Migenix to commence phase 2b studies in hep C
therapy
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BY OUR PHARMA CORRESPONDENT
13th August,2005:Migenix Inc is to start
phase IIb combination study of chronic hepatitis C
virus (HCV) infections treatment MX-3253 (celgosivir).
The company has received a Notice of Authorization
from Health Canada for a clinical trial
application (CTA) to begin the phase 2b studies.
The study is expected to commence in the next few
weeks with results expected around mid-year
calendar 2006, the company announced in a press
statement.
MX-3253 (celgosivir) is an alpha-glucosidase I
inhibitor and is currently the only oral anti-HCV
drug in development that acts through
host-directed glycosylation. In preclinical
studies, celgosivir has demonstrated strong
synergy with interferon-alpha plus ribavirin and
has the potential to be included as part of a
combination therapeutic approach to improve
efficacy. Celgosivir is currently being evaluated
in a phase IIa monotherapy study in
treatment-naive and interferon-intolerant genotype
I HCV patients with results of the study expected
before the end of the third quarter of calendar
2005.
The phase IIb combination study of MX-3253 is a
randomized, multi-center, active-controlled, 12
week evaluation of MX-3253 in three treatment arms
of up to 20 chronic HCV patients each: celgosivir
plus peginterferon alfa-2b plus ribavirin (3-way
combination); celgosivir plus peginterferon
alfa-2b (2-way combination); and placebo plus
peginterferon alfa-2b plus ribavirin (control). An
agreement was completed in July with
Schering-Plough for (a) the supply of Pegetron (peginterferon
alfa-2b powder for solution plus ribavirin 200 mg
capsules) and (b) certain technical and laboratory
support and other services for the study.
Patients for the phase IIb study will be selected
based on having genotype 1 chronic HCV and having
failed to respond to pegylated alpha interferon
plus ribavirin therapy (non-responders). Today,
there are very limited treatment options for the
40% to 50% of hepatitis C patients who have failed
treatment with the current standard of care,
pegylated interferon plus ribavirin. Among this
patient population, approximately 10% respond to
retreatment with pegylated interferon plus
ribavirin. Patients who respond to therapy during
the Phase IIb trial will have the option to
continue on treatment for up to 48 weeks. The
study will measure viral load at various time
points, as well as a number of safety parameters,
the Megenix release said.
Migenix is developing and commercializing drugs in
the areas of infectious and degenerative diseases.
The company’s clinical programs include drug
candidates for the treatment of chronic HCV
infections (phase II), the prevention of
catheter-related infections (phase III), the
treatment of neurodegenerative diseases (phase I)
and the treatment of acne (phase II). Migenix is
headquartered in Vancouver, British Columbia,
Canada with US operations in San Diego,
California.
BY OUR PHARMA CORRESPONDENT |
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