Prostvac, Immunotherapy and Prostate Cancer.
Welcome to our conference.  Today we’ll be discussing the latest treatments for advanced stage prostate cancer, with a particular focus on immunotherapy.  Our speaker today is a noted informational leader on this topic, so we’re in for a truly informative discussion.  First, I’d like to take 30 seconds to tell you a bit about our organization, and then we’ll go straight into our conference.

 

Founded in 1998, Malecare is America’s largest men’s cancer support and patient advocacy non-profit organization.  We facilitate one of the world’s largest prostate cancer support group networks and provide unique support for men with advanced stage disease.  We’re the founding member of the Global Prostate Cancer Alliance, and a leader in advocacy for underserved populations, such as gay men with prostate cancer, and African-American men with prostate cancer.  More information about Malecare’s services can be found at www.malecare.org.  We also fund research through our cancer research funding platform called Start a Cure, which you can find at www.startacure.com.  I also want to draw your attention to an extraordinarily informative website called advancedprostatecancer.net, remember .net for that, truly the world’s leading website for me with advanced stage prostate cancer.

 

Today’s speakers are Joel Nowak and Nicholas Vogelzang.  Dr. Vogelzang is a renowned medical oncologist and cancer researcher who has authored or co-authored numerous peer reviewed articles, [indiscernible] chapters and abstracts, and has given hundreds of lectures and presentations to doctors around the world.  Dr. Vogelzang joined the Comprehensive Cancer Centers of Nevada as a medical oncologist in 2009, and he also serves as Chair and Medical Director of the Developmental Therapeutics Committee, and Co-Chair of the Genitourinary Committee for U.S. Oncology Research.  Prior to joining CCCN, Dr. Vogelzang was Director of the Nevada Cancer Institute from 2004 to 2009.  His other prior experiences include serving as Director of the University of Chicago Cancer Research Center.  Dr. Vogelzang will be interviewed by Joel Nowak.  Mr. Nowak is a Social Worker and Director of Advanced Stage Prostate Cancer and Efficacy at Malecare.  He’s also a prostate cancer survivor.  Gentlemen, I leave it to you.

 

J. Nowak                     Thank you so much, Darryl.  Welcome, Dr. Vogelzang.  I want to say it’s really a pleasure to have this opportunity to speak to you about prostate cancer, which will reinforce our goal of educating survivors on how to live longer and have a better quality of life.  I also would like to remind our listeners that anything you hear in this call is meant to provide them or you with thoughtful questions that you may take back to your own treating physicians.

 

Again, Dr. Vogelzang, it is truly a pleasure.  To jump right in, we all know that the landscape for the treatment of advanced prostate cancer has significantly changed over the last four years.  We’ve gone from having only two treatments for castrate-resistant prostate cancer to now many treatments.  Can you give us a thumbnail of these changes and particularly what it means for men who have metastatic, or advanced prostate cancer?

 

Dr. Vogelzang             I’m delighted to do that, Joel.  Good morning, and thanks for having me on.  It’s somewhat ironic that last night I was in Minneapolis speaking to the Minnesota Society of Clinical Oncology about this very topic, and I struggled to sunrise the entire field in 45 minutes.  I don’t know if I succeeded or not, you’d have to talk to one of my colleagues in Minnesota, but it was a daunting task, actually, [indiscernible]

slide program by listing the new drugs or diagnostic tests and then at least eight or more diagnostic tests still in the pipeline and about to be launched, and hopefully soon.

 

So, the landscape really changed in 1988, when we were told three articles, all of them published by imminent scientists and clinicians, that there was no role for chemotherapy in the treatment of prostate cancer.  And that’s sort [indiscernible] call, because those of us who were actually treating these patients back then knew that there were occasional, not sometimes occasional but quite frequent dramatic benefits of not only hormones but also chemotherapy [indiscernible] selective course.  And by 1999 we saw a sea change, we saw a development of several drugs, the notable one was docetaxel, and we had, in 1996 mitoxantrone got FDA approved, so, by the end of the ’90s we had several drugs.

 

Pretty soon you could just see the market change.  There were people within a quarter of the year, all of a sudden the market for docetaxel shot up and we saw a complete switch in sales from mitoxantrone to docetaxel in the mid-quarter of 1999.  And then the field got that boost in the arm that it needed, the company was actually making money treating prostate cancer.  And within about the next five years we had a whole host of drugs in development [indiscernible] unfortunately didn’t reach fruition until around 2009, 2010.  And that was frustrating, that was a nine, ten year delay where we didn’t see much going on; a lot of activity, but no FDA approvals.

 

In 2010 we got the Provenge, or sipuleucel-T, and in spite of considerable enthusiasm on the part of men there was rather, I would say, a hostile or somewhat cold reception by treating physicians.  The numbers of us who embraced sipuleucel-T or Provenge was rather low.  On the other hand, men were demanding it.  I’ve now treated well over 200 patients with Provenge personally.

 

In 2010 we had been also the recipient of whole decades’ worth of work on hormone therapy, hormone therapy being a rather antiquated concept, developed first by Charlie Huggins at the University of Chicago.  And that was felt simply to be castration type therapy.  But then the folks in Roswell Park and at the University of Washington discovered a startling fact.  That is, that the cancer was making its own testosterone.  That had been noted by a former endocrinologist by the name of Jack Geller in the ’60s, but most of us sort of scratched our heads and said, what’s that about?  We just thought it was making a measurement error.  But Jim Molar and Bruce Montgomery and others proved beyond a shadow of a doubt that there was excess testosterone in the prostate cancer cells themselves on the surface, in the tumor, whichever way you measure it.  That triggered a landslide of development and before you knew it we had enzalutamide, and abiraterone, and a host of competitor drugs that now have dominated the landscape of metastatic prostate cancer.

 

Joel, I don’t want to drone on.  I want to let you interrupt me.  But I can go on and on, as you can tell.

 

J. Nowak                     Yes, so I’m going to jump in.  So, we have all of these new drugs that have been approved.  The question comes, how do we know when and where to give them to men?  I know that initially they get measured usually today against chemotherapy, whether they’re more effective or not, and they’re looked at different stages, in other words, pre or post chemotherapy.  And historically we see that initially they get approved after chemotherapy and then they move into the earlier stages, I think that was true with enzalutamide and it was true with abiraterone, so as a treating physician how do you decide what is the proper treatment to give to a prostate cancer survivor?

 

Dr. Vogelzang             Well, the first principle in medicine remains the first principle of medicine, “Above all do no harm,” and chemotherapy can be quite harsh.  And in fact, we now know that men over the age of 75 have a very difficult time handling chemotherapy.  The chemotherapy was not really well studied in most of those guys.  We all have our marathon runners who are 85 who can take chemotherapy, but even those folks really have trouble, so, the drug has been somewhat relegated to a more late phase of the disease.  So, what I do is begin with the easiest drugs, and those are the immunotherapy drugs, and I always begin with Provenge if I can, or one of the new immunotherapies called Prostvac.  These are drugs that have virtually no serious long term side effects and minimal acute side effects.  And I do those therapies in men for whom castration therapy has begun to fail, usually as measured simply by a consistently rising PSA, or the finding of a new lymph node or such on the x-ray.

 

In the same space, however, the same, if you will, clinical scenario, the drugs like enzalutamide or abiraterone, for those of you who are brand name aficionados it’s Xtandi or Zytiga, those drugs work beautifully well as well.  And so more and more of the time when I am faced with this which one do I choose, I just give them both.  We have a study, for example, published, or not yet published but being worked on, looking at Provenge showing that abiraterone plays beautifully with that drug, so you can easily give Provenge and abiraterone together, or, you can do the same with enzalutamide.   It does not have any negative effect on the cell counts derived from leukapheresis, nor does it have any effect on the immunologic effects.

 

There are some protocol restrictions.  For example, the drug that I’m using right now, Prostvac, derives from work at the National Cancer Institute here in Bethesda, must be given by protocol writing before Provenge, or sipuleucel-T, and cannot be given with other drugs, so, that your sources need to give that smallpox type drug before the other agents.  But it has great potential, as it does sipuleucel-T, or Provenge, to be given in combination with these hormone therapies.

 

J. Nowak                     Right, so let’s go back, because you’ve actually opened up a very interesting area, and that’s Prostvac.  Can you first tell us about what Prostvac is and how it works, and then I guess also just to explain to people, how does it differ from the other immunological therapy we have for prostate cancer, Provenge, which you’ve also mentioned?

Dr. Vogelzang             Yes, it’s a very good question.   Immunotherapy, or the stimulating of the natural immune system to fight cancer, was highlighted on the cover of Science magazine in 2013 as the Breakthrough of the Year for 2013.  And there are many arms or limbs or branches of the immune system.  It’s what makes a human being particularly able to survive against bacteria and viruses and funguses and pollen and all sorts of noxious things in our environment.  We have evolved a dramatic ability to fight off these pestilences, so to speak.  One of them, we believe, is cancer.  We believe that certain cancer cells, as they evolve early on, are eliminated by the body.  We’re not sure, because it’s very difficult to prove it in humans, but certainly it’s the case in animals, and particularly virus related cancers.

 

So, Provenge, to get back to my point, is an artificially engineered smallpox virus that was developed by a scientist, Jeff Schlom, at the National Cancer Institute, and it’s given as a prime and boost strategy.  That is, you give the body this smallpox virus and then boost the activity with an animal smallpox virus called fowl pox.  That process of giving the first dose of smallpox followed by six doses of fowl pox causes the body’s immune system to reach its maximum ability to stimulate the T-cells.

 

Now, the genius of –

 

J. Nowak                     Can I interrupt you a second?

 

Dr. Vogelzang             Sure.

 

J. Nowak                     Because I may have misheard you.  I think you said that was Provenge, but I don’t –

 

Dr. Vogelzang             I meant Prostvac.  That’s right.

 

J. Nowak                     Okay, I just wanted to clarify that.  Please then go ahead.

 

Dr. Vogelzang             No, it’s unfortunate naming there, both starting with “Pro.”

 

J. Nowak                     Yes, we do a lot of that with prostate cancer names for drugs.

 

Dr. Vogelzang             Yes, people think they’re just too cute.

 

J. Nowak                     Yes.

 

Dr. Vogelzang             So the Prostvac is then really a virus therapy.  In contrast, Provenge is really just taking our immune cells and exposing them to a protein that is related to prostate cancer, not exclusively but it’s related, and then allowing our immune system naturally to develop an activity against prostate cancer.  They’re difficult concepts.  This is not 101 Biology, this is pretty advanced biology.  The Prostvac current trial looks at smallpox combined with this fowl pox over about a five month period, and the research looks at plain old smallpox and fowl pox, because we don’t honestly know what a regular vaccination would do for prostate cancer.  We don’t think it would have a major effect, but it might.  And we compare just regular smallpox and fowl pox to a molecularly engineered smallpox and fowl pox virus, and one-third of these patients also get a booster of the immune system called leukine, or GM-CSF.   We know GM-CSF lowers PSA, and that work was done at UCSF by Eric Small and his group, that the abuse of leukine or GM-CSF by itself can induce immune reactions of sometimes long duration.

 

So, the summary for the Prostvac is that it’s going to be a 1,200 patient research program, one-third get the virus, one-third get the virus modified, one-third get the virus modified plus leukine.  And the proof of the pudding is going to be who is going to have a longer duration of response and—

 

J. Nowak                     And this research is currently going on?

 

Dr. Vogelzang             It is.  It’s getting close to the end.  It’s mostly being done in Germany, Denmark, the Scandinavian countries.  I’m one of the largest accruers in the United States.  It’s a remarkably easy treatment.  The only requirement is that patients had no chemotherapy for three years and that there be no prior use of Provenge.  They also are not allowed to get concurrent abiraterone or Zytiga along with enzalutamide, so, there’s a series of restrictions.  But it’s been very easy because I treat a lot of de novo metastatic disease here in Nevada, and that means all I use is hormone therapy, and so when the hormone starts to wear off then I can immediately switch them into Prostvac.

 

J. Nowak                     So that’s what you’re doing.  And how long would a man anticipate being in the trial and then what would their next steps be?

 

Dr. Vogelzang             As I mentioned, it takes about five months, seven injections, monthly at the end, every two weeks in the beginning.  And, for example, I have a retired highway patrolman from Arizona who drives up from northern Arizona, and he drives up in the morning, gets his shot, and goes home with his wife after they’ve had lunch in Las Vegas.  There’s no real side effects.  But the idea of the immune system is not that you suddenly see a drop in the PSA.  You don’t.  It’s a delayed effect.  It takes up to four months, or longer, for the immune system to be activated.  It’s the same with Provenge, you need time for the immune system to activate.  For example, when we give the bone marrow transplant, we don’t get rid of leukemia right away.  We give the new bone marrow cells from the sibling or the donor, and it takes sometimes months, if not longer, four months or beyond, before the immune system is able to eradicate—

 

J. Nowak                     Yes, I’m really glad you’re mentioning that, because a lot of the feedback that we hear about Provenge is people get frustrated, and I’ve heard a lot of people [indiscernible] that Provenge does not work for them because their PSA continued to rise, they have disease progression on scans.  And, is there a way to know if any of these immunological therapies actually do work at some point?   How do we measure that?

 

Dr. Vogelzang             Well, we measure it by fairly sophisticated tests that are not routinely available to the practicing doctor, these are called T-call function assays, and they are available in both the Provenge and in the Prostvac patients.  But right now there is no FDA approved test to show that you’ve had benefit from Provenge or Prostvac.  We are working with the folks at Mount Sinai in New York, William Oh and Matt Gelski, on assays that are very different than the T-cell function assays, trying to be more precise in defining who benefits from Provenge.  In fact, I just sent some samples to Dr. Gelski’s lab yesterday.

The ability to dissect out who’s benefiting and who’s not still, unfortunately, is going to require that they should be treated.  We don’t have a predictive test prior to the use of these immune treatments.  We have to treat all patients.  And it’s clear that some do not benefit, but right now we don’t know who it is that does not benefit from these immune therapies.

 

J. Nowak                     Right.  So we know we’re moving into an era of personalized medicine, that I think that you’re kind of touching on.  What are we going to do, or what do you think will happen going forward as far as being able to predetermine who the proper candidate would be for any of the treatments, hormone therapy, any of the immunological therapies, so that we don’t waste time and we don’t waste money?

 

Dr. Vogelzang             I think we’re a long, long way from being that predictive.  We are a species that has evolved over millions of years, and likewise our prostate has evolved over millions of years.  And probably our prostate cancers have evolved ways to evade our immune system over that same period of time.  We are a drop in the evolutionary bucket, so to speak, and figuring out how this cancer works and evades our best [indiscernible] efforts is going to be the work of a lifetime and beyond.  That’s why it’s so important for us to fund the search and to always have a flow of young doctors coming in.  And we’ve seen remarkable advances in the last 10 or 20 years, but these are still not curative in the vast majority of patients.  And, yes, I understand the frustration, I understand the angst, but we’ve made progress and we have to continue the fight.   But the ultimate progress on full eradication of this disease is going to require more time, but also it is almost certainly going to involve combinations.  It’s going to involve not only suppression of the cancer with hormones, but also using the immune treatments.

 

I, for example, was sitting on the plane last night thinking, now, if I walk in the door tomorrow and am discovered to have prostate cancer in my bones, in spite of having my PSA test done, what would I do?  And the answer is, I would have hormone therapy, I would have probably a vaccine as soon as possible, I would take the new highly potent hormone therapies, and I would probably try radium, the new alpha particle radiation, that allows the body’s stem cells to get rid of those persistent little buggers that hide out in the bone marrow.  So, it’s going to be a combination of things.  It’s not going to be one thing.

 

J. Nowak                     Right.  Just for clarification, you’re talking about radium-235, or also known as exigo, is that correct?

 

Dr. Vogelzang             Yes, yes.

 

J. Nowak                     Okay, just so that people can follow what—

 

Dr. Vogelzang             Yes, yes, sorry.  I’m sort of giving you a philosophic large overview here.

 

J. Nowak                     Well, I think you’re sharing what you would do if you were in that situation is quite interesting.  I think that the problem that I think many of us would face, and you would face, would be the problem of approvals, FDA, and insurance reimbursement, to get all those coming out of the starting gate may be the greatest thing we could do, but it’s not going to happen unless someone self-pays today.

 

Dr. Vogelzang             Right.   You’re absolutely right, there’s no way.  But now let me give you a brief example.  From 2006 through 2011 we did a study of chemotherapy added to hormones, 800 men, hormones to everybody, half got chemo, and that was just reported out this December as dramatically improving overall survival.  So early use of chemotherapy in men with cancer already spread to the bone [indiscernible] diagnosis has, at least in this study, shown significant benefit.  The Brits have completed a study of 1,800 men doing the same thing—I’m sorry for that background noise—and they have shown, well, we hope that they show that, the French did a small study, the Americans did an intermediate study, and now the Brits did a gigantic study, and we may soon have a new paradigm.  Namely, if you have metastatic prostate cancer and you’ve not had hormones, chemotherapy should begin immediately along with the hormone treatment.  That’s really a big advance.

 

J. Nowak                     My understanding, and obviously maybe I’m wrong, is that it showed survival advantage in men who had significant disease, I’m not sure what significant means, and for men with minimal disease it didn’t.   But obviously that’s not a correct understanding.

 

Dr. Vogelzang             No, I think you’re probably right.  But the ultimate description is going to occur at the ASCO meeting in June.  The data are going to be released to the public then.  And we will be able to dissect and chop and dice and slice the data when we actually have the data, and ultimately we need to wait for a paper that needs to be published.  So this will be an ongoing debate.  But, for example, a fellow I saw the other day, I recommended that he get chemotherapy along with hormones even though his PSA was only 180, he felt well, and it really snuck up on him.  For example, the other guy that I started on chemo this week had a PSA of 1,200 and he had liver metastases.  Well, that’s easy, that guy’s case needs the chemotherapy.  But a year ago I would not have recommended chemotherapy to him, although some of my colleagues would.

 

Nonetheless, I think we now have [indiscernible] soon to be established  standard [indiscernible] that Provenge and Prostvac will be given in that same space at the first sign of advanced metastatic disease.  That’s when you probably should use those immune therapies, not after you’ve had radiation and chemo and multiple hormone treatments.

 

J. Nowak                     All right, that makes a whole lot of sense.  Now, there was another immunological therapy approved for melanoma called ipilimumab, and I know that they looked at it for prostate cancer, and I don’t think it really was particularly effective.

 

Dr. Vogelzang             Well, I would disagree with that.

 

J. Nowak                     Okay.

 

Dr. Vogelzang             Dr. Drake from Johns Hopkins reported that if you eliminate from that study the patients with metastases in the liver, that was a very strongly positive study showing that there are a subset of men who have long term disease control.  And Dr. Drake’s work was a bit under the radar because it didn’t overall reach a magic number of 95% confidence.  Do you know what the number was?  Ninety-two percent confident.  Had they increased the size of the study just a bit, it would have been strongly positive.

 

J. Nowak                     That’s interesting, because one of the questions I was going to ask you, I know that there’s a trial going on now combining ipilimumab with Provenge.  I think, was it reported just recently at AACR, I think?

 

Dr. Vogelzang             Yes.  These, just like what I do in my patients when all possible, I give them the Prostvac, I set aside the letter of the law, but as soon as I can I then give them Provenge following it.  And so I believe that a maximum immune stimulation includes more than just the smallpox, because we have a concept called antigen spreading, where once the immune system has started to chew on the cancer cells, if you can boost that activity you can get further activity against the cancer.  So I’m trying very hard to go with Prostvac followed by Provenge.  I asked the Prostvac people how many docs around the country and around the world are giving that sequence, and they said 2%.  So, unfortunately, it’s not popular, it’s not caught on yet.  But that’s, I think, the wave of the future.

 

J. Nowak                     So, if somebody wanted to perhaps consider this, because I know it’s still in a Phase III clinical trial, how would a man go about researching this and perhaps entering the trial?

 

Dr. Vogelzang             Well, the Prostvac is available at multiple sites, for example, in Utah, there’s a site in Boston, and at Dana Farber there’s a site, and you can go to their website, and I’m sorry, I don’t have my computer on, but it’s Bavarian-Nordic, and it’s in IT.  I can’t remember what the IT stands for.  I think immunotherapy.  Or, I’m sure if you search the web for Prostvac you’ll find information.

 

J. Nowak                     Probably also if you go to the U.S. government probably clinicaltrials.gov and search for it, I suspect that you’d find it.

 

Dr. Vogelzang             Yes, they’ll list there the sites that are open and are treating patients.

 

J. Nowak                     And the requirements to get into that clinical trial are what?

 

Dr. Vogelzang             Well, you have to have metastatic prostate cancer.  You have to have it either in the lymph nodes or on the bones.  Interestingly, they don’t allow it if it’s in the liver, which is rare anyway, but nonetheless, and then you have to have a PSA over 2 and rising, you have to set aside a criteria about prior chemotherapy, and you have to be asymptomatic, or relatively asymptomatic.  They’re very skeptical of patients on … .

 

J. Nowak                     But you don’t need to be hormone or castrate-resistant, is that correct?

 

Dr. Vogelzang             No, unfortunately, you do.  You do have to have failed, or at least hormone therapy has to have been used, and in spite of the used state, the PSA state has to be somewhat rising.  That’s the frustration that many men have.  They say to me, “Well, I don’t want to undergo medical or surgical castration.  Why can’t I just take Prostvac?”  And I said, “Well, that’s the next study.”

 

J. Nowak                     Yes.

 

Dr. Vogelzang             You know, it’s not there yet.   Dr. Gulley’s at the National Cancer Institute has a study of Prostvac in the setting of castrate sensitive or hormone sensitive disease.  That study, for his population, is using enzalutamide, or Xtandi, along with Prostvac for the patient who’s never had hormone therapy.  But, again, he has restrictions.  It’s actually only for men with no metastatic disease—

 

J. Nowak                     Right.

Dr. Vogelzang             … rising PSA.

 

J. Nowak                     Just for clarification, when you talk about metastatic disease, are you talking about actual evidence on scans of metastases, or how about just a PSA only type of reoccurrence, would that be—

 

Dr. Vogelzang             Yes, that’s the frustration.  So, Dr. Gulley’s program allows that entity, namely, rising PSA only.  The current Prostvac study requires not only rising PSA but also some evidence of metastatic disease, either small lymph node, a single spot on a bone scan, something that is what would be considered evidence of metastatic disease.  You can even do high resolution MRIs of the bone to look for them.  I’ve been able to get a patient on a fluoride PET bone scan, where a regular bone scan was negative but the fluoride was positive, we just see little tiny spots, and that allowed the patient on the study.

 

J. Nowak                     Right.  So when one has a doctor that wants to have things happen, it’s often possible, so some of us may need to push our doctors a little bit to be a little more aggressive in certain circumstances?

 

Dr. Vogelzang             Right.  Yes, the rising PSA is a patient is in a transition.  We all know that.  The problem is our imaging sensitivity is probably not accurate.  For example, I sent a fellow recently to the Mayo Clinic for the choline study, the carbon-11 choline study, looking to see where could this be hiding.  I think that study is underutilized.  Unfortunately, it requires a very short life isotope that can’t be easily used in most sites in the United States.

 

J. Nowak                     Right, I guess that we’re in the beginning and things hopefully will be changing in the future.  So, we mentioned briefly ipilimumab, some guys refer to it as “ipi,” and you mentioned Dr. Drake’s work with it.  I know that that is a different type of immunological therapy from Prostvac and from Provenge.  Could you maybe give a brief description of that?

 

Dr. Vogelzang             Sure.  Ipilimumab is an antibody.  The last three letters are mab, M-A-B, and every mab, or M-A-B is a monoclonal antibody, that’s what that stands for.  An antibody is a naturally occurring substance that our immune system makes on the T-cell side.  But we can make antibodies.  Just like we make antibodies inside of our body we can make them outside of our body using viruses using yeast or other cells.  And they’re a big business.  I mean, Genentech is a multi-billion dollar company based on their technology, likewise Amgen and some of these other pharmaceutical companies are enormously helpful.  Well, if you make an antibody against a particular little protein on the T-cell surface called CTLA4, that takes the brake off the T-cell, the T-cell has the gas pedal and the brake pedal.  There’s many gas pedals and many brake pedals, but we’ll leave that for a later discussion, you use the antibody, ipilimumab, as a stopping of the brake pedal.  And that, if you will, unleashes the T-cell to be more aggressive.  Now, it can then fight cancer cells better.  It can also then fight your normal body better, and it can cause diarrhea and skin rash and other side effects.  So it has to be given cautiously.  But it does do what it needs to do, in some cases very dramatically.

 

There are a number of these other antibodies that are affecting big brakes, or the gas, and these are rapidly coming into use, particularly in lung cancer, kidney cancer, melanoma, and bladder cancer.  And we expect these to be widely available over the next decade or so against a whole number of cancer cells.   Many big pharmaceutical companies are betting the bank on this, not only Genentech but also Bristol Myers and Merck and a big European company called EMD Serono.  We expect that there will be antibody therapy available against many cancers in the next decade.

 

J. Nowak                     So my question then with this type of therapy, a man who has an autoimmune illness, an arthritic condition, would they be a candidate, or since their own immune system is already attacking their body is this something that they would need to avoid?

Dr. Vogelzang             They would probably need to avoid it.  For example, if a man has rheumatoid arthritis and is taking Remicade, that’s antibody therapy.  They probably would be excluded.  Now, I don’t use ipilimumab because the use of ipilimumab is almost exclusively confined currently to melanoma, to skin cancer, but my colleague, Dr. Sam Wolski here in Las Vegas has a huge practice in melanoma and he uses ipilimumab regularly.  And, yes, he sees side effects, but he’s also very good at managing the side effects.  And we’re seeing people cured of their melanoma with ipilimumab who would never have been cured previously.

 

J. Nowak                     Right.  So, we’ve basically touched upon three different types of immunological therapy.  Are there any others hidden away that we haven’t heard about or that we’re going to probably hear about going forward?

 

Dr. Vogelzang             Yes, there’s a company in Czechoslovakia, or the Czech Republic, that is developing a super Provenge.  They’re going to hopefully get FDA approval to start the trial soon.  The trial will be chemotherapy in everyone, so you might imagine the cancer has to be advanced enough to require chemo, and then men will get just one leukapheresis instead of the three that they currently get with Provenge.  And the one leukapheresis should be sufficient for 10 treatments.  And the treatments will be into the armpits or groins of men, it sounds kind of barbaric, but it’s really quite simple.  And the idea will be to take these immunologically stimulated cells, putting them into the lymph nodes of patients, the lymph nodes being, if you will, the factories of the immune system, and this will be a study that is about to launch in the United States and around the world.  And it will be chemotherapy and the vaccine, or chemotherapy and the vaccine but without the stimulation of the vaccine.

 

J. Nowak                     Right, and what would the name of this be so that if we start hearing it we at least understand—

 

Dr. Vogelzang             Yes, the company is called Sotio, S-O-T-I-O.  I do not have any financial relationships to Sotio, although a number of us are going to be doing the trial.

 

J. Nowak                     Right.  But the name of the drug or the treatment?

 

Dr. Vogelzang             Oh, it’s got a number right now.

 

J. Nowak                     Oh, okay.

 

Dr. Vogelzang             You know, we don’t know what it’s—

 

J. Nowak                     We’ll have to make an effort to amend that to this call when we have it, I guess, so that people can follow.   I’m going to actually ask one last question and it’s going to be kind of a philosophical question but a really important question that’s really coming into the forefront these days, and it pertains to the cost of treatments.  When we started talking about combining multiple treatments and therapies and the resulting combination and then of course our efforts to sequence them, these drugs, these treatments are all very expensive, and this has been in the newspaper a lot recently.  How do you see industry and society addressing, and again, if this is an unfair question just say that, how do you see us as in the medical profession, are you in the medical profession addressing this as an issue or a concern?  Is it a concern of yours, and should it be?  And if you don’t want to answer, I respect that [indiscernible].

 

 

Dr. Vogelzang             You know, at the meeting last night in downtown Minneapolis there were two speakers.  There was myself, and I talked about prostate cancer, all the new treatments and the number of treatments the average man gets, between 7 and 10 treatments of different types over the life span of 5 to 7 years.  And the next guy was a pediatrician working with an insurance provider stating that we have to have parameters to reduce costs.  Fortunately, his company and others have not yet focused on prostate cancer.  They’re focusing on lung, breast, and colon cancer.  But they’re establishing pathways and they’re saying what’s the best way to use treatments.  And I don’t think they’re going to deny the ability to use these drugs.  They’re just going to say when you can’t use them.  Right?  And it’s clear that Provenge extends life.  It’s clear that docetaxel extends life.  It’s clear that Xtandi and Zytiga extend life.  Those will never go away.  Now, they will come down in cost, just like the breast cancer drug tamoxifen dropped from $300 when it was introduced in the early ’80s now to pennies a day.  They will come down in cost with time.  But something like Provenge, that’s not going to get cheaper.  That’s complicated technology.

 

J. Nowak                     Right.

 

Dr. Vogelzang             Likewise, the antibodies, they’re not going to get cheaper.  The ipilimumab is not going to drop much.  So, once we establish who can be treated, then we at least have some predictability for the insurance companies and for the providers to know.  What we don’t want is somebody who’s really not doing well, whose cancer is very advanced, and for some reason the doctor decides at the last minute that, oh, I think I should try Provenge.  Well, it’s too late.  You should have thought of that three years ago.

J. Nowak                     Right.

 

Dr. Vogelzang             And don’t go around asking for charity at that point.  That’s your own fault for not having checked, right?  So that’s what we’re going to get rid of is some of this excess use, or inappropriate use.  I don’t think we’re going to see the regular, appropriate on-label use change.

 

J. Nowak                     Right, so this really goes back to the whole premise of a patient becoming responsible to work with their doctor as a full participant, I mean, this is something that Malecare feels is very important, which means we need to educate ourselves, which is one of the reasons we do calls like this, so that people understand it.

                    This has been a great opportunity and is really consistent with what we’re trying to do at Malecare.  I appreciate the time that you have given us.  I think it’s been a great opportunity for us to learn.  So, thank you, again, so much. 

 

Dr. Vogelzang It’s been my pleasure.