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Greg
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Joined: 21 Dec 2002
Posts: 226
Location: WA

Post Posted: Wed Jan 08, 2003 12:49 am Reply with quote    Back to top    

According to an article on TheStreet.com, revised data released today by InterMune has renewed an old debate over the efficacy of Actimmune in treating IPF. While the survival advantage of patients taking Actimmune has fallen from 40% to 25%, company executives insist that the drug provides a clear benefit to IPF patients, especially since few good alternative treatments exist. On a positive note, there still appears to be a statistically-significant survival benefit for the subgroup of patients with mild to moderate fibrosis.
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Holly



Joined: 22 Dec 2002
Posts: 2268

Post Posted: Wed Jan 08, 2003 12:27 pm Reply with quote    Back to top    

Does someone have these specific results that they can post here for us?
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strayze
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Joined: 22 Dec 2002
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Post Posted: Wed Jan 08, 2003 3:24 pm Reply with quote    Back to top    

Holly, check out the SEC (Securities and Exchange Commission) filing of 01/07/03 posted under "General Discussion" More data is given there as well as a link to their original data from 08/02. I believe that is what is being referred to.
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Holly



Joined: 22 Dec 2002
Posts: 2268

Post Posted: Wed Jan 08, 2003 3:49 pm Reply with quote    Back to top    

Here's the part of the press release I wanted:

Phase III Clinical Trial Summary

A total of 330 patients were randomized into the Company's Phase III clinical trial evaluating Actimmune for the treatment of IPF, which was conducted at 58 centers in North America, Europe and South Africa. The study included a well-defined cohort of IPF patients, and treatment groups were well balanced by baseline characteristics. Patients received either placebo or 200 micrograms of Actimmune injected subcutaneously three times per week.

Final results of the pre-specified analysis from the Phase III clinical trial were presented earlier this year at two international scientific conferences after the 306th patient received 48 weeks of treatment (representing a 60 week median observation period as of June 26th, 2002).

Follow-Up Observation Period

The Company continued to follow patients in the study for three to five additional months beyond the pre-specified analysis of the Phase III clinical trial in June.

In the overall intent-to-treat patient population through the follow-up period, there were 26/162 deaths in the Actimmune treated group (16.0%) compared to 36/168 deaths in the placebo group (21.4%), representing a 25 percent relative reduction in mortality in favor of Actimmune (p = 0.17; log-rank test for survival time).

Exploratory subgroup analyses continue to suggest that Actimmune may have a more favorable effect in IPF patients with mild to moderate disease. In those patients with forced vital capacity (FVC) > 55 percent at study entry, there were 13/126 deaths in the Actimmune-treated group (10.3%) versus 26/128 deaths in the placebo group (20.3%), representing a 49 percent relative reduction in mortality in favor of Actimmune (p = 0.02). In those patients with FVC > 60 percent at study entry, there were 10/90 deaths in the Actimmune-treated group (11.1%) versus 16/92 deaths in the placebo group (17.4%), representing a 36 percent relative reduction in mortality in favor of Actimmune (p=0.15). For the FVC < 55 percent and FVC < 60 percent subgroups, the p values were 0.45 and 0.61, respectively.
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strayze
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Joined: 22 Dec 2002
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Post Posted: Wed Jan 08, 2003 5:47 pm Reply with quote    Back to top    

Holly, this is the exact wording of Intermune's SEC filing of Jan 7, 2003, posted under General Discussion.
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