MONTREAL, Canada I October 24, 2016 I Theratechnologies Inc. (Theratechnologies) (TH.TO) is pleased to announce that it has been notified today by its partner, TaiMed Biologics, Inc., that the last patient enrolled in the Phase III study of ibalizumab, in combination with optimized background regimen, for patients infected with multi-drug resistant HIV-1 has completed the treatment phase of the study. The last patient was enrolled on April 24, 2016, and completed the Week 25 visit last week. Patients who completed the trial are offered participation in the expanded access study. TaiMed and its clinical research organization are now completing the analysis of the data, and top-line results should be available in the coming weeks.
This open label, single arm Phase III study is the last pivotal clinical trial required by the United States Food & Drug Administration (FDA) to complete the Biologics License Application (BLA) submission. The primary end point, defined as the proportion of patients achieving a viral load reduction of at least 0.5 log10 at Day 14, was met successfully by 83% of patients (33/40). As previously disclosed, detailed primary end point data obtained after seven days of treatment will be presented as a late-breaker oral presentation, at the IDWeek 2016™ medical conference in New Orleans at the end of this month.
About Ibalizumab
Ibalizumab is a humanized monoclonal antibody developed for the potential treatment of HIV-1 infection. Unlike other antiretroviral agents, Ibalizumab binds primarily to the second extracellular domain of the CD4 receptor, away from Major Histocompatibility Complex II molecule (MHC II) binding sites. It potentially prevents HIV virus from infecting CD4+ immune cells while preserving normal immunological function. Ibalizumab is active against HIV-1 resistant to all approved antiretroviral agents. Ibalizumab has been tested in phase I and II clinical trials and the phase III study is the last pivotal clinical study necessary for the completion of the BLA.
About Theratechnologies
Theratechnologies (TH.TO) is a specialty pharmaceutical company addressing unmet medical needs to promote healthy living and an improved quality of life among HIV patients. Further information about Theratechnologies is available on the Company’s website at www.theratech.com and on SEDAR at www.sedar.com.
SOURCE: Theratechnologies
Post Views: 132
MONTREAL, Canada I October 24, 2016 I Theratechnologies Inc. (Theratechnologies) (TH.TO) is pleased to announce that it has been notified today by its partner, TaiMed Biologics, Inc., that the last patient enrolled in the Phase III study of ibalizumab, in combination with optimized background regimen, for patients infected with multi-drug resistant HIV-1 has completed the treatment phase of the study. The last patient was enrolled on April 24, 2016, and completed the Week 25 visit last week. Patients who completed the trial are offered participation in the expanded access study. TaiMed and its clinical research organization are now completing the analysis of the data, and top-line results should be available in the coming weeks.
This open label, single arm Phase III study is the last pivotal clinical trial required by the United States Food & Drug Administration (FDA) to complete the Biologics License Application (BLA) submission. The primary end point, defined as the proportion of patients achieving a viral load reduction of at least 0.5 log10 at Day 14, was met successfully by 83% of patients (33/40). As previously disclosed, detailed primary end point data obtained after seven days of treatment will be presented as a late-breaker oral presentation, at the IDWeek 2016™ medical conference in New Orleans at the end of this month.
About Ibalizumab
Ibalizumab is a humanized monoclonal antibody developed for the potential treatment of HIV-1 infection. Unlike other antiretroviral agents, Ibalizumab binds primarily to the second extracellular domain of the CD4 receptor, away from Major Histocompatibility Complex II molecule (MHC II) binding sites. It potentially prevents HIV virus from infecting CD4+ immune cells while preserving normal immunological function. Ibalizumab is active against HIV-1 resistant to all approved antiretroviral agents. Ibalizumab has been tested in phase I and II clinical trials and the phase III study is the last pivotal clinical study necessary for the completion of the BLA.
About Theratechnologies
Theratechnologies (TH.TO) is a specialty pharmaceutical company addressing unmet medical needs to promote healthy living and an improved quality of life among HIV patients. Further information about Theratechnologies is available on the Company’s website at www.theratech.com and on SEDAR at www.sedar.com.
SOURCE: Theratechnologies
Post Views: 132
