Phase 3 Data on HEPLISAV(TM) in Adults Aged 40-70 and Patients With Chronic Kidney Disease Published in VACCINE
(firmenpresse) - BERKELEY, CA -- (Marketwired) -- 09/24/13 -- Dynavax Technologies Corporation (NASDAQ: DVAX) announced today that immunogenicity and safety results of two Phase 3 trials (HBV-16 and HBV-17) of HEPLISAV™ investigational hepatitis B vaccine were published in the journal VACCINE accompanied by a Commentary from Drs. Stanley Plotkin and William Schaffner. The Commentary emphasizes the effect of 1018, the novel adjuvant contained in HEPLISAV, and concludes that the "results from these trials add to the body of evidence that 1018 can be an important new adjuvant for immunization against hepatitis B." These HEPLISAV data have been previously reported at medical conferences.
The article entitled "Immunogenicity and safety of an investigational hepatitis B vaccine with a Toll-like receptor 9 agonist adjuvant (HBsAg-1018) compared to a licensed hepatitis B vaccine in healthy adults 40-70 years of age" by Dr. William Heyward and colleagues, describes the results from a Phase 3 clinical trial of HEPLISAV conducted in the US and Canada in over 2,400 subjects. The article concludes that HEPLISAV induced significantly higher seroprotection rates in all groups (including hyporesponsive populations) than the licensed comparator hepatitis B vaccine in a shorter two-dose schedule over one month while maintaining a similar safety profile.
The article entitled "Immunogenicity and safety of an investigational hepatitis B vaccine with a Toll-like receptor 9 agonist adjuvant (HBsAg-1018) compared with a licensed hepatitis B vaccine in patients with chronic kidney disease" by Dr. Robert Janssen and colleagues, describes the results from a Phase 3 clinical trial of HEPLISAV in over 500 participants with CKD in the US, Canada and Germany. The article concludes that three doses of HEPLISAV provided significantly higher seroprotection rates and earlier and more persistent seroprotection than the licensed comparator hepatitis B vaccine while maintaining a similar safety profile.
HEPLISAV is an investigational adult hepatitis B vaccine that combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist to enhance the immune response. Dynavax has worldwide commercial rights to HEPLISAV.
Dynavax, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious and inflammatory diseases. Dynavax's lead product candidate is HEPLISAV, a Phase 3 investigational adult hepatitis B vaccine. For more information visit .
Michael Ostrach
Vice President and Chief Business Officer
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Datum: 24.09.2013 - 14:00 Uhr
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