31 maj: Skattereform: Ny kapitalpension er generationsrøveri til 150 mia...
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
06 okt - 
Bavarian: Amerikansk hedgefond reducerer igen shortposi..
03 okt - 
Bavarian: Amerikansk investeringsselskab reducerer shor..
03 okt - 
Bavarian/Jyske: To begivenheder mere banker på i år
Relateret debat
22 okt - 
Kan det passe at man har fået resultaterne fra combi st..
20 okt - 
Stroejer, maaske man ogsaa skulle forklare Baronen, at ..
20 okt - 
Hej baron måske du skal begynde at bruge de der kommaer..

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
19 okt
BAVA
Det store prostvac studie fejlede, men nu rekrutteres der til fase to studiet;   Adjuvant PROSTVAC-V..
5
18 okt
BAVA
Ja det lyder bekendt Baronesse?
3
20 okt
BAVA
En lille chance for prostvac kombination kan lykkedes er til en lille grad indregnet i nuværende kur..
1
20 okt
BAVA
I kursen er Prostvac IKKE indregnet. Fat det nu baronen. Alle kursmål er uden Prostvac værdi som er ..
1
20 okt
BAVA
Findes ikke på Bavas hjemmeside;   https://fnih.org/sites/default/files/final/pdf/2017-csc-symposium..
1
19 okt
BAVA
Øøø nej !! Man er vel ikke 12 år når man kan tjene 25.090 kr (heraf 19.700) på Bav. på mindre end 1 ..
1
19 okt
BAVA
Hej Baron. Modsat dig har jeg et job og liv. Sidder ikke herinde 18 af 24 timer.
1
19 okt
BAVA
og  det skyldes slet ikke at marked er i knæ i dag, men alene klaphattens forudsigelse :)
1
19 okt
BAVA
God nyhed ??? hvor meget mon den så falder på dårlige nyheder ??
1
18 okt
BAVA
issy stop det pis, brug hovedet istedet for røven, Bava stiger 2,59
1

Aktier/middag: Banker trækker ned i C20 løftet af FLS og DSV

23-10-2017 11:27:28
Med FLSmidth og DSV som trækheste ligger det danske C20 Cap-indeks mandag ved 11.15-tiden 0,3 pct. højere i 1186,20 og følger en lettere positiv tendens på hovedparten af de øvrige børser i Europa.Markedet kunne fra morgenstunden hente støtte i stigninger i Japan, hvor investorerne reagerede positivt på, at premierminister Shinzo Abe genvandt flertallet i parlamentet.Usikkerhed er der imidlertid f..

Aktier/tendens: Dobbeltløft til Novo inden blød start på aktieugen

23-10-2017 08:27:22
Aktiemarkedet lægger an til en morgen uden de store bølgeskvulp mandag. Weekenden har budt på få nyheder uden store konsekvenser for de finansielle markeder, og mandagens kalender giver en blød start på ugen, hvor der dog tirsdag, onsdag og torsdag bliver mere travlt med regnskaber og rentemøde i Den Europæiske Centralbank.I morgentimerne mandag indikerer de europæiske aktiefutures, at de store in..

Mærsk: Spotrater på Asien-Europa fortsætter faldet

20-10-2017 16:04:59
Spotpriserne for containerfragt på de vigtige ruter mellem Asien og Europa faldt i denne uge med 0,7 pct. til 681 dollar per tyvefodscontainer (teu).Det skriver branchemediet Journal of Commerce, der henviser til data fra Shanghai Shipping Exchange.Spotprisen på verdens travleste handelsrute fortsætter derfor de negative tendenser, der også gjorde sig gældende i sidste uge, hvor spotpriserne faldt..

Mest læste nyheder

  • 24 timer
  • 48 timer
  • 1 uge
1
Aktier/tendens: Dobbeltløft til Novo inden blød start på aktieugen
2
Novo/SHB: Kursmål sættes op til 403 kr. fra 357 kr. - NY
3
Aktier/Sydbank: Der skal opjusteringer til for at forlænge aktiefesten
4
Storbanks mistænkte valutasvindel fanget på bånd
5
Novo: Analysehus ser høj encifret markedsvækst i USA - citat

Relaterede aktiekurser

Bavarian Nordic A/S 271,00 0,4% Stigning i aktiekurs

Køb- og salgsanbefalinger

  • Trend
  • Pengemaskinen

Copyright Euroinvestor A/S 2017  Disclaimer Privatlivspolitik
Aktieinformation leveres af Morningstar.
Data er forsinket 15-20 minutter iht. de enkelte børsers regler om videredistribution.
 
23. oktober 2017 13:33:52
(UTC+01:00) Brussels, Copenhagen, Madrid, Paris
Version: LiveBranchBuild_20171020.1 - EUROWEB2 - 2017-10-23 13:33:52 - 2017-10-23 13:33:52 - 1 - Website: OKAY