Re: Perfinedone application made to the FDA

[Guest guest]

That 's really ODD..I thought that their Clinical Trails had NOT shown any statistically significant successful outcome!

Has anybody read the latest on that Trial??????

in Oz>> I don't know if it's new news, but it is to me. Intermune has applied for > a new drug approval for Perfinedone as a treatment for pulmonary fibrosis. > I was alerted to that by the coalitionforpf.org I'll check with my pulmo > guys and see what that means, if anything. Some time ago I asked them > about the drug, having heard it was in testing, and didn't get much of a rise > out of anybody, so I dunno.> > Bill C. IPF 10/08> N.E. PA>

[Guest guest]

Thanks Bruce..this was my understanding of the Trials as well...why onearth would it be approved if there was no successful outcome ??? Beats me!

GIO> >> > Does anyone know how long it takes for approval - are we looking> at months, or years?> >  Dorothy Reinecke> >> > UIP-7/05> >> >> >> > ________________________________> > From: "Paradis3@" Paradis3@> > To: Breathe-Support > > Sent: Thu, November 5, 2009 9:37:47 AM> > Subject: Perfinedone application made to the FDA> >> > Â> > I don't know if it's new news, but it is to me. Intermune has> applied for a new drug approval for Perfinedone as a treatment for> pulmonary fibrosis. I was alerted to that by the coalitionforpf.> org I'll check with my pulmo guys and see what that means, if> anything. Some time ago I asked them about the drug, having heard> it was in testing, and didn't get much of a rise out of anybody, so I> dunno.> >> > Bill C. IPF 10/08> > N.E. PA> >>

[Guest guest]

I would call your interpretation of the trials accurate. However,

Intermune has put a different spin on it. They try to work within the

primary time frame of the trials and then agree that one trial showed

nothing, but state the other did. Then they try to add the Japanese

trial results in. Of course that trial was criticized for being

prematurely stopped. The point Intermune tends to ignore is that as they

followed the patients longer what benefit might have been shown seemed

to be lost and at 72 weeks there was none.

Now, I think there are many things that could explain the results. For

instance, what if Pirfenidone did help relieve some inflammation, much

as Prednisone does? However, what if it did nothing for the fibrosis? If

those two hypotheses were correct then you'd get some short term benefit

but no real benefit toward treating the disease. Now, I'm not saying

this is the real situation, just that there are many possible things

that could explain the trials.

There will be a lot of pressure on the FDA to approve the medication. I

do not know enough of their inner workings to predict. There are those

who would argue that when you have nothing else, even if the chances it

might help are very slim, why not approve it. I would counter that it

does have many side effects and why lower anyone's quality of life if

its not going to ultimately prolong life. I would also be concerned with

people putting too much stock in this drug and not doing other things

that might benefit them. I also fear that even though its trial was

limited to a very specific form of PF and those in an extremely early

stage that if the drug is approved, doctors will prescribe it for forms

and stages for which it hasn't ever been tested.

Time will tell but the reality is whether it's approved or not, it

wasn't the success everyone had hoped for. Meanwhile we can only hope

for better results on the many trials currently underway.

> >

> > I don't know if it's new news, but it is to me. Intermune has

applied

> for

> > a new drug approval for Perfinedone as a treatment for pulmonary

> fibrosis.

> > I was alerted to that by the coalitionforpf.org I'll check with my

> pulmo

> > guys and see what that means, if anything. Some time ago I asked

them

> > about the drug, having heard it was in testing, and didn't get much

of

> a rise

> > out of anybody, so I dunno.

> >

> > Bill C. IPF 10/08

> > N.E. PA

> >

>

[Guest guest]

Dorothy

Your situation isn't that odd or strange, believe it or not. I would

recommend continued rheumatological labs and exams based on what you

say, probably as frequently as every three months. In fact, I'm in a

somewhat similar situation and my rheumatologist insists on every two

months, has made referrals for more opinions, and I may end up going to

Duke. Now, one would say, why more labs. Because what might today be

classified as Undifferentiated Connective Tissue Disease can then

manifest itself. Why hasn't it so far? Perhaps because its often delayed

or perhaps because the meds you've been on have kept it from doing so.

The meds may have treated the connective tissue disease even though no

one yet knows which one you have.

The muscle pains certainly sound like a Myositis such as Dermatomyositis

or Polymyositis so based on that you might find a muscle biopsy

recommended next.

The main thing I'd say is that the possibility of an underlying

connective tissue disease could still be in your favor as to delaying

the progression of the fibrosis. Perhaps it will become more obvious

over time and be treatable. Or, perhaps you've already been treating it.

It's worth continuing to chase it. It took several years for Beth's

to be to the point they could diagnose it confidently. There's very

strong argument that I might have one but no one has been able to

diagnose it yet. My rheumatologist has suggested many different biopsies

at one time or another but I'm willing to wait (kidney biopsy, muscle

biopsy, lymph node biopsy, skin biopsy, lip biopsy, another lung

biopsy.....lol). I do believe that at some point one of the labs that

jumps back and forth may just take off upward or some additional symptom

that will clear things up might emerge.

So, I think the following for myself personally:

1-As long as it doesn't manifest itself, it's at least somewhat under

control so I won't worry too much.

2-However, I will continue to monitor and see doctors so that if and

when it does manifest itself, it will be discovered and if any treatment

is appropriate, I can get it.

I also see you as having one distinct advantage over me. You have an ILD

but it is not identified as UIP and based on the treatments may well be

one of the others that is treatable and is quite commonly found to have

an underlying connective tissue disease. In my case, mine is determined

firmly to be UIP and so that probability lessened.

Don't give up. Time may be here to repeat a major workup as you have new

more detectable symptoms.

> >

> > Does anyone know how long it takes for approval - are we looking

> at months, or years?

> > Â Dorothy Reinecke

> >

> > UIP-7/05

> >

> >

> >

> > ____________ _________ _________ __

> > From: " Paradis3@ . " Paradis3@

> > To: Breathe-Support@ yahoogroups.

> <mailto:Breathe-Support%40yahoogroups.com> com

> > Sent: Thu, November 5, 2009 9:37:47 AM

> > Subject: Perfinedone application made to the FDA

> >

> > Â

> > I don't know if it's new news, but it is to me. Intermune has

> applied for a new drug approval for Perfinedone as a treatment for

> pulmonary fibrosis. I was alerted to that by the coalitionforpf.

> org I'll check with my pulmo guys and see what that means, if

> anything. Some time ago I asked them about the drug, having heard

> it was in testing, and didn't get much of a rise out of anybody, so I

> dunno.

> >

> > Bill C. IPF 10/08

> > N.E. PA

> >

>

[Guest guest]

Dorothy

By what you quoted, Duke isn't saying one way or another....just saying

ILD. Now that's just not being specific, not necessarily changing or

confirming.

> > >

> > > Does anyone know how long it takes for approval - are we

looking

> > at months, or years?

> > > Â Dorothy Reinecke

> > >

> > > UIP-7/05

> > >

> > >

> > >

> > >________________________________

> > > From: " Paradis3@ . " Paradis3@

> > > To: Breathe-Support@ yahoogroups.

> > <mailto:Breathe-Support%40yahoogroups.com> com

> > > Sent: Thu, November 5, 2009 9:37:47 AM

> > > Subject: Perfinedone application made to the FDA

> > >

> > > Â

> > > I don't know if it's new news, but it is to me. Intermune has

> > applied for a new drug approval for Perfinedone as a treatment for

> > pulmonary fibrosis. I was alerted to that by the coalitionforpf.

> > org I'll check with my pulmo guys and see what that means, if

> > anything. Some time ago I asked them about the drug, having

heard

> > it was in testing, and didn't get much of a rise out of anybody, so

I

> > dunno.

> > >

> > > Bill C. IPF 10/08

> > > N.E. PA

> > >

> >

>

[Guest guest]

Dorothy

Having a pathologist at Duke look might be of benefit as the pathologist

and Dr. Noble might be able to communicate and question things based on

information gathered since the initial time. At the worst it would just

confirm what has already been said.

To me there are two elements gained. First you know that the pathologist

is experienced with ILD's. Second, the pathologist and pulmonologist are

having an interchange of information so the pathologist isn't working in

a vacuum. Pathologist says X, Pulmonologist says how would you explain Y

or how do you relate that to the fact the CT's show Z.

> > >

> > > Does anyone know how long it takes for approval - are we

looking

> > at months, or years?

> > > Â Dorothy Reinecke

> > >

> > > UIP-7/05

> > >

> > >

> > >

> > >____________ _________ _________ __

> > > From: " Paradis3@ . " Paradis3@

> > > To: Breathe-Support@ yahoogroups.

> > <mailto:Breathe- Support%40yahoog roups.com> com

> > > Sent: Thu, November 5, 2009 9:37:47 AM

> > > Subject: Perfinedone application made to the FDA

> > >

> > > Â

> > > I don't know if it's new news, but it is to me. Intermune has

> > applied for a new drug approval for Perfinedone as a treatment for

> > pulmonary fibrosis. I was alerted to that by the coalitionforpf.

> > org I'll check with my pulmo guys and see what that means, if

> > anything. Some time ago I asked them about the drug, having

heard

> > it was in testing, and didn't get much of a rise out of anybody, so

I

> > dunno.

> > >

> > > Bill C. IPF 10/08

> > > N.E. PA

> > >

> >

>