2011-06-16 09:00 
SINGAPORE, June 16, 2011 /PR
Newswire-Asia/ -- Inviragen announced
today the initiation of the first clinical trial of the Company's
proprietary Hand, Foot and Mouth
Disease (HFMD) investigational vaccine, INV21, a highly
purified virus particle preparation designed to protect against
HFMD caused by enterovirus 71 (EV71). The study will be conducted
in Singapore at the Investigational
Medicine Unit at the National University Health System
under Inviragen's
memorandum of understanding with the Duke-NUS Graduate
Medical School. This Phase 1 clinical trial of INV21 will assess
the safety of the vaccine as well as immune responses in healthy
adult volunteers.
"This first clinical study of INV21
is the result of years of research by Inviragen's scientists, and
is an important milestone for our company," commented Dr. Joseph Santangelo,
Inviragen's chief operating officer. "INV21 was developed in
Singapore by Inviragen and our preclinical studies have
demonstrated that this vaccine induces broad, neutralizing
antibodies to multiple EV71 isolates. Duke-NUS and their
strong ties to the hospital community have sped the advance of
INV21 into human clinical testing."
"We are committed to translating
basic science into clinical practice with the ultimate goal of
bringing vaccines such as INV21 to market for the benefit of people
in Singapore and the world," stated the clinical trial principal
investigator Dr. Paul
Tambyah, associate professor of the Department of Medicine,
Yong Loo Lin School of Medicine, National University Singapore and
senior consultant, Division of Infectious Diseases at the National
University Hospital, Singapore. "HFMD can be severely debilitating
for some children with a risk of paralysis and death. It also
remains an ongoing public health threat with significant economic
impact as it continues to affect young children in Singapore and
the region. We are eager to continue to work with Inviragen to
advance the development of INV21, as well as other vaccine
candidates."
The trial is a placebo controlled
randomized clinical study and will enroll healthy adults, aged 21
to 45 years. Each individual will receive two immunizations
separated by four weeks and will be monitored for any adverse
reactions after each administration. Immune responses to INV21 will
be measured one, two and six months after the second
immunization.
About Hand Foot and Mouth
Disease (HFMD)
HFMD is a disease common in children
throughout the world. However, the disease is endemic in the Asia
Pacific where its incidence has been increasing steadily over the
past two decades. Although the disease is typically of short
duration, there has been an increase in severe HFMD cases,
including central nervous system involvement, associated with EV71.
HFMD epidemics have been reported in most Asian countries,
particularly Singapore, Taiwan, Malaysia, Vietnam, Korea, Hong Kong
and mainland China. Recent reports from the Chinese Ministry of
Health revealed more than 1.7 million HFMD infections
resulting in 876 deaths from 1 January to 30 November 2010;
there were 1.1 million infections with 353 deaths
reported for the previous year. In 2010, 30,878 HFMD
infections were reported in Singapore, an
island nation with apopulation of
approximately five million people, of which roughly 200,000 fall
into the most susceptible age group of one-to-five years. No
vaccines currently exist for HFMD.
About Inviragen,
Inc.
Inviragen is focused on developing
vaccines to protect against infectious diseases worldwide.
Inviragen's vaccines to protect against dengue fever and HFMD are
in Phase 1 clinical testing. Vaccines to protect against
chikungunya and Japanese encephalitis which affect millions of
individuals in Asia, are in clinical manufacturing and development.
Vaccines in preclinical research stages include a low-cost human
papilloma virus vaccine, vaccines to protect against new forms of
influenza and a combination plague/smallpox vaccine for biodefense.
Inviragen has offices in Colorado, Wisconsin and Singapore.
See www.inviragen.com for
more details.
About Duke-NUS Graduate Medical
School Singapore
The Duke‐NUS Graduate Medical School
Singapore (Duke‐NUS) was established in 2005 as a strategic
collaboration between the Duke University School of Medicine,
located in N. Carolina, USA and the National University of
Singapore (NUS). Duke‐NUS offers a graduate entry, 4‐year M.D.
(Doctor of Medicine) training programme based on the unique Duke
model of education, with one year dedicated to independent study
and research projects of a basic science or clinical nature. The
first batch of students will graduate in 2011. Duke‐NUS also offers
M.D./PhD and PhD programmes. As a player in Singapore's biomedical
community, Duke‐NUS has identified five Signature Research
Programmes: Cancer & Stem Cell Biology, Neuroscience and
Behavioral Disorders, Emerging Infectious Diseases, Cardiovascular
& Metabolic Disorders, and Health Services and Systems
Research. For more information, please visit www.duke-nus.edu.sg.
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SOURCE Inviragen, Inc.