GAITHERSBURG, Md. and CAPE TOWN, South Africa, Oct. 11 /PRNewswire-FirstCall/ -- Iomai Corporation today announced that Iomai Chief Scientific Officer Gregory Glenn, M.D., presented an overview of the clinical data for Iomai’s patch-based vaccine for travelers’ diarrhea and the implications such a vaccine could have on global health at the Keystone Symposia: Challenges of Global Vaccine Development being held in Cape Town, South Africa.
Last month, Dr. Glenn presented data from a Phase 2 field study of the Iomai travelers’ diarrhea vaccine that showed vaccinated travelers were 75 percent less likely to suffer clinically significant diarrhea and 84 percent less likely to suffer severe diarrhea. The company plans to begin Phase 3 studies next year.
The bacterial causes of travelers’ diarrhea exact a toll not only on travelers, but also on those who live in areas in which those bacteria are endemic. Enterotoxigenic E. coli (ETEC) -- the most common cause of travelers’ diarrhea -- has been linked to more than 200 million cases of diarrhea in infants and children living in the developing world each year, according to the World Health Organization, killing 380,000 annually.
“Diarrheal diseases are a top priority in global public health and we believe that our approach has the potential to save the lives of many of the world’s most vulnerable: infants and children in the developing world,” said Dr. Glenn. “The Bill and Melinda Gates Foundation has named acute diarrheal illness as one of its top funding priorities, and the non-profit group PATH is also working to use innovative solutions to limit the burden of diarrheal disease.”
Dr. Glenn, the founder of Iomai, developed the company’s proprietary transcutaneous immunization technology (TCI) technology. The needle-free technology uses a patch placed on the surface of the skin to deliver vaccines and adjuvants via a group of antigen-presenting cells in the skin to the nearby lymph nodes, where a sustained immune response is triggered.
ABOUT TRAVELERS’ DIARRHEA
This year, approximately 55 million international travelers will visit countries where bacteria that cause travelers’ diarrhea are endemic, particularly Africa, Asia and Latin America, and about 20 million of those travelers will develop travelers’ diarrhea.
A recently completed market study suggested that there is a large market for an effective travelers’ diarrhea vaccine, potentially exceeding $750 million annually. If approved, the Iomai vaccine would be the first vaccine for travelers’ diarrhea available in the United States.
The impact of travelers’ diarrhea goes beyond travelers. The World Health Organization estimates that children in the developing world suffer 200 million episodes of diarrhea caused by ETEC annually, causing 380,000 deaths each year.
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, discovered by researchers at the Walter Reed Army Institute of Research, 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 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 patch vaccine being a prophylaxis for travelers’ diarrhea, the timing for commencing Phase 3 studies, the potential size of the market for a travelers’ diarrhea vaccine; the applicability of TCI technology to other pathogens; and that, if approved, Iomai’s vaccine would be the first available in the U.S. Applicable risks and uncertainties include, among others, 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 trial 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 for travelers’ diarrhea; that estimates of market size overstate the number of travelers who would use such a product, if it were approved; that competitors may develop products that are safer, more effective, or more convenient to use; and the risks identified under the heading “Factors That May Impact Future Results” in Management’s Discussion and Analysis of Financial Condition and Results of Operations in Iomai’s Quarterly Report on Form 10-Q for the three months ended June 30, 2007, and filed with the Securities and Exchange Commission. While Iomai believes that this product candidate is amenable to self-administration, in the Phase 2 study described in this press release, medical professionals administered the vaccine. Whether any approved product would be self-administered would depend on many factors, including the outcome of any studies the Company conducts evaluating self-administration and the views of regulatory agencies. Iomai cautions investors and others not to place undue reliance on the forward- looking statements contained in this press release. Iomai’s business is subject to many risks. For a discussion of such risks, you are encouraged to read the documents the Company files with the U.S. Securities and Exchange Commission, available at http://www.sec.gov. The statements in this press release speak only as of the date of this document, and Iomai undertakes no obligation to update or revise the statements.
CONTACT: Russell P. Wilson, Senior Vice President, Chief Financial Officer
and General Counsel of Iomai Corporation, +1-301-556-4478,
investors@iomai.com; or Brian Reid of WeissComm Partners, Inc.,
+1-703-402-3626, breid@weisscommpartners.com, for Iomai Corporation
Web site: http://www.iomai.com/
