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Hepatitis B Cure now 12-15 years away?
Didn't they just say 2 years ago that it could come as early as 2015? Here's he latest I read, which is not good news to me:
http://hepbblog.org/category/hep-b-treatment/
It takes talent, dedication, lots of time, and a sizable investment to bring a safe and effective drug to market. The Drug Discovery Process YouTube video, compliments of PhRMAPress, introduces the long and arduous drug process from the identification of a compound in the lab, though clinical trials and the FDA approval process. It may sound simple, but this process may take up to 1,000 people, 12-15 years and up to 1.3 to 1.6 billion dollars to put a new drug in the hands of the patient.
Consider this process when following the progress of hepatitis B drugs on the Hepatitis B Foundation Drug Watch page. Compounds could remain in various stages for years. Note that the “preclinical” phase represents the drugs that are still in the lab and not yet ready for human clinical trials.
The Hepatitis B Foundation also maintains a webpage with the latest hepatitis B related clinical trials. Contact information is provided for each trial for those wishing to volunteer to participate. Volunteers must meet the criteria for participation in a trial.
The future looks bright for a functional cure for hepatitis B. It may take a few more years to get the drug into the hands of the patient, but each step of the process is crucial in order to produce a drug that is both effective and safe.
https://www.youtube.com/watch?v=DhxD6sVQEYc
http://hepbblog.org/category/hep-b-treatment/
It takes talent, dedication, lots of time, and a sizable investment to bring a safe and effective drug to market. The Drug Discovery Process YouTube video, compliments of PhRMAPress, introduces the long and arduous drug process from the identification of a compound in the lab, though clinical trials and the FDA approval process. It may sound simple, but this process may take up to 1,000 people, 12-15 years and up to 1.3 to 1.6 billion dollars to put a new drug in the hands of the patient.
Consider this process when following the progress of hepatitis B drugs on the Hepatitis B Foundation Drug Watch page. Compounds could remain in various stages for years. Note that the “preclinical” phase represents the drugs that are still in the lab and not yet ready for human clinical trials.
The Hepatitis B Foundation also maintains a webpage with the latest hepatitis B related clinical trials. Contact information is provided for each trial for those wishing to volunteer to participate. Volunteers must meet the criteria for participation in a trial.
The future looks bright for a functional cure for hepatitis B. It may take a few more years to get the drug into the hands of the patient, but each step of the process is crucial in order to produce a drug that is both effective and safe.
https://www.youtube.com/watch?v=DhxD6sVQEYc
Thanks for sharing. I'm not seeing anything about this on the Hep B site. I will have to ask my doctor... he must know, and mentioned I'd love to get in their clinical trial if it cures me.
Closing of merger: should happen sometime between mid-March and late April
Raise: I think everyone expects this to happen within a month or two of closing unless the entire biotech sector goes down dramatically, taking Tekmira down with it, like it did in the late spring/summer 2014
TKM-HBV Phase I data: should see late spring or summer
Initiation of TKM-HBV Phase II: should happen in second half of 2015. Will be interesting to see if they stick with the multi-dose plan or go with a single dose similar to what Arrowhead did. Let's hope they only try one or two dose levels in this trial, not 3 or 4 like Arrowhead
PLK1 Phase II ACC/GINET final data: Company has guided it will be released in mid-2015. Would be a good sign if it's released at ASCO, which runs from May 29 to June 2 this year.
PLK1 Phase II HCC interim data: I think they have guided this may occur mid-year.
TKM-Ebola-Guinea trial initiation: if this doesn't happen soon, then Oxford/Wellstone may have decided not to move forward with it.
TKM-Ebola-Guinea NHP data: I still think it's possible they are running trials in NHP. We'll see.
TKM-Ebola-Guinea trial date: if initiated soon and set up in Sierra Leone, we could see some data in April or May
TKM-Marburg funding deal: I know Geisbert has funding for Marburg studies, but I think we could see some more money flow in due to the Ebola crisis. Remember the Russians attempted to weaponize Marburg; to my knowledge no one has tried to weaponize Ebola.
IND for TKM-HTG: latest filing states this will occur by the end of 2015.
IND for OnCore TLR9 antagonist: should occur by end of 2015 per latest filing.
Gilead/GlobalImmune and Arrowhead Phase II data: should see by the end of June. May alter the perception of the Tekmira HBV franchise.
Initiation of DCR-PH1 Phase I trial: should occur in late 2015, and should entitle Tekmira to a milestone payment
Update from ALNY-TTR02 Phase II OLE Study: probably in the summer or fall
Resolution of ALNY arbitration: per Alnylam the hearing is scheduled for Q1; if they are operating under AAA rules the arbitrator(s) must issue a ruling within 30 days, so we should get word no later than Q2.
Deals: I think our new chairman will aggressively seek out deals. I hope his aggressiveness makes up for his lack of experience. Here are some potential deals: in license another HBV product; partner Asian rights to HBV drugs; mRNA deal; in license additional RNAi trigger technology; PLK1 rights if Phase II data positive; funding for ALDH2 work; spinoff or sale of non-HBV RNAi assets; Ebola and Marburg franchises
Left field: we may see some surprises along the way. A few contenders: Monsanto early exercise of option (at reduced amount Tekmira agrees to for non-dilutive funding), retirement of Mark Murray (he's 65), loss of Tekmira or Oncore executives as company "right-sizes" executive team, subQ or oral RNAi formulations, announcement of mRNA candidates
Raise: I think everyone expects this to happen within a month or two of closing unless the entire biotech sector goes down dramatically, taking Tekmira down with it, like it did in the late spring/summer 2014
TKM-HBV Phase I data: should see late spring or summer
Initiation of TKM-HBV Phase II: should happen in second half of 2015. Will be interesting to see if they stick with the multi-dose plan or go with a single dose similar to what Arrowhead did. Let's hope they only try one or two dose levels in this trial, not 3 or 4 like Arrowhead
PLK1 Phase II ACC/GINET final data: Company has guided it will be released in mid-2015. Would be a good sign if it's released at ASCO, which runs from May 29 to June 2 this year.
PLK1 Phase II HCC interim data: I think they have guided this may occur mid-year.
TKM-Ebola-Guinea trial initiation: if this doesn't happen soon, then Oxford/Wellstone may have decided not to move forward with it.
TKM-Ebola-Guinea NHP data: I still think it's possible they are running trials in NHP. We'll see.
TKM-Ebola-Guinea trial date: if initiated soon and set up in Sierra Leone, we could see some data in April or May
TKM-Marburg funding deal: I know Geisbert has funding for Marburg studies, but I think we could see some more money flow in due to the Ebola crisis. Remember the Russians attempted to weaponize Marburg; to my knowledge no one has tried to weaponize Ebola.
IND for TKM-HTG: latest filing states this will occur by the end of 2015.
IND for OnCore TLR9 antagonist: should occur by end of 2015 per latest filing.
Gilead/GlobalImmune and Arrowhead Phase II data: should see by the end of June. May alter the perception of the Tekmira HBV franchise.
Initiation of DCR-PH1 Phase I trial: should occur in late 2015, and should entitle Tekmira to a milestone payment
Update from ALNY-TTR02 Phase II OLE Study: probably in the summer or fall
Resolution of ALNY arbitration: per Alnylam the hearing is scheduled for Q1; if they are operating under AAA rules the arbitrator(s) must issue a ruling within 30 days, so we should get word no later than Q2.
Deals: I think our new chairman will aggressively seek out deals. I hope his aggressiveness makes up for his lack of experience. Here are some potential deals: in license another HBV product; partner Asian rights to HBV drugs; mRNA deal; in license additional RNAi trigger technology; PLK1 rights if Phase II data positive; funding for ALDH2 work; spinoff or sale of non-HBV RNAi assets; Ebola and Marburg franchises
Left field: we may see some surprises along the way. A few contenders: Monsanto early exercise of option (at reduced amount Tekmira agrees to for non-dilutive funding), retirement of Mark Murray (he's 65), loss of Tekmira or Oncore executives as company "right-sizes" executive team, subQ or oral RNAi formulations, announcement of mRNA candidates
Let's hope for the pipelines either in Australia or Taiwan then because by the time the drug comes to the market millions of ppl already gone.
The future looks bright...yes, when this corrupt way to market drugs is eliminated from the face of the earth!
today in 2015 we dont get fooled by this anymore, drugs can be much cheaper, much faster into market...time and money is not for our safety but to keep the market on the hands of a few companies and keep the small ones aside.let's hope some small countries will develop drugs independently from US fda (replicor!)
today in 2015 we dont get fooled by this anymore, drugs can be much cheaper, much faster into market...time and money is not for our safety but to keep the market on the hands of a few companies and keep the small ones aside.let's hope some small countries will develop drugs independently from US fda (replicor!)
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