TEMECULA, Calif., Jan. 15 /PRNewswire/ -- LifeTree eClinical, a member of the FFF Enterprises Inc. family of companies and a leading provider of clinical electronic data capture and analysis systems, today announced the company will be managing a Phase II trial for a vaccine patch for traveler’s diarrhea caused by E. coli. The field test will provide the investigators with important information needed to launch a Phase III trial of the needle-free vaccine.
“We are pleased to be managing a clinical trial that may help prevent one of the common side effects of traveling,” said Patrick M. Schmidt, president and CEO of LifeTree and FFF Enterprises. “In today’s global economy, the frequency of international travel increases exposure to bacteria, so this study could ultimately provide an important addition to the healthcare safety precautions we should all be practicing.”
The placebo-controlled study is designed to assess the safety of the vaccine and the frequency of E. coli infection in volunteers traveling to sites where the bacteria is endemic, and to offer other details that will be key for the coming Phase III trial.
“Iomai is excited to work with LifeTree on the trial. This effort will provide crucial information about the vaccine and the disease as we prepare to enter late-stage trials,” said Stanley C. Erck, president and CEO of Iomai. “The vaccine could fill a significant need: as many as 50 percent of travelers to areas where enterotoxigenic E. coli is endemic are sickened, yet no vaccine is available in the United States.”
About LifeTree eClinical
LifeTree eClinical is a member of the FFF Enterprises Inc. family of companies, headquartered in Temecula, California. The LifeTree suite of clinical technologies and services has been used in Phase I through IV trials, patient registries and diagnostic and epidemiological studies. The LifeTree ICTM component of the LifeTree eClinical suite provides tools for clinical study design, data entry and data reporting. The suite is completely workflow driven and contains extensive clinical trial metrics and trial management tools that are built-in for designated roles within the clinical trial process. SAS data on demand and a complete menu for building data reports fully empower a study’s data analyst. The clinical data is fully audit trailed, and it is CDISC- and 21 CFR Part 11-compliant. For more information, call 800-211-2799 ext 1358, email info@lifetree-tech.com or visit www.lifetreeclinical.com.
Contact: K-B Gressitt VP of Communications P: 800-843-7477 x 1143 C: 760-522-1064
LifeTree eClinical
CONTACT: K-B Gressitt, VP of Communications of LifeTree eClinical,+1-800-843-7477, ext. 1143, or cell, +1-760-522-1064
Web site: http://www.lifetreeclinical.com/
