Well, the press-release was today so it is public info: the phase 3 trial testing IFN-gamma vs. placebo in patients with IPF has been discontinued. The independent data monitoring committee did an interim analysis and found no difference between IFN-gamma and placebo for mortality (14.5% in the Actimmune group as compared to 12.7% in the placebo). The adverse reactions were consistent with prior clinical experience(constitutional symptoms, neutropenia and possibly pneumonia).
“The interim results of the INSPIRE trial and our decision to discontinue the trial are disappointing,” said Steve Porter, M.D., Ph.D., Chief Medical Officer at InterMune.
I'm not sure what this means for the company, but they are also running the perfenidone trial, but not so sure this will fare any better...
To me, this is not so surprising, but it really does illustrate the importance of being careful not to read too much into sub group analysis before the next study is done- the original study found that patients with more "mild" IPF (FVC 55-90% predicted) might have a survival advantage and the current study was powered to test that hypothesis. Ultimately it was found not to be the case after all.
People currently taking the IFN-g as part of the study will be instructed to stop it, and everyone will then pack up their bags and move on to the next latest and greatest...
Does anyone have any patients enrolled int his trial?
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You mean that just because I believe in something it doesn't make it true? What if I really, really believe it should work?
InterMune stock has dropped 38.6% since Feb 2nd...
Interestingly, the patents on pirfenidone last only until 2011 in the U.S.
However, since IPF affects so few people, InterMune has been granted orphan drug status for pirfenidone, which will still give it at least seven years of marketing exclusivity to treat IPF in the U.S. and 10 years in the E.U. if the drug gets approved for this indication.
While the financial implications of the trial to InterMune and its stockholders are certainly interesting, let's focus on the implications of this for the treatment of pulmonary fibrosis, shall we?
I'll extend Jennings' point a bit further: not only does this demonstrate that we should all be carful not to overinterpret "trends" for benefit seen in subgroup analyses, it reinforces the point that we need to be careful interpreting the results of any small, preliminary trials showing benefit- even when those small trials are published in widely read, high impact journals like NEJM.
So, this is an instance in which a therapy with substantial pre-clinical and basic science evidence suggesting potential benefit has failed to impact the disease. And although the compound failed, I'm glad that the studies were well designed and executed to answer the question. At least we may finally be done with the Interferon gamma story in IPF.
I think this also highlights the point that all patients with IPF should be considered for clinical trials. We won't know what works or doesn't until they are tested in patients with the disease.
I agree with Jeff on the need to enroll Pts on trials: I remmember as a fellow, trying to recruit clinic patients to the previous IFN trial and several were already on off-label IFN because InterMune reps had gotten to their primary care practitioners first...
>>and several were already on off-label IFN because InterMune reps had gotten to their primary care practitioners first... <<
Probably not an uncommon occurence anymore unfortunately....
>>has failed to impact the disease<<
Perhaps, in part, because maybe the disease "IPF", even as now defined, has heterogenous causes and pathways to the end resulting damage...
IPF almost certainly represents a heterogeneous group of etiologies impacted by variable combinations of genetic, environmental, and possibly infectious factors.
Our failure to impact outcomes in IPF is probably also multifactorial. First, patients frequently present late in their course, at a time when extensive fibrosis is already established. We don't know if the opportunity to impact disease outcomes would improve if we were able to identify it early in the course. Additionally, IFN-gamma is really the first attempt use an "anti-fibrotic" approach, as opposed to an anti-inflammatory or immunomodulatory approach to the treatment of the disease. Other agents targeting specific fibrotic mechanisms are in various phases of clinical or pre-clinical trials now (i.e. Pirfenidone, Bosentan, anti-TGF beta strategies).
Unless we as a communitiy maintain a high suspicion for the disease and make a concerted effort to get patients into clinical trials, we will continue spinning our wheels in this currently untreatable disease.
My husband has been on interferon gamma 1b for 5 years and we believe that it has helped him. We fear what the future may hold for him without the medicine.
Medical decisions need to be based on best evidence, and not anecdotes. It is impossible to know if your husband would have done this well for 5 years with no treatment at all. The clinical trials were well done, and failed to demonstrate a benefit with the use of the drug. So, despite anecdotes and case reports, which we all have, there is no current evidence to support the use of IFN-gamma in the treatments of IPF. There is no justification for its use. Maybe some future trial will identify a specific subpopulation of patients with IPF for whom it is efficacious, but we will never know, and never make progress if we continue to make decisions based solely on anecdotes to the exclusion of the results of large, well designed and well controlled trials.
Seven and a half years ago Bob Morris was diagnosed with Pulmonary Fibrosis. With help from his sister (me) he researched the disease on the internet and came to the sad realization that the current "treatment" for IPF was ineffective and someone diagnosed with this disease would probably be dead in 3 years. Since this was an unacceptable situation we began searching the internet for alternative treatments and discovered a study that was being done in Switzerland using Actimmune. We researched the method,dosage, etc. and then went about finding a supplier for this medicine. We found a supplier, but since it was not approved by the FDA for IPF , my brother could get no help from his medical insurance and ended up spending around $8000 a month for this treatment out of his own pocket. The good news was that it was working for him (we have all of his medical records to prove this available to you as attachments)...but the bad news was that he was quickly running through all of his savings. When the FDA approved this for use for IPF he was so relieved because he could get it now from the VA for $7.00 a week. Everything was going great and into 8 years of using this he has lived and is still living a very active life. Not only has this medicine curbed the spread but he was actually improving. His doctor called him the miracle boy.
Then the news came that the FDA was withdrawing its approval of actimmune for the treatment of this disease because the clinical tests that were being carried on said it was ineffectvie. Well, Bobby is proof that it isn't. Why it works on him and not others we don't know but our big problem now is getting it at a cost that he can afford. He is sure that if he stops taking it he will be dead in a year. PLEASE help him get a break on this. Time is of the essense and he doesn't have enought time to go through the FDA, VA, etc to fight for this. I am sending this letter out to anyone who i think can help us.
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