Bavarian Nordic Announces Initiation of Phase 2 Clinical Trial of RSV Vaccine
(Thomson Reuters ONE) -
* First Phase 2 study will evaluate prime-boost vaccine approach in elderly
population
COPENHAGEN, Denmark, October 18, 2016 - Bavarian Nordic A/S (OMX: BAVA, OTC:
BVNRY) today announced the initiation of the first Phase 2 clinical study of
MVA-BN® RSV, its novel, broad spectrum, vaccine candidate against RSV
(respiratory syncytial virus).
The study, which is being conducted in USA, will enrol 400 healthy subjects,
aged 55 or older who will be randomized into five groups of 80 subjects each.
Subjects will receive two administrations four weeks apart of either low or high
doses of MVA-BN RSV and/or placebo, in order to identify the optimal dose and
schedule for future studies. More information on the trial can be found at
http://www.clinicaltrials.gov/ct2/show/NCT02873286.
Top-line results from the study are anticipated around mid-2017 and will provide
important information for a subsequent Phase 2b field efficacy study, which is
planned for initiation later in 2017.
Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic, said:
"Advancing our RSV program into Phase 2 is an important milestone for Bavarian
Nordic in our efforts to develop a vaccine which potentially offers broad
protection against the virus. RSV remains an area of high unmet medical need
with no approved vaccine available. This Phase 2 study represents an essential
step in the successful development of any vaccine; to ensure we establish an
ideal dose and dosing regimen, prior to exploring this candidate in larger
studies. In this study we will evaluate both a single vaccination, as well as a
prime-boost approach that will determine which regime induces prolonged immune
responses against RSV "
MVA-BN RSV represents a new vaccine approach specifically designed to target
five different RSV proteins to ensure a broad immune response against both RSV
subtypes (A & B). Extensive preclinical studies have shown that MVA-BN RSV
induces a balanced immune response comprised of both antibodies and T cells, in
a similar fashion to the natural response to an RSV infection. These results
were confirmed in a Phase 1 study in healthy adults, reported in May 2016, which
showed that MVA-BN RSV significantly boosted antibodies and T cells against both
RSV subtypes. The vaccine was well tolerated, with no unexpected or serious
adverse reactions. The vast majority of events represented local and systemic
reactions typical for vaccines.
About RSV
Respiratory syncytial virus, or RSV, is the most common cause of bronchiolitis
and pneumonia in infants and a significant cause of respiratory illness in older
adults, resulting in a high number of hospitalizations. RSV infections are
responsible each year for a similar number of deaths as the flu in children up
to age 14, as well as in the elderly population. It is estimated that more than
64 million people are infected globally each year, yet unlike the flu, there is
no vaccine to prevent RSV, presenting a large unmet medical need and market
opportunity.
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. 27 / 2016
2016-27-en:
http://hugin.info/100065/R/2049677/766528.pdf
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Bavarian Nordic A/S via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 18.10.2016 - 15:13 Uhr
Sprache: Deutsch
News-ID 501217
Anzahl Zeichen: 6437
contact information:
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Kategorie:
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