Aa
Benitec Trial anyone heard of this
They have a trial going on now phase 1/11 in usa and Australia , single injection they say will get rid of hcv , what do you think ? you think it would be risky to be included in a trial like this as I cannot find that much information , sounds good, but a little to good .
Benitec Biopharma Limited selects DCRU for upcoming phase I/II trial of TT-034
Benitec Biopharma Limited selects DCRU for upcoming phase I/II trial of TT-034
March 22, 2013 - Duke's Keyur Patel, MD will act as principal investigator for this trial, which will likely begin enrolling patients during the second half of 2013.
In a press release yesterday Australian RNAi-based therapeutics company Benitec Biopharma Limited announced it has selected the Duke Clinical Research Unit as a site for its upcoming phase I/II first-in-man trial for TT-034. Developed using Benitec’s ddRNAi (DNA-directed RNA interface) technology, TT-034 contains three separate RNAi elements targeted against the Hepatitis C (HCV) virus. This treatment is being developed as a potential “one-shot-cure” for HCV.
The phase I/II clinical trial will evaluate the safety and activity of single doses of TT-034 in patients with chronic HCV genotype 1 infection who have failed previous treatments. It is expected that the trial will include 14 patients in 5 sequential dose cohorts. The trial will likely begin enrolling patients during the second half of 2013.
Keyur Patel, MD, Duke’s principal investigator for the study, was selected because of his direct experience in using gene therapy to treat the HCV virus. Patel is also a recipient of the prestigious American Association for the Study of Liver Diseases (AASLD) Shelia Sherlock Clinical and Translational Research award and has over 100 citations in peer-reviewed publications.
"TT-034 is a potentially transformative new treatment," Patel commented. "A therapeutic that could cure an HCV patient with a single injection would obviously be a big step forward compared to even the best treatments that are currently on the horizon, as they all involve comparatively lengthy regimens with a combination of several drugs."
Benitec Biopharma Limited selects DCRU for upcoming phase I/II trial of TT-034
Benitec Biopharma Limited selects DCRU for upcoming phase I/II trial of TT-034
March 22, 2013 - Duke's Keyur Patel, MD will act as principal investigator for this trial, which will likely begin enrolling patients during the second half of 2013.
In a press release yesterday Australian RNAi-based therapeutics company Benitec Biopharma Limited announced it has selected the Duke Clinical Research Unit as a site for its upcoming phase I/II first-in-man trial for TT-034. Developed using Benitec’s ddRNAi (DNA-directed RNA interface) technology, TT-034 contains three separate RNAi elements targeted against the Hepatitis C (HCV) virus. This treatment is being developed as a potential “one-shot-cure” for HCV.
The phase I/II clinical trial will evaluate the safety and activity of single doses of TT-034 in patients with chronic HCV genotype 1 infection who have failed previous treatments. It is expected that the trial will include 14 patients in 5 sequential dose cohorts. The trial will likely begin enrolling patients during the second half of 2013.
Keyur Patel, MD, Duke’s principal investigator for the study, was selected because of his direct experience in using gene therapy to treat the HCV virus. Patel is also a recipient of the prestigious American Association for the Study of Liver Diseases (AASLD) Shelia Sherlock Clinical and Translational Research award and has over 100 citations in peer-reviewed publications.
"TT-034 is a potentially transformative new treatment," Patel commented. "A therapeutic that could cure an HCV patient with a single injection would obviously be a big step forward compared to even the best treatments that are currently on the horizon, as they all involve comparatively lengthy regimens with a combination of several drugs."
I posted updated info
http://www.medhelp.org/posts/Hepatitis-C/1-shot-TT-034-multi-drug-hep-C-cure-USA-trial-NC/show/2105499
before finding this older link
http://www.medhelp.org/posts/Hepatitis-C/1-shot-TT-034-multi-drug-hep-C-cure-USA-trial-NC/show/2105499
before finding this older link
your right it is risky with what is going to be available in the not to far distant future not worth it , thankyou
As a phase one trial this trial is being done to study the safety and dosage to be used in future trials. Unless you have no more treatment options and have advanced liver disease would I ever enter a trial with new technology in phase 1. This trial is to prove if it even works in humans. As the chances of it ever making it through all three phases of studies are very low phase one trials are highly risky and usually only done by patients as a last resort.
The study is being done to study...
" dose-escalation study in infected patients, with interim data on safety and efficacy likely within months of trial commencement"
" enabling the company to commence patient enrollment and dosing in the second half of calendar 2013."
"The expression cassette for TT-034 is delivered via an adenovirus-associated viral vector, known to highly target the liver and known for
persistence for months or even years after a single administration of the drug. When administered at certain levels, a single dose of TT-034 was shown in our murine (mouse) and non-human primate studies to transduce nearly 100% of hepatocytes, the sole site of active HCV replication in humans, without any adverse effects and shRNA was persistent out to 180 days, the duration of the study."
Hector
The study is being done to study...
" dose-escalation study in infected patients, with interim data on safety and efficacy likely within months of trial commencement"
" enabling the company to commence patient enrollment and dosing in the second half of calendar 2013."
"The expression cassette for TT-034 is delivered via an adenovirus-associated viral vector, known to highly target the liver and known for
persistence for months or even years after a single administration of the drug. When administered at certain levels, a single dose of TT-034 was shown in our murine (mouse) and non-human primate studies to transduce nearly 100% of hepatocytes, the sole site of active HCV replication in humans, without any adverse effects and shRNA was persistent out to 180 days, the duration of the study."
Hector
I have a good feeling about this One Shot deal! Would there be a Resistancy issue, to the other 2nd generation Direct Acting Antivirals, such as Sofosbuvir and the other new ones, if you didn't achieve SVR from the shot?
I think they are just in phase 1 at the moment and looking for people to enrol in usa and Australia , they say it looks very good . I am debating on whether to add my name to try and be included .
Hmm, I have heard of this Shot...I am thinking it must stay active in the body for months and months after it is injected.
I dont know if I would want to do a Phase 1 Trial though, can you find one that is in Phase 3, nearby to you?
I dont know if I would want to do a Phase 1 Trial though, can you find one that is in Phase 3, nearby to you?
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