Dynavax Initiates Large-Scale Phase 3 Trial of HEPLISAV(TM)
BERKELEY, CA--(Marketwire - 02/08/10) - Dynavax Technologies Corporation (NASDAQ:DVAX - News) announced today initiation of a large-scale Phase 3 trial designed to demonstrate the lot-to-lot consistency of commercial vaccine and to complete the safety database for HEPLISAV, the Company's investigational adult hepatitis B vaccine. This study and the ongoing Phase 3 trial in chronic kidney disease patients are directed toward fulfilling licensure requirements in the U.S., Canada and Europe. HEPLISAV has been shown in two pivotal Phase 3 trials to enhance protection more rapidly and with fewer doses than a currently licensed vaccine.
The lot-to-lot consistency trial will enroll 2,000 patients in Canada and in the U.S., 1600 of whom will receive HEPLISAV. Patients randomized to the comparator arm will receive Engerix-B, a currently licensed hepatitis B vaccine. The primary objectives are:
-- Non-inferiority of the immune response to HEPLISAV vaccination as measured by the seroprotection rate at 8 weeks after the last active dose, compared to Engerix-B vaccination at 8 weeks after the last active dose; and -- Lot-to-lot consistency for immune response as measured by geometric mean concentration at 4 weeks after the last active dose among 3 consecutively manufactured lots of HEPLISAV.
The secondary objectives include the safety of HEPLISAV as compared to Engerix-B.
Data from this trial is expected in the first half of 2011. The hepatitis B surface antigen in the HEPLISAV lots being evaluated was produced in Dynavax's manufacturing facility in Desseldorf, Germany. This facility was recently upgraded and licensed in the European Union for commercial production of hepatitis B surface antigen.
About HEPLISAV
HEPLISAV is an investigational adult hepatitis B vaccine. In a completed pivotal Phase 3 trial, HEPLISAV demonstrated increased, rapid protection with fewer doses than current licensed vaccines. Dynavax has worldwide commercial rights to HEPLISAV and is developing the vaccine for large, high-value populations that are less responsive to current licensed vaccines, including individuals with chronic kidney disease. HEPLISAV combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist known as ISS to enhance the immune response.
Engerix-B is a trademark of GlaxoSmithKline.
About Hepatitis B Vaccines
Currently available hepatitis B vaccines require three doses over six months to achieve full immunogenicity in healthy patient populations. Because compliance with this vaccine regimen is low, new vaccines are needed to provide increased protection in a shorter timeframe. Furthermore, currently available vaccines do not fully address the needs of several patient populations, including those with chronic kidney disease, HIV or chronic liver disease. In particular, patients with comprised immune systems require both rapid and enhanced protection, either because they are less responsive to conventional vaccine regimens or because they are at high risk of infection.
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, an 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.
[At what point do you think the Heplisav hepatitis B program starts to look interesting? Passing this test is presumably a step in the right direction. If the drug pans out in Phase 3 on both an efficacy and safety front, and is approved by the FDA, any guesstimate on potential sales for a drug that could improve upon Engerix-B (#msg-37352876)?]
Dynavax's Two Phase 3 HEPLISAV Trials Cleared by DSMB to Continue Immunizations Safety Assessment of First Group of Immunized Subjects Complete
BERKELEY, CA--(Marketwire - 04/27/10) - Dynavax Technologies Corporation (NASDAQ:DVAX - News) today announced that the Data Safety Monitoring Board (DSMB) established for Dynavax's two ongoing Phase 3 trials for HEPLISAV™ has assessed subject safety data for 1,548 subjects that received their first injection and 1,225 subjects that received a second injection, and determined that the studies may continue without modification of the existing protocols.
HEPLISAV is an innovative vaccine designed to protect against hepatitis B infection. The DSMB reviewed safety data from two ongoing multi-center Phase 3 trials evaluating HEPLISAV, one trial in adults 40 years and older, and a second trial in chronic kidney disease patients. The DSMB is comprised of an independent group of medical experts who are responsible for reviewing and evaluating subject safety data at regular intervals during the ongoing trials.
About HEPLISAV
HEPLISAV is an investigational adult hepatitis B vaccine. The vaccine candidate is being evaluated in two Phase 3 studies that are directed toward fulfilling licensure requirements in U.S., Canada and Europe. In a completed pivotal Phase 3 trial, HEPLISAV demonstrated increased, rapid protection with fewer doses than current licensed vaccines. Dynavax has worldwide commercial rights to HEPLISAV and is developing the vaccine for large, high-value populations that are less responsive to current licensed vaccines, including individuals with chronic kidney disease. HEPLISAV combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist known as ISS to enhance the immune response.
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, an investigational adult hepatitis B vaccine designed to enhance protection more rapidly and with fewer doses than current licensed vaccines. For more information visit http://www.dynavax.com/.
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