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- R1626 Also Shows a High Barrier to the Development of Resistance
Roche's investigational treatment for hepatitis C, R1626, has shown an impressive end-of-treatment response rate when given in combination with PEGASYS(R) (peginterferon alfa-2a) and COPEGUS(R) (ribavirin).
After 4 weeks of treatment with this triple combination, followed by 44 weeks of Pegasys and Copegus, levels of the hepatitis C virus (HCV) were undetectable in 84% of patients infected with genotype 1 virus. This was higher than in patients treated with Pegasys and Copegus alone for the entire 48-week treatment period (65%).(1) These new data were presented in a late-breaker oral session at the 43rd Annual Meeting of the European Association for the Study of the Liver (EASL), being held in Milan, Italy.
Discovered and developed at Roche, R1626 is a potent polymerase inhibitor which belongs to a new generation of treatments that directly inhibit replication of HCV. It is the most advanced polymerase inhibitor in development.
"These results demonstrate that R1626 holds significant promise to potentially increase the number of hepatitis C patients who can be successfully treated. It is particularly interesting that R1626, a polymerase inhibitor, is demonstrating a higher end-of-treatment response rate than current HCV protease inhibitors in development, together with a high barrier to the development of resistance," said Dr David Nelson, Director of Hepatology and Liver Transplantation at the University of Florida, Gainesville, Florida, USA. "Since most patients responded very early in treatment with R1626, we expect excellent SVR rates that improve significantly on those achieved with the current standard of care. I look forward to SVR data from this Phase IIa study, and to results of the ongoing Phase IIb study."
Patients in this Phase IIa study will be followed for an additional 24 weeks with no treatment to determine the rate of sustained virological response (SVR), indicating a cure.
Rapid development of R1626 - a Large Phase IIb Study is Now Fully Enrolled
A large Phase IIb study with R1626 was initiated in November 2007 to define the optimal dose of R1626, in combination with Pegasys and Copegus. This Phase IIb trial, called POLI 1, is now fully enrolled with approximately 500 patients.
More About the Phase IIa Study and End-of-Treatment Results Presented at EASL
The Phase IIa study is a multicenter trial that enrolled 104 patients with genotype 1 HCV, who had not previously received treatment. Its primary endpoint was to evaluate the 4-week efficacy and safety of combining R1626 with Pegasys alone or with Pegasys plus Copegus, in comparison to a current HCV standard of care, Pegasys plus Copegus.
Patients were randomised into the following treatment groups:
- Group A: R1626 1,500 mg twice a day plus Pegasys 180 mcg weekly for 4 weeks
- Group B: R1626 3,000 mg twice a day plus Pegasys 180 mcg weekly for 4 weeks
- Group C: R1626 1,500 mg twice a day plus Pegasys 180 mcg weekly plus Copegus 1,000/1,200 mg daily for 4 weeks
- Group D (standard of care group): Pegasys 180 mcg weekly plus Copegus 1,000/1,200 mg daily for 4 weeks
Following the 4 weeks of treatment in this study, all patients received Pegasys 180 mcg weekly plus Copegus 1,000/1,200 mg daily for an additional 44 weeks to complete the 48-week trial.
The study found(1):
- Data collected at 4 weeks showed that patients receiving the triple combination (Group C) had a mean decrease in viral load of 5.2 log10 from baseline, indicating a robust and rapid virological response
- At week 48, HCV was undetectable in 84% of patients receiving the triple combination R1626 1,500 mg BID + Pegasys + Copegus, compared with 65% of patients treated with Pegasys and Copegus alone
- A higher incidence of grade 4 neutropaenia was reported in the R1626 treatment arms during the 4-week treatment period; however, after stopping treatment with R1626, absolute neutrophil counts returned to the levels typically seen with patients taking standard of care alone
R1626 - a High Barrier to the Development of Resistance
In a separate oral presentation at EASL, it was reported that R1626 continues to present a high barrier to the development of viral resistance. Resistance is a serious concern in hepatitis C treatment, as resistant viruses have emerged in patients early on in treatment with protease inhibitors. Resistance to R1626 has not been yet been identified, after either 2 weeks of R1626 monotherapy, or after 4 weeks in patients treated with R1626 in combination therapy.(2)
About Hepatitis C
Hepatitis C, the most common chronic blood-borne infection, is transmitted primarily through blood or blood products. Hepatitis C chronically infects 180 million people worldwide, with an additional three to four million people newly infected each year.(3) It is a leading cause of cirrhosis, liver cancer and liver failure, despite being potentially curable. The future of hepatitis C therapy is likely to involve combinations of new small-molecule antiviral drugs and pegylated interferon-based treatment, such as Pegasys.
Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As the world's biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, a market leader in virology and active in other major therapeutic areas such as autoimmune diseases, inflammation, metabolic disorders and diseases of the central nervous system. In 2007 sales by the Pharmaceuticals Division totalled 36.8 billion Swiss francs, and the Diagnostics Division posted sales of 9.3 billion Swiss francs. Roche has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai, and invested over 8 billion Swiss francs in R&D in 2007. Worldwide, the Group employs about 79,000 people. Additional information is available on the Internet at http://www.roche.com.
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(1). Nelson D, Pockros P, Godofsky E, et al. 84% end-of-treatment response (EOTR, week 48) achieved with R1626, peginterferon alfa 2a (40KD) and ribavirin for 4 weeks followed by the standard of care: Results of a phase 2a study in treatment-naive HCV genotype 1 patients. In: 43rd Annual Meeting of the European Association for the Study of the Liver (EASL); 2008 April 26, 2008; Milan, Italy; 2008.
(2). Le Pogam S, Seshaadri A, Kang H, et al. Low level of resistance, low viral fitness and absence of resistance mutations in baseline quasispecies may contribute to high barrier to R1626 resistance in vivo. In: 43rd Annual Meeting of the European Association for the Study of the Liver (EASL); 2008; Milan, Italy; 2008.
(3). World Health Organization. Initiative for Vaccine Research, Viral Cancers, Hepatitis C. 2006. (Accessed July 24, 2006, at http:// www.who.int/vaccine_research/diseases/viral_cancers/en/index2.html.)
ots Originaltext: Roche Pharmaceuticals
Im Internet recherchierbar: http://www.presseportal.ch
Contact: Mike Nelson, Roche, +41-79-572-5165, Michelle Marchione,
Axon Communications, +44(0)208-439-9449