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,
'/>"/>

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

Page: 1 2

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:4/22/2014)... are more likely to have a child who develops ... A recent study from researchers from the Drexel University ... in Sweden provides more insight into how the risk ... ages, and found that the risk of having a ... for older parents., In the study, published in the ...
(Date:4/22/2014)... Based on results of a clinical trial led ... and Drug Administration (FDA) approved a molecularly targeted ... that has progressed after standard chemotherapy has failed. ... was announced by the manufacturer, Lilly Oncology, of ... ramucirumab, it will be sold under the name ...
(Date:4/22/2014)... identify patients who are at highest risk for respiratory ... condition, suggest data from a large multi-center study published ... Affecting nearly 200,000 Americans a year, acute respiratory distress ... caused by a number of issues ranging from smoke ... develop ARDS after surgery. ARDS is difficult to treat ...
(Date:4/22/2014)... out of the University of Calgary,s Hotchkiss Brain Institute ... nerve cells as a means to restore connections after ... a key molecule that directly regulates nerve cell growth ... in the prestigious journal Nature Communications , with ... "We made the surprising discovery that a protein ...
(Date:4/21/2014)... ROCHESTER, Minn. Acute respiratory distress syndrome is ... Patients who develop the lung disorder postoperatively are ... and those who survive the syndrome may still ... A Mayo Clinic-led study is helping physicians better ... toward preventing this dangerous and costly surgical complication. ...
Breaking Medicine News(10 mins):Health News:Child's autism risk accelerates with mother's age over 30 2Health News:Child's autism risk accelerates with mother's age over 30 3Health News:FDA approves first targeted drug for advanced stomach cancer 2Health News:New tool helps doctors better predict, prevent deadly respiratory failure 2Health News:Scientists discover a new way to enhance nerve growth following injury 2Health News:Acute respiratory distress syndrome: Study IDs surgical patients at risk 2
... that Snake Bites are Becoming More Powerful and Patient Reactions ... marks a change in rattlesnake behavior as well. Snakes ... the rattlesnake is. In humans, a rattlesnake bite can ... the past couple of years we have seen an increase ...
... 5 Argus Health Systems, Inc., a leading provider ... Topor has been elected to the National Council for ... three-year term. The Board of Trustees oversees all Council ... development activities. Prior to the election, Topor, a 12-year ...
... support the use of lower cost sharing as an incentive ... in order to reduce costs, according to survey data published ... have been interested in bringing aspects of "consumerism" into health ... 2009 EBRI Notes , which reports the survey data. ...
... aggressive goals to expand nationwide, Wellspring ... Development. Bill will spearhead the newly formed Network Development Division ... in 2010. He is responsible for making Wellspring a household ... former Fortune 100 senior executive with healthcare, insurance and leading ...
... revenues grow by 31% and gross profit increases 85%ROCHESTER, N.Y., ... a leading provider of quantitative imaging for clinical trials, announced ... over $2.1 million, a 31% increase over prior year,s first ... was $1,119,786 compared to $604,119 in the first quarter of ...
... Advisory Board Will Host ,Day of Dialogue, Online Town Hall ... 5, 2009 America,s healthcare and long-term services need to ... of today,s seniors and people with disabilities, according to a ... The report, which will be supported by a nationwide ...
Cached Medicine News:Health News:As the Weather Warms Up Rattlesnakes Come Out to Enjoy the Sun Just as Californians Do 2Health News:New Research from EBRI: Many Support Lower Cost Sharing to Change Health Care System Use 2Health News:Wellspring Hires William Young and Prepares for Nationwide Expansion 2Health News:VirtualScopics Reports Record Revenues and Gross Profit in the First Quarter 2Health News:VirtualScopics Reports Record Revenues and Gross Profit in the First Quarter 3Health News:VirtualScopics Reports Record Revenues and Gross Profit in the First Quarter 4Health News:VirtualScopics Reports Record Revenues and Gross Profit in the First Quarter 5Health News:VirtualScopics Reports Record Revenues and Gross Profit in the First Quarter 6Health News:National Advisory Board Issues 'Declaration for Independence': A Call-to-Action in Healthcare for Seniors and People with Disabilities 2Health News:National Advisory Board Issues 'Declaration for Independence': A Call-to-Action in Healthcare for Seniors and People with Disabilities 3
(Date:1/15/2014)... , Jan. 15, 2014 Most osteoporosis patients ... to a recent online survey* sponsored by Mission Pharmacal ... the National Osteoporosis Foundation online support community, revealed that ... medication that comes in a form other than a ...
(Date:1/15/2014)... , Jan. 15, 2014  Celsion Corporation (the "Company") (NASDAQ: ... commitments from institutional investors to purchase an aggregate of ... an at-the-market registered direct offering, led by a dedicated ... definitive purchase agreements with these investors pursuant to which ...
(Date:1/15/2014)...  Manufacturers, suppliers and distributors of innovative medical-related products ... most important business assets, intellectual property (IP). ... Because of the highly-competitive nature of the Medical ... most litigious industry sectors of cases involving IP ...
Breaking Medicine Technology:Mission Pharmacal Conducts Online Survey of Osteoporosis Patients 2Mission Pharmacal Conducts Online Survey of Osteoporosis Patients 3Celsion Corporation Announces $15 Million At-The-Market Registered Direct Offering 2Celsion Corporation Announces $15 Million At-The-Market Registered Direct Offering 3Intellectual Property Insurance for Medical-related Products and Services 2
... 2010 Abbott Diabetes Care today announced that it ... million strips) of Precision Xtra®, Precision Xceed Pro®, MediSense® ... Strips in the United States and Puerto Rico. ... Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium and ...
... 2010 Heska Corporation (Nasdaq: HSKA ) announces ... to Its Special Meeting of Stockholders on the WebWhen: , ... (click on the Special Meeting of Stockholders link on ... Internet -- Simply log on to the web at the ...
Cached Medicine Technology:Abbott Diabetes Care Announces Recall of Certain Lots of Precision Xtra®, Precision Xceed Pro®, MediSense® Optium™, Optium™, OptiumEZ and ReliOn® Ultima Blood Glucose Test Strips in the United States and Puerto Rico 2Abbott Diabetes Care Announces Recall of Certain Lots of Precision Xtra®, Precision Xceed Pro®, MediSense® Optium™, Optium™, OptiumEZ and ReliOn® Ultima Blood Glucose Test Strips in the United States and Puerto Rico 3Abbott Diabetes Care Announces Recall of Certain Lots of Precision Xtra®, Precision Xceed Pro®, MediSense® Optium™, Optium™, OptiumEZ and ReliOn® Ultima Blood Glucose Test Strips in the United States and Puerto Rico 4Abbott Diabetes Care Announces Recall of Certain Lots of Precision Xtra®, Precision Xceed Pro®, MediSense® Optium™, Optium™, OptiumEZ and ReliOn® Ultima Blood Glucose Test Strips in the United States and Puerto Rico 5Abbott Diabetes Care Announces Recall of Certain Lots of Precision Xtra®, Precision Xceed Pro®, MediSense® Optium™, Optium™, OptiumEZ and ReliOn® Ultima Blood Glucose Test Strips in the United States and Puerto Rico 6Webcast Alert: Heska Corporation's Special Meeting of Stockholders Webcast 2
PremierEdge Stab Knives - 15....
DCR Set, Straight....
... CORNEO-GAGE PLUS pachometers are acknowledged to be ... measurement-reproducible pachometers available. These benefits are due ... transducers and smallest tip footprint available coupled ... average for every displayed reading. Thus corneal ...
... Leica CM1850 cryostat for standard ... laboratory is designed for easy ... A new insulation technology used, ... refrigerating system and maintains stable ...
Medicine Products: