Pharmasset Announces Initiation of Combination Study of Clevudine and Viread(R) for HBV by French National Agency for Research o
July 08 2008 - 8:00AM
PR Newswire (US)
96-week comparative study of Clevudine versus Viread(R) versus
Clevudine+Viread(R) in 150 patients with chronic hepatitis B
PRINCETON, N.J., July 8 /PRNewswire-FirstCall/ -- The French
National Agency for Research on AIDS and Viral Hepatitis (ANRS),
with the support of Pharmasset, Inc. (NASDAQ:VRUS) and Gilead
Sciences, Inc. (NASDAQ:GILD), has initiated the first head-to-head
study of clevudine and Viread(R) (tenofovir disoproxil fumarate)
administered separately, versus their combination, for the
treatment of chronic hepatitis B virus (HBV) infection in
non-cirrhotic patients. The study treatments include clevudine
30mg/day, tenofovir 300mg/day or the combination of both drugs
administered to 150 treatment-naive hepatitis B e-antigen negative
HBV-infected patients for 96 weeks. At that time, all therapy will
be discontinued, and patients will be monitored for sustained
virologic response (SVR) after being off of therapy for 24 weeks,
the primary endpoint of the study. Clevudine is an oral, once-daily
pyrimidine nucleoside analog that has been evaluated in 18 clinical
trials in more than 800 individuals. Phase 3 studies are currently
being conducted in approximately 140 global clinical sites to
support the registration of clevudine in the Americas and Europe.
Pharmasset licensed clevudine for these territories from Bukwang
Pharm. Co., Ltd, who has received South Korean regulatory approval
and is currently marketing clevudine in South Korea under the brand
name Levovir. "Clevudine's unique mechanism of action as a
non-chain terminating nucleoside analog HBV polymerase inhibitor
may demonstrate additive antiviral benefit in combination with
tenofovir's recently demonstrated antiviral potency in HBV," stated
Dr. Michelle Berrey, Pharmasset's Chief Medical Officer. "We also
plan to reproduce the results from earlier studies demonstrating
clevudine's ability to provide a sustained virologic response in
patients with eAg negative chronic HBV infection, as either
monotherapy or in combination, offering infected individuals and
their physicians an important new treatment option." Ongoing
Registration Studies for New Drug Application (NDA) The ongoing
clevudine Phase 3 registration program includes two 48-week
clinical trials designed to demonstrate the superiority of
clevudine 30mg over Hepsera(R) (adefovir dipivoxil) 10mg, each
administered once-daily as monotherapy. Pharmasset plans to submit
the 48-week data from these studies to the FDA as the basis for the
clevudine marketing approval. Please see
http://www.clinicaltrials.gov/ or e-mail for more information about
the clevudine registration studies. South Korean Registration
Studies for Clevudine Bukwang received marketing approval for
clevudine from the South Korean FDA based on two 24-week,
placebo-controlled, double-blind, randomized, multi-center South
Korean Phase 3 registration trials in 337 patients. Study 301
enrolled 248 HBeAg+ patients who received clevudine 30 mg or a
placebo once-daily, and Study 302 enrolled 89 HBeAg- patients who
received clevudine 30 mg or a placebo once-daily. All patients were
evaluated for an additional 24 weeks of follow-up care without
clevudine treatment. At 24 weeks on treatment with clevudine, 59%
of HBeAg+ patients achieved undetectable HBV DNA and 92% of HBeAg-
patients achieved undetectable HBV DNA. These results were
statistically significant compared to placebo. In addition to the
potent antiviral suppression, 16% of the HBeAg- patients who
received clevudine demonstrated a sustained virologic response
(SVR) 24 weeks after stopping therapy, versus 0% of the patients
who had received the placebo. In Study 303, a South Korean
open-label, follow-on study of clevudine, Bukwang observed similar
findings. 80% of HBeAg- patients had undetectable HBV DNA 12 weeks
after completing a 48-week course of therapy. Clevudine was
generally safe and well-tolerated by patients with chronic HBV.
There was no meaningful difference between clevudine and placebo in
the incidence of serious adverse events during treatment in Studies
301 and 302 and during follow-up except that a higher percentage of
placebo-treated patients had elevated liver enzyme levels than
patients treated with clevudine. About Pharmasset Pharmasset is a
clinical-stage pharmaceutical company committed to discovering,
developing and commercializing novel drugs to treat viral
infections. Pharmasset's primary focus is on the development of
oral therapeutics 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, for the treatment of chronic HBV infection, is in Phase
3 clinical trials for registration in the Americas and Europe.
Clevudine is already approved for HBV in South Korea and marketed
by Bukwang Pharmaceuticals in South Korea under the brand name
Levovir. R7128, an oral treatment for chronic HCV infection, is in
a Phase 1/2 clinical trial through a strategic collaboration with
Roche. Racivir, which is being developed for the treatment of HIV
in combination with other approved HIV drugs, has completed a Phase
2 clinical trial. Contact Kurt Leutzinger Chief Financial Officer
Office: +1 (609) 613-4110 Forward-Looking Statements Pharmasset
"Safe Harbor" Statement under the Private Securities Litigation
Reform Act of 1995: Statements in this press release regarding our
business that are not historical facts are "forward-looking
statements" that involve risks and uncertainties, including without
limitation the risk that Clevudine will not demonstrate any
additive antiviral benefit in combination with tenofovir in the
head-to-head study, the risk that Clevudine will not demonstrate
superiority over Hepsera in Clevudine's ongoing Phase 3
registration study, the risk that adverse events could cause the
cessation or delay of any of the ongoing or planned clinical trials
and/or our development of our product candidates, the risk that the
results of previously conducted studies involving our product
candidates will not be repeated or observed in ongoing or future
studies involving our product candidates, the risk that our
collaboration with Roche will not continue or will not be
successful and the risk that any one or more of our product
candidates will not be successfully developed and commercialized.
For a discussion of these risks and uncertainties, any of which
could cause our actual results to differ from those contained in
the forward-looking statements, see the section of our Annual
Report on Form 10-K for the fiscal year ended September 30, 2007
filed with the Securities and Exchange Commission entitled "Risk
Factors" and discussions of potential risks and uncertainties in
our subsequent filings with the Securities and Exchange Commission.
Viread and Hepsera are registered trademarks of Gilead Sciences,
Inc. DATASOURCE: Pharmasset, Inc. CONTACT: Kurt Leutzinger, Chief
Financial Officer, Pharmasset, Inc., +1-609-613-4110, Web site:
http://www.pharmasset.com/ http://www.clinicaltrials.gov/
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