I think you've summed it up pretty well. Near to intermediate term, the market will remain focused on earnings from Actimmune in IPF. But the Infergen studies in HCV will gradually refocus the market. If they can demonstrate superiority with the Infergen/Actimmune combo, they've got something that'll move the price. I would guess that interim results involving the reduction of viral load would be out soon. It would be worth listening in to a presentation to get an idea of when . . .
>>BRISBANE, Calif., June 15 /PRNewswire-FirstCall/ -- InterMune, Inc. (Nasdaq: ITMN - News) today announced that the Company has initiated the DIRECT Trial, a Phase III clinical trial designed to evaluate the safety and efficacy of daily Infergen® (Interferon alfacon-1) in combination with ribavirin for the treatment of patients chronically infected with hepatitis C virus (HCV) who have failed to respond to a previous course of therapy with pegylated interferon alfa-2 plus ribavirin. These patients are referred to as HCV nonresponders.
"HCV nonresponders represent a growing unmet medical need because retreatment options are limited and generally provide very poor response rates," said Robert L. Carithers Jr., M.D., University of Washington Medical Center and Lead Principal Investigator of the study. "Pilot studies of daily Infergen plus ribavirin in the U.S. and in Europe have shown promising response rates in the treatment of nonresponders. We hope to confirm these preliminary findings in this large, well-controlled Phase III study."
The DIRECT Trial is a randomized, open-label pivotal phase III trial enrolling 510 HCV nonresponders at approximately 40 centers in the United States. There will be three arms to the study. Patients in the first two arms will receive combination therapy of daily Infergen at one of two dose levels (9 or 15 micrograms) plus 1000-1200 milligrams ribavirin (based on body weight) daily for up to 48 weeks. The third arm will be a no-treatment control arm and will serve as the comparison for response rates for patients in each of the two treatment arms. Patients in the control arm who have less than a 2 log decrease in HCV RNA at 24 weeks may be eligible to rollover to an additional treatment protocol at the same two dosing levels.
The primary endpoint of the DIRECT Trial is the proportion of patients with sustained viral response (SVR), which is defined as the absence of detectable HCV RNA in serum 68 and 72 weeks after the initiation of treatment. The secondary endpoints of the study are: the proportion of patients with quantitative measurement of serum HCV RNA levels below the level of detection at weeks 24 and 48; and the proportion of patients with abnormal serum alanine transaminase (ALT) levels at baseline, a marker of liver function, that have normal ALT levels at various time points during the study.
"The launch of this trial comes on the heels of promising data presented at the Digestive Disease Week conference last month from two investigator-sponsored studies of daily Infergen plus ribavirin combination therapy in nonresponders," said Dan Welch, Chief Executive Officer and President of InterMune. "The results of those studies provide strong scientific rationale for a Phase III study of daily Infergen plus ribavirin. In addition to this Phase III trial, we are simultaneously conducting a Phase II study to assess the use of daily Infergen in combination with our other marketed interferon, Actimmune® (Interferon gamma-1b), in the treatment of HCV nonresponders."
About Chronic Hepatitis C
According to the Centers for Disease Control an estimated 3.9 million (1.8%) Americans have been infected with HCV, of whom 2.7 million are chronically infected. Hepatitis C causes an estimated 10,000 to 12,000 deaths annually in the United States. The prevalence of chronic hepatitis C is increasing. Standard treatment for patients chronically infected with hepatitis C virus is pegylated interferon alfa-2 plus ribavirin. Approximately half of all patients treated do not respond. There are approximately 150,000 nonresponders in the United States and the number is growing by an estimated 50,000 each year.<<
I don't remember what kind of response you got on the Valuation board, but I'll bet it was similar, and from Peter. rkrw, who is also to be listened to, also follows this stock.
Cheers, Tuck |
