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San Diego, California
January 28, 2003
Epicyte Pharmaceutical, Inc., a San Diego biopharmaceutical
company focused on the discovery and development of human
monoclonal antibodies, today announced that it is growing the
first greenhouse plant lines to yield an antibody product for
the prevention of HIV, an illness that infects 900,000 people in
the U.S. but that experts predict could infect 25 million in
India and 15 million in China by the end of this decade. The HIV
plantibodies were developed as part of a National Institutes of
Health Advanced Technology SBIR award.
"HIV infection rates clearly represent a global health threat of
frightening magnitude," said Kevin Whaley, Epicyte's Director of
Antibody Discovery. "The current high drug production costs and
capacity constraints have been one of the biggest challenges.
But Epicyte's Plantibodies(tm) technology has the potential to
break the production bottleneck and reduce production costs by
50 percent or more."
Epicyte plans to produce three human IgA antibodies in plants:
2G12, 4E10 and 2F5, all of which bind HIV envelope proteins that
are critical in the infectious pathway. These antibodies were
developed and licensed to Epicyte by Dr. Hermann Katinger, head
of the Institute of Applied Microbiology at Vienna's University
of Natural Resources and Applied Life Sciences.
"These antibodies have the potential to neutralize a diverse
array of HIV types and could have a dramatic effect on HIV
prevention," said Dr. Katinger. "These antibodies together with
Epicyte's progress on perfecting its production methods make the
possibility of a preventative product very encouraging."
Epicyte is slated to become the first U.S. company to enter
Phase I clinical trials with a human herpes antibody produced in
plants. The company plans to begin trials this year with HX8, a
treatment for herpes simplex virus, which infects 50 million
people in the U.S. alone. In May 2002, Epicyte also announced
that it had seeded a corn crop with R-19, an antibody to treat
respiratory syncytial virus (RSV).
Epicyte has been awarded three grants from the National
Institute of Allergy and Infectious Diseases to apply the
company's proprietary technology for the cost-effective,
large-scale production of antibodies and hybrid antibodies to
block the transmission of HIV. Successful completion of the two
of the $600,000 phase I grants offers Epicyte the opportunity to
apply for a phase II support that may include $3 million in
clinical trials. The grants are a nondiluting investment in the
development of pipeline products.
About 40,000 new HIV infections occur in the U.S. every year,
according to the Centers for Disease Control. From the beginning
of the epidemic through December 2000, the CDC reported 448,060
deaths. Twenty years into the AIDS epidemic 40 million people
are living with HIV globally, and 25 million have died. If many
countries continue to respond ineffectively, in the next 20
years close to 70 million people will die because of AIDS,
according to a 2002 report by the U.N.
Epicyte has broad and exclusive commercial rights to a U.S.
patent claiming any transgenic plant that expresses any
antibody, including human monoclonal antibodies. This technology
allows Epicyte to produce large quantities of antibodies at
substantially reduced capital and manufacturing costs.
Epicyte Pharmaceutical, Inc. is a biopharmaceutical company
focused on the discovery and development of therapeutics to
treat inflammatory and infectious diseases. The company's
proprietary technology for producing antibodies in plants allows
Epicyte to address an unmet need - making antibody treatments
for common infectious diseases in large enough quantities for
widespread use. High production costs associated with
traditional methods for producing antibodies have limited their
use as a disease treatment. Epicyte's technology for growing
antibodies in plants is scalable and cost effective.
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