Navigation Links
Advanced Life Sciences' Restanza(TM) Shows 100% Survival In Confirmatory Anthrax Study
Date:6/23/2009

protect against human infection from anthrax. In studies conducted by the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), Restanza was shown to be highly active in vitro against 30 strains of anthrax. In May 2007, a non-human primate study showed that a 30-day course of oral Restanza was 100% protective against a lethal dose of inhaled anthrax as compared to the standard of care, Cipro(R) (ciprofloxacin), which demonstrated 90% protection. The FDA has designated Restanza as an orphan drug for the post-exposure prophylactic treatment of inhalation anthrax, but the FDA has not yet approved the drug for marketing in this or any other indication.

In addition to its development in anthrax, Restanza is also being developed to combat other high priority bioterror agents such as Fransicella tularensis (tularemia), Yersinia pestis (plague) and Burkholderia pseudomallei (melioidosis) under a two year, $3.8 million contract with the Defense Threat Reduction Agency (DTRA) of the U.S. Department of Defense.

FDA's "Animal Efficacy Rule" and the Use of Non-Human Primates

The "Animal Efficacy Rule" allows for approval of new drug products based on animal data when adequate and well-controlled efficacy studies in humans cannot be ethically conducted because the studies would involve administering a potentially lethal or permanently disabling toxic substance or organism to healthy human volunteers. Approval of a drug under the "Animal Efficacy Rule" is subject to certain post-approval commitments, including the submission of a plan for conducting post-marketing studies, post-marketing restrictions to ensure safe use (if deemed necessary), and product labeling information intended for patient advising that, among other things, indicates the product's approval was based on efficacy studies conducted in animals alone.

The non-human primates use
'/>"/>

SOURCE Advanced Life Sciences Holdings, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3

Related biology technology :

1. Dendreon Announces Publication of Phase 1 Study Highlighting Immunologic and Clinical Activity of Lapuleucel-T (Neuvenge(R)) in Advanced Breast Cancer Patients
2. Advanced Life Sciences Announces Receipt of Nasdaq Staff Letter
3. Advanced Cell Technology Announces Proposed Financing
4. YM BIOSCIENCES, EUROPEAN PARTNER, ONCOSCIENCE AG, ANNOUNCES INITIATION OF ADVANCED NIMOTUZUMAB TRIALS IN ADULT GLIOMA AND PANCREATIC CANCER
5. Advanced Cell Technologys Dr. Robert Lanza Makes List of 100 Most Inspiring People in the Life-Sciences Industry
6. Advanced Life Sciences to Present at 2007 UBS Global Life Sciences Conference
7. CeloNova BioSciences Announces Worlds First Line of Fully Color-Coded Embolic Particles at CIRSE: Embozene(TM) Color-Advanced Microspheres
8. Edwards Lifesciences Grants UC Irvine $5 Million to Establish the Edwards Lifesciences Center for Advanced Cardiovascular Technology
9. Advanced Bionics Deploys CEVA-TeakLite(TM) DSP Core to Enhance Its Harmony(TM) HiResolution(R) Bionic Ear System
10. NIH Announces Advanced Cell Technologys Single Cell Embryo Biopsy Technique as a Means to Derive Embryonic Stem Cells to be Considered for Federal Funding
11. Cell Therapeutics, Inc. (CTI) Receives SPA Approval from FDA and Launches Gender-Specific Phase III Trial for Advanced Non-Small Cell Lung Cancer
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/1/2014)... New applications of structures and materials that ... nature over millennia are featured in a special ... in biophotonics in the October issue of the ... by SPIE, the international society for optics and photonics, ... articles are accessible via open access. , “Biomimetic and ...
(Date:10/1/2014)... (PRWEB) October 01, 2014 Slone ... Clinical Therapeutics, Healthcare IT, and Laboratory Testing industries, reported ... positions at the director level and above from July ... to stay on top of rapid breakthroughs in diagnostics, ... many diagnostic companies have been forced to fold, consolidate, ...
(Date:10/1/2014)... The U.S. Department of Labor has awarded ... as part of the Trade Adjustment Assistance Community College ... by the Department of Labor and Department of Education. ... E. Perez and Secretary of Education Arne Duncan announced ... to nearly 270 colleges across the country. , ...
(Date:10/1/2014)... Industry leaders from retail ... around the theme, ,Commercial Opportunities in the Era of ... Elsevier , a world-leading provider of scientific, ... a gathering of some of the industry,s most prominent ... today and in the future. The Elsevier ...
Breaking Biology Technology:Biomimetic and bioinspired materials enable new healthcare options, reports Journal of Biomedical Optics 2Biomimetic and bioinspired materials enable new healthcare options, reports Journal of Biomedical Optics 3Slone Partners Meets Growing Demand as Industry Focuses on Reimbursement & Regulation 2U.S. Dept. of Labor Awards SIUE Nearly $10-Million Grant 2U.S. Dept. of Labor Awards SIUE Nearly $10-Million Grant 3U.S. Dept. of Labor Awards SIUE Nearly $10-Million Grant 4Elsevier Healthcare and Pharmaceutical Economics Conference 2014 To Convene Industry Leaders to Discuss Top Healthcare Business Issues 2Elsevier Healthcare and Pharmaceutical Economics Conference 2014 To Convene Industry Leaders to Discuss Top Healthcare Business Issues 3
... 2011 Debiopharm Group™ (Debiopharm), a ... drug development and companion diagnostics, will present tomorrow ... Professor Stefano Piccolo as well as two inaugural ... Professor Etienne Meylan and Doctor Volker Busskamp. The ...
... of the INRS,s Energy, Materials, and Telecommunications Centre, has ... Medal in Chemistry. Granted by the Royal Society of ... major breakthroughs in the fields of molecular self-assembly and ... Dr. Rosei has held the Canada Research ...
... 7, 2011 CMC Biologics and Oxford BioTherapeutics (OBT) ... license agreement providing OBT with access to CMC Biologics, ... have not been disclosed, covers the research, development, and ... CHEF1 cell line development platform promotes high level expression ...
Cached Biology Technology:Debiopharm Group™ Presents the 'Debiopharm Group™ Life Sciences Award 2011' and two 'Junior Debiopharm Group™ Awards 2011' at the ISREC 2011 Life Sciences Symposium 2Debiopharm Group™ Presents the 'Debiopharm Group™ Life Sciences Award 2011' and two 'Junior Debiopharm Group™ Awards 2011' at the ISREC 2011 Life Sciences Symposium 3CMC Biologics Licenses Its CHEF1® Expression System to Oxford BioTherapeutics 2CMC Biologics Licenses Its CHEF1® Expression System to Oxford BioTherapeutics 3CMC Biologics Licenses Its CHEF1® Expression System to Oxford BioTherapeutics 4
(Date:9/30/2014)... (September 30, 2014) People who suffer from asthma ... to control their asthma besides properly taking medications and ... article in the Annals of Allergy, Asthma and ... of Allergy, Asthma and Immunology (ACAAI), asthma sufferers can ... lifestyle. The woman described in the Annals article improved ...
(Date:9/29/2014)... the exposure to tar tended to be lower for ... Similarly, exposure to nicotine tended to be lower. , ... in several countries around the world. Previous studies have ... the smoke of these cigarettes are lower than those ... in the smoke are not necessarily linked to a ...
(Date:9/29/2014)... a NASA story from 2009, "human activities in this area ... issue. Palm oil is increasingly grown for use as a ... processed foods. It has become the most widely produced edible ... years to surpass that of soybean oil. , The environmental ... be cleared to grow the crop, and the preferred method ...
Breaking Biology News(10 mins):Asthma symptoms kicking up? Check your exposure to air pollution 2Slim cigarette smokers not exposed to more harmful chemicals 2
... Bacteria can directly cause human blood and plasma to ... lost during the course of vertebrate evolution, according to ... of Allergy and Infectious Diseases, and Institut Pasteur in ... in Nature Chemical Biology . , The discovery ...
... designing and manufacturing biomedical sensors, healthcare and its related ... learn what to expect from this new and growing ... seminar set for Nov. 6, 2008, from 4:45-6 p.m., ... (ECE) Building, 141 Warren St, at the northwest corner ...
... in Italy have found bacteria in the root of ... the cosmetic and perfumery industries. These bacteria seem to ... change the molecular structure of the oil, giving it ... Studying the root of the tropical Vetiver grass ...
Cached Biology News:Nature study demonstrates that bacterial clotting depends on clustering 2NJIT seminar set for Nov. 6 to focus on bioelectronics -- emerging research area 2Bacteria manage perfume oil production from grass 2
... The MBS Satellite Thermal ... and flexible solution for medium ... The MBS combines the latest ... friendly software and PC control, ...
45° Fixed Angle Rotor for use in the IEC Centra CL2, Centra CL3/CL3R, HN-SII, and the Centra-MP4/MP4R....
Glycerokinase; from Bacillus stearothermophilus...
...
Biology Products: