My thanks to RCMac, copied from Yahoo:
In my earlier post I paraphrased clinical trial results as showing that "Actimmune is effective for IPF, **slowing or halting** disease progression."
I misspoke from memory. I should have said that Actimmune appears to HALT OR REVERSE the lung damage of IPF, not slows or halts it.
This is from ITMN's 10-K, filed March 21, 2002, pp.6-7:
"The results of these earlier clinical trials demonstrated that [Actimmune] can be safely administered with minimal adverse side effects and can halt and reverse the deterioration in lung function in patients.
"The results of one of these clinical trials, a Phase II clinical trial published in October 1999 in The New England Journal of Medicine, demonstrated at a statistically significant level that [Actimmune] may be effective in the treatment of idiopathic pulmonary fibrosis. Investigators at the University of Vienna Medical School conducted the clinical trial with 18 patients who had not responded to treatment with corticosteroids or anti-cancer agents. Nine patients were treated for 12 months with oral prednisolone, a corticosteroid, and nine patients were treated with a combination of [Actimmune] and prednisolone.
"Lung function, as measured by total lung capacity and blood oxygen levels, deteriorated in all nine patients in the group given prednisolone alone. Total lung capacity decreased from a mean of 66% at the start of the trial to 62% after 12 months.
"In contrast, in the group receiving [Actimmune] plus prednisolone, total lung capacity increased from a mean of 70% at the start of the trial to 79% after 12 months.
"Similarly, in the nine patients in the group given prednisolone alone, blood oxygen levels of patients at rest decreased from a mean of 65% at the start of the trial to 62% after 12 months. In the group receiving [Actimmune] plus prednisolone, blood oxygen levels of patients at rest increased from a mean of 65% at the start of the trial to 76% after 12 months. Both of these results are statistically significant, each with a p value of less than 0.001. This means that, applying widely used statistical methods, the chance that these results occurred by accident is less than 1 in 1,000."
In other words, these results show that IPF patients, instead of gradually suffocating to death as their lung function deteriorates, instead gain lung capacity and blood oxygen.
Assuming that phase 3 final results bear this out, Actimmune seems pretty likely to be approved by FDA for IPF. (As noted, since it is already FDA-approved for other indications, no safety issue seems likely to appear [FDA having already declared it safe when it approved Actimmune for the other diseases], and the apparent effectiveness seems likely to carry the day, especially since this is an awful disease with no other effective treatment.)
FDA has previously granted "fast-track" status to Actimmune, so approval should come within 6 months, and maybe faster, after the application is submitted, following the release in November of the complete phase 3 results. Because Actimmune is already approved for other diseases, doctors are now legally free to prescribe it for IPF.
--RCM
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