Press Release
Home > Press Release > PR Newswire
Roche, InterMune and Pharmasset Announce Initiation of INFORM-1, the First Dual-Combination Clinical Trial with Oral Antivirals in Hepatitis C
BRISBANE, Calif., Nov. 10 /PRNewswire-FirstCall/ -- Roche (SWX:ROG),InterMune, Inc. (Nasdaq: ITMN) and Pharmasset (Nasdaq: VRUS) today announcedthat the first patients have been dosed in an innovative clinical trial inpatients chronically infected with the hepatitis C virus (HCV). The trial (runin centers in Australia and New Zealand) is the first to investigate thecombination of two oral antiviral molecules in the absence of interferon.
The initial study will evaluate the safety and combined antiviral activityof R7227 (ITMN-191), a protease inhibitor, and R7128, a polymerase inhibitor,in 14 days of combination therapy in treatment-naive patients infected withHCV genotype 1.
This direct antiviral combination study represents an important first stepin evaluating the therapeutic potential of an all-oral, interferon-freecombination treatment for HCV. Roche is uniquely positioned to develop all-oral combination studies in HCV through its collaborations with InterMune andPharmasset, which provide access to both protease and polymerase inhibitors,respectively.
With InterMune, Roche is developing R7227, an HCV protease inhibitorcompound to be used in combination with PEGASYS(R) (peginterferon alfa-2a) andCOPEGUS(R) (ribavirin), the current standard of care (SOC). Concurrently withPharmasset, Roche is developing R7128, an HCV RNA polymerase inhibitor, alsofor therapy in combination with PEGASYS(R) and COPEGUS(R). Both of thesemolecules have successfully completed Phase 1 monotherapy studies, have beendosed in combination with PEGASYS(R) and COPEGUS(R) and both have individuallydemonstrated their efficacy against HCV.
Current standard of care for HCV comprises pegylated interferon plusribavirin, for a duration that is dependent upon factors such as genotype ofthe virus. For the most difficult to treat genotype 1 virus, a 48-weektreatment course generally results in sustained viral response in about 50% ofpatients. PEGASYS(R) and COPEGUS(R) are the current foundation of HCVtreatment and the preferred pegylated interferon therapy of choice for mostHCV antiviral agents in development.
Nick Cammack, Leader of the Virology Disease Biology Leadership Team atRoche stated: "It is exciting to be at the forefront of designing innovativeclinical approaches in fighting this chronic disease together with ourpartners, InterMune and Pharmasset. Our approach demonstrates our stronginterest in combining molecules in development and investigating allpossibilities that may enable us to deliver a new standard of care forpatients with HCV."
Dan Welch, Chairman, Chief Executive Officer and President of InterMune,said, "The goal is to develop a treatment regimen that is better tolerated,shorter in duration and delivers higher sustained viral response rates. Weare pleased to participate in the first clinical exploration of an all-oral,direct antiviral regimen towards that goal."
"The combination of oral antiviral therapies for HCV represents anexciting step in the evolution of HCV treatment" stated Patrick Higgins,Executive Vice President of Marketing and Sales at Pharmasset. "We believe thedevelopment of an all oral treatment regimen may help attract many morepatients into therapy that are currently not on treatment."
About R7227 (ITMN-191)
R7227 is an inhibitor of HCV NS3/4A protease activity, and has producedmulti-log10 reductions in circulating HCV RNA in chronic HCV patients whenadministered for 14 days as monotherapy. In support of clinical studies thatwill combine R7227 with R7128, including the INFORM-1 study, InterMune, Rocheand Pharmasset have investigated in vitro the combined antiviral effect ofthese compounds.
About InterMune
InterMune is a biotechnology company focused on the research, developmentand commercialization of innovative therapies in pulmonology and hepatology.InterMune has a pipeline portfolio addressing idiopathic pulmonary fibrosis(IPF) and hepatitis C virus (HCV) infections. The pulmonology portfolioincludes the Phase 3 program, CAPACITY, which is evaluating pirfenidone as apossible therapeutic candidate for the treatment of patients with IPF and aresearch program focused on small molecules for pulmonary disease. Thehepatology portfolio includes HCV protease inhibitor ITMN-191 (R7227) in Phase1b, a second-generation HCV protease inhibitor research program, and aresearch program evaluating a new target in hepatology. For additionalinformation about InterMune and its R&D pipeline, please visithttp://www.intermune.com.
About R7128
R7128, being developed for the treatment of chronic HCV infection, is apro-drug of PSI-6130, a cytidine nucleoside analog inhibitor of HCV RNApolymerase. A pro-drug is a chemically modified form of a molecule designed toenhance the absorption, distribution and metabolic properties of thatmolecule. R7128 has shown in vitro activity against all of the most common HCVgenotypes (1, 2, 3 and 4).
About Pharmasset
Pharmasset is a clinical-stage pharmaceutical company committed todiscovering, developing and commercializing novel drugs to treat viralinfections. Pharmasset's primary focus is on the development of oraltherapeutics for the treatment of hepatitis B virus (HBV), hepatitis C virus(HCV) and human immunodeficiency virus (HIV).Pharmasset is currently developing three product candidates. Clevudine, forthe treatment of chronic HBV infection, is enrolling Phase 3 clinical trialsfor registration in North, Central and South America and Europe. Clevudine isalready approved for HBV in South Korea and marketed by BukwangPharmaceuticals in South Korea under the brand name Levovir. R7128, an oraltreatment for chronic HCV infection, is in a 4-week Phase 1 clinical trial incombination with Pegasys(R) plus Copegus(R). Racivir, which is being developedfor the treatment of HIV in combination with other approved HIV drugs, hascompleted a Phase 2 clinical trial.
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world's leadingresearch-focused healthcare groups in the fields of pharmaceuticals anddiagnostics. As the world's biggest biotech company and an innovator ofproducts and services for the early detection, prevention, diagnosis andtreatment of diseases, the Group contributes on a broad range of fronts toimproving people's health and quality of life. Roche is the world leader inin-vitro diagnostics and drugs for cancer and transplantation, and is a marketleader in virology. It is also active in other major therapeutic areas such asautoimmune diseases, inflammatory and metabolic disorders and diseases of thecentral nervous system. In 2007 sales by the Pharmaceuticals Division totaled36.8 billion Swiss francs, and the Diagnostics Division posted sales of 9.3billion Swiss francs. Roche has R&D agreements and strategic alliances withnumerous partners, including majority ownership interests in Genentech andChugai, and invested over 8 billion Swiss francs in R&D in 2007. Worldwide,the Group employs about 80,000 people. Additional information is available onthe Internet at http://www.roche.com.
Forward-Looking Statements
This news release contains forward-looking statements within the meaningof section 21E of the Securities Exchange Act of 1934, as amended, thatreflect InterMune's judgment and involve risks and uncertainties as of thedate of this release. All forward-looking statements and other informationincluded in this press release are based on information available to InterMuneas of the date hereof, and InterMune assumes no obligation to update any suchforward-looking statements or information. InterMune's actual results coulddiffer materially from those described in InterMune's forward-lookingstatements.
Factors that could cause or contribute to such differences include, butare not limited to, those discussed in detail under the heading "Risk Factors"in InterMune's most recent annual report on Form 10-K filed with the SEC onMarch 14, 2008 (the "Form 10-K") and other periodic reports filed with theSEC, including the following: (i) risks related to the long, expensive anduncertain clinical development and regulatory process, including having nounexpected safety, toxicology, clinical or other issues or delays inanticipated timing of the regulatory approval process; (ii) risks related tofailure to achieve the clinical trial results required to commercialize ourproduct candidates; and (iii) risks related to timely patient enrollment andretention in clinical trials. The risks and other factors discussed aboveshould be considered only in connection with the fully discussed risks andother factors discussed in detail in the Form 10-K and InterMune's otherperiodic reports filed with the SEC, all of which are available viaInterMune's web site at http://www.intermune.com.
Pegasys(R) and Copegus(R) are registered trademarks of Roche.
SOURCE InterMune, Inc.
This direct antiviral combination study represents an important first stepin evaluating the therapeutic potential of an all-oral, interferon-freecombination treatment for HCV. Roche is uniquely positioned to develop all-oral combination studies in HCV through its collaborations with InterMune andPharmasset, which provide access to both protease and polymerase inhibitors,respectively.
With InterMune, Roche is developing R7227, an HCV protease inhibitorcompound to be used in combination with PEGASYS(R) (peginterferon alfa-2a) andCOPEGUS(R) (ribavirin), the current standard of care (SOC). Concurrently withPharmasset, Roche is developing R7128, an HCV RNA polymerase inhibitor, alsofor therapy in combination with PEGASYS(R) and COPEGUS(R). Both of thesemolecules have successfully completed Phase 1 monotherapy studies, have beendosed in combination with PEGASYS(R) and COPEGUS(R) and both have individuallydemonstrated their efficacy against HCV.
Current standard of care for HCV comprises pegylated interferon plusribavirin, for a duration that is dependent upon factors such as genotype ofthe virus. For the most difficult to treat genotype 1 virus, a 48-weektreatment course generally results in sustained viral response in about 50% ofpatients. PEGASYS(R) and COPEGUS(R) are the current foundation of HCVtreatment and the preferred pegylated interferon therapy of choice for mostHCV antiviral agents in development.
Nick Cammack, Leader of the Virology Disease Biology Leadership Team atRoche stated: "It is exciting to be at the forefront of designing innovativeclinical approaches in fighting this chronic disease together with ourpartners, InterMune and Pharmasset. Our approach demonstrates our stronginterest in combining molecules in development and investigating allpossibilities that may enable us to deliver a new standard of care forpatients with HCV."
Dan Welch, Chairman, Chief Executive Officer and President of InterMune,said, "The goal is to develop a treatment regimen that is better tolerated,shorter in duration and delivers higher sustained viral response rates. Weare pleased to participate in the first clinical exploration of an all-oral,direct antiviral regimen towards that goal."
"The combination of oral antiviral therapies for HCV represents anexciting step in the evolution of HCV treatment" stated Patrick Higgins,Executive Vice President of Marketing and Sales at Pharmasset. "We believe thedevelopment of an all oral treatment regimen may help attract many morepatients into therapy that are currently not on treatment."
About R7227 (ITMN-191)
R7227 is an inhibitor of HCV NS3/4A protease activity, and has producedmulti-log10 reductions in circulating HCV RNA in chronic HCV patients whenadministered for 14 days as monotherapy. In support of clinical studies thatwill combine R7227 with R7128, including the INFORM-1 study, InterMune, Rocheand Pharmasset have investigated in vitro the combined antiviral effect ofthese compounds.
About InterMune
InterMune is a biotechnology company focused on the research, developmentand commercialization of innovative therapies in pulmonology and hepatology.InterMune has a pipeline portfolio addressing idiopathic pulmonary fibrosis(IPF) and hepatitis C virus (HCV) infections. The pulmonology portfolioincludes the Phase 3 program, CAPACITY, which is evaluating pirfenidone as apossible therapeutic candidate for the treatment of patients with IPF and aresearch program focused on small molecules for pulmonary disease. Thehepatology portfolio includes HCV protease inhibitor ITMN-191 (R7227) in Phase1b, a second-generation HCV protease inhibitor research program, and aresearch program evaluating a new target in hepatology. For additionalinformation about InterMune and its R&D pipeline, please visithttp://www.intermune.com.
About R7128
R7128, being developed for the treatment of chronic HCV infection, is apro-drug of PSI-6130, a cytidine nucleoside analog inhibitor of HCV RNApolymerase. A pro-drug is a chemically modified form of a molecule designed toenhance the absorption, distribution and metabolic properties of thatmolecule. R7128 has shown in vitro activity against all of the most common HCVgenotypes (1, 2, 3 and 4).
About Pharmasset
Pharmasset is a clinical-stage pharmaceutical company committed todiscovering, developing and commercializing novel drugs to treat viralinfections. Pharmasset's primary focus is on the development of oraltherapeutics for the treatment of hepatitis B virus (HBV), hepatitis C virus(HCV) and human immunodeficiency virus (HIV).Pharmasset is currently developing three product candidates. Clevudine, forthe treatment of chronic HBV infection, is enrolling Phase 3 clinical trialsfor registration in North, Central and South America and Europe. Clevudine isalready approved for HBV in South Korea and marketed by BukwangPharmaceuticals in South Korea under the brand name Levovir. R7128, an oraltreatment for chronic HCV infection, is in a 4-week Phase 1 clinical trial incombination with Pegasys(R) plus Copegus(R). Racivir, which is being developedfor the treatment of HIV in combination with other approved HIV drugs, hascompleted a Phase 2 clinical trial.
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world's leadingresearch-focused healthcare groups in the fields of pharmaceuticals anddiagnostics. As the world's biggest biotech company and an innovator ofproducts and services for the early detection, prevention, diagnosis andtreatment of diseases, the Group contributes on a broad range of fronts toimproving people's health and quality of life. Roche is the world leader inin-vitro diagnostics and drugs for cancer and transplantation, and is a marketleader in virology. It is also active in other major therapeutic areas such asautoimmune diseases, inflammatory and metabolic disorders and diseases of thecentral nervous system. In 2007 sales by the Pharmaceuticals Division totaled36.8 billion Swiss francs, and the Diagnostics Division posted sales of 9.3billion Swiss francs. Roche has R&D agreements and strategic alliances withnumerous partners, including majority ownership interests in Genentech andChugai, and invested over 8 billion Swiss francs in R&D in 2007. Worldwide,the Group employs about 80,000 people. Additional information is available onthe Internet at http://www.roche.com.
Forward-Looking Statements
This news release contains forward-looking statements within the meaningof section 21E of the Securities Exchange Act of 1934, as amended, thatreflect InterMune's judgment and involve risks and uncertainties as of thedate of this release. All forward-looking statements and other informationincluded in this press release are based on information available to InterMuneas of the date hereof, and InterMune assumes no obligation to update any suchforward-looking statements or information. InterMune's actual results coulddiffer materially from those described in InterMune's forward-lookingstatements.
Factors that could cause or contribute to such differences include, butare not limited to, those discussed in detail under the heading "Risk Factors"in InterMune's most recent annual report on Form 10-K filed with the SEC onMarch 14, 2008 (the "Form 10-K") and other periodic reports filed with theSEC, including the following: (i) risks related to the long, expensive anduncertain clinical development and regulatory process, including having nounexpected safety, toxicology, clinical or other issues or delays inanticipated timing of the regulatory approval process; (ii) risks related tofailure to achieve the clinical trial results required to commercialize ourproduct candidates; and (iii) risks related to timely patient enrollment andretention in clinical trials. The risks and other factors discussed aboveshould be considered only in connection with the fully discussed risks andother factors discussed in detail in the Form 10-K and InterMune's otherperiodic reports filed with the SEC, all of which are available viaInterMune's web site at http://www.intermune.com.
Pegasys(R) and Copegus(R) are registered trademarks of Roche.
SOURCE InterMune, Inc.
For more iinformation, go to www.prnewswire.com
Recent Press Release
Advertisement
POS Magnetic Card Readers
Online distributor for point of sale equipment, TYSSO and Pegasus.








