Pharmasset Affirms Safety and Continued Progress in Clinical Development of RG7128
- Responds to inaccuracies in PharmaWire article
PRINCETON, N.J., May 4 /PRNewswire-FirstCall/ -- Pharmasset,
Inc. (NASDAQ:
VRUS) , in response to certain inaccuracies in an article
published by PharmaWire on May 3, 2010 about its development
program for treatment of hepatitis C virus (HCV) in collaboration
with Hoffmann-La Roche Inc. and F. Hoffmann-La Roche Ltd, stated
today that the development of RG7128 is on track, and that no
safety or other concerns have delayed the program.
More specifically, M. Michelle Berrey, M.D., M.P.H., Chief
Medical Officer, stated, "In discussions with key colleagues at
Roche, we have confirmed that the clinical data available on RG7128
to date indicate no concern with the safety profile of the
compound. All safety data are reviewed by an independent data
monitoring committee (DMC) throughout the conduct of this ongoing
Phase IIb trial. While additional studies are necessary and
appropriate to assess the safety and efficacy of RG7128, there has
been no indication of anemia, bone marrow suppression, or
nephrotoxicity, as inaccurately indicated in the PharmaWire
article."
Based on the timeline of the PROPEL RG7128 study, almost all of
the 408 patients enrolled in the study have already completed their
scheduled 8 or 12 weeks of the triple combination portion of the
assigned treatment (RG7128 plus standard of care). The last patient
enrolled in this study is to receive his or her last dose of RG7128
or placebo in early May.
The development of RG7128 is not on hold or delayed and there
are no plans to amend any ongoing protocol to explore lower doses,
in refutation of statements in the PharmaWire article.
Paul Lubetkin, Executive Vice President and General Counsel,
said, "Pharmasset is troubled that any news organization would
issue an article rife with unsupportable and false statements. One
of the two named sources in the article confirmed that his
statements, which were in the context of an off-the-record
discussion about R1626, a Roche nucleoside on clinical hold, were
inaccurately reported and misinterpreted as applying to RG7128. The
development efforts for RG7128 are on track and ongoing. We
sincerely hope that PharmaWire promptly publishes a retraction of
this misleading and false article."
About Pharmasset
Pharmasset is a clinical-stage pharmaceutical company committed
to discovering, developing, and commercializing novel drugs to
treat viral infections. Pharmasset is focusing primarily on the
development of oral therapeutics for the treatment of hepatitis C
virus (HCV) and secondarily on the development of Racivir(TM) for
the treatment of human immunodeficiency virus (HIV). Our research
and development efforts focus on nucleoside/tide analogs, a class
of compounds which act as alternative substrates for the viral
polymerase, thus inhibiting viral replication. We currently have
four clinical-stage product candidates. RG7128, a cytosine
nucleoside analog for chronic HCV infection, is in two Phase 2b
clinical trials in combination with Pegasys® plus Copegus®
and is also in the INFORM studies, a series of studies designed to
assess the potential of combinations of two oral, direct acting
antivirals without pegylated interferon and ribavirin to treat
chronic HCV. These clinical studies are being conducted through a
strategic collaboration with Roche. Our other, unpartnered,
clinical-stage candidates for the treatment of HCV include
PSI-7977, a uracil nucleotide analog that is in a Phase 2a trial,
and PSI-938, a guanine nucleotide analog that is in a Phase 1
trial. We also have in our pipeline an additional guanine
nucleotide analog, PSI-661, in advanced preclinical development for
the treatment of HCV. Racivir, for the treatment of HIV, has
completed a Phase 2 clinical trial.
Pegasys® and Copegus® are registered trademarks of Roche. Contact Richard E. T. Smith, Ph.D. VP, Investor Relations and Corporate Communications Office: +1 (609) 613-4181 Forward-Looking Statements
Statements in this press release regarding our business that are
not historical facts are "forward-looking statements" that involve
risks, uncertainties and other important factors, including,
without limitation, 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 and other risks, uncertainties and
important factors, any of which could cause our actual results to
differ from those contained in the forward-looking statements, see
the section entitled "Risk Factors" in our Annual Report on Form
10-K for the fiscal year ended September 30, 2009 and our Quarterly
Report on Form 10-Q for the period ended December 31, 2009 filed
with the Securities and Exchange Commission and discussions of
potential risks, uncertainties and other important factors in our
subsequent filings with the Securities and Exchange
Commission.
Source: Pharmasset, Inc.
CONTACT: Richard E. T. Smith, Ph.D., VP, Investor Relations
and
Corporate Communications, +1-609-613-4181
Web Site: http://www.pharmasset.com/
Posted: May 2010
