Iomai Announces Publication in The Lancet of Phase II Study Demonstrating Significant Efficacy of Travelers' Diarrhea Vaccine
12 6월 2008 - 7:30AM
PR Newswire (US)
GAITHERSBURG, Md. and VIENNA, Austria, June 11
/PRNewswire-FirstCall/ -- Iomai Corporation (NASDAQ:IOMI) today
announced the publication of data from the company's positive Phase
II field study of its travelers' diarrhea vaccine in The Lancet.
The study, which analyzed data from 170 travelers, found that those
who received the Iomai patch-based vaccine were statistically
significantly less likely to suffer from clinically significant
diarrhea than their counterparts who received a placebo. The study,
available online today and to be published in the June 14 edition
of The Lancet, found that of the 59 individuals who received the
novel, patch-based vaccine, only three suffered from moderate or
severe diarrhea, while 23 of the 111 who received a placebo
suffered from 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). "These results suggest that the
Iomai patch has the potential to fundamentally change the way we
approach prevention of this disease, an ailment against which we
now have very few weapons," 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 these results are replicated, the
Iomai vaccine will have the potential to not only mitigate a
disease that sickens millions each year but also keep some patients
from going on to develop the chronic symptoms of irritable bowel
syndrome." As previously announced, Iomai and Intercell AG (VSE:
ICLL) have entered into an agreement whereby Iomai has agreed to be
acquired by Intercell AG. In addition to the acute symptoms of
travelers' diarrhea, which include severe diarrhea, abdominal
cramps and dehydration, patients who suffer a bout of travelers'
diarrhea are also at higher risk of developing irritable bowel
syndrome, a chronic condition characterized by pain, bloating,
diarrhea or constipation. Diarrheal disease also exacts a
significant toll on children in the developing world, where
diarrhea linked to enterotoxigenic E. coli -- the most common
causes of travelers' diarrhea -- sickens 210 million children each
year, killing more than 350,000 annually. "Bacterial diarrheal
disease is a significant medical problem for children and
travelers, and our technology represents an advance in vaccine
delivery and a breakthrough in the field of infectious disease. We
look forward to targeting both the significant travelers market and
developing the vaccine for the children in the developing world who
still suffer serious morbidity and mortality from this disease,"
said Gregory Glenn, M.D., Iomai's Chief Scientific Officer. Iomai
plans to initiate a Phase III program for the needle-free vaccine
patch in 2009. 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. The
Lancet, which has been published since 1823, is an independent and
authoritative voice in global medicine that seeks to publish
high-quality clinical trials that will alter medical practice. The
Lancet delivers in-depth knowledge in key medical disciplines.
(http://www.thelancet.com/) About the Phase II Trek Study The Trek
Study followed travelers to Mexico and Guatemala. Volunteers
received either two doses of the Iomai vaccine patch or a placebo,
2 to 3 weeks apart, with the last dose administered at least 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 Cooperation 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/. Iomai announced on May 12 that it has
entered into an agreement with Intercell AG in which Intercell will
acquire Iomai for $6.60 a share. 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 III 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; that, if approved, Iomai's
vaccine would be the first available in the U.S.; and about the
anticipated acquisition of Iomai by Intercell. 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; that the proposed acquisition of Iomai by Intercell does
not close or that the companies may be required to modify aspects
of the transaction to achieve regulatory approval; that prior to
the closing of the acquisition, Iomai's business suffers due to
uncertainty; that the companies are unable to successfully execute
their integration strategies, or achieve planned synergies; 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, 2008, 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. 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. About Intercell AG Intercell
AG is a growing biotechnology company which focuses on the design
and development of novel vaccines for the prevention and treatment
of infectious diseases with substantial unmet medical need. The
Company develops antigens and adjuvants which are derived from its
proprietary technology platforms and has in-house GMP manufacturing
capabilities. Based on these technologies, Intercell has strategic
partnerships with a number of global pharmaceutical companies,
including Novartis, Merck & Co., Inc., Wyeth, Sanofi Pasteur,
Kirin, and the Statens Serum Institut. The Company's leading
product, a prophylactic vaccine against Japanese Encephalitis,
successfully concluded pivotal Phase III clinical trials in 2006.
The Market Authorization Application (MAA) in Europe as well as the
Biological License Application (BLA) with the US Food and Drug
Administration (FDA) for the use of the vaccine to prevent Japanese
Encephalitis were submitted in December of 2007. The licensure
application to TGA (Therapeutic Goods Administration) in Australia
was submitted in February of 2008. The Company's broad development
pipeline includes a partnered S. aureus vaccine in Phase II, a
therapeutic vaccine against Hepatitis C in Phase II, a Pseudomonas
vaccine in Phase II, a partnered Tuberculosis vaccine (Phase I/II),
and five products focused on infectious diseases in preclinical
development. Intercell is listed on the Prime Market of the Vienna
Stock Exchange under the symbol "ICLL". ISIN: AT0000612601 For more
information on Intercell, please visit: http://www.intercell.com/
Important Additional Information Regarding the Proposed Merger In
connection with the proposed transaction, on May 14, 2008, Iomai
Corporation filed a preliminary proxy statement for its
stockholders with the Securities and Exchange Commission (SEC).
Iomai Corporation will be filing a definitive proxy statement for
its stockholders and other documents regarding the proposed
transaction with the SEC. BEFORE MAKING ANY VOTING OR INVESTMENT
DECISION, IOMAI STOCKHOLDERS AND INVESTORS ARE URGED TO CAREFULLY
READ THE PRELIMINARY PROXY STATEMENT AND, WHEN IT BECOMES
AVAILABLE, THE DEFINITIVE PROXY STATEMENT AS WELL AS ANY OTHER
RELEVANT MATERIALS, IN THEIR ENTIRETY BECAUSE THE DOCUMENTS WILL
CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION AND
IOMAI. Investors and stockholders may obtain copies of the proxy
statements and other relevant documents filed with the SEC by Iomai
free of charge at the SEC's web site at http://www.sec.gov/. In
addition, investors and stockholders may obtain copies of the proxy
statements and other relevant documents filed with the SEC by Iomai
free of charge (when they are available) by going to Iomai's
Investor Relations page on its corporate website at
http://www.iomai.com/. Iomai and its directors, executive officers
and other members of management may be deemed to be participants in
the solicitation of proxies from Iomai's stockholders with respect
to the proposed transaction. Information regarding the interests of
such potential participants in the proxy solicitation is contained
in the preliminary proxy statement and will be contained in the
definitive proxy statement and other relevant materials to be filed
with the SEC when they become available. This communication
expressly or implicitly contains certain advance statements
concerning Intercell AG and its business. Such statements involve
certain known and unknown risks, uncertainties and other factors
which could cause the actual results, financial condition,
performance or achievements of Intercell AG to be materially
different from any future results, performance or achievements
expressed or implied by such advance statements. Intercell AG is
providing this communication as of this date and does not update
any advance statements contained herein as a result of new
information, future events or otherwise. DATASOURCE: Iomai
Corporation CONTACT: Russell P. Wilson, SVP, 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; or Lucia Malfent, Head of Corporate
Communications of Intercell AG, +43-1-20620-303, Web site:
http://www.iomai.com/ http://www.thelancet.com/
http://www.intercell.com/
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