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