PINE BROOK, N.J., April 8, 2014 /PRNewswire/ -- Elusys Therapeutics, Inc. (Elusys), a biopharmaceutical company developing antibody therapies to treat infectious disease, today announced that it has completed validation of the commercial manufacturing process for ETI-204, an anthrax antitoxin currently undergoing Phase 3 clinical trials in healthy volunteers.
ETI-204 is a potential target for future acquisition into the Strategic National Stockpile, the U.S. government's repository of critical medical supplies for biowarfare preparedness. ETI-204 is the only anthrax anti-toxin in advanced stages of development that is being investigated for intravenous (IV) treatment and intramuscular (IM) prophylaxis administration. The ability to administer an antitoxin via IM injection may provide a valuable alternative to IV injection in an emergency where medical resources and personnel may be limited.
"We have completed all the planned validation activities for our commercial manufacturing process, and are now finalizing the supporting documentation to file for licensure," said James Porter, Vice President of Development and Manufacturing at Elusys. "Completing the manufacturing validation work is an important milestone along the path to BLA licensure and confirms our ability to supply commercial quantities of ETI-204 to the Strategic National Stockpile," he added.
The company also announced the appointment of Lawrence (Larry) Gyenes, formerly of Columbia Laboratories, as Chief Financial Officer. Mr. Gyenes has over 25 years of experience in financial leadership within the life sciences industry. Larry served as the senior finance executive at Searle, Reliant, Savient, Zila, Acusphere and, most recently, at Columbia Laboratories. Mr. Gyenes has served as CFO at six public companies and led CompuServe's initial public offering in 1996. He has been at the center of the development and launch of such well-known brands as Ambien, NutraSweet, Equal, Pearle Vision Centers and RandMcNally.com. His extensive experience includes the multi-billion dollar divestitures of DuPont Pharmaceuticals, CompuServe and Helene Curtis, as well as multiple financings, acquisitions, joint ventures and strategic alliances. Mr. Gyenes holds a bachelor of science in Accounting from the University of Illinois and an MBA from the University of Chicago. He is a past nominee for the New Jersey Technology Council's CFO Hall of Fame.
"We will look to Larry's extensive experience to inform and direct our fiscal strategy as we progress through the final stages of product development and the fulfillment of our BARDA contracts for advanced development of ETI-204," said Elizabeth Posillico, PhD, Chief Executive Officer of Elusys.
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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