01 jun: Danmark: Finanspagtens nej-partier klager over Vestager
03 jun: SimCorp på vej mod solid opjustering
02-06-2012 15:01:21

Interim Analysis for Bavarian Nordic's Phase 2 PROSTVAC® Trial Presented at Annual ASCO Meeting

Relateret indhold
05 dec - 
Bavarian/Carnegie: Hæver kursmål med godt 50 pct. ..
04 dec - 
Bavarians booster-dosis er med i nyt Ebola-forsøg ..
01 dec - 
Nordea Markets: Ændringer som følge af ny anbefalingsst..
Relateret debat
17:54 - 
Så skal vi over 200 tirsdag.
17:18 - 
Snow2000 du kikker på den forkerte skærm, den med kurse..
17:04 - 
usa på vej minus,,,, i morgen på vej ned igen

KVISTGAARD, Denmark, June 2, 2012 - Bavarian Nordic A/S (OMX: BAVA) today announces new interim data from an ongoing, Phase 2 randomized trial of the Company's PROSTVAC® therapeutic prostate cancer vaccine being conducted by the National Cancer Institute (NCI). This trial is evaluating PROSTVAC® when used in combination with Quadramet® (samarium-153 EDTMP, or Sm-153), a commercially available skeletal-targeted radiopharmaceutical. The interim data will be presented as a poster during the 2012 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois.

According to the investigators from NCI, this interim analysis suggests that the combination of PROSTVAC® and Sm-153 in patients with metastatic castration-resistant prostate cancer (mCRPC) is well tolerated with similar toxicity profile to Sm-153 alone. The early indication of improved time-to-tumor progression (TTP) warrants continued study accrual.

"A randomized, placebo-controlled Phase 2 study of PROSTVAC® reported an 8.5-month improvement in median overall survival in men with metastatic, castrate resistant prostate cancer. Based upon these encouraging results, we recently initiated our pivotal, global Phase 3 clinical study, PROSPECT," stated Anders Hedegaard, President & CEO of Bavarian Nordic. "To learn more about the potential usefulness of PROSTVAC® in other settings, PROSTVAC® is being studied by the National Cancer Institute in combination with Sm-153, and we are encouraged by these interim results," he added.

This Phase 2 multi-center trial is intended to randomize 68 patients to Sm-153 alone (Arm A) or with PROSTVAC® (Arm B). Of 37 patients enrolled to date, 3 were not evaluable for progression-free survival (PFS). At four months, the PFS for evaluable patients in Arm A was 11.8% compared to 29.4% in Arm B. Median PFS for patients in Arm A was 60 days compared to 117 days in Arm B. The most common side effects were grade 3 or 4 thrombocytopenia occurring in 22% and 26% of treatment cycles on Arms A and B, respectively. "Interim analysis of a phase 2 randomized clinical trial of Samarium-153 (Sm-153) with or without PSA-TRICOM vaccine in metastatic castration resistant prostate cancer (mCRPC) after docetaxel" by Gulley, J. et al. (Abstract No. 2526, Poster Discussion Session, Developmental Therapeutics - Clinical Pharmacology and Immunotherapy, 8:00 AM to 12:00 PM CT, Saturday June 2, 2012.)

On Sunday, June 3, 2012, Bavarian Nordic's PROSPECT clinical trial, a global, randomized, double-blind, placebo-controlled Phase 3 trial of PROSTVAC® in prostate cancer patients with asymptomatic or minimally symptomatic, castrate-resistant, metastatic disease will be the subject of a "Trials in Progress" abstract, which is designed to provide an opportunity for members of the research community to present ongoing trials, foster collaboration, and discuss correlatives and novel trial designs. "Prospect: A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC®" by Olga Bandman (Abstract No. TPS4699, General Poster Session, Genitourinary Cancer, 8:00 AM to 12:00 PM CT, Sunday June 3, 2012.

The abstracts can be accessed through the ASCO website, www.asco.org.

Bavarian Nordic also will be hosting a PROSTVAC® clinical update and reception for investors on Monday, June 4, 2012 in Chicago, Illinois. The principal investigators for the PROSPECT trial, James L. Gulley, M.D., Ph.D., Director of the Clinical Trials Group at the Laboratory of Tumor Immunology and Biology at the National Cancer Institute (NCI), and Philip Kantoff M.D., Professor of Medicine at Harvard Medical School, will be joined by members of the Company's senior management team to discuss plans for the ongoing clinical development of PROSTVAC®. To register for this event, or for more information, please contact Mette Buhl of Bavarian Nordic via email at mette.buhl@bavarian-nordic.com or by phone at +45 33 28 83 00.

Contact

Anders Hedegaard, President & CEO. Phone +45 23 20 30 64

About Prostate Cancer

Prostate cancer is the most frequently diagnosed cancer in men. The disease affects approximately one in six men and an estimated 600,000 new cases of prostate cancer are expected in the U.S. and Europe during 2012. With an estimated more than 100,000 deaths in 2012, prostate cancer is also the second-leading cause of cancer death in men. Approximately 4 million men are living in the U.S. and Europe today who have been diagnosed with prostate cancer. Sources: American Cancer Society and Evaluate Pharma.

About PROSTVAC®

PROSTVAC® is a prime-boost vaccine that sequentially combines two different poxviruses (vaccinia and fowlpox). Administered subcutaneously, it is designed to induce a specific, targeted immune response that attacks prostate cancer cells. In clinical studies to date, the most common side effects of PROSTVAC® were injection site reactions and fatigue.

PROSTVAC® is being developed in collaboration with the National Cancer Institute under a Cooperative Research and Development Agreement with Bavarian Nordic's U.S.-based subsidiary, BN ImmunoTherapeutics. To date, PROSTVAC® and related PSA containing poxviral vaccines have been investigated in 20 ongoing and completed clinical trials involving more than 2,000 patients.

In April 2010, PROSTVAC® was granted Fast Track designation by the FDA for the treatment of men with mCRPC.

About the PROSPECT Phase 3 Clinical Trial

This global, randomized, double-blind, placebo-controlled Phase 3 trial of PROSTVAC® in men with asymptomatic or minimally symptomatic castrate-resistant, metastatic prostate cancer (mCRPC) is expected to enrol about 1,200 patients in three study arms. Patients in the two active study arms will receive either PROSTVAC® alone or PROSTVAC® with adjuvant doses of GM-CSF. Patients who have metastatic disease and are castrate resistant may be eligible to enrol in the study. The primary endpoint is overall survival (OS). For the study outcome to be positive, either one or both of the treatment arms must be superior to placebo. About 300 clinical trial centers in more than 20 countries are expected to participate in the trial. Patient enrolment in the trial is expected to take up to twenty-four months. For more information about the trial, visit http://www.continueyourfight.com

About Bavarian Nordic

Bavarian Nordic is a vaccine-focused biotechnology company developing and producing novel vaccines for the treatment and prevention of life-threatening diseases with a large unmet medical need. The company's pipeline targets cancer and infectious diseases. In oncology, the company's lead program is PROSTVAC®, a therapeutic vaccine candidate for advanced prostate cancer that is the subject of an ongoing pivotal Phase 3 trial and is being developed under a collaboration agreement with the National Cancer Institute. In infectious diseases, the company's lead program is IMVAMUNE®, a third-generation smallpox vaccine candidate that is being developed and supplied for emergency use to the U.S. Strategic National Stockpile under a contract with the U.S. Government. For more information, visit www.bavarian-nordic.com.

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. 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.

20120602uk


This announcement is distributed by Thomson Reuters on behalf of Thomson Reuters 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 Thomson Reuters ONE

HUG#1616939

Opret kommentar

Relateret debat

  • 1 uge
  • 1 måned
  • 1 År
17 dec
BAVA
Den har vi alle lavet , eller kommer til, at lave med tiden. Det hjælper dig selvfølgelig ikke, men ..
2
17:00
BAVA
Min frygt er, at den er ved at danne en ny top her lige under kurs 200. I så fald eer man jo lidt lå..
1
15:50
BAVA
197,5 bliver revet væk når de bliver lagt til salg - tror vi lukker i dagens højeste, og fortsætter ..
1
12:34
BAVA
Vi er over 200 Kr. om ikke særlig længe - den vil formentlig fortsætte imod 220 Kr.
1
18 dec
BAVA
Nej, der er jo dem, der foretrækker dyre damer. Jeg kan godt lide de nøjsomme.
1
17 dec
BAVA
Hvis du mener, at det netop var det du skrev, og det du mente, så falder dit indlæg da helt til jord..
1
17 dec
BAVA
Jeps. Men hvis det er korrekt, at man vurdere at prostvac kan indbringe 1 mia kr. om året, så må det..
1
17 dec
BAVA
Moralen er: Sæt dig aldrig ned for at vente på lykken. Du må skabe den selv!
1
17 dec
BAVA
Ja, set i bakspejlet skulle man have solgt oppe over 190 Kr. som du gjorde :-) Så vi må tage turen o..
1

Norden/Fearnley: Sænker anbefaling til "akkumuler" fra "køb"

22-12-2014 15:17:24
Norske Fearnley Securities har sænket sin anbefaling af rederiet D/S Norden til "akkumuler" fra tidligere "køb", mens kursmålet er skåret til 139 kr. fra tidlig..

G4S: Black Friday og jul skaber travlhed hos Cash Solutions

22-12-2014 12:14:13
G4S' værdihåndteringsdivision, Cash Solutions, havde mere travlt end nogensinde fredag den 28. november, hvor det amerikanske fænomen Black Friday, der sparker ..

Aktier/middag: Vestas fester, mens B&O er i kulkælderen

22-12-2014 11:30:03
Det danske aktiemarked er positivt stemt mandag, hvor Vestas fører an i et let stigende C20-indeks. Baggrunden er, at Vestas har fået den første kommercielle or..

Mest læste nyheder

  • 24 timer
  • 48 timer
  • 1 uge
1
Aktier/tendens: Positiv åbning i vente - B&O og Vestas i fokus
2
Aktier/middag: Vestas fester, mens B&O er i kulkælderen
3
Vestas/Sydbank: Vingeoutsourcing i Kina giver god mening
4
MHI Vestas Offshore vinder første ordre på sin V164-mølle
5
AaB: Succestræner stopper til sommer

Relaterede aktiekurser

Bavarian Nordic A/S 198,00 3,1% Stigning i aktiekurs

Køb- og salgsanbefalinger

  • Trend
  • Pengemaskinen

Relaterede selskaber
Få adgang til information og anbefalinger af relaterede selskaber med PLUS pakken.

Du får adgang til 7 værdifulde investorværktøjer til investering.

Klik her og læs mere om PLUS pakken.

Copyright Euroinvestor A/S 2014  Disclaimer Privatlivspolitik
Aktieinformation leveres af Interactive Data.
Data er forsinket 15-20 minutter iht. de enkelte børsers regler om videredistribution.
 
22. december 2014 22:21:40
(UTC+01:00) Brussels, Copenhagen, Madrid, Paris
Version: LiveBranchBuild_20141219.2 - EUROWEB4 - 2014-12-22 22:21:40 - 2014-12-22 22:21:40 - 1 - Website: OKAY

Når du besøger Euroinvestor.dk accepterer du, at der anvendes cookies, som vi og vores samarbejdspartnere benytter til funktionalitet, statistik og markedsføring. Læs mere om cookies på Euroinvestor.dk her

x