MONTREAL, March 04, 2019 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (Theratechnologies) (TSX: TH) has been informed by its partner, TaiMed Biologics Inc. that the Food and Drug Administration has authorized TMB-302, the study protocol to evaluate an intravenous (IV) slow push formulation of Trogarzo® (ibalizumab-uiyk) injection.
TMB-302 will evaluate the safety and pharmacokinetics of administering undiluted Trogarzo® during the maintenance phase at 800 mg once every two weeks as an intravenous (IV) push over 30 seconds. The study will enroll 20 patients and will be conducted over a 12-week period. Patients will be followed for up to 28 days following the study completion.
“An IV slow push could offer an option over the current IV infusion which would reduce the time of administration and eliminate the need for saline solution and other infusion apparatus,” said Christian Marsolais, Senior Vice President and Chief Medical Officer, Theratechnologies Inc.
About Theratechnologies
Theratechnologies (TSX: TH) is a specialty pharmaceutical company addressing unmet medical needs by bringing to market specialized therapies for people with orphan medical conditions, including those living with HIV. 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 beliefs 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 timing to conduct the study and the advantages of the IV slow-push formulation over the current formulation of Trogarzo®.
Forward-looking statements are based upon a number of assumptions and include, but are not limited to, the following: we will succeed in enrolling 20 patients, the safety and pharmacokinetic profile will allow approval of this formulation by the FDA and, if approved, patients and physicians will accept such new formulation of Trogarzo®.
Forward-looking statements are subject to a variety of risks and uncertainties, many of which are beyond our control that could cause our actual results to differ materially from those that are disclosed in or implied by the forward-looking statements contained in this press release. These risks and uncertainties include, among others, we may not be able to enroll the number of patients required to complete the study leading to a halt of the study, results from the study may not warrant approval of this new formulation by the FDA and the timing to complete the study may be longer than anticipated.
We refer potential investors to the "Risk Factors" section of our annual information form dated February 20, 2019 for additional risks regarding the conduct of our business and Theratechnologies. 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.
For media inquiries:
Denis Boucher
Vice President, Communications and Corporate Affairs
514-336-7800