Shiloh
Editor, Senior Moderator
Source: http://www.cidrap.umn.edu/news-perspective/2014/09/ebola-scan-sep-02-2014
Ebola Scan for Sep 02, 2014
HHS funds for ZMapp; China's Ebola drug approval; 30-minute Ebola test
Filed Under:
Ebola; VHF
HHS contract aims to boost ZMapp development for Ebola
The US Department of Health and Human Services (HHS) will spend up to $42.3 million to help accelerate development of the experimental Ebola drug ZMapp, the agency said in a press release today.
The HHS's Office of the Assistant Secretary for Preparedness and Response (ASPR), through its Biomedical Advanced Research and Development Authority (BARDA), will provide funding as well as access to subject matter experts and technical support, HHS said. The contract covers manufacturing, regulatory, and nonclinical activities for ZMapp through a $24.9-million, 18-month contract with Mapp Biopharmaceutical Inc., of San Diego to speed development of the drug, which has been used without known efficacy on several patients with Ebola virus disease (EVD).
If all goes well, ASPR can extend the contract for up to $42.3 million total, HHS said. The goal is to gain Food and Drug Administration approval.
The funds will go toward manufacturing a small amount of ZMapp for early-stage clinical safety studies and nonclinical studies to demonstrate safety and efficacy in people. Mapp Biopharmaceutical will also work with BARDA on increasing production yields and the scale of manufacturing to make more doses.
"While ZMapp has received a lot of attention, it is one of several treatments under development for Ebola, and we still have very limited data on its safety and efficacy," said Nicole Lurie, MD, MSPH, assistant secretary for preparedness and response, in the news release.
"Developing drugs and vaccines to protect against Ebola as a biological threat has been a long-term goal of the US government, and today's agreement represents an important step forward," she added.
Sep 2 HHS news release
China approves experimental Ebola drug for emergency use
China's first drug against EVD, called JK-05, has obtained regulatory approval for use in emergencies in China, the South China Morning Post reported yesterday.
The drug was developed by Professor Wang Hongquan of the Institute of Microbiology and Epidemiology in the Academy of Military Medical Sciences in Shanghai and has been in studies for 5 years. It has passed preclinical and safety tests, the story said.
The drug is a "micro-molecular chemical," that selectively contains the RNA enzymes of the Ebola virus to inhibit replication, Wang said.
JK-05 resisted the replication of Ebola cells in experiments and animal tests, the story said.
Sep 1 South China Morning Post article
Japanese researchers develop 30-minute Ebola test
Researchers in Japan said they have developed a new test to detect Ebola virus in patients in 30 minutes, potentially speeding diagnosis, Agence France-Presse (AFP) reported today.
"The new method is simpler than the current one and can be used in countries where expensive testing equipment is not available," Professor Jiro Yasuda of Nagasaki University said. He added that technology developed by his colleagues and him is less expensive than polymerase chain reaction (PCR), the current gold standard and the test most commonly used in the current massive outbreak in West Africa.
Yasuda said his team developed a "primer," which amplifies only genes specific to the Ebola virus in a patient's blood or other fluid sample. RNA extracted from the sample is used to synthesize viral DNA, which is then heated and mixed with the primer to amplify Ebola DNA.
PCR requires technicians to heat and cool samples repeatedly and takes up to 2 hours, the story said. Yasuda said the new testing system costs only hundreds of dollars, "which developing countries should be able to afford."
Sep 2 AFP story
Ebola Scan for Sep 02, 2014
HHS funds for ZMapp; China's Ebola drug approval; 30-minute Ebola test
Filed Under:
Ebola; VHF
HHS contract aims to boost ZMapp development for Ebola
The US Department of Health and Human Services (HHS) will spend up to $42.3 million to help accelerate development of the experimental Ebola drug ZMapp, the agency said in a press release today.
The HHS's Office of the Assistant Secretary for Preparedness and Response (ASPR), through its Biomedical Advanced Research and Development Authority (BARDA), will provide funding as well as access to subject matter experts and technical support, HHS said. The contract covers manufacturing, regulatory, and nonclinical activities for ZMapp through a $24.9-million, 18-month contract with Mapp Biopharmaceutical Inc., of San Diego to speed development of the drug, which has been used without known efficacy on several patients with Ebola virus disease (EVD).
If all goes well, ASPR can extend the contract for up to $42.3 million total, HHS said. The goal is to gain Food and Drug Administration approval.
The funds will go toward manufacturing a small amount of ZMapp for early-stage clinical safety studies and nonclinical studies to demonstrate safety and efficacy in people. Mapp Biopharmaceutical will also work with BARDA on increasing production yields and the scale of manufacturing to make more doses.
"While ZMapp has received a lot of attention, it is one of several treatments under development for Ebola, and we still have very limited data on its safety and efficacy," said Nicole Lurie, MD, MSPH, assistant secretary for preparedness and response, in the news release.
"Developing drugs and vaccines to protect against Ebola as a biological threat has been a long-term goal of the US government, and today's agreement represents an important step forward," she added.
Sep 2 HHS news release
China approves experimental Ebola drug for emergency use
China's first drug against EVD, called JK-05, has obtained regulatory approval for use in emergencies in China, the South China Morning Post reported yesterday.
The drug was developed by Professor Wang Hongquan of the Institute of Microbiology and Epidemiology in the Academy of Military Medical Sciences in Shanghai and has been in studies for 5 years. It has passed preclinical and safety tests, the story said.
The drug is a "micro-molecular chemical," that selectively contains the RNA enzymes of the Ebola virus to inhibit replication, Wang said.
JK-05 resisted the replication of Ebola cells in experiments and animal tests, the story said.
Sep 1 South China Morning Post article
Japanese researchers develop 30-minute Ebola test
Researchers in Japan said they have developed a new test to detect Ebola virus in patients in 30 minutes, potentially speeding diagnosis, Agence France-Presse (AFP) reported today.
"The new method is simpler than the current one and can be used in countries where expensive testing equipment is not available," Professor Jiro Yasuda of Nagasaki University said. He added that technology developed by his colleagues and him is less expensive than polymerase chain reaction (PCR), the current gold standard and the test most commonly used in the current massive outbreak in West Africa.
Yasuda said his team developed a "primer," which amplifies only genes specific to the Ebola virus in a patient's blood or other fluid sample. RNA extracted from the sample is used to synthesize viral DNA, which is then heated and mixed with the primer to amplify Ebola DNA.
PCR requires technicians to heat and cool samples repeatedly and takes up to 2 hours, the story said. Yasuda said the new testing system costs only hundreds of dollars, "which developing countries should be able to afford."
Sep 2 AFP story