Navigation Links
Iomai Patch-Based Vaccine Cut Rate of Travelers' Diarrhea by 75 Percent in Phase 2 Field Study
Date:9/18/2007

Statistically Significant Data Detailed at a Late-Breaking Presentation at

ICAAC Meeting

CHICAGO and GAITHERSBURG, Md., Sept. 18 /PRNewswire-FirstCall/ -- Iomai Corporation (Nasdaq: IOMI) today announced that travelers who received the company's patch-based travelers' diarrhea vaccine were significantly less likely to be sickened as compared with travelers who receive a placebo, according to research presented today by Chief Scientific Officer Gregory Glenn, M.D. at a late-breaker presentation during the "Vaccines and Pediatric Infections" session of the 47th Interscience Conference on Antimicrobial Agents and Chemotherapy being held in Chicago.

"We have demonstrated that vaccinated travelers can dramatically cut their risk of diarrhea by using our needle-free patch," said Dr. Glenn, Iomai's founder. "Those who received the Iomai vaccination were much less likely to get sick, and those who were sickened had far milder illness than those who received a placebo. These are clinically significant results that suggest that the patch vaccine will address the most significant unmet need for travel medicine: prophylaxis for travelers' diarrhea."

The study found that of the 59 individuals who received the novel, patch-based vaccine, only three suffered moderate or severe diarrhea, while 23 of the 111 who received a placebo suffered moderate or severe diarrhea, a 75 percent reduction (p=0.007). One of the 59 volunteers in the vaccine group reported severe diarrhea, compared with 12 of the 111 in the placebo group, an 84 percent reduction (p=0.033).

"The results presented at ICAAC are the most robust ever shown in the prevention of travelers' diarrhea, and they suggest we may be near a turning point in the prevention of this common, often-serious disease," 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. "If Phase 3 trials for the vaccine validate these results, those of us in travel medicine will have an excellent new weapon in our arsenal."

The research 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 plans to begin a Phase 3 program for the needle-free vaccine patch vaccine in 2008.

"We are moving this product ahead as quickly as possible," said Chief Executive Officer Stanley C. Erck. "This is a pressing, unmet medical need. Travelers' diarrhea is the most common travel ailment in the world, yet there are no effective vaccines available for the condition. A recently completed market study suggests that there is a $750 million market for effective protection against travelers' diarrhea, an opportunity that we are well-positioned to target."

About the Phase 2 Trek Study

The Trek Study followed 170 travelers to Mexico and Guatemala. Each volunteer received either two doses of the Iomai vaccine patch or a placebo, 2 to 3 weeks apart, with the last dose administered a week before travel. Travelers kept detailed diaries and received in-country checkups. The study met its primary endpoints, which were designed to evaluate the safety of the vaccine and the incidence of enterotoxigenic E. coli (ETEC) bacteria -- the most common cause of travelers' diarrhea. No vaccine-related serious adverse events were reported.

Of the few vaccinated patients who were sickened, the diarrhea lasted only half a day on average, while those in the placebo group endured two days of illness and more than twice as many loose stools. Although not statistically significant, the frequency of new-onset irritable bowel syndrome, a long-term consequence of travelers' diarrhea, was three times greater in placebo than vaccine recipients.

Iomai's vaccine uses an ETEC toxin delivered via a skin patch using the company's novel transcutaneous immunization (TCI) technology. 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.

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.

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.

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, and bringing the product candidate to market; 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.


'/>"/>
SOURCE Iomai Corporation
Copyright©2007 PR Newswire.
All rights reserved

Related medicine news :

1. Vaccine to quit smoking?
2. First Vaccine Designed for Africa Cleared for Testing in Humans
3. New hope for cancer victims – will vaccine cure the deadly bug
4. Vaccine for Alzheimer’s diseas
5. New vaccine helps allergy and asthma patients
6. Man against HIV – new vaccine ready for human trials
7. New vaccine helps allergy and asthma patients
8. Development of AIDS vaccine -- Chiron Corp in talks with four Indian cos
9. HIV did not arise from polio vaccine
10. Double impact vaccine
11. Vaccine Reduces antibiotic-resistant infections in Children
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/8/2016)... ... ... Remember the old saying “rub some dirt on it”? Perhaps you should try ... Clay” the health benefits of integrating clay into a daily diet are numerous, as ... motivational speaker, Perry A~ has since dedicated her life to learning about the benefits ...
(Date:2/8/2016)... , ... February 08, 2016 , ... ... wide variety of organizations. DocuSyst provides a cloud hosted environment for FileHold ... installations include integration with various 3rd party applications using the FileHold web services ...
(Date:2/8/2016)... ... 2016 , ... GrassrootsHealth published data from its D*action public ... in the GrassrootsHealth cohort with substantially higher vitamin D levels than a cohort ... states Carole Baggerly, Director of GrassrootsHealth, “the safety and benefits of vitamin ...
(Date:2/8/2016)... (PRWEB) , ... February 08, 2016 , ... TopConsumerReviews.com recently ... in Mole removal products. , Moles are derived from a cluster of melanin when ... all the wrong places and create a lifetime of embarrassment. Historically, mole removal ...
(Date:2/8/2016)... ... , ... Guruji Mahendra Kumar Trivedi is offering 3 days of accelerated personal ... birthday on February 10th. During this time, people can achieve better health, greater ... people from over 40 different countries as an “ordinary man with an extraordinary gift.” ...
Breaking Medicine News(10 mins):
(Date:2/8/2016)... Feb. 8, 2016  Unilife Corporation ("Unilife" or "Company") (NASDAQ: ... injectable drug delivery systems, today announced that it will release ... December 31, 2015 after market close on February 9, 2016. ... call to discuss these financial results.    About ... --> About Unilife Corporation ...
(Date:2/8/2016)... NORTHBROOK, Ill. , Feb. 8, 2016  Astellas Pharma ... today announced the promotion of James Robinson as ... the company,s operations in North and South America ... president, Astellas Pharma US, representing the commercial organization in ... assumed in 2013. Masao Yoshida , who ...
(Date:2/8/2016)... Palatin Technologies, Inc. (NYSE MKT: PTN), ... for the treatment of diseases with significant unmet ... the United States Patent and Trademark Office (USPTO) ... Patent Application Serial Number 14/313,258 (the ,258 application).  ... female sexual dysfunction using the formulation and dose ...
Breaking Medicine Technology: