Fifth patient dosed with 'one-shot' drug in HCV trial

The fifth and final patient in the phase 1/2a clinical trial of TT-034, a ddRNAi-based therapeutic to treat hepatitis C virus infection, has been dosed, according to a news release from Benitec Biopharma Limited.

The phase 1/2 clinical trial being conducted at the Duke Clinical Research Unit of Duke Clinical Research Institute is an open-label dose escalation study that evaluates the safety and activity of single doses of TT-034 (Benitec), a potential treatment for HCV with a single-dose administration, in patients with chronic HCV genotype 1 infection who have failed previous treatments, according to the Duke Clinical Research Unit website. The trial consists of 14 patients in five sequential dose cohorts.

Patients in cohort two received an increased dose of TT-034 that was a half-log higher than patients dosed in the first cohort, according to the release. The dose level was still below the concentration expected to inhibit HCV viral replication, according to the release.

The Duke Clinical Research Unit will monitor the current patient for 6 weeks and submit results to the Data Safety Monitoring Board (DSMB) for proper review. After review, the DSMB plans to determine whether to recommend the two remaining patients enrolled in the trial be included in the final dosing cohort.

Patients are currently being screened for inclusion in cohort three and Benitec has initiated a new clinical site for participation; the Texas Liver Institute in San Antonio, pending the DSMB’s review.

No significant adverse events related to treatment were reported from the previous cohort, according to a previous release. – by Melinda Stevens

The fifth and final patient in the phase 1/2a clinical trial of TT-034, a ddRNAi-based therapeutic to treat hepatitis C virus infection, has been dosed, according to a news release from Benitec Biopharma Limited.

The phase 1/2 clinical trial being conducted at the Duke Clinical Research Unit of Duke Clinical Research Institute is an open-label dose escalation study that evaluates the safety and activity of single doses of TT-034 (Benitec), a potential treatment for HCV with a single-dose administration, in patients with chronic HCV genotype 1 infection who have failed previous treatments, according to the Duke Clinical Research Unit website. The trial consists of 14 patients in five sequential dose cohorts.

Patients in cohort two received an increased dose of TT-034 that was a half-log higher than patients dosed in the first cohort, according to the release. The dose level was still below the concentration expected to inhibit HCV viral replication, according to the release.

The Duke Clinical Research Unit will monitor the current patient for 6 weeks and submit results to the Data Safety Monitoring Board (DSMB) for proper review. After review, the DSMB plans to determine whether to recommend the two remaining patients enrolled in the trial be included in the final dosing cohort.

Patients are currently being screened for inclusion in cohort three and Benitec has initiated a new clinical site for participation; the Texas Liver Institute in San Antonio, pending the DSMB’s review.

No significant adverse events related to treatment were reported from the previous cohort, according to a previous release. – by Melinda Stevens