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Safety Review Clears Continuation of Hepislav Hepatitis B Vaccine

SUMMARY: Dynavax Technologies announced this week that a Data Safety Monitoring Board has reviewed interim data from more than 2000 participants in 2 Phase 3 studies of the company's investigational hepatitis B vaccine, Hepislav, and determined that the trial may go forward without modification.

By Liz Highleyman

Below is an excerpt from a press release from Dynavax describing the recent development.

Dynavax's Two Phase 3 Heplisav Trials Cleared
by DSMB to Continue Immunizations

Berkeley, CA -- May 27, 2010 -- Dynavax Technologies Corporation (NASDAQ: DVAX) today announced that the Data Safety Monitoring Board (DSMB) established for Dynavax's two ongoing Phase 3 trials for Heplisav has completed the second of its planned safety assessments. The evaluation included data from 2,264 subjects that received their first injection, 1,611 of whom received their first and second injections. The DSMB determined that the studies may continue without modification.

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 www.dynavax.com.

6/4/10

Source
Dynavax Technologies Corp. Dynavax's Two Phase 3 Heplisav Trials Cleared by DSMB to Continue Immunizations. Press release. May 27, 2010.


 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


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