Navigation Links
Advanced Life Sciences' Restanza Shows 100% Survival in Tularemia Pivotal Animal Study
Date:12/16/2009

ters for Disease Control as a Category A Bioterrorism Agent and is prioritized by the Department of Defense and Department of Health and Human Services as one( )of the most serious biological weapons, along with anthrax and plague.

The Working Group on Civilian Biodefense, an expert panel convened by the Center for Civilian Biodefense Studies at the Johns Hopkins Bloomberg School of Public Health, says that tularemia could pose serious consequences if aerosolized and used as a biological weapon and cites a World Health Organization study which projected estimates of 250,000 illnesses and 19,000 deaths in the event that a mass-casualty tularemia biological weapon were used against a modern city of 5 million people.(1)( ) Unlike anthrax, there is no FDA-approved vaccine available to protect against tularemia, and the only antibiotic treatments currently available for improving survival in the event of a tularemia outbreak are older agents, such as gentamicin and doxycycline.

Restanza as a Biodefense Countermeasure

Advanced Life Sciences is developing Restanza as a broad spectrum medical countermeasure for biodefense to combat multiple high priority bioterror agents, such as Bacillus anthracis (anthrax), Fransicella tularensis (tularemia), Yersinia pestis (plague) and Burkholderia pseudomallei (melioidosis) under a two-year, $3.8 million contract with the U.S. Department of Defense. The FDA has designated Restanza as an orphan drug for the post-exposure prophylactic treatment of inhalation anthrax, plague and tularemia, but the FDA has not yet approved the drug for marketing in this or any other indication.

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

The FDA's "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 becaus
'/>"/>

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

Page: 1 2 3 4

Related medicine 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. Baxter Awarded Pandemic Advanced Supply Contract from the Department of Health
3. Callisto Pharmaceuticals Opens Additional Sites for Phase II Clinical Trial of Atiprimod in Advanced Carcinoid Cancer Patients
4. Genta Initiates Phase 3 AGENDA Trial of Genasense(R) for Patients with Advanced Melanoma
5. Advanced Life Sciences Collaborates with U.S. Government to Study Cethromycin as Treatment for Anthrax and Other High-Priority Biodefense Agents
6. Advanced Life Sciences Announces ALS-357 Granted FDA Orphan Drug Designation for Metastatic Melanoma
7. Advanced Life Sciences to Present Data on Selected Cethromycin Therapeutic Studies at the 47th Interscience Conference on Antimicrobial Agents and Chemotherapy
8. ECLIPSE Data on Effects of Otsukas Investigational Novel Treatment, Tolvaptan, on Advanced Heart Failure Patients Hemodynamics and Urine Output Featured in Heart Failure Society of Americas Late Breaking Trials
9. Newly Published Phase II Study Shows the Investigational Drug Vandetanib Prolongs Progression-Free Survival in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC)
10. Avastin Achieves Impressive Rate of Curative Surgery in Patients with Advanced Colorectal Cancer
11. Ardea Biosciences Lead MEK Inhibitor, RDEA119, to Enter Human Clinical Trials in Advanced Cancer Patients
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/28/2014)... 2014   Stone & Magnanini LLP ... and fraud claims between the United States Department ... The settlement covers fraud in connection with the ... ablation of varicose veins for unapproved uses. ... history of representing whistleblowers in groundbreaking settlements, represented ...
(Date:7/28/2014)... CLEVELAND , July 28, 2014  Surgical ... new members to its Business Advisory Board. New ... Senior Vice President for Business Development and New ... (Jim) Fulton , former Senior Vice President and ... unit. Surgical Theater applies flight simulation technology to ...
(Date:7/28/2014)... , July 28, 2014 Southern ... Tipton , Ph.D., President and CEO of Southern ... Controlled Release Society (CRS) for the 2014-2015 term.  ... meeting on July 12 in Chicago ... countries.  The Controlled Release Society ...
Breaking Medicine Technology:Stone & Magnanini LLP Announces $520,000 Department of Justice False Claims Act Settlement With Vascular Solutions, Inc. 2Stone & Magnanini LLP Announces $520,000 Department of Justice False Claims Act Settlement With Vascular Solutions, Inc. 3Surgical Theater Names Former Given Imaging Ltd. and Philips Healthcare Executives to Business Advisory Board 2Surgical Theater Names Former Given Imaging Ltd. and Philips Healthcare Executives to Business Advisory Board 3Surgical Theater Names Former Given Imaging Ltd. and Philips Healthcare Executives to Business Advisory Board 4Surgical Theater Names Former Given Imaging Ltd. and Philips Healthcare Executives to Business Advisory Board 5Arthur J. Tipton, Ph.D., Named President of Controlled Release Society 2Arthur J. Tipton, Ph.D., Named President of Controlled Release Society 3
... Nov. 11, 2010 Applied Precision, a leader in life ... four of its revolutionary DeltaVisio n OMX® ... weeks. The Delta V ision ... than doubles the optical resolution of the traditional light microscope ...
... Reata Pharmaceuticals today announced that the company will present ... clinical trial of bardoxolone methyl in patients with ... The data will be presented in a late-breaking oral presentation ... Conference to be held November 16-21, 2010, in Denver, ...
Cached Medicine Technology:Applied Precision Installs a Record Four New DeltaVision OMX Super-Resolution Imaging Systems in Eight Weeks 2Reata Pharmaceuticals to Present Data from Pivotal Phase 2b Trial in Type 2 Diabetics With Chronic Kidney Disease 2Reata Pharmaceuticals to Present Data from Pivotal Phase 2b Trial in Type 2 Diabetics With Chronic Kidney Disease 3
(Date:7/28/2014)... An estimated 68,000 women and men ... and prostate cancers – an aggressive form of the ... other parts of the body, such as the lungs, ... University College of Medicine have developed a compound ... progression by blocking tumor cells from “re-seeding.” Their discovery ...
(Date:7/28/2014)... Randy Dotinga HealthDay ... Scientists know it takes humans just milliseconds to look at ... Now, a new study finds that certain facial features seem ... The shape and size of the mouth, for example, ... dimensions are keys to attractiveness. The study findings ...
(Date:7/28/2014)... treat severe chronic migraine headaches led to significant symptom ... patients treated at Massachusetts General Hospital (MGH). Physicians ... report that more than half of 35 patients treated ... headaches associated with compression of craniofacial nerves reported ... paper has received advance online publication in the journal ...
(Date:7/28/2014)... 2014 Thousands of DePuy Pinnacle hip ... individuals who were allegedly injured by a metal-on-metal version ... forward in U.S. District Court, Northern District of Texas, ... on July 18, 2014, U.S. District Judge Ed Kinkeade ... Plaintiffs’ Steering Committee that sought the deposition of a ...
(Date:7/28/2014)... (PRWEB) July 28, 2014 Glutamine is ... and it’s considered to be conditionally essential during times ... is an advanced recovery & Immune System Support. , ... glutamine your body produces, supplementing with additional glutamine may ... waste products in the body, digestion and immune system ...
Breaking Medicine News(10 mins):Health News:Drexel Scientists Develop Compound to Stop Spread of Metastatic Cancer Cells 2Health News:Drexel Scientists Develop Compound to Stop Spread of Metastatic Cancer Cells 3Health News:Facial Dimensions May Be Key to First Impressions 2Health News:Facial Dimensions May Be Key to First Impressions 3Health News:Non-endoscopic migraine surgery provides significant symptom relief 2Health News:DePuy Pinnacle Lawsuit News: New Order Issued in Federal Pinnacle Hip Implant Litigation, Bernstein Liebhard LLP Reports 2Health News:DePuy Pinnacle Lawsuit News: New Order Issued in Federal Pinnacle Hip Implant Litigation, Bernstein Liebhard LLP Reports 3Health News:DePuy Pinnacle Lawsuit News: New Order Issued in Federal Pinnacle Hip Implant Litigation, Bernstein Liebhard LLP Reports 4Health News:Betancourt Nutrition Introduces Glutamine Plus with Sustamine® L-Alanyl-L-Glutamine 2Health News:Betancourt Nutrition Introduces Glutamine Plus with Sustamine® L-Alanyl-L-Glutamine 3
... be involved in decisions regarding quality of the donor ... a higher risk of failure, according to research by ... of patients would choose to remain on the waiting ... to the study,s lead author Michael L. Volk, M.D., ...
... (HealthDay News) -- ,The timing of an operation doesn,t affect ... study finds. For example, there,s no difference in death ... morning or on Monday instead of Friday, the researchers said. ... lead to a higher rate of safety problems when operations ...
... with obstructive sleep apnea are more likely to stick ... involved with their treatment, according to a team of ... airway collapses during sleep. It is the most common ... become more elevated in obese people. The first line ...
... Optimism is associated with higher grades for female students, but ... at Ben-Gurion University of the Negev in Israel assessed the ... 72 percent female) aged 20 to 28. The investigators ... grades than those who were less optimistic. However, high levels ...
... a chronic swelling condition common in breast cancer survivors, ... past, most people believed that exercise might induce or ... researchers say the benefits of exercise outweigh the risks ... Jane Armer, professor in the Sinclair School of Nursing, ...
... issue of Hepatology , a journal of the ... uncovered limitations in screening for primary liver cancer, also ... that, if given the choice during a clinical trial, ... of non-screening, therefore making a randomized study of HCC ...
Cached Medicine News:Health News:Transplant candidates seek best quality livers, even if it means waiting longer 2Health News:Time of Surgery Doesn't Influence Results, Study Says 2Health News:Innovative approaches help sleep apnea sufferers benefit from CPAP 2Health News:MU researchers recommend exercise for breast cancer survivors, lymphedema patients 2Health News:Studies of patients with cirrhosis uncover limitations in liver cancer screening 2
Irrigation pump for arthroscopy....
... DVD Burner captures still images and ... patient archives allows for multiple cases ... The unit provides software burned to ... playback and editing. Compatible with DICOM ...
The 15 and 18 Sony Flat Screen Monitors with articulating arm can be used in conjunction with existing surgical monitors or as replacements....
The A3 3-Chip Camera includes digital processing, seamless autoshutter, industry-leading reliability, white balance with memory function, ease of operation, and a 2 year warranty....
Medicine Products: