Bavarian Nordic Announces Initiation of NIH Sponsored Phase 1 Trial of MVA-BN-based Yellow Fever Vaccine
(Thomson Reuters ONE) -
COPENHAGEN, Denmark, July 27, 2016 - Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY)
today announced the initiation of a Phase 1 clinical trial of MVA-BN YF, a new
vaccine candidate based on the Company's proprietary MVA-BN platform, designed
to protect against yellow fever virus. The study is sponsored by the National
Institute of Allergy and Infectious Diseases (NIAID), part of the National
Institutes of Health (NIH).
"We are very pleased to see the advancement of this novel vaccine into human
studies. Clearly there remains an unmet medical need in the protection of
populations who are at risk from potential outbreaks like yellow fever. Now more
than ever it is clear that proactive vaccine development is required for both
existing and emerging threats to public health. We are excited to expand the
scope of our MVA-BN technology and look forward to exploring its potential
further. We remain a dedicated partner to the NIH and the U.S. government, and
look forward to assisting as needed," said Paul Chaplin, President & Chief
Executive Officer of Bavarian Nordic.
A preclinical study conducted by Bavarian Nordic demonstrated that the vaccine
candidate provided complete protection against infection with the virus in
hamsters. Furthermore, preclinical studies suggest that combining MVA-BN with
ISA 720, an adjuvant that has been used in prior clinical trials, induces a
strong immune response after a single dose of vaccine. The preclinical challenge
study was funded by the NIH.
The placebo-controlled, double-blinded clinical trial will evaluate whether the
vaccine is safe, tolerable and induces a human immune response indicating a
potential for preventing yellow fever virus infection. The study will enroll 90
healthy men and women ages 18 to 45. Participants will be divided into six
groups: one that will receive the currently licensed yellow fever vaccine (15
participants) and five groups (15 participants each) will receive MVA-BN YF,
either with or without ISA 720 adjuvant. Additional details about the trial can
be found at ClinicalTrials.gov using the identifier NCT02743455. The study is
being conducted under the supervision of NIAID, contract number
HHSN272200800003C.
About Yellow Fever
Yellow fever virus is found in tropical and subtropical areas in South America
and Africa. It caused an estimated 84,000 to 170,000 severe cases of disease and
29,000 to 60,000 deaths in 2013, according to the World Health Organization
(WHO). The virus is transmitted to people primarily through the bite of infected
female Aedes aegypti mosquitoes. Mild cases of infection can cause fever, back
pain, headache, nausea, vomiting, fatigue and weakness. Most people recover, but
approximately 15 percent of those infected develop severe disease manifested as
yellow eyes and skin (jaundice), hemorrhage and shock, resulting in potentially
fatal kidney, liver or heart conditions.
About Bavarian Nordic
Bavarian Nordic is a fully integrated biotechnology company focused on the
development, manufacturing and commercialization of cancer immunotherapies and
vaccines for infectious diseases, based on the Company's live virus vaccine
platform. Through long-standing collaborations, including a collaboration with
the U.S. government, Bavarian Nordic has developed a portfolio of vaccines for
infectious diseases, including the non-replicating smallpox vaccine,
IMVAMUNE(®), which is stockpiled for emergency use by the United States and
other governments. The vaccine is approved in the European Union (under the
trade name IMVANEX(®)) and in Canada. Bavarian Nordic and its partner Janssen
are developing an Ebola vaccine regimen, which has been fast-tracked, with the
backing of worldwide health authorities, and a vaccine for the prevention and
treatment of HPV. Additionally, in collaboration with the National Cancer
Institute, Bavarian Nordic has developed a portfolio of active cancer
immunotherapies, including PROSTVAC(®), which is currently in Phase 3 clinical
development for the treatment of advanced prostate cancer. The company has
partnered with Bristol-Myers Squibb for the potential commercialization of
PROSTVAC. For more information visit www.bavarian-nordic.com or follow us on
Twitter (at)bavariannordic.
Forward-looking statements
This announcement includes forward-looking statements that involve risks,
uncertainties and other factors, many of which are outside of our control, that
could cause actual results to differ materially from the results discussed in
the forward-looking statements. Forward-looking statements include statements
concerning our plans, objectives, goals, future events, performance and/or other
information that is not historical information. All such forward-looking
statements are expressly qualified by these cautionary statements and any other
cautionary statements which may accompany the forward-looking statements. We
undertake no obligation to publicly update or revise forward-looking statements
to reflect subsequent events or circumstances after the date made, except as
required by law.
Contacts
Rolf Sass Sørensen
Vice President Investor Relations (EU)
Tel: +45 61 77 47 43
Seth Lewis
Vice President Investor Relations (US)
Tel: +1 978 341 5271
Company Announcement no. 22 / 2016
2016-22-en:
http://hugin.info/100065/R/2030889/755591.pdf
This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Bavarian Nordic A/S via GlobeNewswire
[HUG#2030889]
Unternehmensinformation / Kurzprofil:
Datum: 27.07.2016 - 15:00 Uhr
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