Interferon-based
Therapy Reduces or Reverses Liver Fibrosis over the Long-term in Chronic Hepatitis
C Patients  | Two
companies recently announced that their experimental hepatitis C therapies had
moved further along in clinical trials. Novartis completed enrollment and initial
dosing in a Phase 2b clinical trial of Human Genome Science's albumin
interferon alfa-2b (Albuferon), while Pharmasset started a Phase 1b ascending
dose trial of its HCV
polymerase inhibitor PSI-7851. |
Below
are edited excerpts from press release from the 2 companies announcing the recent
developments. Human
Genome Sciences Announces Completion of Enrollment in Phase 2b Monthly-Dosing
Trial of Albuferon.
Trial conducted by Novartis evaluating safety and efficacy of Albuferon administered
every four weeks in combination with ribavirin in patients with genotypes 2 and
3 hepatitis C
Rockville,
MD -- June 19, 2009 -- Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced
that Novartis has completed enrollment and initial dosing in a Phase 2b clinical
trial to evaluate the safety and efficacy of Albuferon
(albinterferon alfa-2b) administered monthly in combination with ribavirin
in treatment-naive patients with genotypes 2 and 3 chronic hepatitis C. Albuferon
is being developed by HGS and Novartis under an exclusive worldwide co-development
and commercialization agreement entered into in June 2006. "It
is estimated that approximately 170 million people worldwide are infected with
hepatitis C virus, including nearly four million in the United States," said
Stephen Pianko, MD, FRACP, PhD, Monash University, Melbourne, Australia. "Even
In developed countries, fewer than half of those who have been diagnosed with
chronic hepatitis C have undertaken treatment - in part due to the side effects
associated with interferon injections, which are currently required on a weekly
basis. A monthly dosing schedule with Albuferon may well result in more patients
choosing to be treated." Mani
Subramanian, MD, PhD, Executive Director, Clinical Research -- Infectious Diseases,
HGS, said, "Novartis has made excellent progress in advancing the study of
albinterferon alfa-2b dosed every four weeks. This dosing regimen of albinterferon
alfa-2b, with a total of six injections, could offer an important treatment option
if it demonstrates safety and efficacy comparable to peginterferon alfa-2a dosed
once every week with a total of 24 injections." About
the Design of the Phase 2b Monthly Dosing Trial This
Phase 2b trial is a randomized, open-label, multi-center, active-controlled, dose-ranging
study to evaluate the safety and efficacy of albinterferon alfa-2b administered
every four weeks plus daily ribavirin in treatment-naïve patients with genotypes
2 and 3 chronic hepatitis C. 391 patients were randomized in a 4:4:4:3 ratio into
four treatment groups, including three that will receive albinterferon alfa-2b
administered once every four weeks (900 mcg, 1200 mcg or 1500 mcg), in addition
to the active-control group, which will receive peginterferon alfa-2a at the standard
180-mcg dose once every week. All patients in the study will receive 800-mg daily
oral ribavirin. The total duration of treatment will be 24 weeks. The primary
efficacy endpoint is sustained virologic response (SVR) at Week 48 (24 weeks following
the end of treatment). About
Human Genome Sciences The
mission of HGS is to apply great science and great medicine to bring innovative
drugs to patients with unmet medical needs. The HGS clinical development pipeline
includes novel drugs to treat hepatitis C, lupus, inhalation anthrax and cancer.
The
Company's primary focus is rapid progress toward the commercialization of its
two lead drugs, Albuferon (albinterferon alfa-2b) for hepatitis C and BENLYSTA
(belimumab, formerly LymphoStat-B) for lupus. Albuferon has now completed Phase
3 development, and the filing of global marketing applications is expected in
fall 2009. Two Phase 3 trials of BENLYSTA are ongoing, with results expected in
July and November 2009. In
April 2009, HGS completed delivery of 20,000 doses of raxibacumab (ABthrax) to
the U.S. Strategic National Stockpile for use in the event of an emergency for
the treatment of inhalation anthrax. The Company also has several drugs in earlier
stages of clinical development for the treatment of cancer, led by the TRAIL receptor
antibody HGS-ETR1 and a small-molecule antagonist of IAP (inhibitor of apoptosis)
proteins. In addition, HGS has substantial financial rights to certain products
in the GSK clinical pipeline including darapladib, currently in Phase 3 development
as a potential treatment for coronary heart disease, and Syncria (albiglutide),
currently in Phase 3 development as a potential treatment for type 2 diabetes.
For
more information about HGS, please visit the Company's web site at www.hgsi.com. |
Pharmasset
Initiates Phase 1b Multiple Ascending Dose Clinical Trial of PSI-7851
in Chronic Hepatitis C Patients
PSI-7851 was generally safe and well tolerated in Phase 1a single ascending
dose trial
Further results from single ascending and multiple ascending dose trials are expected
in second half 2009 Princeton,
NJ -- June 9, 2009 -- Pharmasset, Inc. (Nasdaq: VRUS) announced today that it
had completed the single ascending dose study and begun dosing in a multiple ascending
dose trial with PSI-7851,
a nucleotide analog polymerase inhibitor for the treatment of chronic hepatitis
C virus (HCV) infection. This study is designed to assess the safety, tolerability
and antiviral activity of PSI-7851 over 3 days in HCV-infected individuals. "We
are encouraged by the safety and pharmacokinetics of PSI-7851 thus far,"
stated Michelle Berrey, MD, MPH, Pharmasset's Chief Medical Officer. "We
believe PSI-7851, Pharmasset's lead second generation nucleotide, has the potential
to be administered once a day at low milligram doses, while also continuing to
demonstrate the many benefits nucleos(t)ides have over other classes of HCV direct
acting antivirals, including a high barrier to resistance, pan-genotype potency,
and ability to combine with other classes of compounds." PSI-7851
Phase 1 Program Overview The
Phase 1 program is investigating the safety, tolerability and pharmacokinetics
of PSI-7851 in healthy subjects following single doses (Phase 1a) and in patients
chronically infected with HCV genotype 1 following repeat dosing for 3 days (Phase
1b). The Phase 1b study will additionally investigate hepatitis C viral dynamics
and monitor for the development of drug resistance. Subjects
in the phase 1a single ascending dose study received single doses of PSI-7851
ranging from 25mg to 800mg or a matching placebo. Preliminary data from the phase
1a single ascending dose study demonstrated: -
No serious adverse events or discontinuations; - No dose-related adverse events; -
No grade III / IV lab abnormalities; - No clinically significant changes in
vital signs or ECGs. A
Phase 1b multiple ascending dose trial has now been initiated in patients with
chronic HCV genotype 1 infection. Subjects will be enrolled at multiple centers
and randomized to PSI-7851 (8 per cohort) or placebo (2 per cohort). Based upon
the results from the SAD study, the first dose of PSI-7851 to be tested will be
50mg once daily. The primary objective is to assess the safety, tolerability and
pharmacokinetics of PSI-7851 after repeat dosing over 3 days. The secondary objective
is to evaluate the decrease in HCV RNA. Results
from both studies are expected in the second half of 2009. About
PSI-7851 PSI-7851
is a uridine nucleotide analog currently in development for the treatment of chronic
HCV infection. PSI-7851 has demonstrated potent in vitro anti-HCV activity with
EC50 values of 90 +/- 60 nM, which is approximately 15- to 20-fold more potent
than Pharmasset's first generation nucleoside polymerase inhibitor, R7128. In
vitro studies of PSI-7851 have not shown evidence of any mitochondrial or other
cellular toxicities that may be associated with some nucleoside analogs. The half-life
of the triphosphate in primary human hepatocytes is approximately 38 hours, which
suggests the possibility for once-daily dosing. Like R7128, PSI-7851 has demonstrated
in vitro activity against all of the most common HCV genotypes. 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
C virus (HCV) and, secondarily, on the development of Racivir(R) for the treatment
of human immunodeficiency virus (HIV). Our research and development efforts focus
on nucleos(t)ide analogs, a class of compounds which act to inhibit the enzymes
required for viral replication. We currently have three clinical-stage product
candidates: R7128, a nucleoside analog for chronic HCV infections, has initiated
a Phase 2b clinical trial in combination with Pegasys plus Copegus through a strategic
collaboration with Roche; PSI-7851, an unpartnered, next generation HCV nucleotide
analog, which recently began Phase 1 clinical studies and Racivir, for the treatment
of HIV that has completed a Phase 2 clinical trial.
For
more information, see the web site at www.pharmasset.com. |
7/3/09 Sources Human
Genome Sciences, Inc. Human Genome Sciences Announces Completion of Enrollment
in Phase 2b Monthly-Dosing Trial of Albuferon. Press release. June 19,
2009. Pharmasset,
Inc. Pharmasset Initiates Phase 1b Multiple Ascending Dose Clinical Trial of PSI-7851
in Chronic Hepatitis C Patients. Press release. June 9, 2009.
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