Elusys Submits IND to Initiate Human Studies of Anthrax Drug; Major Milestone in Company's Development of Anthim.

PINE BROOK, N.J. -- Elusys Therapeutics, Inc. announced today that it has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to initiate human safety trials of its anti-anthrax drug, Anthim(TM). Anthim is a therapeutic monoclonal antibody being developed by Elusys to prevent and treat anthrax infections.

"The IND submission is a major milestone in our development of Anthim to protect people exposed to anthrax after a bioterror attack," said Elizabeth Posillico, PhD, president of Elusys. "It demonstrates our commitment to continue to move this very promising and important therapeutic forward as aggressively as we can. With support from several departments of the federal government, Elusys has been able to advance Anthim to the clinical and manufacturing stage in a very short period of time."

Following clearance of the IND by the FDA, Elusys will initiate a Phase I placebo-controlled trial of Anthim in healthy adult volunteers. The trial will examine the safety, tolerability and pharmacokinetics of Anthim.

Strong Animal Data Suggest Benefits in Humans

"Based upon very significant and promising safety and efficacy data we have obtained with Anthim in animals, we are ready to test the safety of the drug in human volunteers," said Linda Nardone, PhD, vice president of clinical and regulatory affairs at Elusys. "Submission of the IND underscores Elusys' achievement of a production process for the manufacture of clinical grade product under Good Manufacturing Processes (GMP). Following our safety studies, Anthim could be made available in the event it is ever required for a national emergency."

Animal studies have demonstrated that a single, low dose of Anthim is 100% effective when given prophylactically, prior to anthrax exposure, and greatly increases survival when given up to two days after anthrax exposure. A study with rabbits exposed to lethal levels of aerosolized anthrax spores found that 80% of the rabbits injected with Anthim 24 hours following exposure survived the 28-day study; 50% given Anthim 36 hours after exposure survived, and 43% treated 48 hours after exposure survived. Importantly, Anthim is equally effective when delivered by intramuscular (IM) injection and thus has the advantage that it can be rapidly given to civilians in an emergency situation. Anthim is the only monoclonal antibody under development that has been demonstrated to protect animals from death when delivered intramuscularly.

Need for Different Anthrax Treatments

Anthrax is a multi-stage organism: it begins as a spore, which is its dormant form. When anthrax enters the body (through the lungs, intestines or skin) it becomes active and germinates into bacteria. Anthrax bacteria release toxins into the bloodstream. When enough toxins are released into the body, people become symptomatic but it is often too late to treat them. Currently there are no viable treatments for exposure to anthrax toxin. Antibiotics kill anthrax bacteria but not the toxin. Anthrax vaccines are effective against the toxin but require several injections over several months and annual booster shots to be effective.

A single dose of Anthim is expected to be able to save patients with active anthrax infections when antibiotic therapy alone would fail. In a study recently published in the journal Infection and Immunity, Anthim was also shown to prevent the spread of anthrax bacteria in the body.

Anthim was developed initially under a Cooperative Research and Development Agreement (CRDA) with the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), and additional funding from the Defense Threat Reduction Agency (DTRA), the Defense Advanced Research Projects Agency (DARPA) and the National Institutes of Health (NIH) provided critical support for more advanced product development.

Dr. Posillico added, "We are very appreciative of the continued support we have received from various U.S. Government agencies that has enabled rapid development of Anthim to meet the nation's need for effective biowarfare countermeasures."

About Elusys

Elusys Therapeutics, Inc. develops first-in-class monoclonal antibody-based therapies using proprietary technology in Heteropolymer antibody chemistry, with a focus on infectious diseases. Current products in the pipeline target Category A biowarfare agents, including anthrax, and antibiotic-resistant infections, including Staphylococcus Aureus. Elusys' corporate offices and drug development operations are based in Pine Brook, N.J. Founded in May 1998, the company currently has 34 employees.