Benitec Biopharma recently announced an agreement with Omnia Biologics, a Maryland-based biotechnology company, to manufacture materials for the TT-034 trial, the first-in-man clinical trial for hepatitis C treatment. The agreement was made in order to ensure that Benitec has enough clinical material to complete the trial. The company is also working towards the establishment of its own manufacturing and scale-up processes for their experimental HCV treatment in collaboration with other companies that potentially supply large markets.
According to the Centers for Disease Control and Prevention (CDC), almost 3.2 million people in the United States suffer from chronic HCV infection and the amount of acute cases of hepatitis C were reported to have increased from 1,229 to 1,778 from 2011 to 2012. The rapid increase in cases is creating new medical needs for not only treating the disease, but also being able to meet production demands for therapies.
TT-034 is a ddRNAi-based therapeutic that is believed to treat and hopefully cure hepatitis C with only one dose. It strikes the hepatitis C viral RNA at 3 different and specific locations, which minimizes the capacity of the virus to mutate in order to hide and escape the therapy.
When it reaches the liver cells, TT-034 immediately enters the nucleus and generates 3 different short-hairpin RNAs continuously. The company believes that this therapeutic approach has great potential to protect against reinfection for months or even years without the need of another treatment.
Benitec had previously announced that it has dosed the third patient in its Phase I/IIa clinical trial with TT-034 for hepatitis C, at the Duke Clinical Research Unit (USA). This marked an important step for the study, since the collective data regarding the first and the second patients’ outcomes were reviewed by the Data Safety Monitoring Board (DSMB) and the independent institution determined that there were no significant adverse events related with the treatment in the first dosing cohort.
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Cepheid recently announced that its quantitative hepatitis C virus infection viral load test, Xpert HCV Viral Load, has achieved CE-IVD status under the European Directive on In Vitro Diagnostic Medical Devices. The test received approval as a medical device and will enable HCV viral load to be monitored and detected while it produces results in less than 2 hours. The test is designed to be used in managing HCV-positive patients currently undergoing antiviral therapy and it can also be used to help predict sustained and non sustained virological responses to HCV therapy, to measure the HCV RNA levels at baseline and during treatment, and to confirm HCV serologic test results.