Intercell Completes Phase I Clinical Trial for an Improved Seasonal Influenza Vaccine Formulated with IC31
» Intercell's adjuvant IC31® demonstrates very good
safety and tolerability profile in first Phase I trial in Flu
» Seroconversion and seroprotection rates support further
clinical development
» Intercell’s strategic Flu partner Novartis to include
IC31® in further clinical trials
VIENNA, Austria, February 27, 2008 – Intercell AG (VSE: ICLL)
today announced the completion of Phase I clinical trials of the
company's adjuvant IC31 in combination with the seasonal, trivalent
influenza vaccine Agrippal from Novartis.
In this randomized, controlled Phase I trial, 72 individuals
received one shot of either Agrippal®, or Agrippal®
combined with one of two different concentrations of IC31®. All
study subjects were healthy, adult volunteers, with an average age
of approximately 31 years. The majority of participants had
pre-existing immune responses against influenza strains prior to
the trial. Subjects were followed for general safety and local
tolerability. Vaccine specific immune responses were analyzed 10
and 21 days after the vaccination. The study was conducted at
Vienna Medical University, Department of Clinical
Pharmacology
The IC31® adjuvanted vaccine showed - even in the highest
IC31® dose group - an excellent safety and tolerability
profile, which was comparable to the non-adjuvanted standard
vaccine. Furthermore in all study groups vaccination with the test
vaccine led to the induction of virus specific T-cells and
protective levels of antibody responses against the three included
influenza
strains
"We are excited about the excellent safety and tolerability profile
of our IC31® in combination with seasonal influenza antigens in
humans", states Gerd Zettlmeissl, Chief Executive Officer of
Intercell. "This result in combination with the outstanding
immunogenicity data in immuno-compromised animals has paved the way
towards the development of improved Flu vaccines."
IC31® has potential as adjuvant for improved influenza
vaccines. Novartis will include IC31® in its further clinical
development program.
More influenza vaccines are needed with superior immune-response
and excellent crossprotection against drifted influenza viruses in
the elderly, the age group with the greatest number of death from
the annual influenza outbreaks.
As part of the agreement between Novartis and Intercell, signed in
July 2007, Novartis has an exclusive license for development of
Intercell’s IC31® adjuvant in novel influenza vaccines
with milestones for Intercell of up to approximately EUR 100 m
during the development period and double-digit royalty rates tied
to sales performance.
About IC31®
Vaccines, based on antigens alone, are not sufficient to provide
full protection. Adjuvants are needed to educate the immune system
to recognize and eliminate the pathogens efficiently. IC31® is
an adjuvant that induces T-cell and B-cell responses by using a
unique synthetic formulation which combines the immunostimulating
properties of an anti-microbial peptide, KLK, and an
immunostimulatory oligodeoxynucleotide, ODN1a. The two component
solution can be simply mixed with antigens; no conjugation is
required.
Intercell currently uses IC31® in collaborations with a number
of global vaccine companies and biotech companies. These
collaborations include amongst others the development of a
tuberculosis vaccine in Phase I clinical trials, which has been
partnered with the Danish Statens Serum Institut and Sanofi
Pasteur.
About Influenza
The flu is a contagious respiratory illness caused by influenza
viruses. The infection usually lasts for about a week. It is
characterized by sudden onset of high fever, myalgia, headache and
severe malaise, non-productive cough, sore throat, and rhinitis.
From 1918 to 1919, the "Spanish Flu" killed more people in the
world-wide pandemic than did the First World War. Influenza viruses
cause disease among all age groups. Rates of infection are highest
among
children, but rates of serious illness and death are highest among
persons aged >65 years and children aged <2 years. Influenza
rapidly spreads around the world in seasonal epidemics and imposes
a considerable economic burden in the form of hospital and other
health care costs and lost productivity.
In annual influenza epidemics 5-15% of the population are affected
with upper respiratory tract infections. Hospitalization and deaths
mainly occur in high-risk groups. Although difficult to assess,
these annual epidemics are thought to result in between three and
five million cases of severe illness and between 250 000 and 500
000 deaths every year around the world.
Vaccination is the principal measure for preventing influenza and
reducing the impact of epidemics. The currently available, mostly
not adjuvanted vaccine products have a suboptimal efficacy profile,
especially in the population groups with the highest disease burden
(elderly and infants). Furthermore, these vaccines only offer
limited cross-protection against other influenza strains, with no
or low T-cell responses. Due to these limitations, novel vaccines
with improved efficacy and T-cell immunity are needed.
About Novartis’ adjuvanted Influenza vaccine programs
Novartis currently is the only vaccine manufacturer offering an
adjuvanted seasonal influenza vaccine, with more than 30 million
doses administered over the past 10 years. FLUAD, when compared to
currently available influenza vaccines, induced a higher level of
immune response, superior clinical effectiveness and protection
against a broader range of influenza strains in vulnerable
populations, at higher risk of post-influenza complications.
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. The Market Authorization Application (MAA)
in Europe as well as the Biological License Application (BLA) with
the US Food and Drug Administration (FDA) for the use of the
vaccine to prevent Japanese encephalitis were submitted in December
2007. The company’s broad development pipeline
includes a Pseudomonas vaccine in Phase II, a therapeutic vaccine
for Hepatitis C in Phase II, partnered vaccines for Tuberculosis
(Phase I) and Staphylococcus aureus (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: www.intercell.com
Contact Intercell AG:
Lucia Malfent
Head of Corporate Communications
Campus Vienna Biocenter 2, A?1030 Vienna
P: +43?1?20620?303
Mail to: LMalfent@intercell.com
This communication expressly or implicitly contains certain advance
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 advance statements.
Intercell AG is providing this communication as of this date and
does not update any advance statements contained herein as a result
of new information, future events or otherwise.
Posted: February 2008
