Dynavax and Merck & Co., Inc. Announce Phase 3 Trial with Investigational Hepatitis B Vaccine (HEPLISAV(TM)) Met its Primary Endpoint
2008-08-05 15:05:00
Dynavax and Merck & Co., Inc. Announce Phase 3 Trial with Investigational Hepatitis B Vaccine (HEPLISAV(TM)) Met its Primary Endpoint
BERKELEY, Calif. & WHITEHOUSE STATION, N.J.–(EMWNews)–Dynavax Technologies Corporation (Nasdaq:DVAX) and Merck & Co., Inc.
announced today top-line immunogenicity results from a Phase 3 clinical
trial comparing HEPLISAV™, an investigational
hepatitis B virus (HBV) vaccine, to a currently marketed HBV vaccine,
Engerix-B® (1). The
study achieved its primary endpoint. HEPLISAV is being jointly developed
by Dynavax and Merck for use in adults and in patients with end stage
renal disease.
This study, called PHAST (Phase 3 HeplisAv Short-regimen Trial),
evaluated a two-dose regimen of HEPLISAV administered at 0 and 1 month
compared to a three-dose regimen of Engerix-B®
administered at 0, 1 and 6 months. The primary endpoint was the
proportion of subjects who developed protective antibodies to hepatitis
B after administration. In PHAST, 95.1 percent of subjects who received
two doses of HEPLISAV (n=1,819) developed protective antibodies to
hepatitis B when measured at 12 weeks versus 81.1 percent of subjects
who received three doses of Engerix-B®
(n=608) when measured at 28 weeks. The multi-center study evaluated
2,427 subjects from 11 to 55 years of age in Canada and Germany. Results
of additional analyses from this trial will be presented in the future.
As previously disclosed, the U.S. Food and Drug Administration (FDA)
placed a clinical hold on the two Investigational New Drug (IND)
Applications for HEPLISAV that is still in effect. In issuing the
clinical hold, the FDA requested a review of clinical and preclinical
safety data for HEPLISAV. Additionally, the FDA requested all available
information about a single case of Wegener’s granulomatosis reported in
this Phase 3 trial.
HEPLISAV is based on Dynavax’s proprietary
immunostimulatory sequence (ISS) that specifically targets Toll-Like
Receptor 9 (TLR9) to stimulate an innate immune response. HEPLISAV
combines ISS with HBV surface antigen (HBsAg) and is designed to enhance
the speed of protection.
Webcast Today
Dynavax will webcast a discussion of the HEPLISAV Phase 3 data along
with the company’s second quarter 2008
financial results on Tuesday, August 5, 2008 at 4:30 p.m. Eastern
Daylight Time / 1:30 p.m. Pacific Daylight Time. The webcast can be
accessed on Dynavax’s website at http://investors.dynavax.com/events.cfm.
A telephonic replay of the discussion will be available through August
19, 2008 by dialing 1-888-203-1112, access code: 4643391. International
callers can dial 1-719-457-0820, access code: 4643391.
About Dynavax
Dynavax Technologies Corporation discovers, develops, and intends to
commercialize innovative TLR9 agonist-based products to treat and
prevent infectious diseases, allergy, 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 clinical product candidates include: HEPLISAV,
a hepatitis B vaccine partnered with Merck & Co., Inc.; a therapy for
metastatic colorectal cancer; and therapies for hepatitis B and C. Our
preclinical asthma and COPD program is partnered with AstraZeneca. The
NIH partially funds our preclinical universal influenza vaccine program
that is being coordinated with Novartis. Symphony Dynamo Inc. (SDI)
funds our colorectal cancer and hepatitis C therapeutic programs. While
the NIH and SDI provide program support, Dynavax has retained rights to
seek strategic partners for future development and commercialization.
For more information, please visit http://www.dynavax.com.
DYNAVAX Forward-Looking Statement
This press release contains “forward-looking statements.” 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, initiation and completion of
clinical trials, the results of clinical trials and the impact of those
results on the initiation and completion of subsequent trials and issues
arising in the regulatory process; achieving our Merck collaborative
agreement objectives and obtaining regulatory approval for HEPLISAV; the
scope and validity of patent protection and the possibility of claims
against us based on the patent rights of others; our ability to obtain
additional financing to support our operations; and other risks detailed
in the “Risk Factors” section of our Quarterly Report on Form 10-Q. We
undertake no obligation to revise or update information herein to
reflect events or circumstances in the future, even if new information
becomes available.
About Merck
Merck & Co., Inc. is a global research-driven pharmaceutical company
dedicated to putting patients first. Established in 1891, Merck
currently discovers, develops, manufactures and markets vaccines and
medicines to address unmet medical needs. The Company devotes extensive
efforts to increase access to medicines through far-reaching programs
that not only donate Merck medicines but help deliver them to the people
who need them. Merck also publishes unbiased health information as a
not-for-profit service. For more information, visit www.merck.com.
Merck Forward-Looking Statement
This press release contains “forward-looking statements” as that term is
defined in the Private Securities Litigation Reform Act of 1995. These
statements are based on management’s current expectations and involve
risks and uncertainties, which may cause results to differ materially
from those set forth in the statements. The forward-looking statements
may include statements regarding product development, product potential
or financial performance. No forward-looking statement can be guaranteed
and actual results may differ materially from those projected. Merck
undertakes no obligation to publicly upda te any forward-looking
statement, whether as a result of new information, future events, or
otherwise. Forward-looking statements in this press release should be
evaluated together with the many uncertainties that affect Merck’s
business, particularly those mentioned in the risk factors and
cautionary statements in Item 1A of Merck’s Form 10-K for the year ended
Dec. 31, 2007, and in any risk factors or cautionary statements
contained in the Company’s periodic reports on Form 10-Q or current
reports on Form 8-K, which the Company incorporates by reference.
(1) Engerix-B® is a
registered trademark of GlaxoSmith Kline
|
Dynavax Relations Boratto, 1-908-423-5185 Communications |
|
Major Newsire & Press Release Distribution with Basic Starting at only $19 and Complete OTCBB / Financial Distribution only $89
Get Unlimited Organic Website Traffic to your Website
TheNFG.com now offers Organic Lead Generation & Traffic Solutions