Intercell AG Partners with Inclinix to Enroll 1800 Volunteers for Phase III Travelers' Diarrhea Vaccine Study
This year, approximately 55 million international travelers will visitcountries where bacteria that cause TD are endemic, particularly Africa, Asiaand Latin America, and nearly 20 million of those travelers develop TD. Theeffects extend beyond the acute symptoms of the disease; between 10 and 30percent of those who develop TD will develop the chronic symptoms of irritablebowel syndrome. If approved, this would be the first vaccine for TD availablein the US.
Inclinix, a Wilmington, NC-based clinical trial enrollment solutionsprovider, will utilize its innovative recruitment tactics to drive theenrollment of 1200 volunteers in the US and 600 in Western Europe beginning inApril 2009.
"We are pleased that Intercell AG has chosen Inclinix as their partner forthe TD study," says J. Tobin Geatz, President and CEO, Inclinix. "We lookforward to the opportunity to contribute to the development of this novel drugthat has potential to make a truly global impact on the medical community."
The recruitment strategy for this study, appropriately named the "TrekStudy" (www.TrekStudy.com), centers on reaching out to specific groups mostlikely to respond to free travel to Mexico or Guatemala while focusing on thesocial and altruistic impacts of clinical trial participation.
In order to build awareness of the Trek Study, Inclinix has developedpartnerships with major travel and tourism websites. In addition, RecruitmentMonitors -- in-field enrollment experts -- will execute events in communitiesnear investigators' sites. "Traditional media combined with a strong relevantsocial and mobile networking presence is a fundamental element of thisenrollment campaign," explains Diane Montross, Director of Patient Recruitmentfor Inclinix. "We are thrilled to be using such innovative solutions to getthe message out. Social communication avenues allow Inclinix to reach aunique audience. We are defining the next patient recruitment landscape."
Trek Study coordinators will be in contact with volunteers through avariety of online and print communications, building excitement and providinghelpful study and travel information. The Trek Study websitewww.TrekStudy.com, allows interested participants to register to receivecontinuously updated information on topics such as travel destinations, grouptravel and study compensation. Volunteers will receive compensation of up to$1500 for participation, along with pre-paid mobile phones and welcome kitswith useful travel tools. In a groundbreaking effort to encourage grouptravel, the Trek Study also features a program that provides referralcompensation to refer friends.
About the Trek Study
Based on compelling Phase II safety and efficacy data, this pivotal PhaseIII trial will follow approximately 1800 healthy volunteers age 18+ to Mexicoand Guatemala, beginning in April 2009. Volunteers will receive two doses ofthe TD vaccine or a placebo, two weeks apart, with the last dose at leastseven days prior to travel. Volunteers will then be surveyed via diary andvisits for 17 days. The purpose of this trial is to evaluate the efficacy ofthe TD vaccine system.
The successful Phase II study followed 170 healthy travelers aged 18-64 toMexico and Guatemala. The study found that of the 59 individuals who receivedthe vaccine, only three suffered from moderate or severe diarrhea, while 23 ofthe 111 receiving a placebo suffered from moderate or severe diarrhea, a 75percent reduction (p=0.007). No vaccine-related serious adverse events werereported.
About Intercell AG
Intercell AG is a growing biotechnology company which focuses on thedesign and development of novel vaccines for the prevention and treatment ofinfectious diseases with substantial unmet medical need. The Company developsantigens and adjuvants, which are derived from its proprietary technologyplatforms, and has in-house GMP manufacturing capabilities. Based on thesetechnologies, Intercell has strategic partnerships with a number of globalpharmaceutical companies, including Novartis, Merck & Co., Inc., Wyeth, SanofiPasteur, Kirin, and the Statens Serum Institut.
Intercell is listed on the Prime Market of the Vienna Stock Exchange underthe symbol "ICLL"
Inclinix, Inc. specializes in customized Phase I-IV clinical trialenrollment solutions that deliver productive investigator sites and qualifiedpatients resulting in successfully completed clinical trials for thepharmaceutical, biotech and medical device industry. Clients benefit from tenyears of experience in multiple therapeutic areas, as well as leading edgetechnologies that meet the challenge of clinical development from feasibilitythrough compliance.
For more information please visit: www.inclinix.com.ISIN: AT0000612601 For more information please visit: www.intercell.com
SOURCE Inclinix, Inc.
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