Hepatitis B Therapeutic Vaccine Appears Safe and Stimulates Immune Response

[Guest guest]

http://www.hivandhepatitis.com/hep_b/news/2011/0111_2010_a.html

Hepatitis B Therapeutic Vaccine Appears Safe and Stimulates Immune Response

SUMMARY: In late December, Dynavax Technologies reported findings from a small

early clinical trial showing that its investigational hepatitis B virus (HBV)

therapeutic vaccine DV-601 -- intended to help control the virus in people

already infected, rather than prevent infection -- was well tolerated and

produced immunological and virological responses at all dose levels. Larger

studies are needed, however, to show whether the vaccine is clinically

effective.

Below is an excerpt from a press release issued by Dynavax describing the study

findings.

Dynavax Reports Phase 1B Safety and Immunogenicity Results for Hepatitis B

Therapy Candidate

Berkeley, CA -- December 23, 2010 -- Dynavax Technologies Corporation (NASDAQ:

DVAX) today reported safety and immunogenicity data from its Phase 1b clinical

trial of DV-601, its proprietary hepatitis B therapeutic vaccine. The dose

escalation study assessed safety and the immunologic and virologic responses in

14 subjects with chronic hepatitis B infection. The Phase 1b data showed:

All doses were generally safe and well tolerated; and

Individual immunologic and virologic responses were observed across cohorts at

all dose levels.

No conclusions regarding the potential clinical impact of the therapy could be

reached in this small study. Dynavax's treatment approach combines both the

surface and core hepatitis B virus (HBV) antigens with Iscomatrix adjuvant

originally entered into development by Rhein Biotech prior to its acquisition by

Dynavax in 2006. The candidate vaccine, DV-601, is designed to induce an immune

response against HBV-infected cells and if proven to be safe and effective, may

offer an alternative therapeutic option for patients chronically infected with

HBV.

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 enhance protection more rapidly and with

fewer doses than current licensed vaccines. For more information, visit

www.dynavax.com.

1/11/11

Source

Dynavax Technologies. Dynavax Reports Phase 1B Safety and Immunogenicity Results

for Hepatitis B Therapy Candidate. Press release. December 23, 2010.

[Guest guest]

http://www.hivandhepatitis.com/hep_b/news/2011/0111_2010_a.html

Hepatitis B Therapeutic Vaccine Appears Safe and Stimulates Immune Response

SUMMARY: In late December, Dynavax Technologies reported findings from a small

early clinical trial showing that its investigational hepatitis B virus (HBV)

therapeutic vaccine DV-601 -- intended to help control the virus in people

already infected, rather than prevent infection -- was well tolerated and

produced immunological and virological responses at all dose levels. Larger

studies are needed, however, to show whether the vaccine is clinically

effective.

Below is an excerpt from a press release issued by Dynavax describing the study

findings.

Dynavax Reports Phase 1B Safety and Immunogenicity Results for Hepatitis B

Therapy Candidate

Berkeley, CA -- December 23, 2010 -- Dynavax Technologies Corporation (NASDAQ:

DVAX) today reported safety and immunogenicity data from its Phase 1b clinical

trial of DV-601, its proprietary hepatitis B therapeutic vaccine. The dose

escalation study assessed safety and the immunologic and virologic responses in

14 subjects with chronic hepatitis B infection. The Phase 1b data showed:

All doses were generally safe and well tolerated; and

Individual immunologic and virologic responses were observed across cohorts at

all dose levels.

No conclusions regarding the potential clinical impact of the therapy could be

reached in this small study. Dynavax's treatment approach combines both the

surface and core hepatitis B virus (HBV) antigens with Iscomatrix adjuvant

originally entered into development by Rhein Biotech prior to its acquisition by

Dynavax in 2006. The candidate vaccine, DV-601, is designed to induce an immune

response against HBV-infected cells and if proven to be safe and effective, may

offer an alternative therapeutic option for patients chronically infected with

HBV.

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 enhance protection more rapidly and with

fewer doses than current licensed vaccines. For more information, visit

www.dynavax.com.

1/11/11

Source

Dynavax Technologies. Dynavax Reports Phase 1B Safety and Immunogenicity Results

for Hepatitis B Therapy Candidate. Press release. December 23, 2010.