College Station, Texas
August 12, 2002
- Could address common cause of
developing world gastrointestinal distress
ProdiGene, Inc. announced
today that it will begin a Phase I clinical trial in cooperation
with the National Institutes of Health's (NIH) National
Institute of Allergy and Infectious Diseases (NIAID), studying
the safety and immunogenicity of an oral vaccine against
Traveler's Diarrhea, a condition caused by Enterotoxigenic E.
coli. This vaccine is produced using ProdiGene's proprietary
transgenic plant technology and delivered using the Company's
patented oral vaccine platform.
Under the agreement, NIAID will fund the trial and ProdiGene
will supply the corn vaccine. In addition to funding the trial,
NIAID will manage the trial and sponsor the submission of an
Investigational New Drug application with the Food and Drug
Administration.
"ProdiGene is very pleased that the NIAID has chosen to
collaborate with us in this Phase I trial designed to test the
Company's patented oral vaccine technology in combination with
the Company's ability to produce recombinant proteins in corn,"
stated Anthony G. Laos, President and Chief Executive Officer of
ProdiGene. "This is the first time that ProdiGene will use its
oral vaccine technology in humans, an event which can have far
reaching consequences for the Company and the medical community,
particularly in developing countries."
About Enterotoxigenic E. coli (ETEC)
ETEC, found globally, are bacteria strains that cause symptoms
commonly referred to as "Traveler's Diarrhea." ETEC strains
carry a heat labile toxin that is comprised of two subunits, "A"
and "B." The B subunit, LtB, alone is non-toxic and does not
cause the symptoms of ETEC. However, LtB is known to produce an
antibody response in humans that is expected to protect the body
against Traveler's Diarrhea. ETEC is a leading cause of
morbidity and infant mortality in developing countries and is
also the main cause of diarrhea in travelers to developing
countries.
About Oral Vaccines
ProdiGene's vaccines are antigens produced using its proprietary
transgenic plant technology and then delivered using its
patented oral vaccine platform. Oral vaccines produced using the
Company's technologies could take the form of a prescribed oral
edible product, and thus are easy to administer. Oral vaccines
are not only more convenient than alternate forms of
administration, such as injection, but are also less costly to
administer and can help make vaccination more widely available,
particularly in developing countries. ProdiGene's oral vaccine
patent was voted one of the "five patents that will transform
business and technology" by the MIT Technology Review magazine
in May 2001.
ProdiGene is a private biotechnology company pioneering the use
of transgenic plants to produce recombinant proteins for the
pharmaceutical, animal health and industrial protein markets.
The Company was the world's first to successfully commercialize
a recombinant protein produced from transgenic plants. Proteins
produced from transgenic plants can provide significant economic
and safety benefits over other protein manufacturing processes.
With more than 18 products in development, ProdiGene is
redefining the protein manufacturing industry and building
acceptance of large scale, plant based protein manufacturing.
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