VIENNA, Austria, Aug. 28 Intercell AG (VSE: ICLL) todayannounced that its collaborator Merck & Co., Inc. has initiated a Phase IIclinical trial of V710, an investigational vaccine for the prevention ofStaphylococcus aureus (S. aureus) infections. This randomized double blind,placebo controlled study aims to evaluate the safety and immunogenicity of thevaccine candidate in patients with end-stage kidney disease on hemodialysis.This trial start follows the initiation of a separate Phase II trial inDecember 2007.
Gerd Zettlmeissl, CEO of Intercell, commented "We are very pleased thatour strategic partner Merck has chosen to initiate a further Phase II clinicaltrial. We look forward to continued progress of the program building onclinical data obtained so far."
The S. aureus vaccine candidate is based on a conserved protein antigendiscovered by Intercell and licensed to Merck & Co., Inc. in 2004 on anexclusive worldwide basis. Merck is responsible for clinical development,manufacturing and marketing. Intercell is eligible to receive milestonepayments and royalties on future net sales. In Phase I clinical trials theS. aureus candidate vaccine was shown to be immunogenic and generally welltolerated.
Hospital-acquired infections caused by bacteria are one of the majorcauses of death and serious illness. Intercell has embarked on a large scale,comprehensive and multi-target antigen identification program to contribute tovaccine efforts in this field. Besides Merck's S. aureus vaccine, based on anantigen identified by Intercell, Intercell is developing a vaccine againsthospital-acquired infections caused by Pseudomonas aeruginosa (Phase II/IIItrial is expected to be initiated in 2008) and a Pneumococcus vaccine (Phase Itrials planned for end 2008). Furthermore Intercell has ongoing pre-clinicalprograms for Enterococcus and Klebsiella vaccine discovery.
About S. aureus
S. aureus is the most frequent cause of hospital-acquired infections. Inaddition to bloodstream infections with a mortality rate of up to 35%,infections of bone, heart and other inner organs are leading to serious healthcomplications, death and economic burden. Today, approximately 50% ofS. aureus strains isolated in hospitals worldwide are resistant to multipleantibiotics, rendering staphylococcal disease management increasinglydifficult and challenging. Hospital-acquired infections are one of the majorcauses of death and serious illness worldwide, resulting in an annual burdenof more than USD 20 billion in the developed world. In the United Statesalone, about two million patients become infected annually while receivinghealth care in hospitals.
About Intercell AG
Intercell AG is a growing biotechnology company which focuses on thedesign and development of novel vaccines for the prevention and treatment ofinfectious diseases with substantial unmet medical need. The Company developsantigens and adjuvants which are derived from its proprietary technologyplatforms and has in-house GMP manufacturing capabilities. Based on thesetechnologies, Intercell has strategic partnerships with a number of globalpharmaceutical companies, including Novartis, Merck & Co., Inc., Wyeth, SanofiPasteur, Kirin, and the Statens Serum Institut.
The Company's leading product, a prophylactic vaccine against JapaneseEncephalitis, successfully concluded pivotal Phase III clinical trials in 2006and is currently in the process of market approval in the US, Europe,Australia and Canada. Market approval in the US, Europe and Australia isexpected for the second half of 2008.
The company's broad development pipeline includes a Travelers' Diarrheavaccine (patch) in Phase II (start of Phase III expected in 2009), aPseudomonas vaccine in Phase II, as well as an immunostimulant vaccine patchin pandemic Flu, a partnered S.