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FDA allows testing of Aethlon device in Ebola patients

REUTERS                                                        Jan. 2, 2015

SAN DIEGO- Calif. --Aethlon Medical Inc said the U.S. Food and Drug Administration had approved the testing in Ebola patients of its bio-filtration device, which was used against the deadly virus in a critically ill patient in Germany who later recovered.

The device, being developed as a broad-spectrum countermeasure against pandemic threats, filters viruses and toxins from the blood.

It is currently being tested in India for its ability to accelerate viral load depletion when used in combination with hepatitis C standard-of-care drug therapy.

Patients will be treated for six to eight hours daily with the device, called Aethlon's Hemopurifier, until the Ebola viral load drops below 1,000 copies/ml.

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http://www.reuters.com/article/2015/01/02/health-ebola-aethlon-med-idUSL3N0UH15720150102

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FDA approves new Roche Ebola test for emergency use

WASHINGTON POST by  Rachel Feltman                      Dec. 29, 2014

Pharmaceutical company Roche announced Monday that the U.S. Food and Drug Administration had provided an Emergency Use Authorization -- a sort of pre-approval for use in particularly bad outbreaks -- for a new kind of Ebola test.

This isn't the first test to get this kind of approval during the 2014 outbreak of the Zaire strain of Ebola, which has killed more than 7,500 people to date and is still an ongoing crisis in parts of West Africa.... 

So it's no surprise that Swiss company Roche has put its version of a rapid test forward. The LightMix Ebola Zaire rRT-PCR Test works in about three hours, and is designed for Roche's testing consoles.

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Clinical trial for potential Ebola treatment started in MSF clinic in Guinea

MEDECINES SANS FRONTIERS                                     Dec. 26, 2014

A clinical trial for a possible treatment for Ebola started in Guinea on the 17th of December. The trial is led by the French medical research institute INSERM and is taking place at MSF’s Ebola Treatment Centre in Guéckédou, in the east of the country. Although every experimental treatment for Ebola patients offers hope, MSF remains prudent. There’s no guarantee that the drug will be effective and safe, and even if it is, it will not mean the end of the epidemic which continues to spread in the three most affected countries of West Africa.

The trial aims to include as many Ebola positive patients presenting at the MSF treatment centre in Guéckédou as possible. There will be no control group (group of patients who do not receive the treatment) in this study, as it is considered unethical to deny a group of patients the higher chance of survival that may come with the new treatment, especially given the high mortality of Ebola. Instead the outcomes of the patients will be measured against those of MSF patients admitted earlier this year, before the trial began. The first conclusive results are not expected before the first trimester of 2015....

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Next in Ebola Plan: UN Teams to Study Lines of Transmission

REUTERS                                                              Dec. 24, 2014

ACCRA—Medical detective work will be the next big phase in the fight against Ebola when the United Nations deploys hundreds of health workers to identify chains of infection as the virus passes from person to person, top U.N. health workers said.
Health workers bury the body of a suspected Ebola victim at a cemetery in Freetown, Dec. 21, 2014.

The health teams will travel to each district and region of Guinea, Sierra Leone and Liberia, the three countries at the center of the epidemic, to trace who each infected person has potentially contacted.

The effort will run in parallel with measures to minimize the spread of infection, such as treating all Ebola patients in specialized centers and burying all victims safely.

But Phase Two of the plan is to contain the virus by understanding its lines of transmission, said World Health Organization Director-General Margaret Chan.

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Ebola raises profile of blood-based therapy

NATURE     by  Delcan Butler                                                                                        Dec. 23, 2014

With no drugs available to treat Ebola, eyes are turning to a therapy that had largely been relegated to the history books: transfusing patients with blood plasma donated by survivors, which contains antibodies against the virus.

Survivors of Ebola carry antibodies that might be used to save the lives of those infected with the virus. Michel du Cille/The Washington Post via Getty Images

Clinical trials of convalescent plasma therapy (CPT) have started in the past few weeks in Liberia, and are due to begin soon in Guinea and Sierra Leone. If the therapy saves lives, the approach could quickly be scaled up.

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On the Front Lines of Ebola’s Most Pressing Mystery

WIRED     by   Erika Check Hayden                                                                              Dec. 23, 2014

KENEMA, Sierra Leone—Mohammed Sankoh Yillah, an outreach worker, spent days in the Ebola ward caring for his sister, nurse Mbalu Fonnie. After Fonnie died in July, Yillah tested positive for the virus. He was transported to another hospital for treatment, but asked to come back to Kenema to die.

But Yillah survived.

Today Yillah sits with four colleagues in an office, discussing a new research project. The study is collecting information about survivors like him. The hope is that the study might help explain why he and others beat Ebola, while their friends and colleagues—Alex, Mbalu—did not.

Epidemiologist Lina Moses runs the meeting. Her colleagues back at Tulane University, she says, hope to analyze blood samples from survivors; she collected 29 such samples here in November. “What they want to know in the laboratory,” she says, “is what kind of antibodies Mohammed Yillah has that helped him to survive Ebola.”

 

                                                                             

 

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Ebola vaccine 'promising in African populations'

BBC     By Smitha Mundasad                                Dec. 22, 2014
The first-ever trial of an Ebola vaccine in Africa shows promising initial results, according to a report in the Lancet medical journal.

Scientists say it is a crucial step as other vaccines have shown lower levels of protection in African populations.

Tests involving Ugandan and American volunteers reveal the vaccine is so far safe and generates an immune response in both populations.

It provides reassurance for other trials currently underway, they say.

No proven vaccine exists to prevent people from getting the disease, though several trials are underway.

Researchers from the National Institutes of Health tested this experimental vaccine on healthy adults in Uganda, having first trialled it in the United States.

Dr Julie Ledgerwood, the lead researcher, said: "This is the first study to show comparable safety and immune response of an experimental Ebola vaccine in an African population.

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http://www.bbc.com/news/health-30577776

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Tekmira Inks Deal to Test New Ebola Drug in Humans

GENOMEWEB                                                                                                                        Dec. 22, 2014
NEW YORK -- Tekmira Pharmaceuticals announced today that it has signed a deal that will support the clinical testing of its experimental Ebola therapy designed against the strain of the virus behind the outbreak in West Africa.

Tekmira has long been developing an siRNA-based Ebola drug called TKM-Ebola, but a Phase I study of that agent was suspended by US regulators until the company could provide additional safety data. Earlier this year, Tekmira management indicated that that trial might not restart as early as anticipated since the firm had begun focusing on a version specifically for the Guinea strain of the Ebola virus, which is driving the ongoing outbreak.

Tekmira said it has now inked a manufacturing and clinical trial agreement with the University of Oxford to provide the new drug, called TKM-Ebola-Guinea, for clinical trials in West Africa. The university is the representative of the International Severe Acute Respiratory and Emerging Infection Consortium, which will be testing TKM-Ebola-Guinea in infected individuals with funding from the Wellcome Trust.

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GSK Ebola vaccine trial seen moving to wider phase in February

REUTERS                                                                                              Dec. 19, 2014

Trials of GlaxoSmithKline's experimental Ebola vaccine are likely to move to a second phase in February, later than previously suggested, after a meeting of national regulators said they needed more information.

The World Health Organization, which hosted a meeting of national regulatory authorities and ethics committees earlier this week, said they had thoroughly discussed all aspects of the proposed trials at the two-day meeting.

"Reviewing countries requested additional documentation from the manufacturer of the vaccine, GlaxoSmithKline, before authorization of the trials," the WHO said in a statement.

Countries where the trials are planned -- Cameroon, Ghana, Mali, Nigeria and Senegal -- should receive and review the additional information by the end of January.

"If these steps are completed to the satisfaction of the national authorities, Phase II trials are likely to begin in February," the statement said.

The GSK vaccine is already undergoing Phase I trials, to check its safety in humans, in Switzerland, Britain, Mali and the United States, and is one of the two leading candidate vaccines for Ebola already undergoing tests.

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The Ebola Treatment You Haven't Heard Of

FORBES       by David Kroll                                                                                              Dec. 19, 2014

Pharmaceuticals and biotechnology-derived products have attracted the greatest public and professional interest in treating victims of Ebola virus disease. But a privately-held, small company with a treatment for shock and multi-organ failure may be the dark horse victor in the race to stop the West African outbreak. LB1148 from San Diego-based Leading BioSciences is starting Phase 2 clinical trials that build on 12 years of NIH-funded research to address an underappreciated, common denominator in shock and organ failure, including shock caused by Ebola infection.

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http://www.forbes.com/sites/davidkroll/2014/12/19/the-ebola-treatment-you-havent-heard-of/

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