Theratechnologies Announces 48-Week Efficacy And Safety Results For Ibalizumab Presented At IDWeek 2017
Published: Oct 04, 2017
HIV Monoclonal Antibody and Long-Acting Investigational Antiretroviral Ibalizumab with Optimized Background Regimen Maintained High Viral Suppression and was Well Tolerated Through Week 48 in Patients with Multidrug Resistant HIV
MONTREAL, QUEBEC--(Marketwired - Oct. 4, 2017) - Theratechnologies Inc. (Theratechnologies) (TSX:TH) today announced 48-week efficacy and safety results for ibalizumab in patients infected with multidrug resistant HIV-1 who completed the 24-week Phase III study (TMB-301) and continued treatment in the Expanded Access Program study (TMB-311). These data are being presented in an oral presentation at IDWeek 2017™ in San Diego (abstract #1686).
Ibalizumab is an investigational humanized monoclonal antibody being developed for the treatment of multidrug resistant 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 T cells while preserving normal immunological function.
Ibalizumab is currently under accelerated review by the FDA following the acceptance of a Biologics License Application on June 30, 2017. The FDA target action date to complete the review of ibalizumab is January 3, 2018.
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 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: the FDA will approve ibalizumab, patients and physicians will accept ibalizumab as a treatment for HIV-infected patients (if approved), treatment with ibalizumab will have the same effects as those observed during the clinical trials and the Company will have set-up on time the necessary infrastructure to launch ibalizumab as a drug (if and when approved). These risks and uncertainties include, but are not limited to, the risk that the FDA does not approve ibalizumab for commercialization, that the effect of a treatment using ibalizumab (if approved) will differ from those observed during the clinical trials and that the Company is unable to set-up its infrastructure on time to successfully launch ibalizumab (if and when approved by the FDA).
We refer potential investors to the "Risk Factors" section of our Annual Information Form dated February 7, 2017 available 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.
Senior Vice President and Chief Financial Officer
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