Dynavax
Reports Promising Early Clinical Trial Data for Experimental Hepatitis
C Drug SD-101
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| SUMMARY:
Dynavax Technologies Corporation recently announced
early findings from laboratory studies and a Phase 1b
clinical trial indicating that the investigational hepatitis
C drug SD-101, a toll-like receptor 9 (TLR9) agonist,
was safe and induced production of higher levels of
interferon (IFN) alpha and lambda. Rather than administering
manufactured interferon -- the current standard therapy
for chronic hepatitis C -- SD-101 is designed to stimulate
the immune system to produce more of these naturally
occurring cytokines. |
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Below
is a press release from Dynavax describing the study results
Dynavax Reports Positive
Phase 1b Data for SD-101
in Chronic Hepatitis C Infection
In
vitro Study Shows SD-101 Induces Both IFN-lambda and IFN-alpha
Berkeley, CA -- January 26, 2010 -- Dynavax Technologies Corporation
(NASDAQ: DVAX) announced today data from two studies that differentiate
SD-101 from standard-of-care as well as emerging treatments for
chronic HCV infection. The findings of a Phase 1b clinical trial
and an in vitro study of SD-101's mechanism of action show that
the second-generation TLR9 agonist (1) is well tolerated and safe
and (2) induces both IFN-lambda and IFN-alpha at concentrations
producing antiviral activity. The data will be presented at the
45th Annual Meeting of the European Association for the Study
of the Liver in Vienna, Austria in April 2010.
Data from the Phase 1b study of SD-101 in treatment-naive, genotype
1 HCV patients show:
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A
safety and tolerability profile that compares favorably to
that of IFN-alpha, at all four doses tested; |
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A
dose-dependent antiviral response, with 100% of patients at
the highest dose experiencing a greater than one (1) log reduction
in viral load; and |
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The
potency of SD-101 as confirmed by biomarker analysis in patients.
The biomarker data point to substantial, dose-related increases
in the expression of key antiviral genes (MX-B and ISG-54k)
and genes indicating enhanced immunity (IP-10 and MCP-1). |
The
Phase 1b study evaluated four dose levels of SD-101 in 34 chronically
infected, treatment-naive, genotype 1 HCV patients. SD-101 was
administered as a monotherapy once weekly, for four weeks, in
doses from 0.1 to 5.0 milligrams per week.
The in vitro data from a study of the drug in human blood
cells demonstrate that compared to first-generation TLR9 agonists,
SD-101 stimulates 20-fold higher levels of both IFN-alpha and
IFN-lambda, two classes of IFNs with potent activity against HCV.
According to the company's Chief Medical Officer, J. Tyler Martin,
MD, "The unique and highly potent pattern of IFN-lambda and
IFN-alpha induction by SD-101 represents a novel, differentiated
approach for HCV. The safety and antiviral activity demonstrated
in this Phase 1b study compares favorably to current treatments,
and we believe that further study may support a role for SD-101
as a supplement to current or emerging therapies to treat HCV."
With the completed acquisition of Symphony Dynamo earlier this
month, Dynavax has full development and commercialization rights
to SD-101. As such, SD-101 has been added to a portfolio of development
programs available for partnership from Dynavax.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical
company, discovers and develops novel products to prevent and
treat infectious diseases. The company's lead product candidate
is Heplisav, a Phase 3 investigational adult hepatitis B vaccine
designed to provide more rapid and increased protection with fewer
doses than current licensed vaccines.
For more information, visit www.dynavax.com.
2/9/10
Source
Dynavax Technologies Corporation. Dynavax Reports Positive Phase
1b Data for SD-101 in Chronic Hepatitis C Infection. Press release.
January 26, 2010.
