Intercell AG Announces Initial Results of Phase II Clinical Trial Evaluating V710, an Investigational Staphylococcus Aureus Vaccine, in Patients with End-Stage Renal Disease
In the randomized double blind, placebo controlled study 201 patients received vaccine or placebo at 12 centers in the U.S. The study was designed to assess whether administration of V710 to ESRD patients receiving hemodialysis at high risk of developing serious S. aureus infections could increase the level of antibodies to the V710 antigen. The primary endpoints of the study were the change of antibody levels compared to baseline at 28 days after a 2-dose regimen provided 28 days apart and all adverse experiences for 14 days after each vaccination. Overall the immunogenicity data suggest that V710 can elicit a sustained immune response in a relatively immunocompromised patient population who are at chronic risk for developing serious S. aureus infections.
Overall, the results of the safety evaluations demonstrated that V710 was generally well tolerated when administered as a single- or multiple-dose regimen at any dosage group studied. There were no vaccine-related serious adverse experiences reported throughout the study duration (Days 1 to 360), and no patients discontinued the study or subsequent vaccinations due to a vaccine-related adverse experience.
Merck plans to present the data at an upcoming medical meeting.
"It is very encouraging to see that the S. aureus vaccine has proven immunogenic and was generally well tolerated in ESRD patients receiving hemodialysis. We are looking forward to the continued progress of the S. aureus program at our strategic partner Merck”, commented Gerd Zettlmeissl, CEO of Intercell.
The S. aureus vaccine candidate is based on a conserved protein antigen discovered by Intercell and licensed to Merck 2004 on an exclusive world wide basis. Merck is responsible for clinical development, manufacturing and marketing. Intercell is eligible to receive milestone payments and royalties on future net sales. In previous studies the S. aureus candidate vaccine was shown to be immunogenic and generally well tolerated.
Hospital-acquired infections
Hospital-acquired infections caused by bacteria are one of the major causes of death and serious illness. Intercell has embarked on a large scale, comprehensive and multi-target antigen identification program to contribute to vaccine efforts in this field.
Besides Merck's S. aureusvaccine, based on an antigen identified by Intercell, Intercell is developing a vaccine against hospital-acquired infections caused by Pseudomonas aeruginosa (Phase II). Furthermore, the vaccine candidate for the prevention of C. difficile is expected to enter Phase I clinical trials still in 2010.
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%, infections of bone, heart and other inner organs are leading to serious health complications, death and economic burden. Today, approximately 50% of S. aureus strains isolated in hospitals worldwide are resistant to multiple antibiotics, rendering staphylococcal disease management increasingly difficult and challenging. Hospital-acquired infections are one of the major causes of death and serious illness worldwide, resulting in an annual burden of more than USD 20 billion in the developed world. In the United States alone, about two million patients become infected annually while receiving health care in hospitals.
About Intercell AG
Intercell AG is an innovative biotechnology company that develops novel vaccines for the prevention and treatment of infectious diseases with substantial unmet medical needs. Intercell's vaccine to prevent Japanese Encephalitis is the Company's first product on the market.
The Company's technology platform includes an antigen-discovery system and human anti-infective monoclonal antibody discovery system, adjuvants and a novel patch-based delivery system (Vaccine Patch, Vaccine Enhancement Patch). Based on these technologies, Intercell has strategic partnerships with a number of global pharmaceutical companies, including GSK, Novartis, Merck & Co., Inc., sanofi-aventis, and Pfizer (formerly Wyeth).
The Company's pipeline of investigational products includes a Travelers' Diarrhea Vaccine Patch (Phase III), a Pseudomonas aeruginosa vaccine candidate (Phase II), a vaccine to prevent Pandemic Influenza combining our Vaccine Enhancement Patch with an injected vaccine (Phase II), a vaccine program for S. aureus, which is being developed with Merck & Co., Inc. (Phase II/III), as well as a vaccine candidate for Pneumococcus (Phase I). A vaccine candidate against infections with C. difficile is expected to enter Phase I clinical trials still in 2010. In addition, further products focused on infectious diseases are in pre-clinical development.
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
Contact Intercell AG
Intercell AG Lucia Malfent Head of Corporate Communications Campus Vienna Biocenter 3, A-1030 Vienna P: +43-1-20620-1303 Mail to: LMalfent@intercell.com