By: Tracey Walker
Breaking News: WOrld Health Organization (W H O) okays experimental drug use in Ebola outbreak
AUG 12, 2014 -The World Health Organization (WHO) has given the green light to the use of experimental drugs in the Ebola outbreak in West Africa. The death toll has reached 1,000. WHO has declared the outbreak to be an international public health emergency. Pressure has been mounting on FDA to expedite approval of an anti-Ebola drug.
Information on WHO guidelines...
One experimental drug is ZMapp (Mapp Biopharmaceutical and LeafBio, which is composed of 3 humanized antibodies manufactured in plants, specifically, Nicotiana. According to a company information sheet, it is an optimized cocktail combing MB-003 and ZMAb. It was first identified as a drug candidate in January 2014. Despite promising results for the ZMapp, it has not yet been evaluated for safety in humans.
According to various news reports, 2 Americans infected with Ebola are improving after being treated with this drug. In addition, British Columbia drug maker Tekmira Pharmaceuticals has announced it has verbal approval that FDA has converted a full clinical hold on its drug, TKM-Ebola to treat the Ebola virus, to a partial clinical hold. Tekmira is developing its experimental Ebola treatment under a $140-million contract with the US Department of Defense, and FDA designated it as fast track status in March. After healthy patients began taking it as part of the first phase of a clinical trial, FDA put a clinical hold on TKM-Ebola because of possible side effects. TKM-Ebola holds a fast track status from FDA.
"If approved, gaining access to the Ebola medication may be an extensive process as there may be numerous requirements that must be met prior to patient administration," said Clarence D. Moore, PharmD, BCPS, assistant professor, Howard University College of Pharmacy, Washington, D.C. It has also been reported in The Hill that GlaxoSmithKline will begin testing an Ebola vaccine. The drug maker will partner with the National Institutes of Health to start a phase 1 trial and administer the vaccine to a limited number of patients over the next few months.
- See more at: http://formularyjournal.modernmedicine.com...
Information on WHO guidelines...
One experimental drug is ZMapp (Mapp Biopharmaceutical and LeafBio, which is composed of 3 humanized antibodies manufactured in plants, specifically, Nicotiana. According to a company information sheet, it is an optimized cocktail combing MB-003 and ZMAb. It was first identified as a drug candidate in January 2014. Despite promising results for the ZMapp, it has not yet been evaluated for safety in humans.
According to various news reports, 2 Americans infected with Ebola are improving after being treated with this drug. In addition, British Columbia drug maker Tekmira Pharmaceuticals has announced it has verbal approval that FDA has converted a full clinical hold on its drug, TKM-Ebola to treat the Ebola virus, to a partial clinical hold. Tekmira is developing its experimental Ebola treatment under a $140-million contract with the US Department of Defense, and FDA designated it as fast track status in March. After healthy patients began taking it as part of the first phase of a clinical trial, FDA put a clinical hold on TKM-Ebola because of possible side effects. TKM-Ebola holds a fast track status from FDA.
"If approved, gaining access to the Ebola medication may be an extensive process as there may be numerous requirements that must be met prior to patient administration," said Clarence D. Moore, PharmD, BCPS, assistant professor, Howard University College of Pharmacy, Washington, D.C. It has also been reported in The Hill that GlaxoSmithKline will begin testing an Ebola vaccine. The drug maker will partner with the National Institutes of Health to start a phase 1 trial and administer the vaccine to a limited number of patients over the next few months.
- See more at: http://formularyjournal.modernmedicine.com...
What's the DOD doing funding drug research?