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 Health & Beauty | August 2006 
Clinical Study Of Vaccine Patch For Travelers' Diarrhea Continues
 pharma-lexicon.com
Iomai Corporation announced today that it has begun enrollment of a Phase 2 trial designed to test its vaccine patch for travelers' diarrhea in volunteers traveling to sites in Mexico and Guatemala. The field test will provide the investigators with the crucial information needed to launch a Phase 3 trial of the needle-free vaccine.
The placebo-controlled study is designed to assess the safety of the vaccine and the frequency of enterotoxigenic E. coli (ETEC) infection in volunteers traveling to sites where the disease is endemic and offer other details that will be key for the coming Phase 3 trial. Most cases of travelers' diarrhea are caused by ETEC, and as many as 50 percent of travelers to areas where the bacteria is endemic are sickened over a one- to two-week period. No ETEC vaccine is available in the United States.
"The Phase 2 field test sets the groundwork for our pivotal trial of the travelers' diarrhea vaccine, which may offer advanced, needle-free protection from a common bacterial infection," said Stanley C. Erck, President and Chief Executive Officer of Iomai. "This study is part of a comprehensive Phase 2 development program also designed to assess the ideal dose and formulation of the patch, as well as gather data on how the vaccine patch can be applied."
Participants in the field study must be traveling to sites in and around Cuernavaca or Guadalajara, Mexico or Antigua, Guatemala. For more information on how to volunteer for the field study, please visit http://www.trekstudy.com.
Based on Iomai's novel transcutaneous immunization (TCI) technology, the patch works by delivering vaccine to a group of antigen-presenting cells in the skin called Langerhans cells, which transport the vaccine to nearby lymph nodes to produce a sustained immune response.
ABOUT IOMAI CORPORATION
Iomai Corporation discovers and develops vaccines and immune system stimulants, delivered via a novel, needle-free technology called transcutaneous immunization (TCI). TCI taps into the unique benefits of a major group of antigen-presenting cells found in the outer layers of the skin (Langerhans cells) to generate an enhanced immune response. Iomai is leveraging TCI to enhance the efficacy of existing vaccines, enable new vaccines that are viable only through transcutaneous administration and expand the global vaccine market. Iomai currently has four product candidates in development: three targeting influenza and pandemic flu and one to prevent E. coli-related travelers' diarrhea.
For more information on Iomai, please visit http://www.iomai.com. |
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