Iomai Vaccine Confers Statistically Significant Protection Against Travelers' Diarrhea in Phase 2 Study
Posted on: Wednesday, 1 August 2007, 06:04 CDT
GAITHERSBURG, Md., Aug. 1 /PRNewswire-FirstCall/ -- Iomai Corporation today announced that its patch-based vaccine for enterotoxigenic E. coli (ETEC) bacteria conferred statistically significant protection from travelers' diarrhea as compared to placebo, particularly for more severe cases, according to interim data from a double-blind Phase 2 field study. Vaccinated travelers were 75 percent less likely to suffer moderate or severe diarrhea from any cause (p<0.01) and 84 percent less likely to be afflicted by severe diarrhea (p<0.05). No vaccine-related serious adverse events were reported.
In addition to the protective effects, investigators found that the frequency and duration of diarrhea in vaccinated subjects who did contract disease was significantly lower than in their unvaccinated peers.
"The results from this study strongly suggest that the use of Iomai's needle-free, patch-based vaccine can have a notable impact in reducing the chances of suffering from the ravages of travelers' diarrhea," said Herbert L. DuPont, M.D., professor and director of the Center for Infectious Diseases at The University of Texas School of Public Health and the principal investigator on the trial. "Right now, we are generally limited to administering antibiotics after the illness has begun. An effective, easy-to-use vaccine would be a vast improvement and have an immediate impact on travel medicine."
The Trek Phase 2 field study followed 170 subjects, 111 who received a placebo and 59 who received two doses of Iomai's patch-based vaccine before traveling to Mexico or Guatemala. These efficacy results were particularly notable as the trial was conducted largely to gather information on the logistics of conducting such a study in the field. The study was conducted in collaboration with researchers from the Johns Hopkins Bloomberg School of Public Health and the University of Texas School of Public Health.
Iomai's vaccine uses the company's novel transcutaneous immunization (TCI) technology, which allows the vaccine to be delivered to the immune system via a simple patch affixed to the skin. ETEC causes illness through the toxins it produces, including one known as heat-labile toxin or LT. Iomai's unique patch-based vaccine enables the safe administration of this potent immunogen into the skin to stimulate the immune response.
"These convincing results, demonstrating high levels of efficacy in a real-world setting, serve as validation of our TCI approach," said Dr. Gregory Glenn, M.D., Iomai's founder and chief scientific officer. "The data suggest that our TCI technology can be used to provide protection against other pathogens. We are moving as quickly as possible to complete our Phase 2 work so we can begin pivotal trials and bring our travelers' diarrhea vaccine candidate to market."
The study met its primary endpoints, which were designed to evaluate the safety of the vaccine and the incidence of ETEC. The secondary objectives included evaluation of vaccine-preventable outcomes, immunogenicity and stool frequency. The study also gathered data on the protective efficacy of the vaccine. Iomai plans to submit the full dataset from the trial for publication as soon as possible. The company intends to launch a Phase 3 program for the vaccine in 2008.
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. "Though we always caution travelers about the best ways to avoid food and drink that may harbor the bacteria, that advice is often not enough, and an effective means of vaccination could substantially reduce the burden of disease," said Robin McKenzie, M.D., an assistant professor at Johns Hopkins and an investigator on the trial.
ETEC, the most common cause of travelers' diarrhea, represents just under half of all cases of travelers' diarrhea for international travelers to areas where ETEC is common. A recently completed market study suggested that there is a large market for an effective ETEC vaccine, potentially exceeding $500 million annually. If approved, the Iomai vaccine would be the first vaccine for travelers' diarrhea available in the United States.
ETEC's impact goes beyond travelers. The World Health Organization estimates that children in the developing world suffer 210 million episodes of diarrhea caused by ETEC annually, causing 380,000 deaths each year.
Conference Call Details
To access the live conference call today at 8:30 a.m. Eastern Time via phone, please dial 866-510-0705 from the United States and Canada or 617-597- 5363 internationally. The conference ID is 26738905. Please dial in approximately ten minutes prior to the start of the call. A telephone replay will be available beginning approximately one hour after the call through Aug. 8 and may be accessed by dialing 888-286-8010 from the United States and Canada or 617-801-6888 internationally. The replay passcode is 85144095.
To access the live and subsequently archived webcast of the conference call, go to the Investor Relations section of the Company's website at http://www.iomai.com/. Please connect to the web site at least 15 minutes prior to the call to allow for any software download that may be necessary. The webcast is also being distributed through the Thomson StreetEvents Network. Individual investors can listen to the call at http://www.earnings.com/, Thomson's individual investor portal, powered by StreetEvents. Institutional investors can access the call via Thomson StreetEvents (http://www.streetevents.com/), a password-protected event management site.
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 timing and expectation for Iomai completing Phase 2 work on this product candidate, commencing Phase 3 studies, and bringing the product candidate to market; the potential size of the market for an ETEC 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 March 31, 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.
Iomai Corporation
CONTACT: Russell P. Wilson, Senior Vice President, Chief FinancialOfficer and General Counsel, Iomai Corporation, +1-301-556-4478,investors@iomai.com; or Brian Reid, WeissComm Partners, Inc., +1-703-402-3626,breid@weisscommpartners.com
Web site: http://www.iomai.com/
Source: PRNewswire-FirstCall
Related Articles
 |
 |
User Comments (0)
RSS Feeds