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InterMune Announces Presentation of Clinical Data From Studies of Daily Infergen With and Without Ribavirin for the Treatment of HCV

Posted on: Monday, 16 May 2005, 06:00 CDT

CHICAGO, May 16 /PRNewswire-FirstCall/ -- InterMune, Inc. announced today the presentation of clinical findings from two investigator-initiated studies evaluating the use of daily Infergen(R) (interferon alfacon-1) in combination with ribavirin or as monotherapy for the treatment of patients with hepatitis C (HCV). The findings were presented Sunday at the Digestive Disease Week (DDW) meeting in Chicago.

"These studies provide further support for the potential efficacy and safety of daily Infergen in a number of important HCV clinical settings," said Dan Welch, President and CEO of InterMune. "We believe treatment with daily Infergen plus ribavirin may become a promising HCV therapy, particularly for those patients who have failed to adequately respond to prior pegylated alpha interferon plus ribavirin therapy (PEG-nonresponders). We are continuing our multicenter Phase III DIRECT Trial to fully evaluate daily Infergen plus ribavirin for PEG-nonresponders."

Predictive Model and Sustained Virologic Response for PEG IFN-alfa-2 + Weight-Based Ribavirin Nonresponders Re-Treated With IFN Alfacon-1 + Weight- Based Ribavarin

Carroll Leevy II, M.D., Director of Clinical Affairs at the New Jersey Medical Liver Center and Sammy Davis Jr. National Liver Center in Newark, N.J., presented data from a retrospective analysis that led to the development of a model that predicts sustained virologic response (SVR) in PEG-nonresponders who were retreated with daily Infergen plus ribavirin.

Dr. Leevy and colleagues retrospectively reviewed data from 137 patients who had participated in a study to evaluate the safety and efficacy of daily Infergen in combination with ribavirin for the treatment of PEG-nonresponders. At enrollment, none of the 137 patients had shown at least a 2 log drop in viral load following 12 weeks of first-line therapy with PEG interferon alpha-2b (1.5 micrograms/kg every week) and weight-based ribavirin. Patients were then retreated with daily Infergen (15 micrograms) plus weight-based ribavirin for 12 weeks and then with three-times-per-week (TIW) Infergen (15 micrograms) plus ribavirin for an additional 36 weeks. At the end of follow-up, 37% of patients (51/137) achieved an SVR.

Using a model to assess the predictive value of viral and demographic factors, the investigators found patients who achieved an SVR with daily Infergen plus ribavirin had significantly greater reductions in HCV RNA after 12 weeks of pegylated interferon alpha-2 plus ribavirin (p<0.01, chi square) compared to the nonresponder group. HCV genotype, the presence of fibrosis, viral copy number at baseline and patient gender were not significant predictors of SVR.

Daily Versus Three-Times Weekly IFN Alfacon-1 in Previously Untreated HCV Patients Results in a Higher Rate of SVR: Final Results of An International, Phase IV Study

Final results were presented from a multicenter study comparing monotherapy Infergen in daily versus TIW dosing. During the trial, which was conducted at 24 centers in the U.S. and Germany, 509 previously untreated patients with chronic hepatitis C were randomized to one of three monotherapy regimens of Infergen: 9 micrograms daily for 48 weeks; 9 micrograms TIW for 48 weeks; or 9 micrograms TIW for 72 weeks. HCV RNA virologic responses (defined as undetectable if less than or equal to 100 copies/mL) were measured at week 12, at the end of the 48- or 72-week treatment period, and at 24 weeks following the end of therapy to determine SVR.

Results showed that 20% (33/168) of patients taking daily Infergen monotherapy achieved an SVR compared to 11% (19/167) for patients who received 48 weeks of TIW monotherapy treatment and 12% (20/171) for those who received 72 weeks of TIW monotherapy treatment. Treatment with daily Infergen was considered to be well tolerated. Nearly all patients reported at least one adverse event, including headache, fatigue, and rigors. Serious adverse events, such as depression, pneumonia, anemia, and convulsions, were seen in 6% (10/168), 3% (5/167), and 2% (3/171) of the treatment groups, respectively, and adverse events that required a dose reduction or withdrawal occurred in 28%, 8%, and 12%, respectively. This study provides further rationale for daily dosing of Infergen, which is being studied in the PEG-nonresponder population in the Company's Phase III DIRECT Trial.

About Chronic Hepatitis C

According to the Centers for Disease Control and Prevention, an estimated 3.9 million Americans (1.8%) have been infected with HCV, of whom 2.7 million are chronically infected. HCV causes an estimated 10,000 to 12,000 deaths annually in the United States and is the leading indication for liver transplant. The prevalence of chronic HCV is increasing. First-line treatment for patients chronically infected with HCV is pegylated interferon alfa-2 plus ribavirin. Approximately half of all patients treated do not respond. There are approximately 200,000 PEG-nonresponders in the United States and the number is growing by an estimated 50,000 each year.

About DDW

Digestive Disease Week (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW takes place May 14-19, 2005 in Chicago. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology.

About Infergen(R) (interferon alfacon-1)

Infergen is a bio-optimized type 1 interferon alpha indicated for treatment of adult patients with chronic HCV infections with compensated liver disease and is dosed three times-per-week. Infergen is the only interferon alpha with data in the label regarding use in patients following relapse or non-response to certain previous treatments. The most common side effects are flu-like symptoms (i.e., headache, fatigue, fever, myalgia, and rigors). Physicians and patients can obtain additional prescribing information regarding Infergen, including the product's safety profile and the black box warning for all interferon alphas regarding neuropsychiatric, autoimmune, ischemic and infectious disorders, by visiting http://www.infergen.com/.

InterMune's Commitment in Hepatology

InterMune is a biopharmaceutical company that is committed to developing and commercializing innovative therapies in hepatology. In addition to the currently marketed product indicated for the treatment of chronic HCV (Infergen(R)), InterMune has a broad and deep late-stage product portfolio addressing HCV, particularly in patients who are considered nonresponders to previous pegylated interferons plus ribavirin therapy. Leading the hepatology portfolio is the DIRECT Trial, an ongoing Phase III study of daily interferon alfacon-1 (Infergen(R)) plus ribavirin, and an ongoing Phase IIb trial of daily interferon alfacon-1 plus interferon gamma-1b (Actimmune(R)) with and without ribavirin. Both of these trials are for the treatment of HCV patients who do not respond to first-line therapy (pegylated interferon alfa 2a or 2b plus ribavirin). In addition, InterMune has an early stage small molecule program targeted at the HCV protease. For additional information about InterMune and its development pipeline, please visit http://www.intermune.com/.

Except for the historical information contained herein, this press release contains certain forward-looking statements that involve risks and uncertainties, including without limitation the statements related to anticipated future financial results and product development. All forward- looking statements and other information included in this press release are based on information available to InterMune as of the date hereof, and InterMune assumes no obligation to update any such forward-looking statements or information. InterMune's actual results could differ materially from those described in InterMune's forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in detail under the heading "Risk Factors" in InterMune's Form 10-Q filed with the SEC on May 10, 2005 and other periodic reports filed with the SEC, including the following: (i) the risk that if physicians do not prescribe Actimmune for the treatment of IPF, an indication for which Actimmune has not been approved by the FDA, or if patient referral rates continue to decline, InterMune's revenues will decline; (ii) risks related to regulation by the FDA and other agencies with respect to InterMune's communications with physicians concerning Actimmune for the treatment of IPF; (iii) risks related to potential increases in Infergen sales; (iv) reimbursement risks associated with third-party payors; (v) risks related to whether InterMune is able to obtain, maintain and enforce patents and other intellectual property; (vi) risks related to significant regulatory, supply and competitive barriers to entry; (vii) risks related to the uncertain, lengthy and expensive clinical development and regulatory process, including having no unexpected safety, toxicology, clinical or other issues; (viii) risks related to achieving positive clinical trial results; (ix) risks related to timely patient enrollment and retention in clinical trials. The risks and other factors discussed above should be considered only in connection with the fully discussed risks and other factors discussed in detail in the 10-Q report and InterMune's other periodic reports filed with the SEC.

InterMune, Inc.

CONTACT: investors, Judy Hayes of InterMune, Inc., +1-415-466-2242, orir@intermune.com, or press, Jani Bergan of WeissComm Partners,+1-415-946-1064, or jbergan@weisscommpartners.com, for InterMune, Inc.

Web site: http://www.intermune.com/

Source: PRNewswire-FirstCall

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