Navigation Links
Bavarian Nordic Reports Positive Data from First EUA Enabling Study with IMVAMUNE(R) Smallpox Vaccine Candidate
Date:11/29/2007

WASHINGTON, DC, November 29 /PRNewswire-FirstCall/ -- Bavarian Nordic reports the successful completion of a large, placebo-controlled Phase II trial in 745 healthy subjects who received either one or two doses of IMVAMUNE(R) next-generation smallpox vaccine candidate. The results of this study are seen as the pivotal step on the path to moving IMVAMUNE(R) into Phase III registration trials in order to achieve a BLA for healthy subjects.

This study, together with other Phase II studies with IMVAMUNE(R) in immune-compromised persons, is also pivotal for obtaining an Emergency Use Authorization (EUA). Bavarian Nordic expects to receive approval of the EUA application in the second-half of 2008.

Traditional smallpox vaccines are associated with a high risk of heart complications (e.g. myo-/pericarditis) in approximately 1 in every 150 people vaccinated for the first time. Therefore, the purpose of this study, aside from assessing general immune response and safety, was to compare cardiac safety in the different study groups following vaccination with IMVAMUNE(R). The large amount of safety data collected from the 745 people who completed this study confirmed the promising safety and tolerability profile of IMVAMUNE(R). Importantly, vaccinations with IMVAMUNE(R) did not result in any clinically significant abnormal cardiac findings and no cardiac events (e.g. cases of myo-/pericarditis).

Moreover, vaccinations with IMVAMUNE(R) resulted in seroconversion (detectable immune responses) in almost all subjects (98.9%) previously not vaccinated against smallpox. Similarly, a single vaccination with IMVAMUNE(R) boosted the immune response in the majority of people who had historically been vaccinated against smallpox.

This study completes the Phase II development of IMVAMUNE(R) in healthy subjects and now leads to planning with the FDA on the design of the Phase III studies expected to begin in 2008.

Anders Hedegaard, President & CEO, said: "We are very satisfied with these results which bring us closer to our EUA application which represents an important milestone in the development of IMVAMUNE(R) as the modern smallpox vaccine."

About Bavarian Nordic

Bavarian Nordic, headquartered in Denmark, is a leading international biopharmaceutical company developing and producing innovative vaccines to prevent and treat infectious diseases and cancer.

In the U.S., Bavarian Nordic operates subsidiary companies, BN ImmunoTherapeutics, in Mountain View, California developing vaccines against cancers, and Bavarian Nordic Inc. in Washington, D.C. focused on business development, marketing, and government relations for the Bavarian Nordic Group. For more information on Bavarian Nordic visit: http://www.bavarian-nordic.com

"Safe Harbour" Statement under the Private Securities Litigation Reform Act of 1995": Except for the historical information contained herein, this release contains "forward-looking statements" within the meaning of the Private Securities Reform Act of 1995. No "forward-looking statement" can be guaranteed, and actual results may differ materially from those projected. Bavarian Nordic undertakes no obligation to publicly update any "forward-looking statement", whether as a result of new information, future events, or otherwise. Additional information regarding risks and uncertainties is set forth in the current Annual Report and in Bavarian Nordic's periodic reports, if any, which we incorporate by reference.


'/>"/>
SOURCE Bavarian Nordic A/S
Copyright©2007 PR Newswire.
All rights reserved

Related medicine news :

1. Nordic Naturals Introduces Ultimate Omega 500 - Their Best Selling Formula Now Available in a Smaller Size Soft Gel!
2. New Study Reports High Injury Rates for Hotel Workers, Even Higher Rates for Women and Nonwhites
3. Haemacure Reports Third Quarter 2007 Results
4. First-Ever List of the 5,000 Fastest-Growing Businesses Reports Total Revenue of $194.5 Billion
5. Consumer Reports Analysis: Drugs for Nerve Pain, Fibromyalgia Effective, But Not Always Best
6. MDS Reports Third Quarter 2007 Results
7. Allied Healthcare Reports Strong Fourth Quarter, Flat Net Income for Fiscal 2007 vs. 2006
8. AtriCure Reports First Human Implant of the Cosgrove-Gillinov Left Atrial Appendage Occlusion System
9. NMHC Reports Fourth Quarter and Fiscal Year 2007 Financial Results
10. Blue Cross and Blue Shield of Florida Reports Eighteenth Consecutive Year of Positive Performance
11. ReBuilder Medical Technologies, Inc. Reports International Sales Expansion
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/26/2016)... ... June 27, 2016 , ... Quality metrics are proliferating in cancer care, and ... in the eye of the beholder, according to experts who offered insights and commentary ... of Managed Care. For the full issue, click here . , For the ...
(Date:6/26/2016)... ... June 26, 2016 , ... Many women ... diagnosed with endometriosis. These women need a treatment plan to not only alleviate ... that can help for preservation of fertility and ultimately achieving a pregnancy. The ...
(Date:6/25/2016)... (PRWEB) , ... June 25, 2016 , ... First ... United States, named Dr. Sesan Ogunleye, as the Medical Director of its new Mesquite-Samuell ... facility Medical Director of our new Mesquite location,” said Dr. James M. Muzzarelli, Executive ...
(Date:6/24/2016)... , ... June 24, 2016 , ... A recent ... most people are unfamiliar with. The article goes on to state that individuals are ... many of these less common operations such as calf and cheek reduction. The Los ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... Global law ... magazine’s 2016 Legal Elite. The attorneys chosen by their peers for this recognition are ... , Seven Greenberg Traurig Shareholders received special honors as members of this year’s Legal ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... 2016  Arkis BioSciences, a leading innovator in ... durable cerebrospinal fluid treatments, today announced it has ... is led by Innova Memphis, followed by Angel ... investors.  Arkis, new financing will accelerate the commercialization ... release of its in-licensed Endexo® technology. ...
(Date:6/23/2016)... , June 23, 2016 Research ... "Pharmaceutical Excipients Market by Type (Organic Chemical (Sugar, Petrochemical, ... (Oral, Topical, Coating, Parenteral) - Global Forecast to 2021" ... The global pharmaceutical excipients market is ... a CAGR of 6.1% in the forecast period 2016 ...
(Date:6/23/2016)... Capricor Therapeutics, Inc. ... company focused on the discovery, development and commercialization ... in its ongoing randomized HOPE-Duchenne clinical trial (Halt ... its 24-patient target. Capricor expects the trial to ... 2016, and to report top line data from ...
Breaking Medicine Technology: