GAITHERSBURG, Md., Aug. 15 /PRNewswire-FirstCall/ -- 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 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 www.iomai.com.
Some matters discussed in this press release constitute “forward-looking statements” that involve known and unknown risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward-looking statements. Such forward-looking statements include statements about the enrollment of volunteers for the trials described in this press release, Iomai’s ability to obtain information from these trials sufficient to launch larger Phase 3, and the design, execution and goals of the Phase 2 development program for Iomai’s travelers’ diarrhea vaccine. Applicable risks and uncertainties include, among others, that results in the trials described in this press release may not provide the needed information necessary to conduct future Phase 2 and Phase 3 trials, that Iomai may not be able to enroll sufficient numbers of patients in these and future clinical trials; that future clinical trials may not replicate results seen in the trials described in this press release; that Iomai may be unable to obtain the regulatory approvals necessary to conduct additional clinical trials or to market any product candidates for travelers’ diarrhea; that development costs may exceed expectations; that Iomai may fail to adequately protect its intellectual property or may be determined to infringe on the intellectual property of others; and the risks identified under the heading “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the three months ended June 30, 2006 and its Annual Report on Form 10-K for the year ended December 31, 2005 and filed with the Securities and Exchange Commission. IOMAI cautions investors and others not to place undue reliance on the forward-looking statements contained in this press release. You are encouraged to read the Company’s filings for a discussion of these and other risks and uncertainties which are filed with the U.S. Securities and Exchange Commission, available at www.sec.gov.
These statements speak only as of the date of this document, and IOMAI undertakes no obligation to update or revise the statements.
Iomai Corporation
CONTACT: Russell P. Wilson, Senior Vice President, Chief Financial Officerand General Counsel, of Iomai Corporation, +1-301-556-4478 orinvestors@iomai.com; or Daryl Messinger of WeissComm Partners, Inc.,+1-415-999-2361 or daryl@weisscommpartners.com, for Iomai Corporation
Web site: http://www.iomai.com/
