Pirfenidone News and Research

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On-going Phase 2b study conducted by Roche of ITMN-191 modified

InterMune, Inc. today announced that the on-going Phase 2b study conducted by Roche of ITMN-191 (RG7227) combined with standard of care (SOC) PEGASYS® (peginterferon alfa-2a) and COPEGUS® (ribavirin) in HCV treatment-naive patients has been modified.

18 Nov 2009

InterMune seeks FDA marketing approval for pirfenidone

InterMune, Inc. today announced that it has submitted an electronic New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market pirfenidone for the treatment of patients with idiopathic pulmonary fibrosis (IPF). Pirfenidone has been granted Orphan Drug and Fast Track designation by the FDA, and also has been granted Orphan Drug status in Europe.

5 Nov 2009

InterMune and National Jewish Health to collaborate in the research of idiopathic pulmonary fibrosis

InterMune, Inc. (Nasdaq: ITMN) today announced that it will be collaborating with National Jewish Health(R)( )investigators in order to help further the research of inherited genetic factors that may play a role in idiopathic pulmonary fibrosis (IPF). InterMune will provide researchers at National Jewish with access to DNA collected from patients who participated in the Company's Phase 3 clinical trials in IPF for both pirfenidone (CAPACITY trials) and Actimmune(R) (interferon gamma-1b) (INSPIRE).

17 Sep 2009

Clinical studies reveal treatment with pirfenidone is safe and well-tolerated

InterMune, Inc. (Nasdaq: ITMN) today announced that the results of a comprehensive review of safety data from four clinical studies were presented at the 2009 European Respiratory Society Annual Congress in Vienna, Austria by Dr. Ulrich Costabel of the Ruhrlandklinik, Essen, Germany.

14 Sep 2009

InterMune receives $20 million event payment from Roche for initiating the Phase 2b trial of RG7227/ ITMN-191

Roche (SIX: ROG.VX; RO.S, OTCQX: RHHBY) and InterMune, Inc. (Nasdaq: ITMN) today announced that the first patient has been dosed in a Phase 2b study evaluating the hepatitis C virus (HCV) protease inhibitor, RG7227/ ITMN-191, in combination with PEGASYS(R) (pegylated interferon alfa-2a) and COPEGUS(R) (ribavirin). The study, to be conducted at 45 sites globally, will further define the safety and efficacy profile of RG7227/ ITMN-191, for a treatment duration of up to 24 weeks. Approximately 300 treatment-naive patients chronically infected with HCV genotype 1 - the most difficult to treat form of the virus - will participate.

20 Aug 2009

Pirfenidone shows promise for idiopathic pulmonary fibrosis

A large, well-controlled, multi-national clinical trial program has demonstrated the effectiveness and safety of what may become the first FDA-approved medicine for idiopathic pulmonary fibrosis, or IPF.

17 May 2009

New treatment option for idiopathic pulmonary fibrosis

Patients with idiopathic pulmonary fibrosis (IPF) may have a new treatment option, according to researchers in Japan.

20 May 2008

Promising results from study of Pirfenidone in idiopathic pulmonary fibrosis (IPF) patients

InterMune today announced that the American Journal of Respiratory and Critical Care Medicine (AJRCCM) published results from a double-blind, randomized, placebo-controlled Phase II trial evaluating pirfenidone for the treatment of patients with idiopathic pulmonary fibrosis (IPF).

2 May 2005