主页 > 医药科学 >
【medical-news】Dynavax's HEPLISAV(TM) Hepatitis B Vaccine
Regardless of Vaccination Schedule in Phase 2 Trial
PR Newswire Europe (inc. UK Disclose) - Dec. 04, 2006
BERKELEY, Calif., Dec. 4 /PRNewswire-FirstCall/ -- Dynavax Technologies
Corporation announced today positive results from a Phase 2 trial comparing
two different vaccination schedules of HEPLISAV, its hepatitis B virus (HBV)
vaccine. The primary endpoint is comparative seroprotection after the second
dose. The data was reported today in a poster at the Canadian Immunization
Conference in Winnipeg, Manitoba, Canada by Dr. Scott A. Halperin, Professor
of Pediatrics and Microbiology and Immunology at Dalhousie University and
Head of Pediatric Infectious Disease at the Halifax-based IWK Health Center.
The data show that 100% seroprotection is achieved whether the second dose
is administered one or two months after the first.
According to Melissa Malhame, project leader for hepatitis B vaccines, "The
data presented in Canada are the first reported that support our decision to
study a two-dose, 0 and 1-month vaccination schedule for HEPLISAV in our
upcoming Phase 3 trials. By vaccinating at 0 and 1 month, we once again see
that HEPLISAV has a rapid onset of immunogenicity that can effectively be
translated to an even shorter, more convenient vaccination schedule without
compromising effectiveness."
Dr. Halperin indicated that 100% of all subjects were seroprotected at month
three (3) and that all subjects sustained seroprotection at month eight .
HEPLISAV was found to be safe and well tolerated.
The Phase 2 trial enrolled more than 40 seronegative subjects, 18 - 39 years
of age, at one study site in Canada. One group of subjects received HEPLISAV
at 0 and 1 month; the other group received HEPLISAV at 0 and 2 months.
Dynavax plans to pursue approval of a two-dose regimen administered at 0 and
1 month, and expects to initiate multi-center, international Phase 3 trials
in Europe, Canada and the United States before the year-end, comparing the
two-dose regimen against Engerix-B in patients from 11 to 55 years of age.
The first dosing is expected in Canada, followed in early 2007 by dosing in
the U.S. and in Europe. These trials are expected to be completed in 2008.
Dynavax's HBV vaccine is based on its proprietary immunostimulatory sequence
(ISS) that specifically targets Toll-Like Receptor 9 (TLR9) to stimulate an
innate immune response. Dynavax's HBV vaccine combines ISS with HBV surface
antigen (HBsAg) and is designed to significantly enhance the level, speed
and longevity of protection. As a result of its acquisition of Rhein Biotech
in April 2006, the company has secured manufacturing capabilities in
Dusseldorf, Germany for producing both clinical and commercial quantities of
the vaccine.
About Dynavax
Dynavax Technologies Corporation discovers, develops, and intends to
commercialize innovative TLR9 agonist-based products to treat and prevent
allergies, infectious diseases, cancer, and chronic inflammatory diseases
using versatile, proprietary approaches that alter immune system responses
in highly specific ways. Our TLR9 agonists are based on immunostimulatory
sequences, or ISS, which are short DNA sequences that enhance the ability of
the immune system to fight disease and control chronic inflammation. Our
pipeline includes: TOLAMBA(TM), a ragweed allergy immunotherapeutic, for
which a major safety and efficacy trial (DARTT) is currently underway, and
that is in a supportive clinical trial in ragweed allergic children;
HEPLISAV(TM), a hepatitis B vaccine in Phase 3; and a therapy for
non-Hodgkin's lymphoma in Phase 2. Our pre-clinical asthma and COPD programs
are partnered with AstraZeneca. Funding for our preclinical programs in
cancer, therapies for hepatitis B and hepatitis C; and for an influenza
vaccine has been provided by Symphony Dynamo, Inc. and the NIH, and these
programs represent future partnering opportunities. For more information,
please visit http://www.dynavax.com/.
This press release contains forward-looking statements that are subject to a
number of risks and uncertainties, including statements about the potential
safety and efficacy of HEPLISAV, whether successful results may be shown in
additional clinical studies, the timing of and whether HEPLISAV may show
similar or supportive results in the planned Phase 3 clinical studies and
the potential for HEPLISAV to achieve clinical and commercial success.
Actual results may differ materially from those set forth in this press
release due to the risks and uncertainties inherent in our business,
including difficulties or delays in development, achieving the objectives of
our collaborative and licensing agreements and obtaining regulatory approval
for our products; the scope and validity of patent protection for our
阅读本文的人还阅读：
作者:admin@医学,生命科学 2011-05-22 19:03
医学,生命科学网