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Basel, Switzerland (ots/PRNewswire) -
- FDA Grants Fast Track Status to R1626
Roche announced today the start of the first phase II development study to evaluate R1626, their promising new polymerase inhibitor, for the treatment of hepatitis C. The investigational drug has also been granted Fast Track status by the US Food and Drug Administration (FDA), a program designed to facilitate the development and to expedite the review of new drugs with the potential to help treat serious or life-threatening conditions.
R1626 has been shown in an earlier study to have a strong antiviral effect against the hepatitis C virus. In the phase I study , the drug achieved significant reductions in viral load in chronic hepatitis C patients infected with the difficult-to-cure genotype 1 virus. By moving R1626 into phase II trials, Roche signifies its commitment to finding more therapeutic solutions for patients with hepatitis C. This trial will evaluate the safety and antiviral effects of R1626 in combination with the current standard of care for hepatitis C, Roche's PEGASYS (peginterferon alfa-2a (40KD)) and COPEGUS (ribavirin).
"New medicines such as R1626 have strong antiviral activity and could be very effective in helping patients to clear the virus, especially when used in combination with current treatments," said Dr. Paul Pockros, Head of the Division of Gastroenterology/Hepatology at The Scripps Clinic and lead investigator of the study. "We know that current hepatitis therapies cure about half of all patients infected with the most common and difficult-to-treat genotype 1 virus, so a product that could potentially improve cure rates is much needed."
About the phase II trial
This on-going multicenter phase II trial that is enrolling patients with genotype 1 chronic hepatitis C who have not previously received treatment.
Patients are randomised into four treatment groups. These treatment groups are:
- Group A: R1626 1500mg twice a day + Pegasys 180mcg as a subcutaneous injection every week for 4 weeks
- Group B: R1626 3000mg twice a day + Pegasys 180mcg as a subcutaneous injection every week for 4 weeks
- Group C: R1626 1500mg twice a day + Pegasys 180mcg as a subcutaneous injection every week + Copegus 1000-1200mg daily for 4 weeks
- Group D: Pegasys 180mcg as a subcutaneous injection every week + Copegus 1000-1200mg daily (standard of care group) for 4 weeks
Following the first 4 weeks of treatment, all patients will receive Pegasys 180mcg subcutaneously every week + Copegus 1000-1200mg daily for another 44 weeks, making the total treatment duration of 48 weeks. The objectives of the study are to evaluate the 4 week safety and antiviral effect of combining R1626 with Pegasys alone or R1626 with Pegasys plus Copegus.
The study is currently enrolling patients in the US. Patients and healthcare providers interested in the trial can find more information at www.roche-trials.com.
About Fast Track status
The criteria for Fast Track status are that the product's indication represents a serious or life-threatening condition and the product has the potential to meet an unmet medical need in treating the condition. Fast Track allows for increased communication between the sponsor and the FDA during the product's development and enables a "rolling submission," which means Roche can submit materials on an ongoing basis which can facilitate the eventual review process for R1626.
"We are delighted to receive the Fast Track designation from the FDA as this recognizes the potential important clinical role for R1626 in reducing viral load and helping patients to clear hepatitis C virus" said Nick Cammack, Head of Viral Diseases Research, Roche "The development of this new treatment R1626 along with our extensive partnerships with other companies and our ongoing research with PEGASYS underscores our long-term commitment to finding effective therapies to benefit patients with chronic hepatitis C."
About Hepatitis C
Hepatitis C, the most common chronic blood-borne infection, is transmitted primarily through blood or blood products. Hepatitis C chronically infects 170 million people worldwide, with an additional three to four million people newly infected each year. It is a leading cause of cirrhosis, liver cancer and liver failure.
Headquartered in Basel, Switzerland, Roche is one of the world's leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people's health and quality of life. Roche is a world leader in diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2005 sales by the Pharmaceuticals Division totalled 27.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.2 billion Swiss francs. Roche employs roughly 70,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Additional information about the Roche Group is available on the Internet (www.roche.com).
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 Roberts S, Cooksley G, et al. Interim results of a multiple ascending dose study of R1626, a novel nucleoside analog targeting HCV polymerase in chronic HCV patients. Presented at the 41st European Association for the Study of the Liver. April 29, 2006.
 Global surveillance and control of hepatitis C. Report of a WHO Consultation organized in collaboration with the Viral Hepatitis Prevention Board, Antwerp, Belgium. J Viral Hepat 1999;6(1):35-47.
ots Originaltext: Roche Pharmaceuticals
Im Internet recherchierbar: http://www.presseportal.ch
Contact: Janet Kettels, Roche, +41-79-597-82-85. Sarah Sheppard, Axon