2014

Elusys Receives Notice of Allowance from U.S. Patent Office for Methods of Preventing or Treating Anthrax with ETI-204, an Anti-Anthrax Antibody, via Intramuscular Injection

PINE BROOK, N.J., March 10, 2014 /PRNewswire/ -- Elusys Therapeutics, Inc. (Elusys), a biopharmaceutical company developing antibody therapies to treat infectious disease, announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for U.S. Application Serial Number 13/076,082, granting a patent which covers methods of preventing or treating anthrax with ETI-204, the company's anti-anthrax antibody, together with antibiotics. The patent also includes claims on intramuscular injection as a route of administration for ETI-204; currently stockpiled anthrax antitoxins are administered solely via intravenous (IV) infusion.

The Notice of Allowance specifically recognizes methods of preventing inhalation anthrax with ETI-204 before or after exposure to the anthrax-causing bacterium B. anthracis, together with antibiotics commonly used to treat inhaled anthrax. ETI-204 neutralizes the toxins produced by B. anthracis by binding to protective antigen (PA), the dominant antigen in anthrax infection, or lethal factor (LF)—proteins that work in combination to produce deadly anthrax toxins. ETI-204, in the late stages of development, is a potential candidate for future acquisition into the Strategic National Stockpile, the U.S. government's repository of critical medical supplies for biowarfare preparedness.

"The patent allowance highlights the potential dosing flexibility of ETI-204, administered via intramuscular injection, for emergency use," said Elizabeth Posillico, PhD, President and Chief Executive Officer, Elusys. "This Notice of Allowance follows the recent milestone achieved when we completed enrollment of three Phase 3 safety studies of ETI-204 for intravenous infusion in adult volunteers, as well as a pharmacokinetics and tolerability study of ETI-204 for IM injection."

"Inhaled anthrax is often fatal despite treatment with antibiotics, in part because symptoms develop in later stages of the disease," said Leslie S. Casey, Ph.D, Vice President, Research. "The option to administer anthrax anti-toxin via intramuscular injection could be important in certain situations, such as an imminent threat to field-based military personnel or citizens," added Dr. Casey.

Inhalation anthrax is a life-threatening infectious disease caused by the bacterium Bacillus anthracis and remains one of the nation's top biowarfare threats. Much of the morbidity and mortality of anthrax can be attributed to anthrax toxins. In the 2001 U.S. anthrax letter attacks, inhalational anthrax had a fatality rate of approximately 50% in humans infected even when victims were given antibiotics and supportive hospital care.

ETI-204 is formulated as a solution and is the only anthrax anti-toxin in advanced stages of development that is being investigated for IV treatment and IM prophylaxis administration. A product that can be given via IM injection is highly desirable because it could provide the capability for more rapid administration in prophylaxis or when IV administration is not feasible.

About ETI-204
ETI-204 is a high-affinity, humanized and deimmunized monoclonal antibody that targets the protective antigen of B. anthracis and neutralizes the lethal effects of anthrax toxins by binding to Protective Antigen. It is an investigational agent being developed for treatment and prophylaxis of inhalational anthrax. ETI-204 is formulated as a solution and is being evaluated for intravenous (IV) and/or intramuscular (IM) administration.

ETI-204's efficacy and safety are being studied in animal models of inhalational anthrax and safety studies are being conducted with healthy human volunteers. Three studies assessing safety and pharmacokinetics of IV administration of ETI-204 in adult volunteers have been completed. The more common adverse events related to ETI-204 administration, across the three studies, included upper respiratory tract infection, nausea, headache, nasal congestion and erythema. ETI-204 was granted Fast Track status and Orphan Drug Designation by the FDA.

This program is supported with federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), the Department of Health and Human Services (HHS) under Contract Nos. HHSO100201000026C and HHS0100201100034C.

About Elusys Therapeutics, Inc.

Elusys Therapeutics, a private company based in Pine Brook, NJ, is focused on the development of antibody therapeutics for the treatment of infectious disease. Elusys has been engaged in the development of ETI-204, an anthrax biowarfare countermeasure since 2000. The company has received multiple grants and contracts totaling over $200 million to support the development of ETI-204 to protect people in the event of an anthrax attack. Today, ETI-204 has advanced to the final stages of development, and is closer to achieving the company's goals of receiving FDA licensure and becoming part of the Strategic National Stockpile. For more information, please visit www.elusys.com.

SAFE HARBOR STATEMENT

This announcement includes statements that are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. This release includes forward looking statements. Any statements, other than statements of historical fact, including statements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, and any other statements containing the words "believes", "expects", "anticipates", "plans", "estimates" and similar expressions, are forward-looking statements. Such statements are based upon the current beliefs and expectations of management that are subject to risks, uncertainties and other important factors that could cause the company's actual results to differ materially from those indicated by such forward-looking statements. The guidance in this presentation is only effective as of the date given and will not be updated or affirmed unless and until the Company publicly announces updated or affirmed guidance.

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SOURCE Elusys Therapeutics, Inc.



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