Iomai Study Shows Self-Applied Travelers' Diarrhea Vaccine Patch Comparable to Clinician-Applied Vaccine Patch
12 Febbraio 2008 - 2:30PM
PR Newswire (US)
GAITHERSBURG, Md., Feb. 12 /PRNewswire-FirstCall/ -- Iomai
Corporation (NASDAQ:IOMI) today announced the interim results of a
study that showed that the second dose of the two-dose regimen for
its novel, patch-based travelers' diarrhea vaccine yields a robust
immune response when self-applied by subjects outside of a clinical
setting. The 160-subject study, part of an extensive Phase 2
program for the vaccine, measured the immune response to the
vaccine patch, which is approximately the size and shape of an
adhesive bandage. Four groups were evaluated: two groups received
both doses of the vaccine from a medical professional and two other
groups of volunteers administered the second vaccine patch
themselves. All groups had robust responses to the vaccine, and a
statistical analysis of immune parameters following vaccination
showed no significant differences between treatment groups at any
time point. "These results confirm our belief that the Iomai patch
can be effectively used by patients without a health care provider
present, removing the need for a second trip to a travel clinic,"
said Stanley C. Erck, Iomai's president and chief executive
officer. "Our research has shown that self-application of the
second dose further enhances the market potential of this product."
As with past studies of the vaccine, no serious vaccine-related
adverse events were reported. Iomai is completing its Phase 2
program and plans to conduct a Phase 3 efficacy study during summer
of 2009, when the travelers' diarrhea season in Latin America is at
its peak. Based on the results of the self-application study, Iomai
is evaluating the feasibility of including self-administration of
the second vaccine dose in that Phase 3 study. The data also
suggests the possibility of self-administration of other Iomai
vaccines, such as the needle-free influenza vaccine, which remains
a priority for the company. Last year, the company presented data
from a Phase 2 field trial of the travelers' vaccine at the
Interscience Conference on Antimicrobial Agents and Chemotherapy
that demonstrated people who received the vaccine before traveling
to Mexico or Guatemala were significantly less likely to report
clinically significant diarrhea. Of the 59 individuals who received
the 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). 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. 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 that Iomai will successfully commercialize its
travelers' diarrhea vaccine patch; that such vaccine would be
approved with self-application of any dose; statements about
Iomai's plans to initiate a Phase 3 study in the summer of 2009 and
the potential size of the market for a travelers' diarrhea vaccine;
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 or financing necessary to conduct additional clinical
trials, to conduct those trials in the indicated timeframes or to
market any product for travelers' diarrhea; that the FDA or other
regulatory authorities may not concur with Iomai's analysis of the
trial results described in this press release; 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 September 30, 2007, and filed
with the Securities and Exchange Commission. Whether any approved
product would be self-administered would depend on many factors,
including the outcome of any additional 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.
DATASOURCE: Iomai Corporation CONTACT: Russell P. Wilson, Senior
Vice President, Chief Financial Officer and General Counsel of
Iomai Corporation, +1-301-556-4478, ; or Brian Reid of WeissComm
Partners, Inc., +1-703-402-3626, , for Iomai Corporation Web site:
http://www.iomai.com/
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