Study Finds Single Dose Of Iomai Patch With Pandemic Flu Vaccine Achieves Protective Levels

Iomai Corporation
(Nasdaq: IOMI) announced positive interim results from the
500-subject Phase 1/2 trial of its immunostimulant adjuvant patch used with
an injected vaccine for H5N1 influenza. The trial met a key endpoint,
demonstrating a clinically relevant adjuvant effect when the Iomai patch
was used with a single dose of the 45-microgram H5N1 vaccine. The trial
found that a single 45-microgram dose of an H5N1 influenza vaccine, coupled
with a single 50-microgram Iomai patch, was sufficient to provide an immune
response considered protective in 73 percent of those tested, a
statistically significant improvement over those who received the H5N1
influenza vaccine alone.



This is one of the first trials to demonstrate that a single dose of
pandemic influenza vaccine may meet the level of protection suggested in
U.S. Food and Drug Administration guidance, which recommends that a
pandemic vaccine achieve immune response levels considered protective in 70
percent or more of vaccine recipients. The trial was conducted under a
$14.5 million contract with the U.S. Department of Health and Human
Services (HHS) with the potential for an additional $114 million in
follow-on funding. Iomai has shared the data with HHS and is now working
with them to determine the next steps.



The only FDA-approved vaccine in the United States for the avian
influenza H5N1 virus requires two 90-microgram doses, administered 28 days
apart, to achieve hemagglutinin inhibition (HI) titers equal to or greater
than 40 in 44 percent of vaccinated individuals.



"During an influenza pandemic, public health officials will face two
large hurdles. The first is the possibility of limited vaccine stocks. The
second is the logistic difficulty of administering two vaccinations over a
period of several weeks to all individuals in the face of a pandemic. This
new research clearly indicates that a single dose of vaccine in combination
with an Iomai patch could provide a significant level of protection,
achieve protective levels more rapidly, and increase compliance," said
Stanley C. Erck, President and Chief Executive Officer of Iomai. "This is a
major breakthrough and could provide public health officials with an
important solution for this looming problem."



The trial tested three different dose levels of Solvay Biologicals,
B.V. (Netherlands) egg-derived H5N1 influenza vaccine, the adjuvant patch
and placebo to determine which combinations would be most effective in a
two-immunization regimen, administered 21 days apart. Data showed that 92
percent of the 50 subjects vaccinated a single time with the 45-microgram
dose in combination with the Iomai patch had an immune response.
Seventy-three percent of those subjects achieved an HI titer of greater
than 40, which is considered protective, offering the potential to
eliminate the need for a second vaccination. About 49 percent of those who
received the vaccine alone, without a patch, had an immune response
considered protective after the first dose, and the 24 percentage point
difference between the patch and no-patch groups was statistically
significant (p








No treatment-related serious adverse events were reported.



With further testing, the patch has the potential to be used in
conjunction with other injected pandemic influenza vaccines. It has been
shown to be suitable for ambient temperature shipping and handling, and has
at least a 2-year storage shelf life, making the product ideal for
stockpiling and rapid distribution. The patch is easily applied and acts
like an adhesive bandage placed at the site of the injection.



"This data also confirms our general approach of using an adjuvant
patch to improve the immune response to injected vaccines and the ability
of our adjuvant to safely and effectively stimulate robust immune responses
via the skin," said Gregory Glenn, Iomai's Chief Scientific Officer. "We
continue to explore ways to bring this approach to other applications in
the high-value field of vaccine adjuvants."



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 iomai.



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
adjuvant patch to provide protective immune responses with a single dose of
pandemic flu vaccine; the significance of the results described in this
press release to government health officials in addressing an outbreak of
pandemic influenza; that Iomai's adjuvant patch may work with pandemic
influenza vaccines from other manufacturers; that the characteristics of
Iomai's adjuvant patch described in this press release would make the
product ideal for stockpile and rapid distribution; and that the U.S.
Department of Health and Human Services, or HHS, might consider these data
sufficient for continuing the existing $128 million government contract.
Applicable risks and uncertainties include, among others, that future
clinical trials may not replicate results seen in the trial described in
this press release; that HHS, as well as, the FDA or other regulatory
authorities, may not concur with Iomai's analysis of the trial results
described in this press release; that Iomai may not be able to enroll
sufficient numbers of subjects in future clinical trials; that Iomai may be
unable to obtain the regulatory approvals or financing necessary to conduct
additional clinical trials, or to develop the product to a point where the
adjuvant patch can be sold to the government for stockpiling for its
pandemic influenza program; that competitors may develop products that are
safer, more effective, or more convenient to use; future clinical results
may not support regulatory approval to commercialize Iomai's adjuvant patch
for pandemic influenza applications, which will depend on the outcome of
additional clinical trials and analysis by regulatory authorities of data
Iomai submits; 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 "Factors That May Impact Future Results"
in Management's Discussion and Analysis of Financial Condition and Results
of Operations in our Quarterly Report on Form 10-Q for the three months
ended September 30, 2007, 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 sec.


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