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Intercell AG Partners with Inclinix to Enroll 1800 Volunteers for Phase III Travelers’ Diarrhea Vaccine Study

January 19, 2009

WILMINGTON, N.C., Jan. 19 /PRNewswire/ — Intercell AG has retained
Inclinix, Inc., to recruit volunteers for their Phase III clinical trial of a
Travelers’ Diarrhea (TD) vaccine system. The TD vaccine is in the form of a
skin patch — a novel method for delivering a vaccine that is especially
compelling because it is needle-free.

This year, approximately 55 million international travelers will visit
countries where bacteria that cause TD are endemic, particularly Africa, Asia
and Latin America, and nearly 20 million of those travelers develop TD. The
effects extend beyond the acute symptoms of the disease; between 10 and 30
percent of those who develop TD will develop the chronic symptoms of irritable
bowel syndrome. If approved, this would be the first vaccine for TD available
in the US.

Inclinix, a Wilmington, NC-based clinical trial enrollment solutions
provider, will utilize its innovative recruitment tactics to drive the
enrollment of 1200 volunteers in the US and 600 in Western Europe beginning in
April 2009.

“We are pleased that Intercell AG has chosen Inclinix as their partner for
the TD study,” says J. Tobin Geatz, President and CEO, Inclinix. “We look
forward to the opportunity to contribute to the development of this novel drug
that has potential to make a truly global impact on the medical community.”

The recruitment strategy for this study, appropriately named the “Trek
Study” (www.TrekStudy.com), centers on reaching out to specific groups most
likely to respond to free travel to Mexico or Guatemala while focusing on the
social and altruistic impacts of clinical trial participation.

In order to build awareness of the Trek Study, Inclinix has developed
partnerships with major travel and tourism websites. In addition, Recruitment
Monitors — in-field enrollment experts — will execute events in communities
near investigators’ sites. “Traditional media combined with a strong relevant
social and mobile networking presence is a fundamental element of this
enrollment campaign,” explains Diane Montross, Director of Patient Recruitment
for Inclinix. “We are thrilled to be using such innovative solutions to get
the message out. Social communication avenues allow Inclinix to reach a
unique audience. We are defining the next patient recruitment landscape.”

Trek Study coordinators will be in contact with volunteers through a
variety of online and print communications, building excitement and providing
helpful study and travel information. The Trek Study website
www.TrekStudy.com, allows interested participants to register to receive
continuously updated information on topics such as travel destinations, group
travel and study compensation. Volunteers will receive compensation of up to
$1500 for participation, along with pre-paid mobile phones and welcome kits
with useful travel tools. In a groundbreaking effort to encourage group
travel, the Trek Study also features a program that provides referral
compensation to refer friends.

About the Trek Study

Based on compelling Phase II safety and efficacy data, this pivotal Phase
III trial will follow approximately 1800 healthy volunteers age 18+ to Mexico
and Guatemala, beginning in April 2009. Volunteers will receive two doses of
the TD vaccine or a placebo, two weeks apart, with the last dose at least
seven days prior to travel. Volunteers will then be surveyed via diary and
visits for 17 days. The purpose of this trial is to evaluate the efficacy of
the TD vaccine system.

The successful Phase II study followed 170 healthy travelers aged 18-64 to
Mexico and Guatemala. The study found that of the 59 individuals who received
the vaccine, only three suffered from moderate or severe diarrhea, while 23 of
the 111 receiving a placebo suffered from moderate or severe diarrhea, a 75
percent reduction (p=0.007). No vaccine-related serious adverse events were
reported.

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.

Intercell is listed on the Prime Market of the Vienna Stock Exchange under
the symbol “ICLL”

    ISIN: AT0000612601
    For more information please visit: www.intercell.com

About Inclinix

Inclinix, Inc. specializes in customized Phase I-IV clinical trial
enrollment solutions that deliver productive investigator sites and qualified
patients resulting in successfully completed clinical trials for the
pharmaceutical, biotech and medical device industry. Clients benefit from ten
years of experience in multiple therapeutic areas, as well as leading edge
technologies that meet the challenge of clinical development from feasibility
through compliance.

For more information please visit: www.inclinix.com.

SOURCE Inclinix, Inc.


Source: newswire



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