Intermune's Pirfenidone announcement

[Guest guest]

It's me, the shameful lurker from Kansas. I'm so bad, but you guys are so chatty - I can't keep up! Grin!

I was just wondering if anyone else saw the announcement from Intermune regarding their Pirfenidone studies and what you thought. If you haven't seen it, I posted the press release on my blog - www.heatherkirkwood.blogspot.com.

We are using Pirfenidone in our clinical trial for Hermansky-Pudlak Syndrome at the NIH - the trial I am currently in. So, needless to say, I can't wait to get my grubby little hands on this data!

I just wish the release had sounded a little more inspiring when it comes to the outcomes. But, I guess since they're moving forward that's good news at least.

Hermansky-Pudlak Syndrome type 1 albinism 02/ PF 06

Kirkwood

Director of Outreach, Vice President

Hermansky-Pudlak Syndrome Network

One South Road

Oyster Bay, NY 11771

1 (800) 789-9HPS

www.hermansky-pudlak.org

Personal blog: www.heatherkirkwood.blogspot.com

Search the Web at www.goodsearch.com and choose the HPS Network as your charity!

[Guest guest]

I summarized on this post:

http://health.groups.yahoo.com/group/Breathe-Support/message/58438

The release with some data is in the files section on this site.

I wish the news was better and I have talked to several local

pulmonologists just to see what the scuttlebutt was and it's not good.

Basically what we have is some evidence that if you take a group of

persons averaging 67 years old, overwhelmingly male, in very early

stages of IPF and confirmed about half the time by biopsy, then

Pirfenidone may improve FVC for the first 36 weeks or so versus a

placebo. After that any advantage appears to start closing.

Also, note that the criticisms of the Japanese test were validated as

they were the chosen measurement, which was made FVC for the US trials

and they were the premature end of the trial. The side effects are

widespread but not life threatening it appears.

There seems to be debate at this point over whether it is probable it

will be approved by the FDA.

I wish I could offer you a more encouraging opinion of these trials.

Perhaps your trial will be different. There have been many trials run

for many years on different potential uses of Pirfenidone. There are

also indications in the document referencing Intermune either having

talks with potential buyers of the rights or pharmaceuticals with whom

to partner. This seems logical although the likelihood of any deal is

subject to speculation. But, they cannot continue to raise money from

investors as they have in these economic times and without that can't

continue to lose money at the rate of close to $90 Million a year. The

do also have the Actimmune litigation facing them as a class action suit

for those prescribed it off label as a result of alleged encouragement

by Intermune. The criminal charges against them regarding that were

handled by an agreement for deferred prosecution. They may have now

satisfied the requirements for dropping them.

While the Capacity trials have been completed the trials the continuing

trials with all participants on Pirfenidone and no Placebo will likely

be closely followed since they may give further indication on any risks

not uncovered in the initial trials and on any longer term benefits.

These trials are scheduled to run to 2011.

Pirfenidone has been the subject of many trials since the 90's and

currently there are 6 clinical trials for various purposes.

>

>

> It's me, the shameful lurker from Kansas. I'm so bad, but you guys are

> so chatty - I can't keep up! Grin!

>

> I was just wondering if anyone else saw the announcement from

Intermune

> regarding their Pirfenidone studies and what you thought. If you

haven't

> seen it, I posted the press release on my blog -

> www.heatherkirkwood.blogspot.com

> http://www.heatherkirkwood.blogspot.com> .

>

> We are using Pirfenidone in our clinical trial for Hermansky-Pudlak

> Syndrome at the NIH - the trial I am currently in. So, needless to

say,

> I can't wait to get my grubby little hands on this data!

>

> I just wish the release had sounded a little more inspiring when it

> comes to the outcomes. But, I guess since they're moving forward

that's

> good news at least.

>

>

>

>

>

> Hermansky-Pudlak Syndrome type 1 albinism 02/ PF 06

>

>

>

>

> Kirkwood Director of Outreach, Vice President Hermansky-Pudlak

> Syndrome Network One South Road Oyster Bay, NY 11771 1 (800) 789-9HPS

> www.hermansky-pudlak.org http://www.hermansky-pudlak.org/>

Personal

> blog: www.heatherkirkwood.blogspot.com

> http://www.heatherkirkwood.blogspot.com/> Search the Web at

> www.goodsearch.com http://www.goodsearch.com/> and choose the HPS

> Network as your charity!

>

[Guest guest]

I summarized on this post:

http://health.groups.yahoo.com/group/Breathe-Support/message/58438

The release with some data is in the files section on this site.

I wish the news was better and I have talked to several local

pulmonologists just to see what the scuttlebutt was and it's not good.

Basically what we have is some evidence that if you take a group of

persons averaging 67 years old, overwhelmingly male, in very early

stages of IPF and confirmed about half the time by biopsy, then

Pirfenidone may improve FVC for the first 36 weeks or so versus a

placebo. After that any advantage appears to start closing.

Also, note that the criticisms of the Japanese test were validated as

they were the chosen measurement, which was made FVC for the US trials

and they were the premature end of the trial. The side effects are

widespread but not life threatening it appears.

There seems to be debate at this point over whether it is probable it

will be approved by the FDA.

I wish I could offer you a more encouraging opinion of these trials.

Perhaps your trial will be different. There have been many trials run

for many years on different potential uses of Pirfenidone. There are

also indications in the document referencing Intermune either having

talks with potential buyers of the rights or pharmaceuticals with whom

to partner. This seems logical although the likelihood of any deal is

subject to speculation. But, they cannot continue to raise money from

investors as they have in these economic times and without that can't

continue to lose money at the rate of close to $90 Million a year. The

do also have the Actimmune litigation facing them as a class action suit

for those prescribed it off label as a result of alleged encouragement

by Intermune. The criminal charges against them regarding that were

handled by an agreement for deferred prosecution. They may have now

satisfied the requirements for dropping them.

While the Capacity trials have been completed the trials the continuing

trials with all participants on Pirfenidone and no Placebo will likely

be closely followed since they may give further indication on any risks

not uncovered in the initial trials and on any longer term benefits.

These trials are scheduled to run to 2011.

Pirfenidone has been the subject of many trials since the 90's and

currently there are 6 clinical trials for various purposes.

>

>

> It's me, the shameful lurker from Kansas. I'm so bad, but you guys are

> so chatty - I can't keep up! Grin!

>

> I was just wondering if anyone else saw the announcement from

Intermune

> regarding their Pirfenidone studies and what you thought. If you

haven't

> seen it, I posted the press release on my blog -

> www.heatherkirkwood.blogspot.com

> http://www.heatherkirkwood.blogspot.com> .

>

> We are using Pirfenidone in our clinical trial for Hermansky-Pudlak

> Syndrome at the NIH - the trial I am currently in. So, needless to

say,

> I can't wait to get my grubby little hands on this data!

>

> I just wish the release had sounded a little more inspiring when it

> comes to the outcomes. But, I guess since they're moving forward

that's

> good news at least.

>

>

>

>

>

> Hermansky-Pudlak Syndrome type 1 albinism 02/ PF 06

>

>

>

>

> Kirkwood Director of Outreach, Vice President Hermansky-Pudlak

> Syndrome Network One South Road Oyster Bay, NY 11771 1 (800) 789-9HPS

> www.hermansky-pudlak.org http://www.hermansky-pudlak.org/>

Personal

> blog: www.heatherkirkwood.blogspot.com

> http://www.heatherkirkwood.blogspot.com/> Search the Web at

> www.goodsearch.com http://www.goodsearch.com/> and choose the HPS

> Network as your charity!

>

[Guest guest]

Hey Bruce,

I had a feeling someone has posted something and I'd missed it. I can hardly wait to get to ATS and hear their presentation of the data as I'm interested in the breakdown on the sub groups. I'm speaking at ATS, so I WILL be there - yippee!

In our previous studies it seemed that the earlier in the process a patient got the drug, the more effective it was. As we know that people with HPS types 1 and 4 will all develop PF, usually starting in their 30s, that sort of early intervention data is important to us. Our problem is that HPS is so rare that often our folks don't get diangosed until they're already quite ill. I was lucky. I got a diagnosis before I had PF so I was being monitored carefully and managed to get into a trial as soon as the CT started showing PF.

As I am now 35, you can imagine where I'm coming from. My PF showed up at 32.

My younger brother, 32, also has HPS.

You know the sad thing is that when there's nothing on the market, it only has to be marginal to be something.

Hermansky-Pudlak Syndrome albinism 02/ PF 06

Kirkwood

Director of Outreach, Vice President

Hermansky-Pudlak Syndrome Network

One South Road

Oyster Bay, NY 11771

1 (800) 789-9HPS

www.hermansky-pudlak.org

Personal blog: www.heatherkirkwood.blogspot.com

Search the Web at www.goodsearch.com and choose the HPS Network as your charity!

> >> >> > It's me, the shameful lurker from Kansas. I'm so bad, but you guys are> > so chatty - I can't keep up! Grin!> >> > I was just wondering if anyone else saw the announcement from> Intermune> > regarding their Pirfenidone studies and what you thought. If you> haven't> > seen it, I posted the press release on my blog -> > www.heatherkirkwood.blogspot.com> > <http://www.heatherkirkwood.blogspot.com> .> >> > We are using Pirfenidone in our clinical trial for Hermansky-Pudlak> > Syndrome at the NIH - the trial I am currently in. So, needless to> say,> > I can't wait to get my grubby little hands on this data!> >> > I just wish the release had sounded a little more inspiring when it> > comes to the outcomes. But, I guess since they're moving forward> that's> > good news at least.> >> >> >> > > >> > Hermansky-Pudlak Syndrome type 1 albinism 02/ PF 06> >> >> >> >> > Kirkwood Director of Outreach, Vice President Hermansky-Pudlak> > Syndrome Network One South Road Oyster Bay, NY 11771 1 (800) 789-9HPS> > www.hermansky-pudlak.org <http://www.hermansky-pudlak.org/> > Personal> > blog: www.heatherkirkwood.blogspot.com> > <http://www.heatherkirkwood.blogspot.com/> Search the Web at> > www.goodsearch.com <http://www.goodsearch.com/> and choose the HPS> > Network as your charity!> >>

[Guest guest]

Hey Bruce,

I had a feeling someone has posted something and I'd missed it. I can hardly wait to get to ATS and hear their presentation of the data as I'm interested in the breakdown on the sub groups. I'm speaking at ATS, so I WILL be there - yippee!

In our previous studies it seemed that the earlier in the process a patient got the drug, the more effective it was. As we know that people with HPS types 1 and 4 will all develop PF, usually starting in their 30s, that sort of early intervention data is important to us. Our problem is that HPS is so rare that often our folks don't get diangosed until they're already quite ill. I was lucky. I got a diagnosis before I had PF so I was being monitored carefully and managed to get into a trial as soon as the CT started showing PF.

As I am now 35, you can imagine where I'm coming from. My PF showed up at 32.

My younger brother, 32, also has HPS.

You know the sad thing is that when there's nothing on the market, it only has to be marginal to be something.

Hermansky-Pudlak Syndrome albinism 02/ PF 06

Kirkwood

Director of Outreach, Vice President

Hermansky-Pudlak Syndrome Network

One South Road

Oyster Bay, NY 11771

1 (800) 789-9HPS

www.hermansky-pudlak.org

Personal blog: www.heatherkirkwood.blogspot.com

Search the Web at www.goodsearch.com and choose the HPS Network as your charity!

> >> >> > It's me, the shameful lurker from Kansas. I'm so bad, but you guys are> > so chatty - I can't keep up! Grin!> >> > I was just wondering if anyone else saw the announcement from> Intermune> > regarding their Pirfenidone studies and what you thought. If you> haven't> > seen it, I posted the press release on my blog -> > www.heatherkirkwood.blogspot.com> > <http://www.heatherkirkwood.blogspot.com> .> >> > We are using Pirfenidone in our clinical trial for Hermansky-Pudlak> > Syndrome at the NIH - the trial I am currently in. So, needless to> say,> > I can't wait to get my grubby little hands on this data!> >> > I just wish the release had sounded a little more inspiring when it> > comes to the outcomes. But, I guess since they're moving forward> that's> > good news at least.> >> >> >> > > >> > Hermansky-Pudlak Syndrome type 1 albinism 02/ PF 06> >> >> >> >> > Kirkwood Director of Outreach, Vice President Hermansky-Pudlak> > Syndrome Network One South Road Oyster Bay, NY 11771 1 (800) 789-9HPS> > www.hermansky-pudlak.org <http://www.hermansky-pudlak.org/> > Personal> > blog: www.heatherkirkwood.blogspot.com> > <http://www.heatherkirkwood.blogspot.com/> Search the Web at> > www.goodsearch.com <http://www.goodsearch.com/> and choose the HPS> > Network as your charity!> >>

[Guest guest]

Hey Bruce,

I had a feeling someone has posted something and I'd missed it. I can hardly wait to get to ATS and hear their presentation of the data as I'm interested in the breakdown on the sub groups. I'm speaking at ATS, so I WILL be there - yippee!

In our previous studies it seemed that the earlier in the process a patient got the drug, the more effective it was. As we know that people with HPS types 1 and 4 will all develop PF, usually starting in their 30s, that sort of early intervention data is important to us. Our problem is that HPS is so rare that often our folks don't get diangosed until they're already quite ill. I was lucky. I got a diagnosis before I had PF so I was being monitored carefully and managed to get into a trial as soon as the CT started showing PF.

As I am now 35, you can imagine where I'm coming from. My PF showed up at 32.

My younger brother, 32, also has HPS.

You know the sad thing is that when there's nothing on the market, it only has to be marginal to be something.

Hermansky-Pudlak Syndrome albinism 02/ PF 06

Kirkwood

Director of Outreach, Vice President

Hermansky-Pudlak Syndrome Network

One South Road

Oyster Bay, NY 11771

1 (800) 789-9HPS

www.hermansky-pudlak.org

Personal blog: www.heatherkirkwood.blogspot.com

Search the Web at www.goodsearch.com and choose the HPS Network as your charity!

> >> >> > It's me, the shameful lurker from Kansas. I'm so bad, but you guys are> > so chatty - I can't keep up! Grin!> >> > I was just wondering if anyone else saw the announcement from> Intermune> > regarding their Pirfenidone studies and what you thought. If you> haven't> > seen it, I posted the press release on my blog -> > www.heatherkirkwood.blogspot.com> > <http://www.heatherkirkwood.blogspot.com> .> >> > We are using Pirfenidone in our clinical trial for Hermansky-Pudlak> > Syndrome at the NIH - the trial I am currently in. So, needless to> say,> > I can't wait to get my grubby little hands on this data!> >> > I just wish the release had sounded a little more inspiring when it> > comes to the outcomes. But, I guess since they're moving forward> that's> > good news at least.> >> >> >> > > >> > Hermansky-Pudlak Syndrome type 1 albinism 02/ PF 06> >> >> >> >> > Kirkwood Director of Outreach, Vice President Hermansky-Pudlak> > Syndrome Network One South Road Oyster Bay, NY 11771 1 (800) 789-9HPS> > www.hermansky-pudlak.org <http://www.hermansky-pudlak.org/> > Personal> > blog: www.heatherkirkwood.blogspot.com> > <http://www.heatherkirkwood.blogspot.com/> Search the Web at> > www.goodsearch.com <http://www.goodsearch.com/> and choose the HPS> > Network as your charity!> >>

[Guest guest]

Yes, their documents paint a very positive picture even though admitting

one of the two trials did not achieve the goals. But, we must keep in

mind they were aimed at shareholders and potential investors and did

have the effect of raising the stock price.

However, within the documents Ken put in the files section is all the

detailed information I posted here and more. I don't know where it will

lead. I would imagine if you went to a dozen different medical centers

you'd get that many opinions. Opinions spread fast within university

medical center staffs and then to all those affiliated doctors in the

region. The sad thing is that while the Pirfenidone trials are

disappointing, all the other things prescribed for PF (Imuran,

Prednisone, even Colchicine or NAC or others) have never even been

through a government recognized clinical trial for PF (many are in some

now). So, all the prescribing there is based on anecdotal evidence. I

wouldn't dismiss anecdotal by any means, as actual use and observation

certainly has its place.

I believe ultimately we'll see Revatio and Tracleer successful in their

trials for just what they are being tested and that is to increase

exercise tolerance. That makes perfect sense, knowing the other things

they both do and help. However, that is still far different than doing

anything to stop PF or slow its progression.

I'm sure if Pirfenidone is ultimately approved, it will be widely

prescribed as physicians so want to give you something even if they

don't necessarily believe it will benefit you. They feel helpless when

they can't prescribe a cure. My rheumatologist is working so hard to

find something so he'll actually have a disease he can prescribe

something for.

> > >

> > >

> > > It's me, the shameful lurker from Kansas. I'm so bad, but you guys

> are

> > > so chatty - I can't keep up! Grin!

> > >

> > > I was just wondering if anyone else saw the announcement from

> > Intermune

> > > regarding their Pirfenidone studies and what you thought. If you

> > haven't

> > > seen it, I posted the press release on my blog -

> > > www.heatherkirkwood.blogspot.com

> > > http://www.heatherkirkwood.blogspot.com> .

> > >

> > > We are using Pirfenidone in our clinical trial for

Hermansky-Pudlak

> > > Syndrome at the NIH - the trial I am currently in. So, needless to

> > say,

> > > I can't wait to get my grubby little hands on this data!

> > >

> > > I just wish the release had sounded a little more inspiring when

it

> > > comes to the outcomes. But, I guess since they're moving forward

> > that's

> > > good news at least.

> > >

> > >

> > >

> > >

> > >

> > > Hermansky-Pudlak Syndrome type 1 albinism 02/ PF 06

> > >

> > >

> > >

> > >

> > > Kirkwood Director of Outreach, Vice President

> Hermansky-Pudlak

> > > Syndrome Network One South Road Oyster Bay, NY 11771 1 (800)

> 789-9HPS

> > > www.hermansky-pudlak.org http://www.hermansky-pudlak.org/>

> > Personal

> > > blog: www.heatherkirkwood.blogspot.com

> > > http://www.heatherkirkwood.blogspot.com/> Search the Web at

> > > www.goodsearch.com http://www.goodsearch.com/> and choose the HPS

> > > Network as your charity!

> > >

> >

>

[Guest guest]

Yes, their documents paint a very positive picture even though admitting

one of the two trials did not achieve the goals. But, we must keep in

mind they were aimed at shareholders and potential investors and did

have the effect of raising the stock price.

However, within the documents Ken put in the files section is all the

detailed information I posted here and more. I don't know where it will

lead. I would imagine if you went to a dozen different medical centers

you'd get that many opinions. Opinions spread fast within university

medical center staffs and then to all those affiliated doctors in the

region. The sad thing is that while the Pirfenidone trials are

disappointing, all the other things prescribed for PF (Imuran,

Prednisone, even Colchicine or NAC or others) have never even been

through a government recognized clinical trial for PF (many are in some

now). So, all the prescribing there is based on anecdotal evidence. I

wouldn't dismiss anecdotal by any means, as actual use and observation

certainly has its place.

I believe ultimately we'll see Revatio and Tracleer successful in their

trials for just what they are being tested and that is to increase

exercise tolerance. That makes perfect sense, knowing the other things

they both do and help. However, that is still far different than doing

anything to stop PF or slow its progression.

I'm sure if Pirfenidone is ultimately approved, it will be widely

prescribed as physicians so want to give you something even if they

don't necessarily believe it will benefit you. They feel helpless when

they can't prescribe a cure. My rheumatologist is working so hard to

find something so he'll actually have a disease he can prescribe

something for.

> > >

> > >

> > > It's me, the shameful lurker from Kansas. I'm so bad, but you guys

> are

> > > so chatty - I can't keep up! Grin!

> > >

> > > I was just wondering if anyone else saw the announcement from

> > Intermune

> > > regarding their Pirfenidone studies and what you thought. If you

> > haven't

> > > seen it, I posted the press release on my blog -

> > > www.heatherkirkwood.blogspot.com

> > > http://www.heatherkirkwood.blogspot.com> .

> > >

> > > We are using Pirfenidone in our clinical trial for

Hermansky-Pudlak

> > > Syndrome at the NIH - the trial I am currently in. So, needless to

> > say,

> > > I can't wait to get my grubby little hands on this data!

> > >

> > > I just wish the release had sounded a little more inspiring when

it

> > > comes to the outcomes. But, I guess since they're moving forward

> > that's

> > > good news at least.

> > >

> > >

> > >

> > >

> > >

> > > Hermansky-Pudlak Syndrome type 1 albinism 02/ PF 06

> > >

> > >

> > >

> > >

> > > Kirkwood Director of Outreach, Vice President

> Hermansky-Pudlak

> > > Syndrome Network One South Road Oyster Bay, NY 11771 1 (800)

> 789-9HPS

> > > www.hermansky-pudlak.org http://www.hermansky-pudlak.org/>

> > Personal

> > > blog: www.heatherkirkwood.blogspot.com

> > > http://www.heatherkirkwood.blogspot.com/> Search the Web at

> > > www.goodsearch.com http://www.goodsearch.com/> and choose the HPS

> > > Network as your charity!

> > >

> >

>