"Reductions in mortality rates of 50 percent or more"

Agennix Initiates A Randomized Double-Blind, Placebo-Controlled Phase
2 Study of Oral Talactoferrin in Severe Sepsis
4/22/2008


HOUSTON, April 22 /PRNewswire/ -- Agennix, Inc. announced today that
it has initiated a randomized, double-blind, placebo-controlled Phase
2 study of oral talactoferrin alfa in patients with severe sepsis.
This is the first clinical trial of talactoferrin in sepsis and is
based on both the mechanism of action of talactoferrin, and promising
preclinical data demonstrating a significant reduction in mortality by
talactoferrin in a variety of animal models of sepsis, including some
that cause 100% mortality in untreated animals. The Phase 2 trial,
which has started enrollment, will be conducted at approximately 25
leading U.S. centers with investigators who are very experienced in
conducting trials in severe sepsis.

The study is being supported by a Small Business Innovative Research
(SBIR) grant awarded from the National Institutes of Health (NIH). The
total amount of the grant, $3 million, will provide the financial
resources necessary to conduct the 190-patient study, which is
designed to evaluate the safety and activity of talactoferrin in
patients with severe sepsis. Results from the trial are anticipated in
mid-2009.

"The number of sepsis-related deaths is on the rise, in spite of
available treatment options," said Kalpalatha K. Guntupalli, M.D.,
Professor of Medicine, Chief of Pulmonary, Critical Care, and Sleep
Medicine at Baylor College of Medicine and the Principal Investigator
for the Phase 2 study. "Talactoferrin is a very promising compound
with broad immunomodulatory and anti-inflammatory properties. The
preclinical data in sepsis are very exciting, with talactoferrin
demonstrating reductions in mortality rates of 50 percent or more in
various animal models. We hope that the preclinical results translate
to the drug showing activity in the Phase 2 study by reducing the
number of deaths in patients with severe sepsis."

Sepsis is a clinical syndrome defined by the presence of known or
suspected infection and associated inflammatory response. Multi-organ
damage from high levels of circulating cytokines originating from the
gut is an important contributor to sepsis-induced morbidity and
mortality. Talactoferrin modulates these gut-induced cytokine surges
through its effects on the Gut Associated Lymphoid Tissue (GALT). In
preclinical experiments, oral talactoferrin significantly reduced
mortality from endotoxin- and bacterially-induced sepsis, as well as
the systemic cytokine surge induced by endotoxin.

"Severe sepsis is a serious medical condition that is associated with
the failure of one or more organ systems, such as cardiovascular or
respiratory," said Mitchell M. Levy, M.D., Professor of Medicine,
Brown Medical School, Medical Director, Medical Intensive Care Unit,
Rhode Island Hospital, and an Investigator in the study. "New
therapies for this disease are desperately needed. Talactoferrin is
particularly exciting because of its unique mechanism of action
mediated through its effect on the gastrointestinal tract and the
GALT, and its potential to impact many of the abnormal pathways that
contribute to sepsis-induced organ damage and associated morbidity and
mortality."

About the SBIR Grant

The Small Business Innovation Research (SBIR) program of the National
Institutes of Health is a set-aside program (2.5% of an agency's
extramural budget) for supporting domestic small business concerns to
engage in Research or Research and Development in areas that have the
potential for commercialization. Some of the objectives of the SBIR
Program include using small businesses to stimulate technological
innovation, strengthening the role of small business in meeting
Federal Research or Research and Development needs, and increasing
private sector commercialization of innovations developed through
Federal SBIR Research and Development funding.

"The SBIR grant for sepsis, with its $3 million budget, will allow us
to conduct the study with enough patients to provide an answer
regarding talactoferrin's activity in the clinical setting," said
Robert Lodato, M.D., Associate Professor of Medicine, University of
Texas Health Science Center, and Medical Monitor for the study.

About the Phase 2 Study

The double-blind, placebo-controlled Phase 2 study of talactoferrin
will enroll 190 patients who have a diagnosis of sepsis with at least
one organ dysfunction due to sepsis. Patients will receive standard
therapy (including, at the discretion of the primary physician,
drotrecogin alfa activated, marketed as Xigris(R)(1), and will be
randomly assigned (1:1) to receive either talactoferrin (1.5 g) or
placebo three times a day for up to 28 days or until discharge from
the intensive care unit (ICU), whichever occurs first. The primary
efficacy endpoint of the trial is 28-day all-cause mortality.
Secondary endpoints include number of ICU days, shock-free days,
incidence and severity of organ failure/dysfunction and circulating
levels of pro- inflammatory cytokines. Safety will be monitored and
patients will be followed for survival at three and six months post-
randomization.

About Sepsis

Sepsis is a clinical syndrome consisting of known or suspected
infection and associated inflammatory response. Severe sepsis is
defined as the presence of sepsis with dysfunction of one or more
organs. The incidence of sepsis in the United States is estimated to
be approximately 750,000 cases per year, with an annual increase of
approximately 1.5%, and estimated mortality due to sepsis of 210,000
deaths each year. According to the Centers for Disease Control and
Prevention, sepsis is among the top 10 leading causes of death in the
United States.

Treatment for sepsis consists of eradicating the underlying infection
and providing supportive care for any associated organ dysfunction. In
November 2001, FDA approved the first biologic treatment for severe
sepsis. This drug, Xigris(R), is a genetically engineered form of a
naturally occurring human protein, activated Protein C. Despite the
availability of Xigris(R), treatment for severe sepsis remains an area
of significant unmet medical need.

About Talactoferrin Alfa

Talactoferrin, a novel dendritic cell recruiter and activator (DCRA),
is a unique recombinant form of human lactoferrin, an important
immunomodulatory protein. Talactoferrin is an orally administered
protein that mediates its activity through the gut and the GALT - the
largest lymphoid organ in the body.

In 1988, scientists at Baylor College of Medicine, Houston, Texas,
discovered a way to produce this protein in the laboratory, thus
paving the way for testing its potential to help fight serious
diseases that cause enormous suffering worldwide.

Lactoferrin, found in the highest concentration in milk, is expressed
throughout the body in immune cells and on all body surfaces exposed
to the external environment. Lactoferrin plays an important role in
helping to establish the immune system, including the GALT, in
infants. Talactoferrin is produced in Aspergillus niger, a filamentous
fungus, and is structurally identical to native human lactoferrin in
all material respects, differing only in its glycosylation.

About Agennix

Agennix is a private biotechnology company developing a first-in-class
molecule with activity in several types of cancer and in other
indications with unmet medical needs. This molecule, talactoferrin, is
a targeted dendritic cell recruiter and activator with a novel
mechanism of action. Agennix is preparing to initiate Phase 3 trials
in two non-small cell lung cancer indications (talactoferrin in
combination with chemotherapy in previously untreated patients and
talactoferrin monotherapy in patients who have failed two or more
previous therapies), a Phase 2b trial in renal cell cancer, and Phase
2 trials in other indications. Talactoferrin's potential advantages in
non-small cell lung cancer and in other tumor types include its
promising anti-tumor activity, its well tolerated safety profile
including a reduction of some chemotherapy toxicities, its oral route
of administration, and its apparent usefulness in multiple tumor types
both as a single agent and in combination with other drugs. The oral
formulation of talactoferrin is also being developed in severe sepsis
and the topical formulation is being developed in patients with
diabetic foot ulcers. Agennix retains all of the commercial and
economic rights to talactoferrin for all indications worldwide, and
has strong global intellectual property protection for talactoferrin
that has been tested and upheld.

More information about Agennix is available on the Company's web site
at http://www.agennix.com.

(1) Xigris is a registered trademark of Eli Lilly and Company

CONTACT: Rick Barsky, Chief Executive Officer, +1-713-552-1091, or
Atul
Varadhachary, President & COO, +1-713-552-1091, both of Agennix, Inc.;
or
Media, Daniel Budwick, BMC Communications Group, +1-212-477-9007 ext.
21

Web site: http://www.agennix.com/



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