Phase 3 Data on HEPLISAV(TM) in Adults Aged 40-70 Published in VACCINE
BERKELEY, CA, Mar 13, 2012 (MARKETWIRE via COMTEX) -- Dynavax Technologies
Corporation (DVAX) announced today that results of an early Phase 3 trial
(HBV-04) of HEPLISAV(TM) investigational hepatitis B vaccine were published
online in the journal VACCINE. The article concludes that HEPLISAV was
well-tolerated and demonstrated superior and more durable seroprotection earlier
than the licensed comparator hepatitis B vaccine.
The article, entitled "Demonstration of Safety and Enhanced Seroprotection
Against Hepatitis B with Investigational HBsAg-1018 ISS Vaccine Compared to a
Licensed Hepatitis B Vaccine" by first author Benjamin Sablan, describes the
results from a Phase 3 clinical trial of HEPLISAV conducted in Asia. The trial
compared the safety and immunogenicity of HEPLISAV with Engerix-B(R) in 412
adults 40-70 years of age. The seroprotection rate at one month after the second
dose in the HEPLISAV group was 97% versus 24% in the Engerix-B group (p <
0.0001). At one month after the third dose, the seroprotection rates were 100%
for HEPLISAV and 73% for Engerix-B (p < 0.0001). Seroprotection rates at one
year after the first dose were 100% for HEPLISAV and 69% for Engerix-B (p <
0.0001).
Senior study author and Vice President of Clinical Development at Dynavax, Dr.
William Heyward, commented, "The 97% seroprotection rate of HEPLISAV after two
doses in older adults in this trial was early evidence of the potential of
HEPLISAV as a highly effective two-dose vaccine for older adults. These results
provided important information leading to the design of our pivotal Phase 3 trial
in adults 40-70 years of age in which HEPLISAV provided a peak seroprotection of
98%".
Dynavax plans to submit the BLA for HEPLISAV by the middle of May for an
indication in adults 18-70 years of age.
About HEPLISAV
HEPLISAV is an investigational adult hepatitis B vaccine. In Phase 3 trials,
HEPLISAV demonstrated higher and earlier protection with fewer doses than
currently licensed vaccines. Dynavax has worldwide commercial rights to HEPLISAV.
HEPLISAV combines hepatitis B surface antigen with a proprietary Toll-like
Receptor 9 agonist to enhance the immune response.
Engerix-B(R) is a registered trademark of GlaxoSmithKline
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company,
discovers and develops novel products to prevent and treat infectious and
inflammatory diseases. The Company's lead product candidate is HEPLISAV, a Phase
3 investigational adult hepatitis B vaccine designed to provide higher and
earlier protection with fewer doses than currently licensed vaccines. For more
information visit dynavax.com. |
