BASEL, Switzerland, October 13 /PRNewswire/ --
- FDA Grants Fast Track Status to R1626
Roche announced today the start of the first phase II development studyto evaluate R1626, their promising new polymerase inhibitor, for thetreatment of hepatitis C. The investigational drug has also been granted FastTrack status by the US Food and Drug Administration (FDA), a program designedto facilitate the development and to expedite the review of new drugs withthe potential to help treat serious or life-threatening conditions.
R1626 has been shown in an earlier study to have a strong antiviraleffect against the hepatitis C virus. In the phase I study[1] , the drugachieved significant reductions in viral load in chronic hepatitis C patientsinfected with the difficult-to-cure genotype 1 virus. By moving R1626 intophase II trials, Roche signifies its commitment to finding more therapeuticsolutions for patients with hepatitis C. This trial will evaluate the safetyand antiviral effects of R1626 in combination with the current standard ofcare for hepatitis C, Roche's PEGASYS (peginterferon alfa-2a (40KD)) andCOPEGUS (ribavirin).
"New medicines such as R1626 have strong antiviral activity and could bevery effective in helping patients to clear the virus, especially when usedin combination with current treatments," said Dr. Paul Pockros, Head of theDivision of Gastroenterology/Hepatology at The Scripps Clinic and leadinvestigator of the study. "We know that current hepatitis therapies cureabout half of all patients infected with the most common anddifficult-to-treat genotype 1 virus, so a product that could potentiallyimprove cure rates is much needed."
About the phase II trial
This on-going multicenter phase II trial that is enrolling patients withgenotype 1 chronic hepatitis C who have not previously received treatment.
Patients are randomised into four treatment groups. These treatmentgroups are:
- Group A: R1626 1500mg twice a day + Pegasys 180mcg as asubcutaneous injection every week for 4 weeks
- Group B: R1626 3000mg twice a day + Pegasys 180mcg as asubcutaneous injection every week for 4 weeks
- Group C: R1626 1500mg twice a day + Pegasys 180mcg as asubcutaneous 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 receivePegasys 180mcg subcutaneously every week + Copegus 1000-1200mg daily foranother 44 weeks, making the total treatment duration of 48 weeks. Theobjectives of the study are to evaluate the 4 week safety and antiviraleffect of combining R1626 with Pegasys alone or R1626 with Pegasys plusCopegus.
The study is currently enrolling patients in the US. Patients andhealthcare providers interested in the trial can find more information atwww.roche-trials.com.
About Fast Track status
The criteria for Fast Track status are that the product's indicationrepresents a serious or life-threatening condition and the product has thepotential to meet an unmet medical need in treating the condition. Fast Trackallows for increased communication between the sponsor and the FDA during theproduct's development and enables a "rolling submission," which means Rochecan submit materials on an ongoing basis which can facilitate the eventualreview process for R1626.
"We are delighted to receive the Fast Track designation from the FDA asthis recognizes the potential important clinical role for R1626 in reducingviral load and helping patients to clear hepatitis C virus" said NickCammack, Head of Viral Diseases Research, Roche "The development of this newtreatment R1626 along with our extensive partnerships with other companiesand our ongoing research with PEGASYS underscores our long-term commitment tofinding effective therapies to benefit patients with chronic hepatitis C."
About Hepatitis C
Hepatitis C, the most common chronic blood-borne infection, istransmitted primarily through blood or blood products. Hepatitis Cchronically infects 170 million people worldwide[2], with an additional threeto four million people newly infected each year. It is a leading cause ofcirrhosis, liver cancer and liver failure.
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world's leadingresearch-focused healthcare groups in the fields of pharmaceuticals anddiagnostics. As a supplier of innovative products and services for the earlydetection, prevention, diagnosis and treatment of disease, the Groupcontributes on a broad range of fronts to improving people's health andquality of life. Roche is a world leader in diagnostics, the leading supplierof medicines for cancer and transplantation and a market leader in virology.In 2005 sales by the Pharmaceuticals Division totalled 27.3 billion Swissfrancs, and the Diagnostics Division posted sales of 8.2 billion Swissfrancs. Roche employs roughly 70,000 people in 150 countries and has R&Dagreements and strategic alliances with numerous partners, including majorityownership interests in Genentech and Chugai. Additional information about theRoche Group is available on the Internet (www.roche.com).
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References:
[1] Roberts S, Cooksley G, et al. Interim results of a multiple ascendingdose study of R1626, a novel nucleoside analog targeting HCV polymerase inchronic HCV patients. Presented at the 41st European Association for theStudy of the Liver. April 29, 2006.
[2] Global surveillance and control of hepatitis C. Report of a WHOConsultation organized in collaboration with the Viral Hepatitis PreventionBoard, Antwerp, Belgium. J Viral Hepat 1999;6(1):35-47.
Roche Pharmaceuticals
Contact: Janet Kettels, Roche, +41-79-597-82-85. Sarah Sheppard, Axon Communications, +44-7876-618-321
