Researchers in Sierra Leone today began a new phase II study of an investigational drug in patients Ebola. The first participant received an injection of the therapeutic, TKM-Ebola called this morning to Ebola treatment unit in Port Loko * . The trial can be extended to other sites; the study team hopes for an early response so that it can either switch to another drug or to begin a study of TKM-Ebola Phase III.
Produced by Tekmira Pharmaceuticals in Burnaby, Canada, TKM-Ebola is made of synthetic fibers, siRNA packaged in lipid nanoparticles. target RNA three of the seven Ebola virus gene, blocking the replication of the virus. TKM-Ebola has been shown to work well in monkeys; humans the efficacy trial begins only because there were not enough drugs available sooner. In addition, NRAs have been adapted to the circulating strain when
The study was not placebo arm. All patients on the trial site are eligible for the drug, and researchers hope to determine whether it works by comparing them with patients treated elsewhere.
However, not all patients Ebola in the unit can actually get the drug for practical reasons. The treatment is given as a 2 hour infusion every day for a week; Patients should be monitored for 8 hours after the infusion because of concerns that the drug might produce a dangerous inflammatory response known as a cytokine storm. Doctors and nurses can spend much time in their protective equipment in the tropical heat, which means they may not be able to serve everyone. "The staff has a very narrow window, and there are many patients who qualify in the morning, we should choose a random" said Trudie Lang, global health researcher at the University of Oxford in the United Kingdom and one of the leaders of the study. patients test site who do not receive the drug could also be used as controls in the study.
the trial aims to register up to 100 patients, but Lang says he can arrive at an answer much sooner. "We are looking for a great effect, and there is a big yes and a big step, we hope see that soon. "if there is a clear signal that the drug does nothing, the team wants to try to test another experimental drug before Sierra Leone reduced the number of cases to zero. Liberia neighbor does not seen new cases in more than 2 weeks, although the outbreak of Sierra Leone has slowed considerably, there are still about 10 new cases every day.
If TKM-Ebola is not working, the team wants to go to a greater III clinical trial phase. It is "essential that we push forward with clinical trials while we still have a realistic chance to get answers about what, if any, candidate treatments can save lives in this area, and in the future outbreaks, "said lead researcher Peter Horby in a statement released today by the Wellcome Trust, a charity which funds the trial.
Liberia, the group had already tested brincidofovir Horby, a drug developed for cytomegalovirus and adenovirus has also shown anti-Ebola activity in the lab. the trial had to be stopped last month when Chimerix, the production company of the drug, withdrew their support. There were too few cases of Ebola in Liberia, and scientists were not able to expand the trial in Sierra Leone, Lang said. Only a handful of patients were treated; these data will be released in the coming months "will be important when we can go back from the business of running this trial to explore what went wrong and what went well in the implementation of testing during this epidemic. "she said.
Until now, no drug has been proven to be effective against Ebola. virus a study of Japanese drug influenza favipiravir happens Guinea, and scientists have reported a weak first signal that can help some patients. a test using the serum recovered Ebola patients as a therapy for others is underway in Guinea and the National US Institutes of Health said it plans a trial of an antibody cocktail called zmapp
* update:. the story said the trial had started in a processing unit Ebola in Kerry Town, its file in this Pan African Clinical Trials Registry. It actually started in Port Loko and can be expanded later to Kerry Town.
* Ebola files: Science and Science Translational Medicine made a collection of research articles and news about the Ebola virus and the current epidemic available for researchers and the general public.
0 Komentar