“In the past 5 years, Bavarian Nordic has delivered 28 million smallpox vaccine doses to the U.S. government’s stockpile to protect against renegade stocks or re-engineered viruses. Global revenue for small pox vaccine was nearly $31.8 billion in 2011. This market is expected for small pox vaccine to increase from $65.6 billion in 2020. WTF! In the case of USA $11.3billion in 2011 ,but it will increase half of the percentage by the end of 2017. Geographically,south America, dominates the market followed by Europe. South America accounted for about ~38% share in the small pox vaccine market in 2013 owing to the heavy investments by multinational companies in research and development of vaccine . On the other hand, Asia-Pacific market would grow at the promising CAGR of 8.7% during the forecast period.”
Remember this? Bioresearch lab in Maryland mishandled vials of smallpox.
What did the NIH say? “Two research laboratories”
The smallpox virus is considered a bioterrorism threat and is only permitted in two labs in the world: One at the CDC’s Atlanta headquarters and another at the VECTOR Institute in Russia.
House oversight subcommittee reports on safety of bioresearch labs
Thursday, Apr 21, 2016 @ 1:36pm by BioPrepWatch Reports
The House Energy and Commerce Subcommittee on Oversight and Investigations has released a report on its investigation of allegations that a bioresearch lab in Maryland mishandled vials of smallpox.
“There’s a problem when the government somehow loses track of smallpox and other deadly agents, only to have them turn up in a soggy cardboard box,” Energy and Commerce Committee Chairman Fred Upton (R-MI) and Oversight and Investigations Subcommittee Chairman Tim Murphy said in a joint statement. “What’s worse, the urgency that should accompany such a discovery has failed to spur absolutely necessary changes. Today serves as an important opportunity to ask some of the agencies in question about their next steps to ensure safety for those working in the labs, as well as the general public.”
Vials of the virus that causes smallpox were found in a National Institutes of Health research building that was unequipped and unapproved to handle the deadly pathogen, according to the Centers for Disease Control and Prevention.
U.S. HOUSE OF REPRESENTATIVES COMMITTEE ON ENERGY AND COMMERCE
TO: Members, Subcommittee on Oversight and Investigations
FROM: Majority Staff
RE: Supplemental Memorandum:
Committee Investigation on the 2014 Discovery of Smallpox Vials at the National Institutes of Health, Bethesda, Maryland Campus
Corporate Headquarters Madison Avenue, New York, NY
SIGA Labs, Corvallis, OR
SIGA Technologies reaches final stages of smallpox drug trial.
April 25, 2016
SIGA Announces Enrollment of First Patients in the Final Cohort of Phase III Study of Tecovirimat
NEW YORK–(BUSINESS WIRE)– SIGA Technologies, Inc. (SIGA) (OTCMKTS:SIGA), a company specializing in the development of pharmaceutical agents to combat bio-warfare pathogens, announced today that it has begun enrolling the second and final cohort of healthy subjects for the Phase III clinical study for its lead drug candidate, TPOXX (tecovirimat), for the treatment of orthopoxvirus. This Phase III study, which is wholly funded the by the Biomedical Advanced Research and Development Authority (BARDA) will be conducted at eleven approved investigative sites with a total of approximately 360 subjects.
The initial Phase III lead cohort of 40 subjects in this trial has already completed participation without any reports of serious adverse events.
Screening of subjects for the second Phase III cohort initiated on April 11, 2016, and the first subject was enrolled and dosed on April 18, 2016. Since tecovirimat is being developed under the FDA “Animal Rule,” there are no efficacy endpoints in this clinical trial. This study will generate safety and pharmacokinetic data in support of the prescribing information that will be part of the New Drug Application (NDA) filing.
source businesswire.com: www.businesswire.com/news/home/20160425006486/en/
Siga launches clinical study for TPOXX IV formulation.
Tuesday, Mar 22, 2016 @ 6:27pm by BioPrepWatch Reports
Siga Technologies Inc., a company that focuses on the creation and sale of solutions for biodefense and medical needs with unmet problems, recently launched its phase-one single ascending dose clinical study for TPOXX in an intravenous (IV) formulation.
TPOXX is the top drug candidate at the company. It is designed to treat orthopoxvirus diseases. To conduct the study, Siga collaborated with the Biomedical Research and Development Authority (BARDA).
The purpose of the study is to determine the safety and pharmacokinetic value of developing a protocol for the company’s next phase-one clinical trial within its IV program. The next phase is a multiple ascending dose safety as well as pharmacokinetic trial.
“This collaboration with BARDA on an IV formulation is an important step toward realizing the full capability of TPOXX,” Siga CEO Eric Rose said. “This trial advances our efforts to ensure better protection of Americans from a smallpox outbreak.”
Siga’s ultimate goal within its IV program is to develop formulations of IVs that can be used as alternative treatments for people who have dysphagia. It will also be useful for patients who are seriously sick, hospitalized or cannot swallow the traditional oral capsules.
Organizations in this story
Siga Technologies, Inc.
660 Madison Ave New York, NY 10173
Tuesday, Mar 1, 2016 @ 7:53pm by BioPrepWatch Reports
SIGA Technologies has reached the final stages of its clinical trial for a drug that could cure small pox.
The final stages come on the heels of a receipt from the U.S. Food and Drug Administration (FDA) to continue the human study of tecovirimat for concurrence on dosage.
The drug will also work on other orthopoxvirus diseases, such as smallpox.
“We are pleased to receive FDA concurrence on dosage for our clinical safety studies and look forward to the future development and distribution of this critical antiviral,” SIGA CEO Eric Rose said.
The concurrence on dosage gives SIGA the instruction to follow through on phase three, which will include an expanded trial on humans. The drug will be taken orally.
SIDA is a company that develops drugs for medical needs that are serious, yet unmet. The tecovirimat is also known as ST-246.
Siga Technologies, Inc.
660 Madison Ave New York, NY 10173
SIGA Technologies, Inc., a pharmaceutical company, was set up in 1995 and is now based in New York City. The company markets on pharmaceutical solutions for smallpox, Ebola, dengue, Lassa fever, and other lethal disease-causing pathogens.
SIGA has strong relationship with federal agencies and academic laboratories for its research and development activities. SIGA is providing countermeasures to the Strategic National Stockpile (SNS) and the Department of Defense (DoD), such as Category A pathogens.
2009, SIGA Technologies received a $1.6 million research fund from the National Institutes of Health (“NIH”) for its broad-spectrum antiviral candidates.
2011, SIGA Technologies was awarded a $7.7 million grant from the National Institutes of Health (NIH) to develop an antiviral drug for treating and preventing Lassa fever and others of Arenavirus origin.
2011, Siga was ordered to pay $232 million in damages in a legal dispute with PharmAthene over rights to the smallpox drug tecovirimat.
2013, SIGA Technologies delivered about 590,000 courses of its smallpox antiviral drug tecovirimat (Arestvy) to the United States Government’s Strategic National Stockpile (SNS), meeting the requirement of Government’s Biomedical Advanced Research and Development Authority (BARDA).
2013, Siga laid off its entire research & development division located in Corvallis, Oregon. The company liquidated all laboratory equipment at auction from that site.
In 2014, Siga filed for bankruptcy protection.
company webpage: siga.com
Our lead product is tecovirimat, also known as ST-246®, an orally administered antiviral drug that targets orthopoxviruses. While tecovirimat is not yet licensed as safe or effective by the U.S. Food & Drug Administration, it is a novel small-molecule drug that is being delivered to the Strategic National Stockpile under Project BioShield.
Who is BARDA?
Biomedical Advanced Research and Development Authority is a division of the Office of the Assistant Secretary for Preparedness and Response. The Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (H.R. 307; 113th Congress) Pub.L. 113–5 reauthorized the provisions of the PAHPA.
BARDA manages the procurement and advanced development of medical countermeasures for chemical, biological, radiological, and nuclear agents, as well as the advanced development and procurement of medical countermeasures for pandemic influenza and other emerging infectious diseases.
from the US Dept of Health and Human Services phe.gov/about/barda/Pages/2011barda-stratplan.aspxOver the last decade, our nation has responded to deliberate biological attacks – the mailing of anthrax-laden letters – and severe naturally occurring disease outbreaks including SARS and the 2009-H1N1 influenza pandemic. On October 4, 2011, the Biomedical Advanced Research and Development Authority (BARDA) issued the BARDA Strategic Plan 2011-2016, which articulates the guiding principles, goals, and strategies it will implement to enhance the capability of the U.S. government to develop medical countermeasures (MCMs) to these and other natural and intentional threats to public health.
Who is PharmAthene?
PharmAthene: “dedicated to a safer world”
Corporate Headquarters is in Annapolis, MD
Ranging from expertise in infectious diseases and genome science across the spectrum to pharmaceutical marketing and management
PharmAthene has established relationships with numerous U.S. government and corporate partners, including: the Biomedical Advanced Research and Development Authority (BARDA), the National Institutes of Health (NIH), the National Institute of Allergy and Infectious Diseases (NIAID), the Defense Advanced Research and Project Agency (DARPA), the United States Army Medical Research and Materiel Command (USAMRMC), the United States Army Medical Research Institute of Chemical Defense (USAMRICD), the U.K. Defence Science & Technology Laboratory (dstl), Bristol-Myers Squibb (formerly Medarex), and Diosynth RTP.
PharmAthene forms alliance with federal contractor in Florida
September 08, 2014 | By Scott Dance, The Baltimore Sun
Annapolis biodefense company PharmAthene Inc. has formed a strategic alliance with a Florida-based federal contractor to collaborate on development of a nerve agent treatment and other products.
PharmAthene and Nanotherapeutics Inc. will share their expertise and resources under an agreement, financial details of which they did not disclose. Their first collaboration will be on PharmAthene’s medical countermeasure for nerve agent poisoning.
Nanotherapeutics, based in Alachua, Fla., has a $359 million, 10-year contract with the Department of Defense to develop and manufacture vaccines and other treatments.
“There is a real concern that the nation is not as prepared for manmade and naturally occurring biothreats as it can be and should be,” PharmAthene CEO Eric I. Richman said in a statement. “We believe our alliance with Nanotherapeutics will accelerate the development and availability of promising medical countermeasures.”
“we have been successful in obtaining non-dilutive government contracts and grants (over $500 million to date) for the advanced development and manufacturing of products. These funds have been used for preclinical to clinical development of multiple programs, which would otherwise require investor funds. In addition, these non-dilutive funds have allowed us to build our manufacturing and quality management systems infrastructure.”
The X-Files (season 3)
don’t know which one and haven’t found it en.wikipedia.org/wiki/The_X-Files_%28season_3%29
“Scully investigates the possible involvement of the smallpox eradication program in human genetic experimentation, discovering that a Nazi scientist who defected during Operation Paperclip has been conducting human experimentation to create alien-human hybrids.”
Note from Omega...dunno if this is helpful? Series 10 Episode 6 Back in Washington, D.C., Scully receives a phone-call from O'Malley, who has arrived at Mulder's house for a pre-arranged meeting to discover that there are signs of a struggle. O'Malley explains that he suspects alien DNA has been injected into every American citizen in order to facilitate the widespread outbreak of a contagion, the Spartan Virus. Designed to strip humans of their immune systems, this contagion quickly begins to manifest itself nationwide, with Scully and Einstein noting a sharp increase in patients admitted to hospitals and triage centers.
More of the same with Anthrax
Pentagon anthrax blunder reveals ‘chain of errors’ in government lab protocols
Scientists say the accidental shipment by the US army of live anthrax from a laboratory in Utah could point to deficiencies in the military’s system for handling the bacteria.
Pentagon officials told reporters that Dugway Proving Ground in Utah had inadvertently shipped live anthrax to commercial labs in nine states – California, Delaware, Maryland, New Jersey, New York, Tennessee, Virginia, Texas and Wisconsin – and South Korea.
Anthrax in 2001 Letters Was Traced to Maryland by Genetic Mutations
The 2001 anthrax letter attacks panicked the nation. Ten years later, researchers are finally able to discuss how they identified the origins of the deadly bacteria, which they were able to trace to an Army research lab in Maryland.
The anthrax attacks in September 2001 killed five people and sickened 17, the worst biological attack in U.S. history. Anthrax spores (a dormant form of the bacteria) were sent in letters to Sens. Tom Daschle and Patrick Leahy and several news organizations.
The intensive investigation, dubbed “Amerithrax” by the FBI, fingered Bruce Ivins as the main suspect. Ivins was a researcher at the government’s biodefense labs at Fort Detrick, Md., where he had access to anthrax, but some question the evidence against him. Ivins took his own life as the FBI was preparing its case.
Live Flu Virus in Vaccines nearly killed 60% of Europe
‘Accidental’ Contamination Of Vaccine With Live Avian Flu Virus Virtually Impossible
Czech newspapers are questioning if the shocking discovery of vaccines contaminated with the deadly avian flu virus which were distributed to 18 countries by the American company Baxter were part of a conspiracy to provoke a pandemic.
The claim holds weight because, according to the very laboratory protocols that are routine for vaccine makers, mixing a live virus biological weapon with vaccine material by accident is virtually impossible.
“The company that released contaminated flu virus material from a plant in Austria confirmed Friday that the experimental product contained live H5N1 avian flu viruses,” reports the Canadian Press.
Baxter flu vaccines contaminated with H5N1 – otherwise known as the human form of avian flu, one of the most deadly biological weapons on earth with a 60% kill rate – were received by labs in the Czech Republic, Germany, and Slovenia.
Initially, Baxter attempted to stonewall questions by invoking “trade secrets” and refused to reveal how the vaccines were contaminated with H5N1. After increased pressure they then claimed that pure H5N1 batches were sent by accident. This was seemingly an attempt to quickly change the story and hide the fact that the accidental contamination of a vaccine with a deadly biological agent like avian flu is virtually impossible and the only way it could have happened was by wilful gross criminal negligence.
Pharmaceutical firm dumps polio virus into Belgium river
Staff working at a GlaxoSmithKline (GSK) facility dumped more than 45 liters of concentrated live polio into the water at a Belgian treatment plant earlier this month.
The incident happened on September 2, although news of the event has only recently been reported. According to a statement from the Federal Public Service (FPS) Health, Food Chain Safety and Environment in Belgium “human error” resulted in the live virus making its way into the Lasne and Dyle rivers in Rixensart.
The cause of the “human error” is unknown, although it seems that some safety protocols were not followed. Facing Finance suggests that the error was due to an employee making a mistake in a usually routine tank cleaning process. What is known is that approximately 45 litres of water that was infected with the polio virus leaked from a water purification plant at the factory, according to Flanders News.
National Institutes of Health is in Bethesda, MD
“Currently, there is no evidence of naturally occurring smallpox transmission anywhere in the world. Although a worldwide immunization program eradicated smallpox disease decades ago, small quantities of smallpox virus officially still exist in two research laboratories in Atlanta, Georgia, and in Russia.”
Smallpox, when this bio-weapon is used, you now know who is responsible.
Smallpox was an infectious disease caused by either of two virus variants, Variola major and Variola minor. The disease was originally known in English as the “pox” or “red plague”; the term “smallpox” was first used in Britain in the 15th century to distinguish variola from the “great pox” (syphilis). The last naturally occurring case of smallpox (Variola minor) was diagnosed on 26 October 1977.
There were two clinical forms of smallpox. Variola major was the severe and most common form, with a more extensive rash and higher fever. Variola minor was a less common presentation, and a much less severe disease, with historical death rates of 1 percent or less.
Subclinical (asymptomatic) infections with variola virus were noted but were not common. In addition, a form called variola sine eruptione (smallpox without rash) was seen generally in vaccinated persons. This form was marked by a fever that occurred after the usual incubation period and could be confirmed only by antibody studies or, rarely, by virus isolation.
The incubation period between contraction and the first obvious symptoms of the disease is around 12 days.
Transmission occurs through inhalation of airborne variola virus, usually droplets expressed from the oral, nasal, or pharyngeal mucosa of an infected person. It is transmitted from one person to another primarily through prolonged face-to-face contact with an infected person, usually within a distance of 6 feet (1.8 m), but can also be spread through direct contact with infected bodily fluids or contaminated objects (fomites) such as bedding or clothing.
The global eradication of smallpox was certified, based on intense verification activities in countries, by a commission of eminent scientists on 9 December 1979 and subsequently endorsed by the World Health Assembly on 8 May 1980.
A medical photographer, Janet Parker, contracted the disease at the University of Birmingham Medical School and died on September 11, 1978, after which Professor Henry Bedson, the scientist responsible for smallpox research at the university committed suicide.
All known stocks of smallpox were destroyed or transferred to one of two WHO reference laboratories which had BSL-4 facilities; the Centers for Disease Control and Prevention (CDC) in the United States and the State Research Center of Virology and Biotechnology VECTOR in Koltsovo, Russia.
In 1986, the World Health Organization first recommended destruction of the virus, and later set the date of destruction to be 30 December 1993. This was postponed to 30 June 1999. Due to resistance from the U.S. and Russia, in 2002 the World Health Assembly agreed to permit the temporary retention of the virus stocks for specific research purposes.
shrt lnk: http://wp.me/p5eLCS-h7