WHO fast tracks experimental drugs to fight Ebola New Scientist Sep 9
More promising might be two wide-spectrum antiviral drugs, BCX4430 and favipiravir. Both resemble the nucleotide molecules that make up the virus's RNA genome, and fool the virus's RNA-copying enzyme – but not a human's – into using them, crippling viral replication
There seems to be a news blackout about the Working group on experimental Ebola drugs being headed up by Asst Secty for Preparedness Dr. Nicole Lurie, ie, they don't want to indicate panic, but inside the beltway,
at Fort Belvoir, down in Atlanta, they're in a panic. Time to batten down the hatches, and that means buy up and fund everything that might be an MCM for the EEP (Exponential Ebola Pandemic).
From a Sep 3 story-ready to increase from 25 to 40 million.
Mapp Biopharmaceutical has landed an 18-month, $24.9 million contract with the Department of Health and Human Services to further develop ZMapp, an antibody drug designed to treat the Ebola virus.
HHS’ Biomedical Advanced Research and Development Authority will provide financial, preclinical and manufacturing support to Mapp with the goal of obtaining U.S. regulatory approval for the Ebola medicine, HHS said Tuesday.
The agency says it could increase ZMapp project funding up to $42.3 million.
“Developing drugs and vaccines to protect against Ebola as a biological threat has been a long-term goal of the U.S. government, and today’s agreement represents an important step forward,” said Dr. Nicole Lurie, HHS assistant secretary for preparedness and response.
BARDA plans to collaborate with the National Institute of Allergy and Infectious Diseases, Defense Department and National Institutes of Health to expedite drug development.
FBO award Pandemic and all Hazards Preparedness - Sanofi Pasteur Sep 1.
Contract Award Date:
September 1, 2014
Contract Award Number:
Contract Award Dollar Amount:
Contractor Awarded Name:
Sanofi Pasteur, Inc.
Contractor Awarded DUNS:
Contractor Awarded Address:
1 Discovery Drive
Swiftwater, Pennsylvania 18370
Peramivir news as single dose flu treatment from ICAAC was on CBS news on the hour and the results are all over the twitterverse among #flu site tweeters. This is all just advance prep for FDA approval.
WHO Press release says discussed small molecule therapies. Acknowledges human safety is an unknown, but still says "intl community mobilizing to find ways to accelerate evaluation and use..." Today just a buying oppty, one order at ask only produced 100 shares. MM reluctant to sell below 12.30
Statement on the WHO Consultation on potential Ebola therapies and vaccines
5 September 2014
After two days of discussion on potential Ebola therapies and vaccines, more than 150 participants, representing the fields of research and clinical investigation, ethics, legal, regulatory, financing, and data collection, identified several therapeutic and vaccine interventions that should be the focus of priority clinical evaluation at this time.
Currently, none of these vaccines or therapies have been approved for human use to prevent or treat EVD. A number of candidate vaccines and therapies have been developed and tested in animal models and some have demonstrated promising results. In view of the urgency of these outbreaks, the international community is mobilizing to find ways to accelerate the evaluation and use of these compounds.
Safety in humans is also unknown, raising the possibility of adverse side effects when administered. Use of some of these products is demanding and requires intravenous administration and infrastructure, such as cold chain, and facilities able to offer a good and safe standard of care.
Materials provided by Biocryst say trials will start in SEPTEMBER with Army USAMRIID. THAT IS WITHIN NEXT 30 DAYS.
Evidence for BCX4430 Efficacy in EBOV Infection: BCX4430 demonstrated significant efficacy, even when dosing was delayed up to 4 days after infection, in four in vivo studies in a mouse model of EBOV infection that utilizes a mouse-adapted EBOV variant. A dose-ranging study of BCX4430 in NHP experimentally infected with wild-type EBOV-Zaire is planned to start in September at US Army Medical Institute of Infectious Diseases (USAMRIID).
Dr Sina Bavari, CIV US Army Medcom USA MRIID, USA
Dr Luciana Borio, Director, Office of Counterterrorism and Emerging Threats (OCET) in the Office of the Chief Scientist, U.S. Food and Drug Administration (FDA), Rockville, USA
Dr George Christopher, Chief Medical Officer, Joint Project Manager – Medical Countermeasure Systems, Department of Defense, Rockville, USA
Dr Marion Danis, Head, Section on Ethics and Health Policy, NIH, Bethesda, USA
Dr Jesse Goodman, George Town University, Washington, USA
Dr Barney Graham, Vaccine Research Centre, National Institute of Allergy and Infectious Diseases, NIH, Bethesda, USA
Dr Fred Hayden, University of Virginia/WHO consultant, Charlottesville, USA
Dr Lisa Hensley, National Institute of Allergy and Infectious Diseases, NIH , Bethesda, USA
Dr Elizabeth Higgs, Global Health Science Advisor, Office of the Director, Division of Clinical Research, National Institute of Allergy and Infectious Diseases, NIH, Bethesda, USA
Dr David Hone, Chief, Vaccine Branch, Research and Development Directorate (J9), Defense Threat Reduction Agency (DTRA), Department of Defense, Fort Belvoir, USA
Dr Franca Jones, Medical Director, Chemical and Biological Defense Program, Office of the Assistant Secretary of Defense for Nuclear, Chemical, and Biological Defense Programs OASD(NCB/CB), Rockville, USA
Dr Christopher Karp, Deputy Director, Discovery and Translational Sciences, Bill & Melinda Gates Foundation, Seattle, USA
Dr Steve Kern, Deputy Director, Integrated Development, Bill & Melinda Gates Foundation, Seattle, USA
Dr Michael Kurilla, Director, Office of BioDefense, Research Resources, and Translational Research, Associate Director for BioDefense Product Development, NIAID, NIH, Rockville, USA
Dr Mike Levine, Director, Center for Vaccine Development, University of Maryland School of Medicine, Baltimore, USA
Dr Nicole Lurie, Assistant Secretary for Preparedness and Response (ASPR), U.S. Department of Health and Human Services, Washington, USA
Dr Eric Mast, Deputy Director Science and Research, Center for Disease Control and Prevention, Atlanta, USA
Dr Robin Robinson, Director, Biomedical Advanced Research & Development Authority, US Department of Health and Human Services, Washington, USA
Dr Kacey Wulff, Special Assistant to the Assistant Secretary of Preparedness and Response, US Department of Health and Human Services, Washington, USA
WHO Summary document says AVI drug human tolerability shown, some efficacy, 100 doses next year
The active pharmaceutical ingredient is available for 20 to 25 courses by mid-October. Potential production of approximately 100 treatment courses by early 2015In monkey studies, doses of 14 to 40 mg/kg for 14 days showed typical survival ranging from 60% to 80% when given at the time of infection Human tolerability has been demonstrated in early studies. AVI 7537 (Sarepta) Phosphoro- diamidate oligonucleotide.
Dr Jay Wang, Program Manager, Emerging Infectious Diseases Therapeutics, Joint Project Manager – Medical Countermeasure Systems, Department of Defense, Rockville, USA Dr Linghang Wang, Beijing Ditan Hospital, Beijing, China Dr John Whitehead, Lancaster, United Kingdom of Great Britain & Northern Ireland Dr Christopher Whitty, Director Research & Evidence and Chief Scientific Adviser, Department for International Development, London, United Kingdom of Great Britain & Northern Ireland Dr Michael Wong, Sarepta Therapeutics, Sarepta, USA Dr Tom Wong, Director, Centre for Immunization and Respiratory Infectious Diseases, Public Health Agency of Canada, Ottawa, Canada Dr Kacey Wulff, Special Assistant to the Assistant Secretary of Preparedness and Response, US Department of Health and Human Services, Washington, USA 137. 138. 139. 140. 141. 142. 143.
RESEARCH TRIANGLE PARK, N.C., Sept. 4, 2014 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) today announced its participation in a consultation on potential Ebola therapies and vaccines hosted by the World Health Organization (WHO). The meeting
The project with Mapp Biopharmaceutical is the first BARDA program supporting the development of a product against viruses that cause viral hemorrhagic fever.
Even the most advanced potential therapeutics and vaccines for Ebola are entering early clinical trials. BARDA is working with other federal agencies to accelerate the development of Ebola therapeutics and vaccines and to identify ways to optimize and expand their production. BARDA is exploring whether its Centers for Innovation in Advanced Development and Manufacturing, its Fill Finish Manufacturing Network, or other measures can accelerate the manufacturing time.
BARDA is seeking additional proposals for the advanced development of antibody treatments, antiviral drugs, and vaccines against the Ebola and Marburg viruses, both of which cause viral hemorrhagic fever. Program requirements are described in BARDA’s Broad Agency Announcement BARDA-BAA-13-100-SOL-00013
Comment: Hmmm, BCX 4430 specifically designed for Marburg, already noticed, heading for clinical trials quickly.
Pediatric mortality from influenza is a serious issue which has been heretofore treated with tamiflu capsules opened (dosing issues) and mixed with syrup (uptake issues). Peramivir will be a staple therapy for pediatric treatment and the ICAAC presentations will lay foundation for use.
“The window of opportunity to stop Ebola from spreading widely throughout Africa and becoming a global threat for years to come is closing, but it is not yet closed,” Dr. Frieden
Here’s the current status of new drugs to fight Ebola virus and what works best now
By Celine Gounder SEPTEMBER 2, 2014
BCX 4430 mentioned in middle of blog says awaiting human trials.
Session: 197-Transmission of Viral Pathogens In the Healthcare Setting
Monday, Sep 08, 2014, 3:00 PM - 5:00 PM
Presentation Title: K-1858a - Responding to the Ebola Outbreak in West Africa: Current Status and Lessons Learned
Location: Room 207 B
Pres. Time: Monday, Sep 08, 2014, 4:15 PM - 4:40 PM
Author(s): Barbara Knust; CDC, Atlanta, GA
Bloomberg reporting on Sep 8-18, trading 19th
The Chinese e-commerce operator, which plans to sell shares on the New York Stock Exchange, may set its IPO value at $154 billion, or 22 percent below analyst valuations, in a move that could avoid repeating Facebook Inc. (FB)'s listing flop, according to the average estimate in a Bloomberg survey of five analysts last month. The poll respondents give Alibaba an average post-listing valuation of $198 billion.
Alibaba is expected to begin an eagerly awaited roadshow for what could be the largest initial public offering ever early during the week of September 8, and its shares could list as soon as September 18 or 19, according to a person familiar with the situation.
The marketing trip will kick off in Asia, the person said. The Chinese e-commerce company is expected to raise about $20 billion when it lists on the New York Stock Exchange, rivaling the Agricultural Bank of China's $22.1 billion IPO from July 2010, currently the largest on record. A price range for the shares is typically given just ahead of the start of the roadshow.
Above from CNBC - also says internal valuation increased to $140 billion from $133
So Sep 18-19 Thursday or Friday IF SEC review completed
BioCryst Pharmaceuticals also rose after it announced plans to initiate a study of its Ebola drug on primates. It’s received an additional $2.4 million in government funding for the test. Shares were up more than two percent to $13.50.
New funding for BCX4430 is for dosing study, one of key elements of Animal rule approval (look up Animal Rule FDA Emeregency) is understanding PK well enough to have good idea of dosing.