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

Company also announces Award of a National Institutes of Health Small Business Innovative Research (SBIR) Grant to support the Phase 2 Trial

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

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

SOURCE Agennix, Inc.
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