Alle Storys
Folgen
Keine Story von Intercell AG mehr verpassen.

Intercell AG

euro adhoc: Intercell AG
Joint Ventures/Cooperation/Collaboration / Intercell's investigational vaccine against Japanese Encephalitis shows excellent safety and immunogenicity in Phase II trials in children

  Disclosure announcement transmitted by euro adhoc. The issuer is responsible
  for the content of this announcement.
Research & Development
15.04.2008
» Japanese Encephalitis (JE) Vaccine meets primary endpoints in Phase
II   trials in children » The results fully support Intercell's 
development plan for endemic regions   and pave the way towards late 
stage development and licensure - planned for   late 2009 / early 
2010
Vienna (Austria), April 15, 2008 - Intercell AG and its partner 
Biological E. Ltd. (Hyderabad, India) today announced the analysis of
Phase II data for its investigational pediatric vaccine against 
Japanese Encephalitis.
The randomized and controlled study shows an excellent safety and 
immunogenicity profile amongst children in endemic areas. The study 
which started in 2007 enrolled 60 healthy children at the age of one 
to three years.
The seroconversion rate of the test vaccine (given in two doses at 
days 0 and 28) in the IC51-3mcg dose group ("half adult dose") was 96
% and thus comparable to seroconversion rates observed in adults in 
former pivotal Phase III clinical trials.
Also the geometric mean titers (GMT of about 200) observed at day 56 
after the first vaccination for recipients in the "half adult dose" 
group were in a similar range to the ones recorded in the pivotal 
Phase III trials for adults. The safety profiles of IC51 in children 
were very favorable and are fully in line with the data obtained from
the broad Phase III safety studies in adults.
In summary the data suggest that IC51 in young children (one to three
years of age) has a comparable excellent immunogenicity and safety 
profile as in adults even if only half of the adult dose is applied. 
This allows Intercell and its partner Biological E. to enter into 
late stage development towards the licensure of the vaccine for the 
use in children in India and other parts of South East Asia. Start of
Phase III clinical trials in India are planned for end 2008/early 
2009.
"These results clearly confirm our straight forward development 
process and leadership for our Japanese Encephalitis vaccine for 
children, which are living in endemic areas and are threatened by 
this terrible disease. We are now even more encouraged to enforce all
necessary activities to make our novel product also available to the 
children in Asia in the fastest possible way.", states Gerd 
Zettlmeissl, Chief Executive Officer of Intercell AG.
Vijay Kumar Datla, Chairman and Managing Director of Biological E. 
Ltd added: "The success of this Phase II study is a significant 
milestone in our program. With these encouraging study results we 
hope to accelerate the program and make the product available at the 
earliest for the protection of vulnerable pediatric and adult 
population living in JE endemic regions."
Besides the approval and launch of Intercell's investigational 
vaccine against Japanese Encephalitis for adult travelers and 
military personnel in Europe, USA and Australia, the development of a
vaccine to prevent children in endemic areas from Japanese 
Encephalitis, is a major goal.
About Japanese Encephalitis
Japanese encephalitis is the most important cause of viral 
encephalitis in Asia. The Japanese encephalitis virus (JEV) is 
estimated to cause at least 50 000 cases of clinical disease every 
year, mostly in children younger than 10 years. The disease is 
endemic in Southeast Asia, a region with more than 3 billion 
inhabitants. Only within 1 month in the year 2005, Japanese 
encephalitis killed more than 1200 children during an epidemic 
outbreak in Uttar Pradesh, India, and Nepal.
About Biological E. Ltd
Over the last 50 years, Biological E. Ltd. (BE) has been a leading 
vaccine and pharmaceutical company. The company produces a range of 
critical vaccines and has been an active partner in the National 
Immunization Program of India. The company is currently commissioning
large scale cGMP facilities in order increase its capacities and 
product range to offer these vaccines on a global basis. In addition 
to its current pipeline of combination vaccines that are entering 
pivotal trials, BE has R&D programs to develop novel vaccines for 
both vector borne and enteric diseases. The company has entered into 
a number of strategic collaborations with leading biotech companies 
and research institutes for basic R&D. Biological E. is a privately 
held company. Biological E will manufacture Intercell´s JE vaccine 
for the Asian markets and will exclusively market and distribute the 
product in India, Nepal, Bhutan and Bangladesh. For more information 
please visit: www.biologicale.com
end of announcement                               euro adhoc

Further inquiry note:

Intercell AG
Lucia Malfent
Head of Communications
Tel. +43 1 20620-303
lmalfent@intercell.com

Branche: Biotechnology
ISIN: AT0000612601
WKN: A0D8HW
Börsen: Wiener Börse AG / official market

Weitere Storys: Intercell AG
Weitere Storys: Intercell AG