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Iomai Dose-Ranging Trial Demonstrates Needle-Free Patch Vaccine for Travelers' Diarrhea Stimulates Immune Response Even at Low Doses

Posted on: Thursday, 26 April 2007, 12:12 CDT

GAITHERSBURG, Md. and LISBON, Portugal, April 26 /PRNewswire-FirstCall/ -- Iomai Corporation today announced results from a 400-patient, Phase 2 dose-ranging trial of its patch-based vaccine for travelers' diarrhea. The trial was conducted to assess the ability of a range of vaccine doses to generate an immune response against enterotoxigenic E. coli (ETEC) bacteria -- the most common cause of travelers' diarrhea. Researchers found that even at the lowest dose tested, an Iomai patch applied to the arm generated a robust response in more than 95 percent of patients.

The results were presented today by Iomai's Vice President of Clinical Development, Sarah A. Frech, DVM, at the Vaccines for Enteric Diseases 2007 conference in Lisbon, Portugal.

"These results demonstrate the power of Iomai's technology by showing that even a small dose of vaccine, applied to the skin via a patch, is enough to stimulate a robust immune response. The data will help us determine the dose that we will use in our ETEC product," said Gregory M. Glenn, MD, Senior Vice President and Chief Scientific Officer of Iomai. "Iomai's research has shown that, in addition to showing potential benefits against ETEC, the active ingredient in the patch also works as an immune-boosting adjuvant when the patch is used in combination with injected vaccines for influenza. Thus, the results from the dose-ranging ETEC study will also help determine doses for future studies of the Iomai booster patch for seasonal and pandemic influenza."

Travelers' diarrhea sickens between 20 and 50 percent of international travelers to areas where the bacteria is endemic, but no ETEC vaccine is available in the United States. The existing strategy for avoiding travelers' diarrhea -- prophylactic antibiotics -- raises concerns about antibiotic resistance and drug side effects.

The dose-ranging trial was designed to measure levels of an antibody, IgG, that is associated with protection against enterotoxigenic E. coli. Four different doses -- 7.5 micrograms, 22.5 micrograms, 37.5 micrograms and 50 micrograms -- and a placebo patch were tested, and antibody levels were checked at 21 and 42 days. The results showed that nearly all patients in the four dosing groups responded to the vaccine, with even the lowest dose of the vaccine evoking a response in more than 95 percent of patients.

Iomai's ETEC vaccine uses "heat labile" toxin, or LT, produced by E. coli, to induce an immune response against the bacteria, and LT also functions as a potent adjuvant in the company's influenza patch programs.

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 five product candidates in development: four 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/ .

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 ability of Iomai's travelers' diarrhea patch vaccine to stimulate robust immune responses, the use of these results to determine doses for future studies of Iomai's vaccine candidates for travelers' diarrhea and pandemic and seasonal influenza. Applicable risks and uncertainties include, among others, that results in the trial described in this press release may not provide the needed information necessary to conduct future trials, that Iomai may not be able to enroll sufficient numbers of patients in 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, pandemic and seasonal influenza; 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 its Annual Report on Form 10-K for the year ended December 31, 2006 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 http://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 FinancialOfficer and General Counsel of Iomai Corporation, +1-301-556-4478,investors@iomai.com; or Brian Reid of WeissComm Partners, Inc.,+1-703-402-3626, or breid@weisscommpartners.com, for Iomai Corp.

Web site: http://www.iomai.com/

Source: PRNewswire-FirstCall

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