MONTREAL, Feb. 15, 2017 /PRNewswire/ -- Theratechnologies Inc. (Theratechnologies) (TSX: TH) announced today that pharmacokinetics (PK) and pharmacodynamics (PD) data comparing the intramuscular (IM) with the intravenous (IV) administration of ibalizumab were presented at the annual Conference on Retroviruses and Opportunistic Infections (CROI) 2017.
The PK and PD of two doses of ibalizumab, 800 mg bi-weekly and 2000 mg every 4 weeks, administered IM were evaluated under study TMB-121. This data was compared to the PK and PD data of similar doses of ibalizumab administered IV from a previous study. The results showed that the PK and PD profiles of both doses of ibalizumab administered IM were comparable with IV profiles. Ibalizumab was well tolerated when administered IM or IV.
About TMB-121
TMB-121 is a Phase I/II, randomized study primarily assessing the PK/PD of IM administration of ibalizumab. The study is conducted in Taiwan, by our partner TaiMed Biologics inc, and enrolled patients with HIV-1 RNA ?5000 copies/mL who have not received antiretroviral (ARV) treatment for at least one year. The primary objective of the study is to evaluate the PK and PD profile of ibalizumab when administered by different routes of administration.
About ibalizumab
Ibalizumab is an investigational humanized monoclonal antibody currently being developed for the potential treatment of Multiple Drug Resistant Human Immunodeficiency Virus-1 (MDR HIV-1) infection. Unlike other antiretroviral agents, ibalizumab binds primarily to the second extracellular domain of the CD4+ T cell receptor, away from major histocompatibility complex II molecule binding sites. It potentially prevents HIV 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 trial is the last pivotal clinical study necessary for the completion of a Biologics License Application (BLA) expected to be submitted to the Food and Drug Administration (FDA).
Ibalizumab has received "Breakthrough Therapy" designation from the FDA. This designation is given to a therapy that may provide a substantial improvement over what is currently available to address a serious and life-threatening condition. Ibalizumab also received "Orphan Drug" designation by the FDA.
About Theratechnologies
Theratechnologies (TSX: TH) 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.
Forward-Looking Information
This press release contains forward-looking statements and forward-looking information, or, collectively, forward-looking statements, within the meaning of applicable securities laws, that are based on our management's belief and assumptions and on information currently available to our management. You can identify forward-looking statements by terms such as "may", "will", "should", "could", "would", "outlook", "believe", "plan", "envisage", "anticipate", "expect" and "estimate" or the negatives of these terms, or variations of them. The forward-looking statements contained in this press release include, but are not limited to, the completion and filing of a BLA with the FDA for ibalizumab and the approval of ibalizumab as a treatment for patients with MDR HIV-1 infection.
Forward-looking statements are based upon a number of assumptions and are subject to a number of risks and uncertainties, many of which are beyond Theratechnologies' control that could cause actual results to differ materially from those that are disclosed in or implied by such forward-looking information. These assumptions include but are not limited to, the following: all data required to file a BLA with the FDA will be available to support such filing, ibalizumab will be approved by the FDA as a treatment for MDR HIV-1 infection, and, if ibalizumab is approved, Theratechnologies will have set-up on time the necessary infrastructure to launch and commercialize ibalizumab in the United States. These risks and uncertainties include, but are not limited to, the risk that all data required to file a BLA with the FDA are not satisfactory enough to proceed with such filing, that the FDA does not approve ibalizumab as a treatment for MDR HIV-1 infection, or if approved, impose a significant limitation of its use, that the FDA requires additional clinical trials to be conducted and that Theratechnologies is unable to have all the necessary infrastructure in place to successfully launch and commercialize ibalizumab in the United States.
We refer potential investors to the "Risk Factors" section of our Annual Information Form (AIF) dated February 7, 2017 for additional risks and uncertainties about Theratechnologies. The AIF is available on the Corporation's website at www.theratech.com and on SEDAR at www.sedar.com.
The reader is cautioned to consider these and other risks and uncertainties carefully and not to put undue reliance on forward-looking statements. Forward-looking statements reflect current expectations regarding future events and speak only as of the date of this press release and represent our expectations as of that date. We undertake no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise, except as may be required by applicable law.
Contact: Philippe DubucSenior Vice President and Chief Financial OfficerTel. : (514) 336-7800, ext. 297
Advertisement
The PK and PD of two doses of ibalizumab, 800 mg bi-weekly and 2000 mg every 4 weeks, administered IM were evaluated under study TMB-121. This data was compared to the PK and PD data of similar doses of ibalizumab administered IV from a previous study. The results showed that the PK and PD profiles of both doses of ibalizumab administered IM were comparable with IV profiles. Ibalizumab was well tolerated when administered IM or IV.
Advertisement
About TMB-121
TMB-121 is a Phase I/II, randomized study primarily assessing the PK/PD of IM administration of ibalizumab. The study is conducted in Taiwan, by our partner TaiMed Biologics inc, and enrolled patients with HIV-1 RNA ?5000 copies/mL who have not received antiretroviral (ARV) treatment for at least one year. The primary objective of the study is to evaluate the PK and PD profile of ibalizumab when administered by different routes of administration.
About ibalizumab
Ibalizumab is an investigational humanized monoclonal antibody currently being developed for the potential treatment of Multiple Drug Resistant Human Immunodeficiency Virus-1 (MDR HIV-1) infection. Unlike other antiretroviral agents, ibalizumab binds primarily to the second extracellular domain of the CD4+ T cell receptor, away from major histocompatibility complex II molecule binding sites. It potentially prevents HIV 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 trial is the last pivotal clinical study necessary for the completion of a Biologics License Application (BLA) expected to be submitted to the Food and Drug Administration (FDA).
Ibalizumab has received "Breakthrough Therapy" designation from the FDA. This designation is given to a therapy that may provide a substantial improvement over what is currently available to address a serious and life-threatening condition. Ibalizumab also received "Orphan Drug" designation by the FDA.
About Theratechnologies
Theratechnologies (TSX: TH) 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.
Forward-Looking Information
This press release contains forward-looking statements and forward-looking information, or, collectively, forward-looking statements, within the meaning of applicable securities laws, that are based on our management's belief and assumptions and on information currently available to our management. You can identify forward-looking statements by terms such as "may", "will", "should", "could", "would", "outlook", "believe", "plan", "envisage", "anticipate", "expect" and "estimate" or the negatives of these terms, or variations of them. The forward-looking statements contained in this press release include, but are not limited to, the completion and filing of a BLA with the FDA for ibalizumab and the approval of ibalizumab as a treatment for patients with MDR HIV-1 infection.
Forward-looking statements are based upon a number of assumptions and are subject to a number of risks and uncertainties, many of which are beyond Theratechnologies' control that could cause actual results to differ materially from those that are disclosed in or implied by such forward-looking information. These assumptions include but are not limited to, the following: all data required to file a BLA with the FDA will be available to support such filing, ibalizumab will be approved by the FDA as a treatment for MDR HIV-1 infection, and, if ibalizumab is approved, Theratechnologies will have set-up on time the necessary infrastructure to launch and commercialize ibalizumab in the United States. These risks and uncertainties include, but are not limited to, the risk that all data required to file a BLA with the FDA are not satisfactory enough to proceed with such filing, that the FDA does not approve ibalizumab as a treatment for MDR HIV-1 infection, or if approved, impose a significant limitation of its use, that the FDA requires additional clinical trials to be conducted and that Theratechnologies is unable to have all the necessary infrastructure in place to successfully launch and commercialize ibalizumab in the United States.
We refer potential investors to the "Risk Factors" section of our Annual Information Form (AIF) dated February 7, 2017 for additional risks and uncertainties about Theratechnologies. The AIF is available on the Corporation's website at www.theratech.com and on SEDAR at www.sedar.com.
The reader is cautioned to consider these and other risks and uncertainties carefully and not to put undue reliance on forward-looking statements. Forward-looking statements reflect current expectations regarding future events and speak only as of the date of this press release and represent our expectations as of that date. We undertake no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise, except as may be required by applicable law.
Contact: Philippe DubucSenior Vice President and Chief Financial OfficerTel. : (514) 336-7800, ext. 297
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/theratechnologies-announces-comparative-pk-data-on-the-intramuscular-and-intravenous-administration-of-the-monoclonal-antibody-and-long-acting-investigational-antiretroviral-ibalizumab-300408253.html
SOURCE Theratechnologies Inc.
