Bavarian Nordic Provides Update on Anticipated Timing of PROSPECT Study
(Thomson Reuters ONE) -
COPENHAGEN, Denmark, June 16, 2017 - Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY)
today provided updated guidance for the current anticipated timing of interim
and final results from its ongoing 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).
As previously communicated, Bavarian Nordic still expects the PROSPECT study to
read out final data in the second half of 2017. The company now further updates
this timeline to indicate the final data is expected in the fourth quarter of
the year. Prior to the final data analysis, however, a third interim analysis is
planned. The results of the third interim analysis will be reviewed by an
independent Data Monitoring Committee (DMC) and the DMC now plans to convene for
this analysis in September 2017. The Company will provide an update following
this interim analysis.
About the PROSPECT study
The PROSPECT study is a global randomized, double-blind, placebo-controlled
study in patients with asymptomatic or minimally symptomatic mCRPC. The trial is
being conducted under a Special Protocol Assessment agreement with the FDA. The
primary objective of the study is to determine whether the overall survival of
patients receiving PROSTVAC (with or without the addition of granulocyte
macrophage colony-stimulating factor; GM-CSF), is superior to that of patients
receiving placebo. The final analysis of the study will occur at 534 events
(deaths) in each comparison of the two treatment arms versus placebo. Three pre-
specified interim analyses of data have been integrated into the statistical
plan to evaluate whether the trial should continue as planned, or potentially be
stopped early for efficacy or futility. Two of these interim analyses have
already occurred, with the conclusion that the study continue without
modification.
The study completed recruitment in January of 2015 with a final enrolment of
1,297 men. Based on the dosing schedule of PROSTVAC, all men would have
completed their course of therapy no later than June 2015.
About PROSTVAC
PROSTVAC (rilimogene galvacirepvec/rilimogene glafolivec) 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 19 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 9.9 months in patients with advanced
prostate cancer.
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. 16 / 2017
2017-16-en:
http://hugin.info/100065/R/2113698/804104.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: 16.06.2017 - 07:30 Uhr
Sprache: Deutsch
News-ID 548276
Anzahl Zeichen: 6505
contact information:
Town:
Kvistgård
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 274 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"Bavarian Nordic Provides Update on Anticipated Timing of PROSPECT Study"
steht unter der journalistisch-redaktionellen Verantwortung von
Bavarian Nordic A/S (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
