COVENTRY, England, April 6 /PRNewswire-FirstCall/ -- Iomai Corporation announced today the completion of a Phase 1/2 clinical trial in which its dry vaccine patch for travelers’ diarrhea achieved high immune responses in those vaccinated and outperformed its earlier liquid-based patch. Iomai’s Chief Scientific Officer Gregory Glenn, M.D., presented the data today at the Society for General Microbiology’s 158th Meeting in the United Kingdom.
In this U.S. study, the Company enrolled 160 subjects to compare its new dry patch formulation with its prior wet patch. One hundred subjects were dosed using a dry formulation and 60 subjects have been dosed using the prior wet formulation. The study was designed to determine whether immune responses after wearing the dry patch formulation were equal to those obtained with wet patches. Subjects were tested weekly for immune responses to enterotoxigenic E. coli (ETEC), the major cause of travelers’ diarrhea. By the second week, the fold rise in antibodies to the ETEC antigen in the dry patch groups were significantly greater for all time points. In addition, dry patch recipients had greater than 95 percent seroconversion rates with one dose.
“Our dry vaccine patch is easy to apply and well tolerated, and the patch delivers the vaccine to the immune system remarkably well. We are very encouraged by the high seroconversion rates after one dose,” said Dr. Glenn.
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.
E. coli-related Diarrhea
Most cases of travelers’ diarrhea are caused by enterotoxigenic E. coli bacteria (ETEC), and the Centers for Disease Control and Prevention (CDC) estimates that 20 percent to 50 percent of travelers to areas where the bacteria is endemic are sickened over a one- to two-week period. The international market for a vaccine has been estimated at $450 million annually, and there are currently no approved vaccines in the United States against travelers’ diarrhea caused by ETEC.
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, develop 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 IOMAI ‘s ability to stimulate stronger immune responses, ease of application and tolerability of the dry patches and the estimated size of the travelers’ diarrhea market. Applicable risks and uncertainties include, among others, that results in future Phase 2 and Phase 3 trials may not replicate results seen in the trials described in this press release; that IOMAI may not be able to enroll sufficient numbers of patients in future clinical trials; 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 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/
