US begins testing Ebola treatment in early-stage trial
Washington, May 27: US researchers have started the first-in-human trial evaluating an experimental treatment for Ebola virus disease, the National Institutes of Health (NIH) Clinical Centre said in a statement.
The Phase 1 clinical trial, named as VRC 608, is examining the safety and tolerability of a single monoclonal antibody called mAb114, developed from an Ebola survivor.
Investigators aim to enroll between 18 and 30 healthy volunteers aged 18 to 60. The trial will not expose participants to Ebola virus.
"We hope this trial will establish the safety of this experimental treatment for Ebola virus disease -- an important first step in a larger evaluation process," said Anthony S. Fauci, Director at the National Institute of Allergy and Infectious Diseases (NIAID) in Maryland, US
"Ebola is highly lethal, and reports of another outbreak in the DRC (the Democratic Republic of Congo) remind us that we urgently need Ebola treatments.
"This study adds to NIAID efforts in conducting scientifically and ethically sound biomedical research to develop countermeasures against Ebola virus disease," Fauci added.
MAb114 is a monoclonal antibody -- a protein that binds to a single target on a pathogen -- isolated from a human survivor of the 1995 Ebola outbreak in a city in the DRC.
Researchers from the NIAID discovered that survivor retained antibodies against Ebola 11 years after infection.
They isolated the antibodies and tested the most favourable ones in the laboratory and non-human primate studies, and selected mAb114 as the most promising.
The researchers illustrated that MAb114 binds to the hard-to-reach core of the Ebola virus surface protein and blocks the protein's interaction with its receptor on human cells.
A single dose of mAb114 protected non-human primates days after lethal Ebola virus infection.
In the trial, which would be fully enrolled by July 2018, the first three participants will receive a 5 milligram per kilogram intravenous infusion of mAb114 for 30 minutes.
The team will evaluate safety data to determine if the remaining participants can receive higher doses (25 mg/kg and 50 mg/kg).
Participants will have blood taken before and after the infusion and will bring a diary card home to record their temperature and any symptoms for three days.
Participants will visit the clinic approximately 14 times over six months to have their blood drawn to see if mAb114 is detectable and to be checked for any health changes, the report said.
Ebola virus disease is a serious and often fatal illness that can cause fever, headache, muscle pain, weakness, fatigue, diarrhea, vomiting, stomach pain and haemorrhage (severe bleeding).
First discovered in humans in 1976 in the DRC, the largest outbreak, occurred in West Africa from 2014 to 2016. It caused more than 28,600 infections and more than 11,300 deaths, according to the World Health Organization.
In May 2018, the DRC reported new Ebola outbreak. While there are no licensed treatments available for Ebola virus disease yet, multiple experimental therapies are being developed.
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RSS man's defamation case against Rahul: Key witness unavailable, hearing adjourned to Dec 20
Thane (PTI): A court in Bhiwandi in Thane district on Saturday adjourned the hearing in the criminal defamation case filed against Congress leader Rahul Gandhi by a Rashtriya Swayamsevak Sangh (RSS) worker to December 20 due to non-availability of a crucial prosecution witness.
Advocate Narayan Iyer, counsel for Rahul Gandhi, confirmed the adjournment, stating that the witness, Ashok Saykar, currently Deputy Superintendent of Police in Barshi in Solapur, could not remain present due to personal reasons.
Saykar's evidence is now likely to be recorded on December 29.
His testimony is considered key because he, as police sub inspector in 2014, conducted the preliminary inquiry into the private defamation matter under Section 202 of the Code of Criminal Procedure (CrPC).
It was on the basis of Saykar's submitted report that the court subsequently issued process (summons) against Rahul Gandhi under Section 500 of the Indian Penal Code (IPC).
The criminal defamation case was filed by local RSS worker Rajesh Kunte following a speech given by Rahul Gandhi at an election rally near Bhiwandi on March 6, 2014.
The case stems from the Congress leader's alleged statement that "the RSS people killed (Mahatma) Gandhi."
The matter is being heard by Bhiwandi Joint Civil Judge, Junior Division, P M Kolse.
The hearing had previously been adjourned on November 15 after the complainant's counsel, Advocate Prabodh Jaywant, moved an application seeking permission to examine Saykar, who had submitted the probe report to the court.
The matter was originally scheduled for November 29 but was deferred to December 6 after Rahul Gandhi's legal team sought an adjournment citing their non-availability. The proceedings will now resume on December 20.
