Investors Hangout Stock Message Boards Logo
  • Mailbox
  • Favorites
  • Boards
    • The Hangout
    • NASDAQ
    • NYSE
    • OTC Markets
    • All Boards
  • Whats Hot!
    • Recent Activity
    • Most Viewed Boards
    • Most Viewed Posts
    • Most Posted
    • Most Followed
    • Top Boards
    • Newest Boards
    • Newest Members
  • Blog
    • Recent Blog Posts
    • Recently Updated
    • News
    • Stocks
    • Crypto
    • Investing
    • Business
    • Markets
    • Economy
    • Real Estate
    • Personal Finance
  • Market Movers
  • Interactive Charts
  • Login - Join Now FREE!
  1. Home ›
  2. Stock Message Boards ›
  3. User Boards ›
  4. News Desk 2018 Message Board

Theratechnologies Announces Comparative PK Data on

Message Board Public Reply | Private Reply | Keep | Replies (0)                   Post New Msg
Edit Msg () | Previous | Next


Post# of 617763
(Total Views: 197)
Posted On: 02/15/2017 7:30:04 PM
Avatar
Posted By: News Desk 2018
Theratechnologies Announces Comparative PK Data on the Intramuscular and Intravenous Administration of the Monoclonal Antibody and Long-Acting Investigational Antiretroviral Ibalizumab

MONTRÉAL, QUÉBEC--(Marketwired - Feb. 15, 2017) - 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.

Theratechnologies Inc. Philippe Dubuc Senior Vice President and Chief Financial Officer (514) 336-7800, ext. 297 www.theratech.com


(0)
(0)








Investors Hangout

Home

Mailbox

Message Boards

Favorites

Whats Hot

Blog

Settings

Privacy Policy

Terms and Conditions

Disclaimer

Contact Us

Whats Hot

Recent Activity

Most Viewed Boards

Most Viewed Posts

Most Posted Boards

Most Followed

Top Boards

Newest Boards

Newest Members

Investors Hangout Message Boards

Welcome To Investors Hangout

Stock Message Boards

American Stock Exchange (AMEX)

NASDAQ Stock Exchange (NASDAQ)

New York Stock Exchange (NYSE)

Penny Stocks - (OTC)

User Boards

The Hangout

Private

Global Markets

Australian Securities Exchange (ASX)

Euronext Amsterdam (AMS)

Euronext Brussels (BRU)

Euronext Lisbon (LIS)

Euronext Paris (PAR)

Foreign Exchange (FOREX)

Hong Kong Stock Exchange (HKEX)

London Stock Exchange (LSE)

Milan Stock Exchange (MLSE)

New Zealand Exchange (NZX)

Singapore Stock Exchange (SGX)

Toronto Stock Exchange (TSX)

Contact Investors Hangout

Email Us

Follow Investors Hangout

Twitter

YouTube

Facebook

Market Data powered by QuoteMedia. Copyright © 2025. Data delayed 15 minutes unless otherwise indicated (view delay times for all exchanges).
Analyst Ratings & Earnings by Zacks. RT=Real-Time, EOD=End of Day, PD=Previous Day. Terms of Use.

© 2025 Copyright Investors Hangout, LLC All Rights Reserved.

Privacy Policy |Do Not Sell My Information | Terms & Conditions | Disclaimer | Help | Contact Us