safety data from the PROPEL trial. 29% or 19 of the first 65 evaluable patients enrolled in the trial experienced either a complete or partial response as assessed by central independent oncology review. 45% or 29 of the first 65 evaluable patients experienced either complete or partial response as assessed by the PROPEL investigators.
Patients were considered evaluable if they received at least one dose of Pralatrexate and the diagnosis of PTCL was confirmed by independent review. The median duration of response for these patients could not be estimated due to the current length of follow up.
The most common drug related grade 3 or 4 adverse events were mycocitis and thrombocytopenia which were observed in 14% and 23% of patients respectively. Significantly these patients had received a median of three prior treatments or regimens.
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 the clinical trial protocol intended to form 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 data analysis are acceptable to the FDA.
The response rate, duration of response and safety profile required to support FDA approval are not specified in the PROPEL trial protocol and will be subject to FDA review. Beyond PROPEL, we are also evaluating the potential clinical utility of Pralatrexate in other hematologic malignances 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 Pralatrexate in these indications.
In June, we announced the presentation of interim data from our Phase I open-label multi-center study of Pralatrexate in patients with relapsed or refractory CTCL at the 10th International Conference of Malignant Lymphoma in Lugarno, Switzerland.
Data were presented on 17 patients including 14 evaluable patients who completed at least one cycle of treatment with Pralatrexate at doses ranging from 15 to 30 milligrams per meter squared as part of the weekly schedule for two or three weeks followed by a week of rest.
Patients received a median of three prior systemic therapies. Investigator assessed responses were observed in 7 of 14 evaluable patients or 50% including two complete responses and five partial responses. Notably, the responses were observed in all four treatment cohorts.
The most common adverse event was mycocitis with grade 2 mycocitis observed in seven out of 17 patients and grade 3 mycocitis observed in two of 17 patients. There were no grade 4 toxicities and no thrombocytopenia above grade 1. We are encouraged by this data and look forward to providing an update to this study at ASH.
During the quarter we also made important progress with our Pralatrexate solid tumor development program. We continue to advance patient enrollment in our Phase IIb randomized multi-center study comparing Pralatrexate and [alatenib] in patients with Stage 3b/4 non-small cell lung cancer which we initiated in January of this year.
We are pleased with the progress we've made and expanding investigator interest and patient enrollment in this study since its initiation. Based on our current enrollment and enrollment rate we expect to complete patient enrollment in this study in the second half of 2009.
In July we expanded our Pralatrexate solid tumor development program through the initiation of patient enrollment in a Phase II open-label single-arm multi-center study of Pralatrexate in patients with advanced or metastatic relapsed transitional cell carcinoma or TCC of a urinary bladder.
The primary endpoint of the study is objective response rate which includes complete and partial responses. Secondary endpoints include duration of response, clinical benefit rate, progression free survival, overall survival and the safety and tolerability of Pralatrexate. The study will seek to enroll approximately 41 patients in up to 20 investigative sites worldwide.
In summary, we continue to be encouraged by the progress of our Pralatrexate development program. Based on pralatrexate's rational design for improved uptake and retention in malignant cells, we believe Pralatrexate has potential across multiple indications in both hematologic malignancies and solid tumors
We especially look forward to the presentation of top line data from our pivotal Phase II PROPEL file at the December ASH conference and following our review of the trial results we intend to submit a new drug application for Pralatrexate for the treatment of patients with relapsed or refractory PTCL as expeditiously as possible.
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.
I will now turn the call over to Jim who will update you on our commercial planning efforts.
Jim Caruso
The potential future launch of Pralatrexate for the treatment of patients with relapsed or refractory PTCL is a first to market opportunity for Allos. Currently, there are no pharmaceutical agents or multi-agent chemotherapy regimens approved by the FDA for use in the treatment of either first line or relapsed or refractory PTCL. This emphasizes the need for new therapies to treat patients with aggressive T-cell lymphoma.
According to the medical literature, patients with aggressive PTCL have an overall five-year survival rate of approximately 25 to 30%. WE estimate that PTCLs account for approximately 10 to 15% of all cases of NHL in the United States and has an annual U.S. prevalence of approximately 9,500 patients.
We are excited by our preliminary market research in which 97% of participating NHL physicians reacted positively to the interim 65 patient PROPEL data which demonstrated a 29% response rate as determined by a central independent review and a 45% response rate as reported by PROPEL investigators.
We believe this product profile will support trial, use and adoption of Pralatrexate. We remain focused on preparations for a potential future launch. In addition to pricing adoption work, we are conducting research on product brand name and positioning, market dynamics and customer segmentation. We also continue to drive important commercial infrastructure activities including sales force structure, sizing and optimization and the design and implementation of a customer relations management system.
We are also in the process of establishing our specialty distribution channels which we plan to have in place prior to the potential launch of Pralatrexate. Our objective is to build a high performance oncology sales and marketing organization and to achieve the necessary share of voice with key treatment decision makers and providers.
In our view the U.S. oncology market space is highly scalable with a sizable number of PTCL patients treated at relatively large cancer centers and institutions that we believe can be addressed by an appropriately sized sales force.
Importantly, Allos retains exclusive worldwide rights to Pralatrexate for all indications. While we are focused on preparing for a potential U.S. launch outside of the U.S. we will continue to review our strategic partnership opportunities with the intent to selectively pursue those partnerships that we believe are in the best interest of our company, customers and shareholders.
With that update I will now turn the call over to David Clark for a financial review.
David Clark
For the quarter ended September 30, 2008, we reported a net loss of $13.2 million or $0.16 per share. This compares to the net loss of $9.3 million or $0.14 per share for the third quarter of 2007.
R&D expenses for the quarter ended September 30, 2008 were $6.4 million as compared to $4.4 million for the same period last year. This increase was primarily a result of increased clinical trial costs due to our initiation of two new trials for Pralatrexate during 2008.
For the nine months ended September 30, 2008, the company reported a net loss of $37 million or $0.50 per share compared to a net loss of $28.1 million or $0.43 per share for the same period last year. For the nine months ended September 30, 2008, net cash used in operating activities were $30.7 million.
As of September 30, 2008, our cash, cash equivalents and investments in marketable securities totaled $96.4 million. Consistent with our previous guidance, we expect that our net cash use in operating activities for fiscal year 2008 will approximate $45 to $49 million.
With that I will now turn the call back to Paul.
Paul Berns
Before we move on to the Q&A portion of today's call, I would like to take the opportunity to thank all of the individuals who have been instrumental in helping us advance our clinical development program, especially the PROPEL trial.
We gratefully acknowledge the investigators and patients for participating in the PROPEL trial and for their important role in helping to evaluate the safety and efficacy of Pralatrexate for treatment of patients with relapsed or refractory PTCL, a disease for which there are currently no FDA approved treatments.
We believe that Pralatrexate has the potential to offer a new treatment option for patients with this challenging disease and look forward to the presentation of top line results from the PROPEL trial at ASH.
In summary, we are pleased with the advances we have made during the first three quarters of 2008. We have achieved several significant milestones further advancing our PDX development program in both hemo malignancies and solid tumors.
We believe we have established a strong foundation for continued progress and look forward to providing future updates. With that I will now turn the call over to the operator for your questions.
Question-and-Answer Session
(Operator Instructions). Your first question comes from Katherine Kim – Banc of America Securities.
Katherine Kim – Banc of America Securities
The first is the ASH abstracts which should be available soon. Do you expect to have any incremental or information in those abstracts from the presentations you're expecting? Or is this just going to be pretty much placeholders?
Paul Berns
I'll have Pablo speak to that because I think as you know, ASH is a organization like many tier one medical type conferences where the information is embargoed up until the point of which they really buy the organization at the meeting. But to that I'll have Pablo comment.
Pablo Cagnoni
It's our understanding that the abstract will be posted online at the ASH website on November 10. I'm afraid because, as Paul mentioned, because of the nature of the embargo placed by ASH on the data we cannot comment on what's contained in those abstracts.
Katherine Kim – Banc of America Securities
But if they're going to, can you just say if there's going to be any incremental information? Not necessarily talk about the data, but just if there's going to be new things? Or is it going to be just – like, for example, the PROPEL trial, is it just going to be a placeholder showing this interim data that was – the top line data that was announced back in May.
Pablo Cagnoni
There is more data in the abstract than was presented to the press release in May. That's all I can say at this point.
Katherine Kim – Banc of America Securities
OK. And then, for PROPEL, beyond the response rates and the duration of response, what other parameters should we be focused on?
Pablo Cagnoni
Well, those are the two key end points of efficacy as you mentioned, so the primary endpoint of the study as you know is overall response rate and I think you should focus on the response rate. You should focus on the number of complete responses in this study and the durability of those responses. All that in the context of the safety of PROPEL compound considering the population that was treated in the study which as we mentioned several times, was a very heavily pre-treated group of patients with PTCL.
All this has to be put into context of that group of patients. They're heavily pre-treated, therefore, the safety of PROPEL as well has to be put in context and the efficacy has to be put in that context as well. But I think you hit of the two key efficacy endpoints. I will just add that safety is the other key part of that.
Katherine Kim – Banc of America Securities
So, in your earlier comments when you talked about physicians looking at the interim data and being excited about it. Is there any other things that they're as particularly excited about besides the two – what we just talked about?
Paul Berns
Well, that's a great question. When we presented to a group of high prescribing NHL clinicians who specialize in peripheral T-cell lymphoma as well as the number of key opinion leaders, the priorities in terms of rank of importance would be your overall response rate, your complete response rate, your duration of response, your adverse event profile and then also, interestingly enough, dosing.
So those would be the key elements that these clinicians looked at, and they – the data specifically that they reviewed was that data that was presented to top line interim data, if you will, that we presented back in May. I will tell you that 97% of them said that the data was very favorable and perceived it to be positive which 3% were neutral to okay. So the data was received, as you would expect, very, very well.
Katherine Kim – Banc of America Securities
Okay and then, just final question. On TCC, when do you expect to have some preliminary data from that trial?
Pablo Cagnoni
In the bladder study we will probably have data some point next year. We have not given any guidance beyond that at this point, Katherine.
Your next question comes from Lucy Lu – Citigroup.
Lucy Lu – Citigroup
I just wanted to know if you could provide us with some color on the timing and the sale of the commercial infrastructure of the potential future line PDX? And how this may be impacted by the cash reserves at hand as a near term financing climate?
Paul Berns
I think we've been public that our expectation is to have a potential launch in the back half of 2009. Currently we are, as you would expect, preparing with your standard pre-launch marketing types of elements in terms of competitive analyses, market intelligence, understanding of disease state as well.
Our market research both qualitative and quantitative to have a better understanding of market dynamics and those inputs that impact brand decisions such as market landscape, etc. Doing pricing sensitivity work, forecast validation work, messaging, physicianing, and then your standard market preparation as it relates to medical education of providers and payers on the unmet need, on treatment challenges of peripheral T-cell lymphoma and then profile T-accounts, and then your infrastructure related elements as well.
I can share with you that we've had – which is typically the case when you have a novel, exciting, new oncology technology there is a great deal of excitement within the industry especially on the commercial side. And so we have a pretty extended queue, both for your sales specialist, additional marketing support, medical liaisons, etc., your managed care teams.
Because of the excitement around the technology that this compound has not only in our first to market mover position with peripheral T-cell lymphoma, but as Pablo has discussed, in the past, obviously, the opportunity that exists for us in both hematologic malignancies such as CTCL and D-cell as well as the unique nature of this compound for its potential activity in solid tumors as well.
Lucy Lu – Citigroup
I just wanted to see if you could focus more about how the marketing activities could be impacted the cash at hand and the current financing climate in the near term?
David Clark
We do have a good cash position. Our total cash position as of September 30, was $96.4 million, and if you recall, we completed a secondary offering in May which resulted in net proceeds of $65.2 million. So based upon our current product development and commercialization plan, part of those which was with Jim was speaking to, we currently have at least 12 months of cash on hand. We disclosed that in our 10-Q which we'll file today. But as a matter of corporate policy, we just simply don't provide guidance on our future financing plans.
Paul Berns
I can share with you we have a lot of experience on the commercial side of the equation and we are very judicious and with appropriate targeted spend we generate a lot of intelligence and a lot of data just based on our history of launching these types of compounds.
Lucy Lu – Citigroup
Excellent. And my last question is regarding operating expenses. Would you expect fourth quarter R&D expenses to decline relative to the current quarter given that the PROPEL study is going to be finished?
David Clark
We do actually expect that our fourth quarter R&D expenses will slightly increase as we look to continue enrollment with our lung trial and our bladder trial which we started in 2008 and also as we look to potentially advance other trials earlier in the first half of 2009. So we do expect R&D expenses to slightly increase in the fourth quarter.
Your next question comes from the line of Mark Monane – Needham & Company.
Mark Monane – Needham & Company
You've done a nice job in the past talking about other orphan agents or agents used like [Aranon] and Zolar with response rates that were deemed acceptable to the FDA. Can you talk about duration of response and how we should think about this in terms of what would be acceptable to – what would be good in terms of the clinical trial results and what would be advantageous to physicians when the physicians when and if they are making choices about treatment options for this disorder? Have you done market research for this?
Pablo Cagnoni
So when you look at the previous approvals in a similar space in patients with relapsed or refractory hematologic malignancies and drugs have been approved ion the basis of Phase II single run trials, as you mentioned, the response rates in those trials have ranged from 22 to maybe 32% in the number of approvals for the last ten years.
The durability of those responses depended on the disease, obviously, and they ranged for brief responses, in some cases in the leukemia trials, although some of those patients were censored because they underwent transplant to more prolonged duration response in patients who [inaudible] disease. We think that PTCL, since it's a heterogeneous disease will probably fall between those two extremes, from very brief duration responses in acute leukemia to much longer in indolent cases.
What would I consider positive or a good result? I think anything over two to three months of median durational response is probably a good outcome. As we discussed earlier, we did not have that data ready for release in May. But anything over that, I think, would be considered good results. In addition to that, I think what commissions wants to see when they look at results of a trial like this is the possibility of really prolonged responses in at least a small percentage of patients. So not only the median is important, but the fact that some of the patients have really prolonged durational response; it's going to be a key point.
Finally, let me just make a distinction when the results are presented that there's two different ways to look at this. One is durational response and the other one is duration of treatment. Duration of treatment is obviously another key important – even though it's not a formal endpoint of the study, it's another important piece of data.
As you probably remember from the design of PROPEL you cannot be a responder before the end of cycle one which is seven week cycle of therapy. Therefore, when you look at the median duration of response and duration of treatment, they're going to be slightly different because of that fact and that should be kept in mind.
Mark Monane – Needham & Company
Could you explain to us again how often patients are surveyed during the trial and can you talk about that?
Pablo Cagnoni
Yes. For instance in PROPEL are the first assessment of responses at the end of cycle one. Each cycle of therapy is six weeks with a week of rest, so at the end of week seven, the patient is assessed for response and then patients are assessed every cycle after that; so cycle one, three, five, seven, nine, so on.
Paul Berns
The only other thing I would add, Mark, to Pablo's comments regarding this topic is that anything greater based on the heavily pre-treated peripheral T-cell lymphoma patients, anything greater than three months was really perceived in a very positive manner in terms of three months of duration.
Mark Monane – Needham & Company
And in terms of the thrombocytopenia or the mycocitis, can you comment on is this the right dose of B12 and folic supplementation? Is there a dose response that might be more advantageous going forward or in the real world? Or is this level one that we expect to see generally with anti-folic therapy?
Pablo Cagnoni
The vitamin B12 folic acid supplementation regimen that is in PROPEL is similar to the one that we've used for ALIMTA in all the trials and is similar to what we've used in other PDX trials. I can't comment on whether there's a better supplementation regimen. We haven't done any comparison and none of the studies have included a different supplementation regimen, Mark, so, I can't comment on that at this point.
Paul Berns
And then the other comment that I would add from the market research in terms of assessing value to clinical attributes for this patient population, obviously we want the right balance between efficacy and adverse events. But, typically, your adverse event profile fall further down in terms of your priority rankings for these oncologists.
Mark Monane – Needham & Company
Yes, that was helpful. You reviewed that before. And then, finally, how many people now at the Allos? Have you made any recent additions to the executive team or to the core teams and what's the optimal number going forward into 2009?
Paul Berns
Clearly as we've laid out we've been very clear about this in the design of the product development commercialization strategic plans for Pralatrexate focusing on PROPEL as a lead registrational effort. So we clearly intend as we've reviewed again today and we're excited about the opportunity of building our own commercial medical affairs organization in the U.S.
We believe that this – that we are the cusp of perhaps realizing great potential in ultimately serving the end user, the patient, with this agent downstream, and we feel like we're in a great position to provide an indelible benefit to patient hopefully later in the process. Having said that, we continue to, as you would expect on an interim basis, review our strategic plan, look at the required headcount that we need. I will tell you that I think we've demonstrated to date that we're a fairly judicious organization.
I think frankly our size is one of our greatest competitive advantages with the functional and leadership skills of the individuals that we have added to the organization over the last couple of years. We'll continue to be, I think thoughtful about continuing to build up the organization and frankly speaking not getting out in front of ourselves. Said another way we will scale it appropriately, but I think once again one of our greatest attributes is to maintain a flat, nimble organization and make sure that we do not become top heavy.
I don't have a specific number in mind to give you only because we continually look to review as part of our strategic planning opportunities where we think PDX, Pralatrexate, can add value to other [inaudible] patient populations and as we gain data from the studies that we're investing in, I think that will inform us.
But we believe that we will be in a very efficient organization as Jim alluded to from the commercial side of the business and we've accounted for as, David spoke to, looking forward in our statement where we believe we have a minimum of 12 months of cash looking forward. That's in anticipation of all of the strategic commercial planning and scale up work that we've reviewed with you today.
Your next question comes from Thomas McGahren – Merrill Lynch.
Thomas McGahren - Merrill Lynch
Hi just a few quick questions for the [CT Sealcone] program is the data at ASH going to be updated data concerning additional patients you previously put out data on the first 17 patients or will it be presentation on those patients?
Pablo Cagnoni
There will be data on additional patients presented.
Thomas McGahren - Merrill Lynch
Will it be all 56 patients in the trial?
Pablo Cagnoni
No the trial of [Sealacone] patients will give an interim analysis of what we have at that point.
Thomas McGahren - Merrill Lynch
Okay and regarding the abstract on the preclinical data, the same combination with VELCADE, what are you thinking about in terms of going forward with going forward with maybe VELCADE or other combinations?
Pablo Cagnoni
So as you know the treatment of patients with non-Hodgkin's lymphoma particularly B-cell is mainly combination therapy. So we are doing a fair amount of preclinical work to try to investigate different potential combinations for Pralatrexate and the VELCADE data that was generated over in O'Connor's lab we thought that it was very exciting and it was certainly worth reporting at ASH.
Whether that will be the first combination we take into the clinic, we are in the process of evaluating different potential options and that trial is going to be one of those that we contemplate.
Paul Berns
I think kind of the problem with why we're and I think you heard Dr. O'Connor mention this at his poster presentation, but there is a lot of excitement giving the prospective view that we share with our advisors and investigators that are looking at potential combinations, to Pablo's comments, and we think that PDX has potential to form interesting multiple foundations with multiple potential therapeutic combinations in the future which are clearly worth exploring as we look to advance the clinical and commercial utility of Pralatrexate. Rather exciting time.
Thomas McGahren - Merrill Lynch
Okay and then just lastly regarding the LUMP lung program what would be a rate limiting step for partnering tat program? I guess you're not going to complete enrollment I guess until the back half of '09, is it possible that it could be partnered before then or after positive safety data?
Paul Berns
I think just historically if you look back at historical partnership with other products in the solid tumor environment just maybe narrow the focus a bit, it's certainly not uncommon to have seen historical partnerships post Phase II study results and certainly there's enough history there that we can all point to.
I think as we lay it out in our strategic approach that we maintain an open opportunistic view with regards to the inbound interest that certainly organizations have expressed in learning more about Pralatrexate's potential.
That includes all facets from the hematological malignancies as well as solid tumor potential for Pralatrexate. Having said that I think we have a well vetted product developing commercialization plan for PDX in solid tumors. Obviously the lung cancer program is an exciting one.
And I don't think there is any reason for us to rush into that necessarily from a partnering perspective, but at the same token our position has always been, Tom to your comment, we will look, to listen, to see and understand the attributes and potential contributions of other parties as we think about global development frankly for Pralatrexate
Your next question comes from Jason Kantor – RBC Capital Markets.
Jason Kantor – RBC Capital Markets
Thank you, couple of question, one on the financial guidance. It looks like you burned through only about $26 million to date this year if you net out the cash situation in Q2, so to get to your $45 to $49 million, unless I'm doing the math wrong, it looks like you have to nearly double the burn in the fourth quarter. So I guess is that correct? What are those costs and would that be a new run rate going into '09?
David Clark
So year to date through Q3 we've used $30.7 million in cash used in operations, so our guidance is 45 to 49. So really, if you look at Q4 that would sort of -- if you do the math there that equates to a guidance of 14.3 to 18.3 for the fourth quarter.
And I think as we look at that guidance some of that spend relates to one time manufacturing expense as we scale up manufacturing for a potential launch in the second half and then also looking to ramp up some commercialization investments as we look to a potential launch.
So, I think some of those expenses in the fourth quarter are one time and obviously as we just move into that fourth quarter we'll see some also increases in R&D expenses as I spoke to earlier.
Paul Berns
I was just going to say this reiterates, David's point, I wouldn't look at the fourth quarter in a vacuum in the context of letting that guide you to what potentially the future cash use needs would be for 2009. That would at this point be misleading to do so. We'll certainly give that guidance at our fourth quarter year end conference call.
Jason Kantor- RBC Capital Markets
And would this spending all run through he P&L or is some of this like the manufacturing, something that is going to get amortized over some period or show up in cost of goods later?
David Clark
For now it'll hit our P&L until when and if we get a product approved. Until we do that those expenses would run through our P&L.
Jason Kantor- RBC Capital Markets
And then one last question on the regulatory path so I assume you get this all tracked in and looked the data at hand. So based on the data that you've already seen have you essentially made the decision to file the NDA or is there some data that you internally are still waiting on to make that decision formally?
Pablo Cagnoni
We are in the process of reviewing the data and we are still in process of collecting data from the study quite honestly. This is an ongoing study; patients are still on drugs and we are still following them and new assessments of response continue to be performed.
So what we've said all along it is that we'll present the data, the top line data at ASH And after that we'll continue to clean up the data and our intention is to file an NDA as soon as possible after that.
(Operator Instructions). I show that there are no further questions at this time please continue.
Paul Berns
All right thank you operator and to conclude today's call, I would like to summarize our three key corporate operating principles, certainly first, focused on excellence in innovation and development and execution of our clinical programs. Second we proactively evaluate opportunities to grow our business through potential product acquisition, partnership and other strategic initiates.
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.
Ladies and gentlemen, this concludes the Allos Therapeutics' third quarter 2008 results conference call.
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Then Jesus was led up by the Spirit into the wilderness to be tempted by the devil.- Matthew 4:1
The Lord's discipline The disciplines by which God shapes us into new wineskins for His purposes are both active and passive in nature. The active disciplines – prayer, reading and meditation, solitude, fasting, and so on – we take up in obedience to God's instruction and command, seeking to maintain a regimen of such disciplines that the Spirit of God can use to form us from the inside-out into the image of Jesus Christ. The passive disciplines are strictly in the Lord's hand; He brings them to us when He will, and for whatever purposes is agreeable to His plan for our lives
[H]ere we have no lasting city, but we seek the city that is to come. Hebrews 13:15
Holidays and hardship The Thanksgiving holiday is upon us, a time when we are called to think back over the events of the previous year and give thanks for the many blessings we've received. For some it will be a time of unalloyed joy, but not everyone finds it so easy to count their blessings. The past year may have been one of personal hardship and tragedy, a time marked by the experience of sickness or death of loved ones. All are not thriving in the present economy, and many experience anxiety about the political status quo and fear about the future. You can be sure the media will be reminding us that depression strikes many especially hard during the holiday season, and we can understand why this is the case. There can be a deep sense of disconnection between the bitterness of daily life in a fallen world and the saccharine sweetness of seasonal pomp.
[G]uard the deposit entrusted to you…. 1 Timothy 6:20a
An action plan For the past two weeks, we have been looking at what Christians in America need to do in order to bring revival to our shores. We started with a look at a bleak prediction by British poet (and agnostic) Philip Larkin in his 1955 poem, "Church Going," in which he imagined a future when his fellow citizens would abandon the Christian faith. In his mind, the Church in Britain was a "going" institution, as in going away – fading into disbelief and disuse, a process he viewed an inevitable.
A recipe for revival Last week, we looked at "Church Going," a poem written in 1955 by the British writer Philip Larkin, who predicted a bleak future for Christianity in his homeland. He imagined a time when his fellow citizens would set aside their superstitions and leave church buildings empty and ready to be re-purposed or left to fall into ruins. In other words, he envisioned a post-Christian culture like the one we see across much of Western Europe today. The problem is not limited to Britain's shores, however. That is why, as I explained, I read Larkin's poem as a warning for Christians everywhere to get serious about their faith in order to prevent the spiritual decline he reflects upon.
Not worth it
In his 1955 poem "Church Going," British poet – and agnostic – Philip Larkin (1922-1985) tells the story of an impromptu stop at an English church which he made while on a bicycle tour. The first stanza offers his initial impressions of the place, followed by his musings on the future of similar church buildings and, by extension, of Christianity itself. In the process, Larkin represents the skeptical, secular worldview which eventually undermined Britain's spiritual heritage, creating the post-Christian culture we observe there today.
Between law and freedom
In part 1 of this series, we saw that a central aspect of Burke's critique of the French Revolution was his concern that terror had been allowed to flourish because there had first been a prior loss in good manners. Burke believed that manners are absolutely essential for the preservation of civilization.
I think Burke was right. Society, like nature itself, abhors a vacuum. Consequently when a society abandons good manners, the vacuum tends to be filled by either totalitarian tyranny or anarchical chaos. The social modus operandi which highly developed cultures observe dictates a broad range of behaviors which mere law can never cover. When these mannerly modes of operating are neglected, law attempts to fill the void as an alternative to complete anarchy.
Remember Me


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Francesco Totti has told L'Equipe: "I don't know my limitations, but I do know my character perfectly well."
The Roma captain is the second all-time top scorer in Serie A history on 227 goals and at age 36 is still a key figure for his team.
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[Updated 4/3/07 - Added recommendation to move add/remove methods to a custom collection.]
While using NHibernate 1.0x, developers who wanted support for generics often turned to Ayende's Hibernate.Generics. Since the use of generics is now natively supported by NHibernate 1.2, you'll no longer need this extremely helpful utility. Unfortunately, there's not a very simple way to migrate away from NHibernate.Generics without getting your hands a bit dirty, especially if you used the automatic wiring support for managing parent/child relationships. The steps described below outline a general approach to upgrading from Ayende's NHibernate.Generics to NHibernate's native support for generics. The entire process should take a couple hours to a couple days to complete, depending on the size of your project. Furthermore, once you've taken the initial upgrade steps, you can migrate each parent/child relationship, one at a time, without having to do them all at once.
NHibernate.Generics was certainly cool in that it provided automatic wiring between parent/child relationships. So when a child was added to parent, the parent was automatically assigned to the child. This all happened with a bit of pixie magic which was great for the wow effect. But there's a lot to be said for being explicit, and, as Ayende has explained, losing the magic will be better for project maintenance in the long run. If you've had to troubleshoot these automatic relationships or bring a new developer up to speed, you probably already know this.
<hibernate-mapping xmlns="urn:nhibernate-mapping-2.0">
At this point, you should be able to get all your unit tests passing again and have the application behaving as it did before the upgrade. Although the above steps are the only required steps for getting to NHibernate 1.2, it is highly recommended that you proceed with replacing all usages of Ayende's NHibernate.Generics with NHibernate's native support for generics. The following steps allow you to refactor away from Ayende's NHibernate.Generics, one parent/child relationship at a time, without breaking much of the existing code.
As an example, assume you have a Customer class having a one-to-many relationships to Orders. The Customer class, among other code, contains the following:
Customer.hbm.xml then contains:
The Order class, the "many" side of the relationship includes:
Finally, Order.hbm.xml contains:
<many-to-one name="OrderedBy" column="CustomerID"
class="BasicSample.Core.Domain.Customer, BasicSample.Core"
access="NHibernate.Generics.GenericAccessor, NHibernate.Generics">
In addition to the above code hiding complexity via automatic wiring, it also exposes the Orders list directly. Essentially, the Orders collection may be directly modified with no enforceable business rules. Suppose, for instance, that a Customer may only have 10 Orders for some reason. Exposing the collection directly makes it very difficult to impose the collection-modifying business rule. So during the refactoring process, we'll also want to improve collection encapsulation.
Another arguable smell in the code is that the parent/child relationship may be modified from either side. This introduces additional maintenance, adds complexity to managing the relationship, and increases opportunities to introduce bugs. Although we'll want to maintain the bi-directional traversability, we'll want to consolidate relationship management to the Customer side of the many-to-one relationship. (As a side note, Jimmy Nilsson, in Applying Domain-Driven Design and Patterns, asserts that even bi-directional traversability should be avoided in general. This is a point worth considering; but since we're focusing on migrating existing functionality, we'll keep the bi-directional traversability for now.)
To refactor the preceding code from Ayende's NHibernate.Generics to NHibernate 1.2 native support for generics with minimal breakage to existing code, repeat the following steps for each parent/child relationship:
Although it looks like a lot of work, the above represents a structured path for refactoring the code with minimal breakage to existing code. This is the way to go if you have a large development team and can only check out a few files at a time. You could certainly bypass a few steps and do "bulk" changes if you don't mind code being broken; but if you take that path, I would recommend not checking anything in until all your unit tests are passing.
Taking this a bit further...E.T., in the comments, noted that adding AddOrder/RemoveOrder to Customer makes the class less cohesive; besides managing itself, it's now managing the orders collection as well. This could get a bit out of hand if additional collections are added to the Customer class. To alleviate this and keep Customer more cohesive, consider creating a custom collection for managing orders and then move add/remove from Customer to this custom collection. In this way, business rules may still be enforced without cluttering Customer with others' responsibilities. You'll need to take some extra steps to bind NHibernate to a custom collection using IUserCollectionType. Alternatively, if you don't need a full-blown cutom type, you can also simply create a collection wrapper to better encapsulate your collection related methods. An example of doing this is found in the sample code at the NHibernate Best Practices article.
The simple example described in this post has not taken into account the variety of cascade options that are available nor various object life-cycle scenarios. So unfortunately, the above refactoring steps will most likely not account for every parent/child relationship in your code. Consequently, it's very important that you have a strong base of unit tests to ensure that your migration from NHibernate.Generics to NHibernate's support for generics has been completed successfully. As may be assumed, the NHibernate documentation is well written and is your best resource for dealing with the variety of situations that you will likely encounter. For each refactored parent/child relationship, it's good to test the following:
As always, your comments (corrections?) are most welcome. If you have a particular scenario which you're having trouble resolving using the sample above and the NHibernate documentation, I'd recommend posting your question to the NHibernate Forums which are generally very responsive.
Finally, I'm happy to say that I'll be releasing the 2nd edition of NHibernate Best Practices very soon which will demonstrate a number of relationship types using NHibernate 1.2.
Billy McCafferty
Awesome job Billy!
Thanks Billy. Couldn't have read your new article at a better time.
Wow. What a great example of real world changes, using tests to help you with the change, and refactoring while maintaining backward compatibility.
I don't see why you'd want to get rid of IList property. Replacing it with AddX()/RemoveX() methods is an unnecessery burden on the containing class. You are forgetting that your business class is not just a convinient way of getting data from a DB to the UI and back. Using your example, simply define CustomerOrders collection class that doesn't allow holding more than 10 items.
Keeping IList around has an additional benefit of working out-of-the-box with frameworks like Windows Forms and ASP.NET. That's the definition of cohesive I believe.
I agree that exposing IList would keep it more cohesive...but not encapsulated. I also agree that defining a custom CustomerOrders collection class would be an even better way to go. My order of preference would be: custom collection, Add/Remove methods on containing class, and then directly exposed IList. Directly exposing the underlying IList is akin to making the private member public. It's convenient and keeps overhead to a minimum, but also opens itself to misuse. On the other hand, that may not be an issue if there are no limitations on the collection and it's OK to add nulls to it, to clear it, adding children to it which point to a different parent, etc. But that's not often the case.
WIth that said, you've prompted me to add a note to the post, recommending to carry the add/remove methods to a custom collection, which is a good idea to emphasize.
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Microsoft provided an update today about its future Exchange Online Protection plans.
Microsoft recently noted a problem with its Outlook Web App and its Exchange Admin Center when used with the latest Google Chrome browser.
Microsoft gave notice this week that it's planning to update its Office 365 certificates later this month, and the update could affect some hybrid Exchange deployments.
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