Iomai Corporation (Nasdaq: IOMI) announced today that it has received clearance from the U.S. Food and Drug Administration to launch a head-to-head trial comparing its needle-free, patch-based influenza vaccine with the traditional vaccine,
delivered via intramuscular injection. The study will enroll up to 300
patients and begin later this month. The randomized, double-blind Phase 1
study will track the safety of the vaccinations and measure the immune
response to both forms of the vaccine in healthy adults.
"Iomai's needle-free influenza vaccine patch is simple and easy to use,
and this comparison trial will help us assess how the vaccine compares to
the usual injected vaccine in the clinic," said Stanley C. Erck, President
and Chief Executive Officer of Iomai. "Public health officials have said
they plan to more than double the number of people who receive an annual
flu vaccination, and we believe our patch can play a crucial role in
attaining that goal."
Patients in the trial will receive either a single dose of the
injectable vaccine or wear the Iomai patch, about the size of an adhesive
bandage. Volunteers will then be followed to assess the safety of the
vaccination methods, and researchers will use blood tests to assess the
immune response generated by each method.
The influenza vaccine patch uses Iomai's proprietary transcutaneous
immunization (TCI) technology, which delivers vaccine to a group of
antigen- presenting cells in the skin called Langerhans cells. Those cells,
in turn, transport the vaccine to nearby lymph nodes to produce a sustained
immune response.
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 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, enable 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 E. coli-related 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 timing and size of
enrollment of volunteers for the trial described in this press release,
Iomai's ability to obtain information from this trial sufficient to make
comparisons directly with injectable influenza vaccines, the attributes of
Iomai's needle-free influenza vaccine, and the role of Iomai's needle-free
flu vaccine in attaining public health immunization goals. Applicable risks
and uncertainties include, among others, that Iomai may not be able to
enroll sufficient numbers of patients in this and future clinical trials;
that the timing of clinical trials is dependent on sufficient coordination
and cooperation with third-party clinical research organizations; that the
results in the trial described in this press release may not provide the
needed information necessary to make definitive comparisons with injectable
influenza vaccines; that future clinical trials may not replicate results
sought 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 candidates for influenza vaccines;
that results in this and future clinical trials may fail to demonstrate our
TCI technology is simple and easy to use; that Iomai's product candidates
may not satisfy public health needs when marketed; 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 "Risk
Factors" in the Company's Quarterly Report on Form 10-Q for the three
months ended June 30, 2006 and its Annual Report on Form 10-K for the year
ended December 31, 2005 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.
These statements speak only as of the date of this document, and Iomai
undertakes no obligation to update or revise the statements.
Iomai Corporation
iomai
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