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GI 13020 Phase 1a clinical trial
(Thomson Reuters ONE via COMTEX) -- LOUISVILLE, Colo., Jan. 28, 2013 - GlobeImmune, Inc., today announced the initiation of a Phase 1a clinical trial to investigate the safety and immunogenicity of GI-13020 in healthy volunteers. The GI-13020 Tarmogen�, which GlobeImmune is developing in collaboration with Gilead Sciences, Inc., consists of whole, heat-killed, recombinant S. cerevisiae yeast genetically modified to express hepatitis B (HBV) antigens. This study is being conducted under an Investigational New Drug application (IND) that was filed with the U.S. Food and Drug Administration in December 2012. As a result of successfully filing the IND, GlobeImmune received a milestone payment from Gilead.
The GI-13020-01 Phase 1a clinical trial is a randomized, open-label, dose escalation trial assessing the safety, tolerability and immunogenicity of various doses of GI-13020 in healthy adults. This study is designed to enroll 48 evaluable subjects at a single U.S. center.
"While approved anti-viral drugs have been shown to effectively suppress replication of the hepatitis B virus, they rarely result in cures and must be taken indefinitely," said David Apelian, M.D., Ph.D., Chief Medical Officer at GlobeImmune. "GI-13020 is designed to activate an antigen-specific immune response against HBV, and our development strategy will be to combine GI-13020 with direct-acting antiviral medicines to determine if the combination can increase rates of surface antigen seroconversion, thereby leading to a cure for infected patients."
The GI-13020-01 Phase 1a clinical trial is a randomized, open-label, dose escalation trial assessing the safety, tolerability and immunogenicity of various doses of GI-13020 in healthy adults. This study is designed to enroll 48 evaluable subjects at a single U.S. center.
"While approved anti-viral drugs have been shown to effectively suppress replication of the hepatitis B virus, they rarely result in cures and must be taken indefinitely," said David Apelian, M.D., Ph.D., Chief Medical Officer at GlobeImmune. "GI-13020 is designed to activate an antigen-specific immune response against HBV, and our development strategy will be to combine GI-13020 with direct-acting antiviral medicines to determine if the combination can increase rates of surface antigen seroconversion, thereby leading to a cure for infected patients."
Nice! Looks like with the soon to be saturated market of Hep C drugs the focus on Hep B drugs is growing.
Great news, now when you see the USA market moving towards a cure you know we are around the end of hep B's lifetime!
It could take 10 years. Drugs go through many phases til they are in the market. I forgot the statistic but out of thousands of drugs only a few make it.
The good thing is that Gilead is behind this. They are the #3 top biotechnology company in the world.
The good thing is that Gilead is behind this. They are the #3 top biotechnology company in the world.
Good progress ..
we hope to finish sooooooooon ..
no need to try this drug on turtles .. to see the results ..
no need for complicated long procedure until approve such drug ..
every day more than one hbver dies because of hbsag ..
we hope to finish sooooooooon ..
no need to try this drug on turtles .. to see the results ..
no need for complicated long procedure until approve such drug ..
every day more than one hbver dies because of hbsag ..
this is very promising. until the cure is realised, let's hold the fort and keep on fighting. :)
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