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IBALIZUMAB 24-WEEK PIVOTAL PHASE III STUDY RESULTS ACCEPTED AS A LATE BREAKER WILL BE PRESENTED AT CROI 2017
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Primary Efficacy Endpoint and Safety Results of Ibalizumab in a Phase 3 Study of Heavily Treatment-Experienced Patients with Multi-Drug Resistant HIV-1 Infection http://www.natap.org/2016/IDSA/IDSA_06.htm
Theratechnologies Announces Results from the Last Pivotal Phase III Trial of HIV Long Acting Biologic (LAB) Investigational Antiretroviral Ibalizumab
http://www.natap.org/2016/HIV/111116_01.htm
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IBALIZUMAB 24-WEEK PIVOTAL PHASE III STUDY RESULTS ACCEPTED AS A LATE BREAKER WILL BE PRESENTED AT CROI 2017
Montreal, Canada - January 17, 2017 - Theratechnologies Inc. (Theratechnologies) (TSX: TH) announces that the abstract submitted by its partner, TaiMed Biologics, Inc., for the 24-week study results of the ibalizumab (IBA) phase III study (TMB-301) has been selected for a late breaker presentation, Tuesday, February 14th, 2017, at the Conference on Retroviruses and Opportunistic Infections (CROI) to be held in Seattle, WA, from February 13 to 16, 2017. These results were first announced in our press release of November 10, 2016. Dr. Brinda Emu, Assistant Professor of Medicine, Infectious Diseases, Yale School of Medicine, CT, will be presenting additional efficacy and safety data related to the 24-week study.
In addition, an abstract presenting the preliminary pharmacokinetics (PK) and pharmacodynamics (PD) data of a study comparing the intramuscular (IM) to the intravenous (IV) administration of ibalizumab has also been accepted for a presentation, Wednesday, February 15, 2017. The results of this study demonstrate that the PK profile of 800 mg IBA bi-weekly IM administration was comparable to the 800 mg IV bi-weekly administration while maintaining effective concentration during the dosing period.
About TMB-301, ibalizumab Phase III study
TMB-301 is a single arm, 24-week study of ibalizumab plus optimized background regimen (OBR) in treatment-experienced patients infected with multi-drug resistant HIV-1. The primary objective of the study is to demonstrate the antiviral activity of ibalizumab seven days after the first dose of ibalizumab. Patients receiving their current failing antiretroviral therapy (ART), or no therapy, were monitored during a seven-day control period. Thereafter, a loading dose of 2,000 mg of intravenous (IV) ibalizumab was the only ART added to their regimen. The primary efficacy endpoint is the proportion of patients achieving a ≥ 0.5 log10 decrease in HIV-1 RNA seven days after initiating ibalizumab therapy, day 14 of the study. Ibalizumab is continued at doses of 800 mg IV every two weeks through 24 weeks on study treatment. A total of 40 patients have been enrolled in the study. After completion of treatment, patients are offered participation in the expanded access study (TMB-311). TBM-311 is also open for recruitment of any patients with limited options. For more information about TMB-301 and TMB-311, please refer to theClinicalTrials.govwebsite (www.clinicaltrials.gov).
About ibalizumab
Ibalizumab is an investigational humanized monoclonal antibody currently being 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 binding sites. It potentially prevents HIV from infecting CD4+ immune cells while preserving normal immunological function. 2 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 a biologics license application (BLA) expected to be filed with the United States Food and Drug Administration (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 atwww.theratech.comand on SEDAR atwww.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 filing of a BLA with the FDA and the approval of ibalizumab as a treatment for HIV patients by the FDA.
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: results from the Phase I, II and III studies using ibalizumab will allow the filing of a BLA with the FDA, an approval of the BLA by the FDA, patients and physicians will accept ibalizumab as a treatment for HIV-infected patients, if approved, and Theratechnologies will have the necessary infrastructure in place to launch and commercialize ibalizumab as a drug, if approved. These risks and uncertainties include, but are not limited to, the risk that results from the Phase I, II and/or III studies are not good enough to file a BLA with the FDA, that the FDA does not approve the BLA for ibalizumab and that Theratechnologies is unable to set-up its infrastructure on time to successfully launch and commercialize ibalizumab, if approved by the FDA.
We refer potential investors to the "Risk Factors" section of our Annual Information Form dated February 24, 2016 available on SEDAR atwww.sedar.comfor other risks regarding our business and affairs. 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. 3 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.
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