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Merck & Co., Inc. (MRK) and Intercell AG Announce Termination of Phase II/III Clinical Trial of Investigational Staphylococcus aureus Vaccine, V710
6/8/2011 6:26:41 AM
WHITEHOUSE STATION, N.J. & VIENNA--(BUSINESS WIRE)-- Merck (NYSE:MRK - News), known as MSD outside the United States and Canada, and Intercell AG (VSE:ICLL.v - News) today announced that following a detailed analysis of the data from the Phase II/III clinical trial evaluating V710, an investigational vaccine for the prevention of Staphylococcus aureus (S. aureus) infection, the independent Data Monitoring Committee (DMC) has unanimously recommended termination of the study.
As previously announced, following a pre-planned meeting in April, the DMC informed Merck that the trial had not met the formal futility criteria. However, the DMC recommended that enrollment in the Phase II/III clinical trial be suspended pending completion by Merck of additional analyses on the benefits and risks of vaccination. Following further review of the statistical analyses by the DMC -- which also considered events that had occurred after the pre-specified data cutoff date utilized for the April meeting -- the recommendation to terminate was made based upon both the observation that V710 was unlikely to demonstrate a statistically significant clinical benefit as well as a safety concern regarding overall mortality and multi-organ dysfunction that occurred with greater frequency in vaccine recipients, compared with placebo recipients. In the additional analyses that were performed, this safety difference was not found to be statistically significant and was also determined not to warrant any action beyond routine safety follow-up. Merck plans to present the final detailed findings of the clinical trial at an upcoming medical meeting.
About S. aureus
S. aureus is the most frequent cause of hospital-acquired infections. In addition to bloodstream infections with a mortality rate of up to 35 percent, infections of bone, heart and other inner organs can often lead to serious health complications, death and economic burden. Today, approximately 50 percent of S. aureus strains isolated in hospitals worldwide are resistant to multiple antibiotics, rendering staphylococcal disease management increasingly difficult and challenging.
Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com.
About Intercell AG
Intercell AG is a vaccine-biotechnology company with the clear vision to develop and commercialize novel immunomodulatory biologicals to prevent disease and reduce suffering around the world.
Intercell's vaccine to prevent Japanese Encephalitis is the Company's first product on the market.
The Company's technology platform includes novel platforms, such as the patch based delivery system or the proprietary human monoclonal antibody discovery system eMab®, in addition to the well established technologies through which Intercell has materialized strategic partnerships with a number of leading pharmaceutical companies, including GSK, Novartis, Merck & Co., Inc., sanofi-aventis.
The Company's pipeline of investigational products includes a development program for the pediatric use of Intercell´s JE-Vaccine IXIARO® in endemic (in collaboration with partner Biological E) and non-endemic markets. Furthermore, a Pseudomonas aeruginosa vaccine candidate (Phase II/III) with Novartis, a vaccine to prevent Pandemic Influenza by combining our Vaccine Enhancement Patch with an injected vaccine (Phase I), a vaccine program for S. aureus, which is being developed by Merck & Co., Inc. (Phase II/III), as well as a combination treatment approach for Hepatitis C (Phase II) with Romark, and a vaccine candidate against infections with C. difficile entered Phase I clinical trials in 2010 are in clinical trials.
Intercell is listed on the Vienna Stock Exchange under the symbol "ICLL" (U.S. level one ADR symbol "INRLY").
For more information, please visit: www.intercell.com