Elusys, a biopharmaceutical company, has received Notice of Allowance from the United States Patent and Trademark Office (USPTO) for US Application Serial Number 13/076,082, a patent which covers methods of preventing or treating anthrax with ETI-204, the company's anti-anthrax antibody, together with antibiotics.

The patent 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 recognises 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 neutralises the toxins produced by B. anthracis by binding to protective antigen (PA).

"The patent allowance highlights the potential dosing flexibility of ETI-204, administered via intramuscular injection, for emergency use," says, Elizabeth Posillico, 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,'' he adds.

According to Dr Leslie S. Casey, vice president, research, in a release, inhaled anthrax is often fatal despite treatment with antibiotics in part because symptoms develop in later stages of the disease," "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," says 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 per cent 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, the release concluded.