There was a partial transcript posted, but this is the whole thing. Mostly just for me to link to in research blog.

1:01


Matt Ironside:
Hello everbody, we're about ready to get started. Dr. Celestia Higano, David Miller is there anything you want ot say to get started?
Tuesday May 4, 2010 11:01 Matt Ironside
11:01


Dr. Higano, UW SCCA:
Yes, ready.
Tuesday May 4, 2010 11:01 Dr. Higano, UW SCCA
11:01


David Miller:
Thanks for having this and honored to be on the same chat with Dr. Higano.
Tuesday May 4, 2010 11:01 David Miller
11:01


Dr. Higano, UW SCCA:
This is an exciting time for prostate cancer patients.
Tuesday May 4, 2010 11:01 Dr. Higano, UW SCCA
11:02


Matt Ironside:
This question comes from Ruth in Seattle:

Would you recommend recently diagnosed patients who have had a prostatectomy take Provenge immediately? What are the variables you would address in making that recommendation?
Tuesday May 4, 2010 11:02 Matt Ironside
11:02


Dr. Higano, UW SCCA:
I don't know anything about the breast cancer study.
Tuesday May 4, 2010 11:02 Dr. Higano, UW SCCA
11:03


Dr. Higano, UW SCCA:
No, Provenge is for men with metastatic disease. It has not been studied in early PC.
Tuesday May 4, 2010 11:03 Dr. Higano, UW SCCA
11:04


Matt Ironside:
From Rick in Everett:

I have had surgery, radiatoin, and Lupron for my prostate cancer that had begun to spread. There is no lymph or bone involvement and the article on Provenge indicated a man in my situation may benefit the most from Provenge.
Tuesday May 4, 2010 11:04 Matt Ironside
11:06


Dr. Higano, UW SCCA:
We do not know yet if someone in your situation will benefit from Provenge. Again, Provenge is only approved for men with metastatic disease that we can see on scans.
Tuesday May 4, 2010 11:06 Dr. Higano, UW SCCA
11:07


David Miller:
I'll let Dr. Higano take the medical questions, of course.
Tuesday May 4, 2010 11:07 David Miller
11:07


Matt Ironside:
This is from Cheryl in Baltimore:
As the availability will probably be limited at first, how will recipients be selected? And what are the typical side effects of Provenge?
Tuesday May 4, 2010 11:07 Matt Ironside
11:07


David Miller:
I'll take the first one.
Tuesday May 4, 2010 11:07 David Miller
11:08


Dr. Higano, UW SCCA:
OK
Tuesday May 4, 2010 11:08 Dr. Higano, UW SCCA
11:09


David Miller:
Dendreon has worked with patient groups, medical associations,and the doctors to create a system of what I call "Provenge Authorized" enters. There are about 50 nationwide. The docs at those centers will choose which of their patients will be first in line according to their medical condition. 2,000 patients will be treated in the next 12 months.
Tuesday May 4, 2010 11:09 David Miller
11:09


Dr. Higano, UW SCCA:
The side effects at the same as those we might see from a blood transfusion and include fever, chills, muscle aches, all usually resolve within 24 hours.
Tuesday May 4, 2010 11:09 Dr. Higano, UW SCCA
11:09


[Comment From GuestGuest: ]
When is Provenge likely to be used to treat intermediate and low risk PC?
Tuesday May 4, 2010 11:09 Guest
11:10


David Miller:
After 12 months, there will be more manufacturing capacity available. by the end of 2011, Provenge should be available to whomever is eligible.
Tuesday May 4, 2010 11:10 David Miller
11:10


Dr. Higano, UW SCCA:
It is probably going to be some time before clinical trials demonstrate benefit in those settings, however.
Tuesday May 4, 2010 11:10 Dr. Higano, UW SCCA
11:11


David Miller:
lol Dr. Higano, when is the big co-op study going to start in adjuvant use? Dr. Higano is right. Since we don't have good surrogate endpoints for PCa, it will be some time.
Tuesday May 4, 2010 11:11 David Miller
11:11


Matt Ironside:
From Norton in Smallwood:

Hello, Do you have information regarding how long the Dendreon vaccine would be active in an individual? Is this months, years, decades?
Tuesday May 4, 2010 11:11 Matt Ironside
11:11


Dr. Higano, UW SCCA:
I don't know. It often takes cooperative grops 24 months to get phase III trials started.
Tuesday May 4, 2010 11:11 Dr. Higano, UW SCCA
11:12


Dr. Higano, UW SCCA:
We don't know for sure how long it is active but this will be studied in future trials.
Tuesday May 4, 2010 11:12 Dr. Higano, UW SCCA
11:12


Sandi Doughton:
Dr. Higano: How many of your patients will be able to receive Provenge in the next 12 months, and how will you decide which patients?
Tuesday May 4, 2010 11:12 Sandi Doughton
11:13


David Miller:
Norton, it depends on the individual. Dendreon has seen patients with immune response to the core PA2024 antigen at 12 months. My *guess* is some patients have a response for even longer
Tuesday May 4, 2010 11:13 David Miller
11:15


Dr. Higano, UW SCCA:
Each of the 50 sites around the country will have slots for only 2 patients per month. The main criterion for treatment is that the patient have metastatic castration resistant prostate cancer, have minimal symptoms from cancer, not on narcotics and have a life expectancy of over 6 months. Just like the patients in the phase III trial.
Tuesday May 4, 2010 11:15 Dr. Higano, UW SCCA
11:15


[Comment From CalifiaCapitalCalifiaCapital: ]
I'd like ask Dr Higano and Mr Miller about off label use of provenge in earlier stage PC. Do you think it will be significant and what is the route to label expansion? Do we need to wait for a better surrogate?
Tuesday May 4, 2010 11:15 CalifiaCapital
11:17


David Miller:
From my perspective there will be off label use. I do not think we'll see much of it until after everyone who is a label candidate can get access - so probably not until late 2011 or 2012 to clear the backlog. The route to label expansion is a very large, very lengthy trial - 2-3 years to enroll, probably 10 years of follow up. As Dr. Higano noted, probably 2 years to even get started.
Tuesday May 4, 2010 11:17 David Miller
11:17


Dr. Higano, UW SCCA:
Off label use in earlier stage disease will probably not occur until the availability of Provenge improves. As for expansion of the label, it would certainly help to have better surrogates of survival, but we really don't have such surrogates at the moment.
Tuesday May 4, 2010 11:17 Dr. Higano, UW SCCA
11:18


Matt Ironside:

From Ken

I have heard that the treatment costs about $90,000 and only extends life about 3-4 months -- is this not a bad risk/reward outcome for our cash strapped Medicare system (6-7 years extension would make more sense)?
Tuesday May 4, 2010 11:18 Matt Ironside
11:18


David Miller:
Maybe the abiraterone trial gives us CTCs as a surrogate, but maybe NOT for earlier stage disease
Tuesday May 4, 2010 11:18 David Miller
11:19


Dr. Higano, UW SCCA:
The 4 month survival benefit is a median, meaning half the patients benefited longer than 4 months. There are many examples of drugs that cost this much and result in the same, or even less, survival benefit.
Tuesday May 4, 2010 11:19 Dr. Higano, UW SCCA
11:20


David Miller:
Provenge has the largest treatment benefit for any drug approved for this stage of disease. The MEDIAN man has a 4+ month benefit, but that undersells the benefit. At three years, guys are about about 3x more likely to be alive taking Provenge according to the 9901 study.
Tuesday May 4, 2010 11:20 David Miller
11:20


Dr. Higano, UW SCCA:
Agree!
Tuesday May 4, 2010 11:20 Dr. Higano, UW SCCA
11:20


[Comment From DougDoug: ]
When will we know how much treatment will cost, after Medicare reimbursement?
Tuesday May 4, 2010 11:20 Doug
11:21


David Miller:
That depends on whether you have supplemental insurance or not. Dendreon has a hotline program (www.Provenge.com) to help you figure this out.
Tuesday May 4, 2010 11:21 David Miller
11:21


[Comment From MartMart: ]
In your opinion, for the indication Provenge has been approved for, should it always be the first line treatment now? And the other treatment options be secondary (taxotere, etc.)
Tuesday May 4, 2010 11:21 Mart
11:22


David Miller:
Well, I have an opinion but let's hear from Dr. Higano :)
Tuesday May 4, 2010 11:22 David Miller
11:24


Dr. Higano, UW SCCA:
That is a bit of a tricky question. According to the data, all patients with asymptomaitc metastatic CRPC should be treated with Provenge, in a manner similar to what we do with women who have "high risk" breast cancer (we give them 6 cycles of chemotherapy).
Tuesday May 4, 2010 11:24 Dr. Higano, UW SCCA
11:24


Matt Ironside:
This question is from Brad in Seattle:

I was wondering if David Miller could comment on Dr. Gold's significant sale of Dendreon stock. After such a long fight, you can't blame anyone for cashing out somewhat after the approval, but the magnitude of his sale ($28 million and a large majority of his share) is quite eye opening and I think borders on a material event. I makes one wonder if even he believes Dendreon is slightly over-hyped.
Tuesday May 4, 2010 11:24 Matt Ironside
11:25


David Miller:
Loaded question there, lol...
Tuesday May 4, 2010 11:25 David Miller
11:25


Dr. Higano, UW SCCA:
BTW, there are many new treatment options coming along that will be good options to docetaxel (Taxotere).
Tuesday May 4, 2010 11:25 Dr. Higano, UW SCCA
11:26


David Miller:
Shareholders vote executives and employees shares. Unless you expect them to use the certificates as pretty wallpaper, you should expect sales. That said, if the guy who knows most in the world about what is going on is taking some off the table, perhaps you should talk with your financial advisor about doing the same.
Tuesday May 4, 2010 11:26 David Miller
11:26


[Comment From actionjackactionjack: ]
How long before we see Provenge used with other forms of treatment?
Tuesday May 4, 2010 11:26 actionjack
11:26


David Miller:
And no, I don't believe Dendreon is overhyped.
Tuesday May 4, 2010 11:26 David Miller
11:27


Dr. Higano, UW SCCA:
You will see Provenge studied in combination with other forms of therapy in the near future. It is the next logical step in clinical development.
Tuesday May 4, 2010 11:27 Dr. Higano, UW SCCA
11:28


David Miller:
From a business perspective, I know many companies are itching to get their hands on Provenge to run combination trials. I would expect to see that get seriously underway after the patient backlog is dealt with.
Tuesday May 4, 2010 11:28 David Miller
11:28


David Miller:
I should remind people, however, the Provenge manufacturing capability in Seattle is capable of doing clinical trial manufacturing. It is small, though, and about to move locations.
Tuesday May 4, 2010 11:28 David Miller
11:29


Matt Ironside:
Dr. Higano, when you say "other forms of therapy," any specifics?
Tuesday May 4, 2010 11:29 Matt Ironside
11:29


Dr. Higano, UW SCCA:
We are conducting clinical trials with Provenge from the Seattle plant.
Tuesday May 4, 2010 11:29 Dr. Higano, UW SCCA
11:31


Dr. Higano, UW SCCA:
Yes, other immunotherapies such as ipilimumab, for example, other interesting hormonal therapies such as abiraterone or MDV3100, immune modulators such as cyclophosphamide...endless.
Tuesday May 4, 2010 11:31 Dr. Higano, UW SCCA
11:31


[Comment From LindseyLindsey: ]
Can you be more specific about what "minimal symptoms from cancer" means? Also, when you say "not on narcotics" - does that mean patients who are on other medications for other conditions i.e. diabetes would be ineligible? And is that ineligible during this first phase in 2010, or ineligible period? Thank you.
Tuesday May 4, 2010 11:31 Lindsey
11:31


David Miller:
From the business side, I know Bristol Myers badly wants to do a combination trial with their drug ipilimimab. I assume Sanofi-Aventis wants to do one with Taxotere. Celgene talked on their conference call about doing one with Revlamid.
Tuesday May 4, 2010 11:31 David Miller
11:32


David Miller:
But Dr. Higano is right. Really endless combinations.
Tuesday May 4, 2010 11:32 David Miller
11:32


Dr. Higano, UW SCCA:
If a man is on a narcotic for some other reason than pain due to prostate cancer, that's OK. Diabetes is OK.
Tuesday May 4, 2010 11:32 Dr. Higano, UW SCCA
11:33


David Miller:
This will be permanent, not just in 2010, as that is part of the label.
Tuesday May 4, 2010 11:33 David Miller
11:33


[Comment From BudBud: ]
how does one locate a Dr. who is participating in the Provenge treatment>
Tuesday May 4, 2010 11:33 Bud
11:34


David Miller:
My understanding is that information will be up on either the Dendreon.com or Provenge.com web sites.
Tuesday May 4, 2010 11:34 David Miller
11:34


Dr. Higano, UW SCCA:
There are two sites in Seatte, the Seattle Cancer Care Alliance and Virgina Mason. You can go to the website listed earlier for more information about how to locate site.
Tuesday May 4, 2010 11:34 Dr. Higano, UW SCCA
11:34


[Comment From Bob FeutzBob Feutz: ]
Dr. Higano (Hi) Have there been any long term side effects noticed - good or bad?
Tuesday May 4, 2010 11:34 Bob Feutz
11:35


Dr. Higano, UW SCCA:
Improved survival is a good long term side effect :).
No definitive bad long term side effects.
Tuesday May 4, 2010 11:35 Dr. Higano, UW SCCA
11:36


Dr. Higano, UW SCCA:
Hi Bob!
Tuesday May 4, 2010 11:36 Dr. Higano, UW SCCA
11:36


David Miller:
Remarkably low side effects for the survival benefit.
Tuesday May 4, 2010 11:36 David Miller
11:36


[Comment From Kevin HollingsworthKevin Hollingsworth: ]
Admittedly quite speculative here but, with the technology that's been approved, is it possible we are witnessing the beginning technology that could eventually teach/train our immune systems to fight most or all cancers into the future? Say with further understanding, further strengthening the immune system and further technological advances in immunotherapy? (or is there just too many variables/differences amongst the different families of cancer?)
Tuesday May 4, 2010 11:36 Kevin Hollingsworth
11:37


Dr. Higano, UW SCCA:
Absolutely, that is what I anticipate over the next decade.
Tuesday May 4, 2010 11:37 Dr. Higano, UW SCCA
11:37


David Miller:
I think we still have a ways to go with choosing the right antigens and packaging them correctly, but clearly this is the first of what I believe will be many of these products. Be careful, though, of those who use bits of tumors. I think we're a decade or two away from success there.
Tuesday May 4, 2010 11:37 David Miller
11:38


Matt Ironside:
Zonked in Hollywood California asks:

What should DNDN be focused on next, breast, Colon, other cancers and do you expect these to respond as favorably as Provenge has for PC?
Tuesday May 4, 2010 11:38 Matt Ironside
11:38


David Miller:
Next up is a randomized Phase II trial for Neuvenge in bladder and ovarian cancers. That trial should start this year or early next.
Tuesday May 4, 2010 11:38 David Miller
11:38


David Miller:
I think colon cancer will be the next one after that, probably in late 2011 for Phase I trials.
Tuesday May 4, 2010 11:38 David Miller
11:39


[Comment From hammerli22hammerli22: ]
How many of the patients in the Phase 1 , Phase 2 are still living ?
Tuesday May 4, 2010 11:39 hammerli22
11:39


Dr. Higano, UW SCCA:
Impossible to know if the approach will be successful in bladder or other cancers. We are participating in Neuvenge bladder cancer trial.
Tuesday May 4, 2010 11:39 Dr. Higano, UW SCCA
11:39


Dr. Higano, UW SCCA:
I don't have the latest figures, but Bob is one of them!
Tuesday May 4, 2010 11:39 Dr. Higano, UW SCCA
11:40


David Miller:
I don't know the answer to that question any longer, sorry.
Tuesday May 4, 2010 11:40 David Miller
11:40


[Comment From EmilyEmily: ]
When do you anticipate that Provenge will be at full-scale production, and what will that look like, (i.e. how many patients a year will treatment be available to)?
Tuesday May 4, 2010 11:40 Emily
11:41


David Miller:
The rest of the Jersey facility will be online in early 2011. The LA and Atlanta facilities in mid-2011. As far as how many patients, I'd guess north of 20,000 a year conservatively.
Tuesday May 4, 2010 11:41 David Miller
11:41


[Comment From ArtArt: ]
I'm 80 with untreated prostate cancer and my PSA has gradually moved up to 11. Am I a good candidate for Provenge?
Tuesday May 4, 2010 11:41 Art
11:41


David Miller:
But NOT right way. I doubt they get to those numbers until 2012 or 2013.
Tuesday May 4, 2010 11:41 David Miller
11:41


Dr. Higano, UW SCCA:
No.
Tuesday May 4, 2010 11:41 Dr. Higano, UW SCCA
11:42


[Comment From MaryMary: ]
Do you think Provenge will ever play a role pre-prostatectomy? Is the PAP antigen found on healthy tissue in or outside of the prostate? If so, does that preclude Provenge from ever being used on men whose prostate is intact?
Tuesday May 4, 2010 11:42 Mary
11:44


Dr. Higano, UW SCCA:
Good question. We are currently studying this question by giving Provenge before radical prostatectomy. PAP is mainly on prostate cancer cells and normal tissue has not been harmed by Provenge so far as we can tell.
Tuesday May 4, 2010 11:44 Dr. Higano, UW SCCA
11:44


David Miller:
Dendreon is studying this in a trial called PROAct - or at least studying what Provenge does to the prostate pre-prostatectomy. We're more then a decade away from knowing for sure. PAP is on healthy tissue outside of the prostate, but there are not indications Provenge has an adverse effect there - at least that I know of.
Tuesday May 4, 2010 11:44 David Miller
11:44


David Miller:
lol
Tuesday May 4, 2010 11:44 David Miller
11:44


Dr. Higano, UW SCCA:
:)
Tuesday May 4, 2010 11:44 Dr. Higano, UW SCCA
11:44


[Comment From LindseyLindsey: ]
My father had a postatectomy nearly 4 years ago, and was cancer free for one year. At that point his PSA started to elevate. He is currently undergoing hormone therapy, but has seen steady, but moderate increases in his PSA every 3 months. He is currently at a PSA of 9. Is PRovenge a remedy that he should look into at this point, or is it something that is only approved for later stages? And if later stages, at what PSA level?
Tuesday May 4, 2010 11:44 Lindsey
11:46


Dr. Higano, UW SCCA:
He should probably have some scans to make sure he does not have metastases. If he does, he might qualify for Provenge. The PSA value does not necessarily reflect whether or not there are bone metastases.
Tuesday May 4, 2010 11:46 Dr. Higano, UW SCCA
11:46


[Comment From Saul KSaul K: ]
David--Think Dendreon is the fabled "next Amgen"?
Tuesday May 4, 2010 11:46 Saul K
11:47


David Miller:
Hi Saul... I know you think so! Amgen is the next Amgen because of multiple products. We're several years from that with Dendreon.
Tuesday May 4, 2010 11:47 David Miller
11:47


David Miller:
And take a look at the Amgen chart... It doesn't always go up :)
Tuesday May 4, 2010 11:47 David Miller
11:48


[Comment From Pete McGrathPete McGrath: ]
Pete from tennessee. Can Provenge be used only after prostetectomy, can it be used after radioactive seed implants followed by external beam radiation?
Tuesday May 4, 2010 11:48 Pete McGrath
11:49


Dr. Higano, UW SCCA:
It does not matter what the primary therapy was. Provenge can be used for anyone with metastases and a rising PSA on hormonal therapy.
Tuesday May 4, 2010 11:49 Dr. Higano, UW SCCA
11:49


[Comment From ElliseEllise: ]
David: Do you see a secondary offering to finance an EU buildout/launch or a ROW which MG has said no to as stated on CC 4/29?
Tuesday May 4, 2010 11:49 Ellise
11:49


David Miller:
Dr. Higano, what if they had no prior definitive therapy?
Tuesday May 4, 2010 11:49 David Miller
11:50


David Miller:
I think EU buildout is a 2012 or later deal with launch not until middle of this decade. While they may well do a secondary to cushion cash, it won't be for that.
Tuesday May 4, 2010 11:50 David Miller
11:50


Dr. Higano, UW SCCA:
If they are now on hormonal therapy and have mets and a rising PSA, tha's OK even if no prior surgery or radiation. Some men present with metastases and they are eligible if the PSA is rising.
Tuesday May 4, 2010 11:50 Dr. Higano, UW SCCA
11:51


[Comment From hammerli22hammerli22: ]
Is there a maximum time limit a patient can wait between infusions ?
Tuesday May 4, 2010 11:51 hammerli22
11:52


Dr. Higano, UW SCCA:
The infusions are spaces two weeks apart. That is the only time frame that should be used for now until further information is available. So, 3 infusions over one month.
Tuesday May 4, 2010 11:52 Dr. Higano, UW SCCA
11:52


[Comment From ArtArt: ]
How does one find out if his cancer has spread outside the prostate?
Tuesday May 4, 2010 11:52 Art
11:52


Dr. Higano, UW SCCA:
Depends, usually scans (bone scan and CT) but ask your doctor.
Tuesday May 4, 2010 11:52 Dr. Higano, UW SCCA
11:53


[Comment From GuestGuest: ]
Does the anticipated wide availability of Provenge in the near future suggest that men now contemplating treatment options for low/intermediate PC should re think starting existing/available aggressive combined treatment therapies now?
Tuesday May 4, 2010 11:53 Guest
11:53


Dr. Higano, UW SCCA:
No, way too early to suggest that.
Tuesday May 4, 2010 11:53 Dr. Higano, UW SCCA
11:54


David Miller:
Furthermore, it is not "near future" Wide availability is 18 months away assuming nothing goes awry. No way should you wait.
Tuesday May 4, 2010 11:54 David Miller
11:54


Dr. Higano, UW SCCA:
David, you never answered the question about whether all men with CRPC should get Provenge.
Tuesday May 4, 2010 11:54 Dr. Higano, UW SCCA
11:54


David Miller:
Except in those patients with rapidly advancing disease, Provenge's combination of superior efficacy and much lower side effects should make it first line therapy for patients with asymptomatic/minimally symptomatic, metastatic CRPC.
Tuesday May 4, 2010 11:54 David Miller
11:55


David Miller:
I answered and saved it :)
Tuesday May 4, 2010 11:55 David Miller
11:55


Dr. Higano, UW SCCA:
Thanks, I'm glad we agree.
Tuesday May 4, 2010 11:55 Dr. Higano, UW SCCA
11:55


Sandi Doughton:
How well understood is the mechanism behind Provenge? What research is underway to tease out the details of the immune response?

Tuesday May 4, 2010 11:55 Sandi Doughton
11:55


David Miller:
And even then, I think maybe EBT or Tax to dampen the aggressiveness, THEN Provenge...
Tuesday May 4, 2010 11:55 David Miller
11:56


David Miller:
There's the million dollar question, Sandi.
Tuesday May 4, 2010 11:56 David Miller
11:56


David Miller:
I think every immunologist at the NCI is working on that or submitting a grant to work on it :)
Tuesday May 4, 2010 11:56 David Miller
11:57


Dr. Higano, UW SCCA:
I am not an immunologist, but I think it is safe to say that we don't fully understnd the mechanism of action, although we know that the immune system is activated in response to Provenge. The pre-op study will help elucidate some mechanisms as will newer techniques to study immune response.
Tuesday May 4, 2010 11:57 Dr. Higano, UW SCCA
11:57


[Comment From Mary Jo , PoulsboMary Jo , Poulsbo: ]
My friend has agressive PC . After surgery and radiation, he still has high PSA, but nothing shows on scans. Wouldn't a lowering of PSA be as much a sign of effectiveness as shrinkage shown on scans? Does Provenge do that?
Tuesday May 4, 2010 11:57 Mary Jo , Poulsbo
11:59


Dr. Higano, UW SCCA:
Provenge does not always lower the PSA and that is one of the difficulities in understanding the data. It has been studies in combination with hormone therapy in your friend's situation but the results are pending publication.
Tuesday May 4, 2010 11:59 Dr. Higano, UW SCCA
11:59


David Miller:
In the clinical trials, Provenge didn't demonstrate any reduction in PSA. Some men might see that, but they shouldn't expect it. In the pivotal trials, data on tumor shrinkage was mixed but most men shouldn't expect that, either.
Tuesday May 4, 2010 11:59 David Miller
12:00


Matt Ironside:
Are both of you okay for a couple more questions?
Tuesday May 4, 2010 12:00 Matt Ironside
12:00


Dr. Higano, UW SCCA:
But, survival better and so disease must be slowed even though not seen on scans.
Tuesday May 4, 2010 12:00 Dr. Higano, UW SCCA
12:00


Dr. Higano, UW SCCA:
yes
Tuesday May 4, 2010 12:00 Dr. Higano, UW SCCA
12:00


David Miller:
I agree 100% Tia.
Tuesday May 4, 2010 12:00 David Miller
12:00


David Miller:
And I'm OK for more, too.
Tuesday May 4, 2010 12:00 David Miller
12:01


[Comment From CherylCheryl: ]
E.g. must a patient currently be on hormonal therapy, or is it only necessary that hormonal therapy failed in the past?
Tuesday May 4, 2010 12:01 Cheryl
12:01


Dr. Higano, UW SCCA:
Must be on hormonal therapy now, sorry.
Tuesday May 4, 2010 12:01 Dr. Higano, UW SCCA
12:01


[Comment From geotoxgeotox: ]
David, would the 'other' companies pay for the Provenge during these studies, or because of mutual commercial benefit, donate the treatment?
Tuesday May 4, 2010 12:01 geotox
12:02


David Miller:
Both. If the trial was co-sponsored by Dendreon, then Dendreon would donate the drug. If not, then the "other" company would pay for it
Tuesday May 4, 2010 12:02 David Miller
12:02


Dr. Higano, UW SCCA:
This is what is done in other situations we have worked in.
Tuesday May 4, 2010 12:02 Dr. Higano, UW SCCA
12:03


David Miller:
Dendreon might also ask to be reimbursed for the cost.
Tuesday May 4, 2010 12:03 David Miller
12:03


David Miller:
Instead of donating 100%
Tuesday May 4, 2010 12:03 David Miller
12:03


Matt Ironside:
This is from froggmeister:

This is a huge breakthrough, and we hope this opens the door to other immunotherapies. Which other immunotherapy drugs do you think have a chance of being the next to be granted FDA approval and become available to cancer patients?
Tuesday May 4, 2010 12:03 Matt Ironside
12:04


Dr. Higano, UW SCCA:
Prostvac, ipilimumab are two in the prostate cancer world.
Tuesday May 4, 2010 12:04 Dr. Higano, UW SCCA
12:04


David Miller:
Hey Frogg... I've not seen any I would bet large sums of money on. Most havent' figured out the manufacturing characterization, have too many mfg failures, or other issues. Personally, I think ProstVac fails.
Tuesday May 4, 2010 12:04 David Miller
12:05


[Comment From investorjdinvestorjd: ]
Can a patient receive a booster infusion after a few years of being treated?
Tuesday May 4, 2010 12:05 investorjd
12:05


David Miller:
But I know I'm a minority on that one inside the PCa world.
Tuesday May 4, 2010 12:05 David Miller
12:05


Dr. Higano, UW SCCA:
Yes, boosters are possible and are being studied now.
Tuesday May 4, 2010 12:05 Dr. Higano, UW SCCA
12:05


David Miller:
The PROTECT study is looking at booster shots in a different disease state.
Tuesday May 4, 2010 12:05 David Miller
12:07


[Comment From GuestGuest: ]
Why are they limited to 200 patients for the first year. The NJ plant is 25% builtout. The math comes out to a higher number.
Tuesday May 4, 2010 12:07 Guest
12:07


Dr. Higano, UW SCCA:
2,000 patients per year x 3 doses each
Tuesday May 4, 2010 12:07 Dr. Higano, UW SCCA
12:08


David Miller:
It's 2,000 patients. The math comes out higher if you assume 3 shifts right away, but they are not doing that. They are also not going to manufacture as quickly as they will at later dates.
Tuesday May 4, 2010 12:08 David Miller
12:08


David Miller:
There is a training curve for new hires.
Tuesday May 4, 2010 12:08 David Miller
12:08


[Comment From Steven SBSteven SB: ]
I some rare cases Provenge appears to be a cure. That is,Patients live for six, seven and eight years with quality of life. Is there any work being done to figure out who might benefit the most from Provenge?
Tuesday May 4, 2010 12:08 Steven SB
12:09


David Miller:
Clearly, guys who see the biggest upregulation during manufacturing for an immune marker called CD54 benefit the most. As to pre-screening patients, that is still a work in progress.
Tuesday May 4, 2010 12:09 David Miller
12:09


Dr. Higano, UW SCCA:
Yes, as David said earlier, many researchers are trying to figure out why such outliers seem to benefit and others do not or benefit less so.
Tuesday May 4, 2010 12:09 Dr. Higano, UW SCCA
12:10


David Miller:
Incidentally, pre-screening patients to predict response is a BIG topic in oncology. All drugs are going through this, not just Provenge.
Tuesday May 4, 2010 12:10 David Miller
12:10


Dr. Higano, UW SCCA:
Very true and also appropriate.
Tuesday May 4, 2010 12:10 Dr. Higano, UW SCCA
12:10


Matt Ironside:
Well, that's all we have time for right now.
Tuesday May 4, 2010 12:10 Matt Ironside
12:10


David Miller:
Thanks UK's NICE for starting that :)
Tuesday May 4, 2010 12:10 David Miller
12:11


Dr. Higano, UW SCCA:
Thanks for all the questions.
Tuesday May 4, 2010 12:11 Dr. Higano, UW SCCA
12:11


Matt Ironside:
Do either of you have anything you want to add before we wrap up?
Tuesday May 4, 2010 12:11 Matt Ironside
12:11


David Miller:
Thanks for the questions, everyone. I had a great time. Dr. Higano, pleasure as always.
Tuesday May 4, 2010 12:11 David Miller
12:11


Dr. Higano, UW SCCA:
Stay tuned for more new therapies and combinations!
Tuesday May 4, 2010 12:11 Dr. Higano, UW SCCA
12:11


Matt Ironside:
A big thanks to Dr. Celestia Higano and David Miller for participating today. And thank you all for questions.
Tuesday May 4, 2010 12:11 Matt Ironside
12:11


David Miller:
Ditto.
Tuesday May 4, 2010 12:11 David Miller
12:12


Dr. Higano, UW SCCA:
Same
Tuesday May 4, 2010 12:12 Dr. Higano, UW SCCA
12:12


Matt Ironside:
And one more note:

David will attempt to answer some of the questions we did not have a chance to get to during the chat. You can submit questions until 3 p.m. PST on this site: http://community.seattletimes.nwsource.com/reader_feedback/public/display.php?thread=300375
Tuesday May 4, 2010 12:12 Matt Ironside
12:12


Matt Ironside:
Thanks all for participating.
Tuesday May 4, 2010 12:12 Matt Ironside
12:12


David Miller:
Business questions, mostly. Talk to your doc about the specific medical questions.
Tuesday May 4, 2010 12:12 David Miller
12:13


Dr. Higano, UW SCCA:
Good idea!