November 28, 2014 12:09 PM ET

Biotechnology

Company Overview of Elusys Therapeutics, Inc.

Company Overview

Elusys Therapeutics, Inc. operates as a biopharmaceutical company that develops antibody therapeutics for the treatment of life-threatening infectious disease. The company develops Anthim, a humanized and deimmunized monoclonal antibody that targets the protective antigen of B. anthracis and neutralizes the lethal effects of anthrax toxins. Elusys Therapeutics, Inc. was formerly known as ErythroMed, Inc. The company was founded in 1998 and is based in Pine Brook, New Jersey.

25 Riverside Drive

Unit One

Pine Brook, NJ 07058

United States

Founded in 1998

Phone:

973-808-0222

Fax:

973-808-0322

Key Executives for Elusys Therapeutics, Inc.

Chief Executive Officer
Chief Financial Officer
Age: 63
Senior Director of Human Resources & Administration
Vice President of Corporate Development
Age: 52
Vice President of Development and Manufacturing
Compensation as of Fiscal Year 2014.

Elusys Therapeutics, Inc. Key Developments

Elusys Therapeutics, Inc. Announces Results from Three Phase 3 Safety Studies of its Anthrax Anti-Toxin, Obiltoxaximab (ETI-204)

Elusys Therapeutics, Inc. announced it has completed three phase 3 healthy adult volunteer safety studies of obiltoxaximab (ETI-204). Obiltoxaximab is an anti-toxin in development for the treatment of inhalational anthrax and data from these studies support the safety and tolerability of the antitoxin when administered intravenously (IV) at the intended therapeutic dose. The conclusion of these studies marks the completion of Elusys' Phase 3 clinical development program required for filing a biologics license application. Elusys also announced it has completed an additional dose escalation study to evaluate intramuscular (IM) administration of obiltoxaximab. Obiltoxaximab 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. The first study was a double-blind, randomized, placebo-controlled expanded safety study that evaluated the safety and tolerability of a single intravenous (IV) dose (16mg/kg) of obiltoxaximab in healthy men and women greater than or equal to 18 years of age. The study enrolled 280 healthy adult subjects and was conducted at four sites in the US. Subjects were randomized upon entry to receive either obiltoxaximab (210 subjects) or placebo (70 subjects). Most adverse events (AEs) reported during the study were mild to moderate in severity. The most frequently reported AEs related to obiltoxaximab were pruritus (itching) and headache. Approximately 5% of subjects in the obiltoxaximab group experienced AEs consistent with hypersensitivity reactions. The most frequently reported hypersensitivity events were pruritus, rash and urticaria. A second trial was a double blind, randomized, placebo-controlled study that evaluated the safety and tolerability of repeat IV administration of obiltoxaximab (16mg/kg) in 70 healthy volunteers. The study was conducted at two sites in the US. Adult men and women greater than or equal to 18 years of age were randomly placed into one of two different treatment groups upon entry: Group A (35 subjects) received obiltoxaximab on days 1 and 14 and placebo on day 120 of the study; Group B (35 subjects) received obiltoxaximab on days 1 and 120 and placebo on day 14. Most adverse events reported during the study that were considered related to obiltoxaximab were mild to moderate in severity. The most frequently reported AEs considered related to obiltoxaximab were infusion site swelling, infusion site erythema, and infusion site pain. There was no increase in the number AEs related to obiltoxaximab with repeat administration of obiltoxaximab, whether the second dose was administered 14 days or 120 days after the first dose. There were no serious adverse events related to obiltoxaximab administration reported in this study. The company has also completed an open label, randomized, parallel group drug-drug interaction study to assess the safety and tolerability of obiltoxaximab when given with ciprofloxacin, an antibiotic used to treat anthrax infection after inhalational exposure. Forty healthy males and females between 18 years to 65 years of age were enrolled at one center in the US. The subjects were randomized to one of two treatments: Group 1 (20 subjects) received IV obiltoxaximab (16mg/kg) followed by a single dose of IV ciprofloxacin (400mg), followed by oral ciprofloxacin (750mg) every 12 hours starting on day 2 until the morning of day 9; Group 2 (20 subjects) received IV obiltoxaximab (16mg/kg) alone. All AEs reported during the study that were considered related to obiltoxaximab were mild to moderate in intensity. The most frequently reported AE related to obiltoxaximab was urticaria (hives). Ciprofloxacin had no effect on the pharmacokinetics of obiltoxaximab, and the frequency of adverse events did not appear to increase with co-administration of obiltoxaximab and ciprofloxacin. There were no serious adverse events related to obiltoxaximab administration reported in this study.

Elysys Therapeutics, Inc. Presents at BioNJ CEO Summit 2013, Oct-04-2013 08:00 AM

Elysys Therapeutics, Inc. Presents at BioNJ CEO Summit 2013, Oct-04-2013 08:00 AM. Venue: Bridgewater Marriott, Bridgewater, New Jersey, United States. Speakers: Elizabeth Posillico, President and CEO.

Elusys Therapeutics, Inc. Presents at 12th Annual BIO Investor Forum, Oct-08-2013 09:30 AM

Elusys Therapeutics, Inc. Presents at 12th Annual BIO Investor Forum, Oct-08-2013 09:30 AM. Venue: The Palace Hotel, 2 New Montgomery Street, San Francisco, CA 94105, United States.

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