Navigation Links
Elusys Initiates Third Clinical Safety Study of Anthim, a New Anthrax Treatment; Company Successfully Completes Manufacturing at Commercial Scale
Date:10/24/2011

PINE BROOK, N.J., Oct. 24, 2011 /PRNewswire/ -- Elusys Therapeutics, Inc. (Elusys), a biopharmaceutical company focused on the development of antibody therapeutics, announced today that it is initiating a new clinical study to further demonstrate the safety of Anthim (ETI-204), the company's anti-toxin in late-stage development for prevention of disease and death from exposure to inhaled anthrax. The company also announced it has successfully manufactured Anthim at commercial scale. Anthim is an anti-toxin that significantly increases survival in anthrax-infected animals and is a promising candidate for the treatment of anthrax infection in people following a biowarfare attack.

(Logo: http://photos.prnewswire.com/prnh/20090420/NY01624LOGO)

The double blind, placebo-controlled dose-escalating study will include a total of 108 healthy human subjects and is designed to collect additional safety and pharmacokinetic (PK) data on Anthim.

"Our development timeline for Anthim is right on track, and this additional safety and PK data will further prove Anthim's utility as a strong candidate for addition to the Strategic National Stockpile," said Elizabeth Posillico, PhD, President and Chief Executive Officer of Elusys. "Anthim is demonstrating the potential to deliver significant therapeutic benefit to Americans infected with anthrax in a bioterrorism emergency."

Dr. Posillico will be presenting an update on Anthim's development program at the 10th Annual BIO Investor Forum in San Francisco on October 26.

"We have successfully manufactured Anthim at commercial scale, and look forward to finalizing our commercial production process to ensure the large-scale capacity needed to deliver high quality, consistent quantities of Anthim for the long term," added James Porter, Vice President of Development and Manufacturing at Elusys.

Anthrax is a life-threatening infectious disease caused by the bacterium Bacillus anthracis and remains one of the nation's top biowarfare threats. Inhaled anthrax is usually fatal, despite treatment with antibiotics, unless the patient is treated soon after exposure.

If all activities in the Anthim development program are completed to the U.S. Food and Drug Administration's (FDA) satisfaction, the federal government could purchase Anthim for the Strategic National Stockpile (SNS) under Project BioShield. Project BioShield was established in 2004 to provide much needed funding to procure important countermeasures to protect the American public in the event of a biowarfare attack.

Elusys has the potential to receive funding totaling up to $143 million for a base plus four option year contract, awarded December 2009, for development of Anthim for treatment of symptomatic patients. The company also received the first U.S. government contract, awarded September 2011, for a base plus three option year contract for $68.9 million, to develop an anthrax anti-toxin for pre- and post-exposure prophylaxis (PEP) use via intramuscular injection (IM).

About Anthim

Anthim 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. It is being developed for prevention and treatment of inhalational anthrax following a biowarfare attack.

Anthim has been extensively tested for efficacy and safety in animals and safety in human volunteers. It shows excellent potential as an effective, life-saving therapeutic for the treatment of people infected by or exposed to anthrax spores. A single dose of Anthim consistently protects 70% to 100% of anthrax-infected animals from death.

This project is supported with federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), under Contract No. HHSO100201000026C, the National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Health (NIH), and the Department of Health and Human Services (HHS), under Contract No. HHSN272200700035C.

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 life-threatening disease. Elusys has been engaged in development of biodefense countermeasures since 2000. The company has established experience in government contract management and to date has received multiple grants and has the potential to receive funding totaling up to $246 million in government funding. Anthim, a highly effective, anthrax anti-toxin, is in late-stage development, and is a strong candidate for future procurement into the Strategic National Stockpile. For more information, please visit www.elusys.com.


'/>"/>
SOURCE Elusys Therapeutics
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Elusys Awarded $68 Million Contract to Develop Anthim for Intramuscular Pre- and Post-Exposure Prophylaxis of Anthrax Infection
2. Elusys Therapeutics and Lonza Extend Manufacturing Agreement for Anthim, a New Anthrax Treatment in Late-Stage Development
3. Elusys Presents Data From Anthim(R) Anthrax Anti-Toxin Studies at the HHS Stakeholders Workshop 2009 & BARDA Industry Day
4. Elusys Anthrax Anti-Toxin, Anthim(TM), Enters Second Phase I Clinical Study
5. Niaid / Barda Awards Elusys a $12 Million Contract to Further Develop Anthim, the Companys Anthrax Therapeutic
6. CryoLife Initiates Enrollment in U.S. Clinical Trial for BioFoam®
7. CareFusion Initiates Class I Recall of EnVe Ventilators
8. Takeda Initiates Phase 3 Clinical Trial Program in the United States, Latin America, and Europe for Investigational Type 2 Diabetes Therapy TAK-875
9. ChemoCentryx Initiates Phase II Clinical Trial for CCX168, a Novel Small Molecule C5aR Antagonist for the Treatment of Vasculitis
10. Merrimack Pharmaceuticals Initiates Enrollment in a Neoadjuvant Phase 2 Study of MM-121 with Paclitaxel in HER2-negative Breast Cancer Patients
11. Adamas Pharmaceuticals Initiates a Phase 2/3 Clinical Study of ADS-5102 for Parkinsons Disease
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/10/2016)... Calif., Feb. 10, 2016   Genomic Health, Inc. (Nasdaq: ... the quarter and year ended December 31, 2015. ... fourth quarter of 2015, compared with $69.1 million in the fourth ... currency basis, revenue increased 9 percent compared with the same period ... U.S. revenue was $63.9 million in the fourth quarter of ...
(Date:2/10/2016)... 2016 Mylan N.V. (NASDAQ, TASE: MYL) today ... ended December 31, 2015. --> ... total revenues of $9.45 billion, up 28% on a ... revenues of $9.43 billion. Excluding the impact of the ... branded generics business (the "EPD Business"), full year adjusted ...
(Date:2/10/2016)... -- CSI Specialty Group (CSI) expanded its specialty pharmacy ... Pharmacy Podcast. A free, weekly show, the Specialty Pharmacy ... discussion and context amongst specialty pharmacy peers and professionals. ... The Specialty Pharmacy Podcast, hosted by industry leader ... DiMascio, CHE, CMCE, CPC, is available for streaming and/or ...
Breaking Medicine Technology:
(Date:2/10/2016)... ... February 10, 2016 , ... ... offering education, research and medical media, has launched Contagion® , a ... diseases. , As the all-inclusive resource for infectious disease information, Contagion features ...
(Date:2/10/2016)... (PRWEB) , ... February 10, 2016 , ... ... company is unveiling its revolutionary new 2.0 version at the International Roofing Expo ... “put the power of the world's most advanced weather technology in the hands ...
(Date:2/10/2016)... , ... February 10, 2016 , ... ... Video Remote Interpreting (VRI) within Healthcare, recently partnered with Heart City Health ... (VRI). , For nearly 23 years, Heart City Health Center has provided the ...
(Date:2/10/2016)... Huntington, NY (PRWEB) , ... February 10, 2016 ... ... web-based compliance tracking solution, The Guard, to associations of medical professionals throughout the ... HIPAA compliance, including security risk assessments, policies and procedures, employee training, regulatory updates, ...
(Date:2/10/2016)... ... 10, 2016 , ... Emergency rooms provide emergency care to stabilize critical health ... patients with dental emergencies at risk of losing a tooth or their smiles. Dr. ... , Common dental emergencies include:, , Avulsed or knocked-out teeth ...
Breaking Medicine News(10 mins):