WILMINGTON, North Carolina, June 3, 2010 /PRNewswire/ -- Intercell AG has retained Inclinix, Inc., to recruit volunteers for their Phase III clinical trial of an investigational 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 innovative 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, with nearly 20 million of those travelers developing 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.
Inclinix, a Wilmington, North Carolina, USA-based clinical trial enrolment solutions provider, will utilize its innovative recruitment tactics to drive the enrolment of 1800 volunteers in Western Europe beginning in April 2009. Current departure cities where clinics are conducting the TREK Study are Belfast, Glasgow, London, Manchester, Birmingham and Reading in the UK and Berlin, Munich, Potsdam and Hamburg in Germany.
We are pleased that Intercell AG has chosen Inclinix as their partner for the Trek Study, says J. Tobin Geatz, President and CEO, Inclinix. We look forward to the opportunity to contribute to the development of this novel vaccine that has such potential to make a truly global medical impact.
Travel to Guatemala and the surrounding countries increased 13% in 2007, while Mexico was cited as the 10th most visited country in the world with almost 20 million arrivals in-country. These findings coincide with Intercell's interest in reaching large numbers of travelers interested in experiencing Guatemala or Mexico.
TREK travel specialists will be in contact with volunteers through a variety of communication methods, building excitement and providing helpful study and travel information. The TREK research study web site http://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 for participation, along with pre-paid mobile phones and welcome kits with useful travel tools.
About the TREK Study
Based on the Phase II safety and efficacy data, this pivotal Phase III trial will follow approximately 1800 healthy volunteers age 18+ to Mexico and Guatemala. 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 primary 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 USA, Inc. is a subsidiary of 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's technology platforms include an antigen-discovery system, adjuvants and a novel patch-based delivery system (Vaccine Patch, Vaccine Enhancement Patch). Based on these technologies, Intercell has strategic partnerships with a number of global pharmaceutical companies, including GSK, Novartis, Merck Co., Inc., Sanofi Pasteur, and Wyeth.
For more information on Intercell, please visit: http://www.intercell.com
About Inclinix, Inc.
Inclinix, Inc., a global clinical trial solutions provider specializing in customized Phase I-IV clinical trial enrolment solutions. Comprehensive enrolment solutions include site recruitment, patient recruitment, clinical and medical marketing, monitoring, and patient compliance and education. Inclinix corporate headquarters is located in Wilmington, North Carolina USA, with additional offices in Annapolis, Maryland USA, and Gothenburg, Sweden. http://www.inclinix.com
SOURCE: Inclinix, Inc.
CONTACT: Kristin Sacre, +1-910-332-2682, ksacre@inclinix.com
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