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ViroPharma Announces Completion Of Enrollment In 500mg BID Arms Of HCV-796 Phase 2 Study
ViroPharma Incorporated
(Nasdaq: VPHM) today announced that patient enrollment has been completed
in the 500mg BID arms of the ongoing Phase 2 study in hepatitis C patients
with HCV-796, a unique orally dosed non nucleoside hepatitis C viral
polymerase inhibitor that interferes with the replication of hepatitis C
virus (HCV). The Phase 2 study is being conducted with Wyeth
Pharmaceuticals, a division of Wyeth (NYSE: WYE), ViroPharma's partner in
development of HCV-796.
The companies expect to release four week treatment data from these
arms in the third quarter of 2007, and 12 week treatment data in the fourth
quarter of 2007. The companies are performing certain Phase 3 preparatory
work at risk to allow initiation of the Phase 3 program as soon as
possible.
"We are extremely pleased with our HCV-796 Phase 1b data, as well as
the progress and interest in the program overall; our goal remains to be
the 'first in class' among non nucleoside polymerase inhibitors, a class of
compounds which we believe will play a significant role in future antiviral
combination therapies for patients with hepatitis C," commented Stephen
Villano, ViroPharma's vice president of clinical research and development.
"Our Phase 1b data have helped elucidate the tolerability profile of
HCV-796 and the strong antiviral activity of the drug in combination with
pegylated interferon. We believe that, thus far, HCV-796 continues to be
well- positioned for inclusion in future combination trials to assess
improvement in the lives of those afflicted with hepatitis C and increased
cure rates in these patients."
The objectives of this Phase 2 trial are to assess the safety,
tolerability, pharmacokinetic profile, and antiviral activity of HCV-796,
when used in combination with pegylated interferon alfa-2b (PEG-Intron(R))
plus ribavirin (REBETOL(R)) compared to the current standard of care in
treatment- naive subjects with HCV genotype 1 infection and in patients
with HCV genotype 1 infection who were null-responders (who have failed to
achieve a 2 log reduction in viral titer) following prior interferon based
HCV therapy. The companies intend to add additional treatment cohorts to
the trial to further elaborate antiviral activity.
Phase 2 Design
The Phase 2 study is a randomized, open-label study of the safety,
tolerability, antiviral activity, and pharmacokinetics of HCV-796
administered in combination with pegylated interferon plus ribavirin versus
pegylated interferon plus ribavirin (standard of care) in HCV genotype
1-infected subjects who are naive to treatment. The combination of HCV-796,
pegylated interferon and ribavirin is also being assessed in a group of HCV
genotype 1 patients who have previously failed treatment (null-responders).
All dose cohorts will be treated for up to 48 weeks with combination
therapy, and will be followed for a further 24-week period.
Patients have been enrolled into 3 dosing groups of at least 74
patients per group: (1) treatment naive patients receiving PEG-Intron and
ribavirin (control therapy); (2) treatment naive patients receiving
PEG-Intron, ribavirin, and 500 mg of HCV-796 every 12 hours; and (3)
null-responders receiving PEG-Intron, ribavirin, and 500 mg of HCV-796
every 12 hours.
Outcomes assessed in the treatment groups will include:
-- Antiviral activity and percentage of subjects with undetectable plasma
HCV RNA levels at weeks 4, 12, 24, and 48;
-- Percentage of subjects with sustained virologic response (SVR), defined
as undetectable (less than 10 IU/mL, as measured by the Roche COBAS
TaqMan(R) assay) plasma HCV RNA levels at 24 weeks after the end of
treatment.
About Hepatitis C
Hepatitis C is a blood-borne virus recognized as a major cause of
chronic hepatitis worldwide. The World Health Organization estimates that
170 million persons worldwide are infected with HCV, and three to four
million persons are newly infected globally each year. According to the
U.S. Centers for Disease Control and Prevention (CDC), about four million
people in the U.S., or 1.8 percent of the population, are infected with
HCV.
Currently, there is no specific antiviral agent directed against HCV
that is commercially available, and no vaccine for prevention of HCV
infection. Several interferon products are available worldwide, but there
are substantial limitations to the use of these products when given as
monotherapy or in conjunction with ribavirin in the treatment of chronic
HCV infection. In addition to the relatively poor treatment response in
patients infected with genotype 1 HCV, the most common strain in the U.S.,
Western Europe and Japan, the considerable side effects frequently
associated with the use of interferon can lead to discontinuation of
therapy in approximately 20 percent of patients.
About ViroPharma Incorporated
ViroPharma Incorporated is committed to the development and
commercialization of products that address serious diseases treated by
physician specialists and in hospital settings. ViroPharma commercializes
Vancocin(R), approved for oral administration for treatment of antibiotic-
associated pseudomembranous colitis caused by Clostridium difficile and
enterocolitis caused by Staphylococcus aureus, including
methicillin-resistant strains (for prescribing information, please download
the package insert at http://www.viropharma.com/docs/Vancocin_pi_2007.htm
ViroPharma currently focuses its drug development activities in viral
diseases including cytomegalovirus (CMV) and hepatitis C (HCV). For more
information on ViroPharma, visit the company's website at
http://www.viropharma.com.
Certain statements in this press release contain forward-looking
statements that involve a number of risks and uncertainties including those
relating to the company's progress of its HCV clinical development program
as well as its proposed timelines for release of clinical trial data,
initiation of a Phase 3 program, and the Company's belief that HCV-796
continues to be well-positioned for inclusion in future combination trials
to assess improvement in the lives of those inflicted with hepatitis C and
increased cure rates in these patients. Our actual results could differ
materially from those results expressed in, or implied by, these
forward-looking statements. Conducting clinical trials for investigational
pharmaceutical products is subject to risks and uncertainties. The data
that is described in this press release is preliminary and full analysis of
the data, or further testing such as the ongoing Phase 2 clinical studies
of HCV-796 with pegylated interferon, may not support any or all of the
statements in this press release. There can be no assurance that
ViroPharma's additional HCV studies will yield positive results, that the
FDA or other regulatory authorities will require additional or
unanticipated studies or clinical trial outcomes before granting regulatory
approval, or that ViroPharma will be successful in gaining regulatory
approval of any of its HCV product candidates. These factors, and other
factors, including, but not limited to those described in ViroPharma's
quarterly report on Form 10-Q for the quarter ended March 31, 2007 filed
with the Securities and Exchange Commission, could cause future results to
differ materially from the expectations expressed in this press release.
The forward-looking statements contained in this press release may become
outdated over time. ViroPharma does not assume any responsibility for
updating any forward-looking statements.
PEG-Intron and REBETOL are registered trademarks of Schering-Plough
Corporation.
ViroPharma Incorporated
http://www.viropharma.com
View drug information on Peg-Intron; Rebetol.
ViroPharma anunþã încheierea de înscriere în 500mg oferta de arme de-VHC 796 studiu de fazã 2 - ViroPharma Announces Completion Of Enrollment In 500mg BID Arms Of HCV-796 Phase 2 Study - articole medicale engleza - startsanatate