Dynavax Completes Enrollment Of First Cohort Of Patients In Phase 1b Clinical Trial For Hepatitis B Therapy

Main Category: Liver Disease / Hepatitis
Also Included In: Clinical Trials / Drug Trials
Article Date: 20 Nov 2009 - 2:00 PST

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Dynavax Technologies Corporation (NASDAQ: DVAX) announced today that enrollment has been completed for the first of three cohorts of patients receiving DV-601 hepatitis B therapy in a Phase 1b clinical trial. The safety profile of patients in the first cohort met pre-specified criteria for dose escalation and the second cohort has been opened for enrollment. Dynavax expects to report top-line data from this trial in the second half of 2010. DV-601 is the first hepatitis B therapy to combine both the surface and core HBV antigens, and Dynavax has retained all commercial rights to this product.

About the Phase 1b Hepatitis B Therapy Trial

In this open-label, dose-escalating Phase 1b trial being conducted in Europe, up to 30 patients will receive 6 injections of DV-601 over a three month period. The primary endpoints of this trial are safety and tolerability of DV-601. The secondary endpoints are immunologic and virologic measures of efficacy.

About HBV

Over 350 million individuals worldwide are chronically infected with the hepatitis B virus (HBV), which can lead to cirrhosis of the liver and liver cancer. The current worldwide market for HBV therapeutics is estimated to be over $1 billion annually and available therapies have modest efficacy.

Source
Dynavax