Bavarian Nordic Provides Update on Anticipated Timing of PROSPECT Study
(Thomson Reuters ONE) -
* PROSTVAC® overall survival data anticipated in the second half of 2017
COPENHAGEN, Denmark, January 4, 2017 - Bavarian Nordic A/S (OMX: BAVA, OTC:
BVNRY) today provided guidance for the current estimated timing of interim and
final overall survival analysis from the PROSPECT study - a placebo controlled
Phase 3 study designed to investigate the efficacy of PROSTVAC to prolong the
survival of men with metastatic castration-resistant prostate cancer (mCRPC).
The company maintains its previous guidance that full data is expected within
this year, albeit in the second half of 2017, with the third interim analysis
likely to occur around mid-2017. This estimate is based on a decline in the
number of average monthly events currently seen in the PROSPECT study.
"As there has been speculation that the third interim could occur during first
quarter of 2017, we believe it is important to update the market on the current
estimated timelines for readout of the Phase 3 study" said Paul Chaplin,
President and CEO of Bavarian Nordic.
While the company remains blinded to all patient specific data, the latest
estimates have been provided by the independent Data Monitoring Committee (DMC)
following a routine analysis of the current survival data.
"While we will have to await the final read out of the PROSPECT study to
establish the efficacy of PROSTVAC, we are encouraged that the current monthly
event rate has declined. This is great news for the patients. Not only is this
consistent with an improvement in the standard of care for patients with mCRPC,
which has been observed in recent years, but could also be indicative of a
therapeutic effect of PROSTVAC as well" said Paul Chaplin.
About the PROSPECT study
PROSPECT is a global, randomized, double-blind, placebo-controlled phase 3 study
being conducted under a Special Protocol Assessment (SPA) from the FDA. The
objective of the study is to determine whether PROSTVAC alone or in combination
with GM-CSF is effective in prolonging overall survival. The study has been
fully enrolled with 1,297 asymptomatic or minimally symptomatic mCRPC patients
as of January 2015. Patients were enrolled at more than 200 sites in 15
countries. Both the first and second interim analyses confirmed that the study
would continue as planned. Final study data requires 534 events in both
comparisons of treatment arms versus placebo, and the third interim analysis
will occur at 427 events.
About PROSTVAC
PROSTVAC (rilimogene galvacirepvec/rilimogene glafolivec, or "rilimogene") is a
prostate specific antigen (PSA)-targeted immunotherapy candidate designed to
enhance or stimulate the body's immune response, specifically T cells that will
home to and kill prostate cancer cells, altering the course of the disease and
improving overall survival (OS) of patients with prostate cancer. A robust data
package has been established that includes 18 ongoing or completed clinical
studies, comprising more than 2,000 patients of which more than 1,100 patients
have been actively treated with PROSTVAC, which has been generally well-
tolerated. A randomized, placebo-controlled Phase 2 trial demonstrated the
potential of PROSTVAC to extend the median overall survival by 8.5 months in
patients with advanced prostate cancer. These results led to the initiation of
the PROSPECT pivotal Phase 3 study.
PROSTVAC is being developed in collaboration with the National Cancer Institute
under a Cooperative Research and Development Agreement.
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. 02 / 2017
2017-02-en:
http://hugin.info/100065/R/2068843/777004.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: 04.01.2017 - 14:26 Uhr
Sprache: Deutsch
News-ID 515798
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