Bad news about denufosol trials :-(

LisaGreene

New member
Hi All,

I am sad to be the bearer of bad news this morning but I wanted you to know this:


There was very disappointing news regarding the Inspire clinical program for denufosol.The trial did not achieve its primary endpoint for lung function improvement.

Press release: <a target=_blank class=ftalternatingbarlinklarge href="http://www.streetinsider.com/Corporate+News/Inspire+Pharma+(ISPH)+TIGER-2+Top-Line+Results+of+TIGER-2+Not+Statistically+Significant/6187814.html
">http://www.streetinsider.com/C...nificant/6187814.html
</a>
I am SO bummed. Inspire is going to keep digging into the data. It's confusing because earlier trials showed real promise.
Take good care and stay hopeful,
Lisa G
mom of 2 kids with cf and author

www.TipsForCFParents.com
www.ParentingChildrenWithHealthIssues.com
 

LisaGreene

New member
Hi All,

I am sad to be the bearer of bad news this morning but I wanted you to know this:


There was very disappointing news regarding the Inspire clinical program for denufosol.The trial did not achieve its primary endpoint for lung function improvement.

Press release: <a target=_blank class=ftalternatingbarlinklarge href="http://www.streetinsider.com/Corporate+News/Inspire+Pharma+(ISPH)+TIGER-2+Top-Line+Results+of+TIGER-2+Not+Statistically+Significant/6187814.html
">http://www.streetinsider.com/C...nificant/6187814.html
</a>
I am SO bummed. Inspire is going to keep digging into the data. It's confusing because earlier trials showed real promise.
Take good care and stay hopeful,
Lisa G
mom of 2 kids with cf and author

www.TipsForCFParents.com
www.ParentingChildrenWithHealthIssues.com
 

LisaGreene

New member
Hi All,
<br />
<br />I am sad to be the bearer of bad news this morning but I wanted you to know this:
<br />
<br />
<br />There was very disappointing news regarding the Inspire clinical program for denufosol.The trial did not achieve its primary endpoint for lung function improvement.
<br />
<br />Press release: <a target=_blank class=ftalternatingbarlinklarge href="http://www.streetinsider.com/Corporate+News/Inspire+Pharma+(ISPH)+TIGER-2+Top-Line+Results+of+TIGER-2+Not+Statistically+Significant/6187814.html
">http://www.streetinsider.com/C...nificant/6187814.html
</a><br />
<br />I am SO bummed. Inspire is going to keep digging into the data. It's confusing because earlier trials showed real promise.
<br />Take good care and stay hopeful,
<br />Lisa G
<br />mom of 2 kids with cf and author
<br />
<br />www.TipsForCFParents.com
<br />www.ParentingChildrenWithHealthIssues.com
<br />
 

hmw

New member
%$#@#$%#$ Oh how disappointing!! <img src="i/expressions/face-icon-small-sad.gif" border="0">

Stay hopeful... but since stuff like this happens to so many of the things in development even very late in the trial process, we need to be sure we are tempering hope with reality.
 

hmw

New member
%$#@#$%#$ Oh how disappointing!! <img src="i/expressions/face-icon-small-sad.gif" border="0">

Stay hopeful... but since stuff like this happens to so many of the things in development even very late in the trial process, we need to be sure we are tempering hope with reality.
 

hmw

New member
%$#@#$%#$ Oh how disappointing!! <img src="i/expressions/face-icon-small-sad.gif" border="0">
<br />
<br />Stay hopeful... but since stuff like this happens to so many of the things in development even very late in the trial process, we need to be sure we are tempering hope with reality.
 

ktsmom

New member
Cr*p....we were in TIGER-2 for 48 weeks (drug vs placebo) and we are on the second year of the open label extension. All of that extra testing (which she totally hated) on my kiddo for nothing, I guess. <img src="i/expressions/face-icon-small-sad.gif" border="0">

She has been clincally stable so good news there and no harm done. Will probably be going back on Hypertonic Saline ASAP, which she also totally hated.

Bummed.
 

ktsmom

New member
Cr*p....we were in TIGER-2 for 48 weeks (drug vs placebo) and we are on the second year of the open label extension. All of that extra testing (which she totally hated) on my kiddo for nothing, I guess. <img src="i/expressions/face-icon-small-sad.gif" border="0">

She has been clincally stable so good news there and no harm done. Will probably be going back on Hypertonic Saline ASAP, which she also totally hated.

Bummed.
 

ktsmom

New member
Cr*p....we were in TIGER-2 for 48 weeks (drug vs placebo) and we are on the second year of the open label extension. All of that extra testing (which she totally hated) on my kiddo for nothing, I guess. <img src="i/expressions/face-icon-small-sad.gif" border="0">
<br />
<br />She has been clincally stable so good news there and no harm done. Will probably be going back on Hypertonic Saline ASAP, which she also totally hated.
<br />
<br />Bummed.
 

hmw

New member
Dana, I want to thank you and your daughter for participating in the clinical trial process for so long (and your dd for hanging in there through so much testing despite disliking it so much!) It's so important and the only way we ultimately WILL get successful drugs out there to market.
 

hmw

New member
Dana, I want to thank you and your daughter for participating in the clinical trial process for so long (and your dd for hanging in there through so much testing despite disliking it so much!) It's so important and the only way we ultimately WILL get successful drugs out there to market.
 

hmw

New member
Dana, I want to thank you and your daughter for participating in the clinical trial process for so long (and your dd for hanging in there through so much testing despite disliking it so much!) It's so important and the only way we ultimately WILL get successful drugs out there to market.
 

ktsmom

New member
<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>hmw</b></i>

Dana, I want to thank you and your daughter for participating in the clinical trial process for so long (and your dd for hanging in there through so much testing despite disliking it so much!) It's so important and the only way we ultimately WILL get successful drugs out there to market.</end quote></div>

<img src="i/expressions/heart.gif" border="0">
 

ktsmom

New member
<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>hmw</b></i>

Dana, I want to thank you and your daughter for participating in the clinical trial process for so long (and your dd for hanging in there through so much testing despite disliking it so much!) It's so important and the only way we ultimately WILL get successful drugs out there to market.</end quote>

<img src="i/expressions/heart.gif" border="0">
 

ktsmom

New member
<div class="FTQUOTE"><begin quote><i>Originally posted by: <b>hmw</b></i>
<br />
<br />Dana, I want to thank you and your daughter for participating in the clinical trial process for so long (and your dd for hanging in there through so much testing despite disliking it so much!) It's so important and the only way we ultimately WILL get successful drugs out there to market.</end quote>
<br />
<br /><img src="i/expressions/heart.gif" border="0">
 

kitomd21

New member
We haven't really experienced the failure of a drug this "promising" as we are still relatively new to the CF community. It seemed like such a hopeful medication. One thing that is always in the back of my mind about these drugs is the body's ability to desensitize itself to some medications (think the movie Awakenings!). I routinely think about how great a medication may be in the short-term...then come to find out it becomes ineffective or dangerous. This was one of the very things I worried about with Denufosol and the possibility of the alternate Na channel/Ca-activated channel to become desensitized to the medication. Not sure if that's even what happened...but it makes me wonder given that the initial results were promising.

Sorry to add to the downer mood...just what's going through my mind. <img src="i/expressions/face-icon-small-sad.gif" border="0">
 

kitomd21

New member
We haven't really experienced the failure of a drug this "promising" as we are still relatively new to the CF community. It seemed like such a hopeful medication. One thing that is always in the back of my mind about these drugs is the body's ability to desensitize itself to some medications (think the movie Awakenings!). I routinely think about how great a medication may be in the short-term...then come to find out it becomes ineffective or dangerous. This was one of the very things I worried about with Denufosol and the possibility of the alternate Na channel/Ca-activated channel to become desensitized to the medication. Not sure if that's even what happened...but it makes me wonder given that the initial results were promising.

Sorry to add to the downer mood...just what's going through my mind. <img src="i/expressions/face-icon-small-sad.gif" border="0">
 

kitomd21

New member
We haven't really experienced the failure of a drug this "promising" as we are still relatively new to the CF community. It seemed like such a hopeful medication. One thing that is always in the back of my mind about these drugs is the body's ability to desensitize itself to some medications (think the movie Awakenings!). I routinely think about how great a medication may be in the short-term...then come to find out it becomes ineffective or dangerous. This was one of the very things I worried about with Denufosol and the possibility of the alternate Na channel/Ca-activated channel to become desensitized to the medication. Not sure if that's even what happened...but it makes me wonder given that the initial results were promising.
<br />
<br />Sorry to add to the downer mood...just what's going through my mind. <img src="i/expressions/face-icon-small-sad.gif" border="0">
 
M

Mommafirst

Guest
That is a huge bummer. In just the 4+ years we've been in the CF world, there seems to be several disappointing results. I hate that. It makes me cynical that other meds like the vertex drugs and atalauren will really do all that they promise to.
 
M

Mommafirst

Guest
That is a huge bummer. In just the 4+ years we've been in the CF world, there seems to be several disappointing results. I hate that. It makes me cynical that other meds like the vertex drugs and atalauren will really do all that they promise to.
 
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