VIENNA, Austria, Aug. 28 – Intercell AG (VSE: ICLL) today
announced that its collaborator Merck & Co., Inc. has initiated a Phase II
clinical trial of V710, an investigational vaccine for the prevention of
Staphylococcus aureus (S. aureus) infections. This randomized double blind,
placebo controlled study aims to evaluate the safety and immunogenicity of
the vaccine candidate in patients with end-stage kidney disease on
hemodialysis. This trial start follows the initiation of a separate Phase
II trial in December 2007.
Gerd Zettlmeissl, CEO of Intercell, commented “We are very pleased that
our strategic partner Merck has chosen to initiate a further Phase II
clinical trial. We look forward to continued progress of the program
building on clinical data obtained so far.”
The S. aureus vaccine candidate is based on a conserved protein antigen
discovered by Intercell and licensed to Merck & Co., Inc. in 2004 on an
exclusive worldwide basis. Merck is responsible for clinical development,
manufacturing and marketing. Intercell is eligible to receive milestone
payments and royalties on future net sales. In Phase I clinical trials 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. aureus
vaccine, based on an antigen identified by Intercell, Intercell is
developing a vaccine against hospital-acquired infections caused by
Pseudomonas aeruginosa (Phase II/III trial is expected to be initiated in
2008) and a Pneumococcus vaccine (Phase I trials planned for end 2008).
Furthermore Intercell has ongoing pre-clinical programs for Enterococcus
and Klebsiella vaccine discovery.
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 a growing biotechnology company which focuses on the
design and development of novel vaccines for the prevention and treatment
of infectious diseases with substantial unmet medical need. The Company
develops antigens and adjuvants which are derived from its proprietary
technology platforms and has in-house GMP manufacturing capabilities. Based
on these technologies, Intercell has strategic partnerships with a number
of global pharmaceutical companies, including Novartis, Merck & Co., Inc.,
Wyeth, Sanofi Pasteur, Kirin, and the Statens Serum Institut.
The Company’s leading product, a prophylactic vaccine against Japanese
Encephalitis, successfully concluded pivotal Phase III clinical trials in
2006 and is currently in the process of market approval in the US, Europe,
Australia and Canada. Market approval in the US, Europe and Australia is
expected for the second half of 2008.
The company’s broad development pipeline includes a Travelers’ Diarrhea
vaccine (patch) in Phase II (start of Phase III expected in 2009), a
Pseudomonas vaccine in Phase II, as well as an immunostimulant vaccine
patch in pandemic Flu, a partnered S. aureus vaccine in Phase II and five
products focused on infectious diseases in preclinical development.
Intercell is listed on the Vienna stock exchange under the symbol
“ICLL”.
For more information please visit: http://www.intercell.com
This communication expressly or implicitly contains certain
forward-looking statements concerning Intercell AG and its business. Such
statements involve certain known and unknown risks, uncertainties and other
factors which could cause the actual results, financial condition,
performance or achievements of Intercell AG to be materially different from
any future results, performance or achievements expressed or implied by
such forward- looking statements. Intercell AG is providing this
communication as of this date and does not undertake to update any
forward-looking statements contained herein as a result of new information,
future events or otherwise.
SOURCE Intercell AG