Theratechnologies Announces All U.S. Oncology Clinical Sites Now Enrolling for Phase 1 Trial of Sudocetaxel Zendusortide
MONTREAL, Aug. 30, 2023 (GLOBE NEWSWIRE) — Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, today announced that all five of the U.S.-based clinical sites participating in the conduct of the Phase 1 clinical trial of the Company’s lead investigational peptide drug conjugate, sudocetaxel zendusortide, are now activated to screen, enroll and dose advanced ovarian cancer patients. A sixth site based in Canada is finalizing its start-up activity.
Full details about the study design, participation criteria and contact information for the sites can be found at : https://clinicaltrials.gov/study/NCT04706962.
About Sudocetaxel Zendusortide and SORT1+ Technology™
Sudocetaxel zendusortide is currently Theratechnologies’ lead investigational peptide drug conjugate candidate for the treatment of cancer derived from its SORT1+ Technology™. It is the Company’s proprietary peptide linked to docetaxel – a commonly used cytotoxic agent used to treat many cancers. The FDA granted fast track designation to sudocetaxel zendusortide as a single agent for the treatment of all sortilin-positive recurrent advanced solid tumors that are refractory to standard therapy. Sudocetaxel zendusortide is currently being evaluated in a phase 1 clinical trial.
Theratechnologies is currently developing a platform of proprietary peptides called SORT1+ Technology™ for cancer drug development targeting SORT1 receptors. The SORT1 receptor plays a significant role in protein internalization, sorting and trafficking. It is highly expressed in cancer cells compared to healthy tissue, which makes SORT1 an attractive target for cancer drug development. Expression of SORT1 is associated with aggressive disease, poor prognosis and decreased survival. It is estimated that the SORT1 receptor is expressed in 40% to 90% of cases of endometrial, ovarian, colorectal, triple-negative breast and pancreatic cancers.
Theratechnologies (TSX: TH) (NASDAQ: THTX) is a biopharmaceutical company focused on the development and commercialization of innovative therapies addressing unmet medical needs. Further information about Theratechnologies is available on the Company’s website at www.theratech.com, on SEDAR at www.sedarplus.ca and on EDGAR at www.sec.gov.
This press release contains forward-looking statements and forward-looking information (collectively, the “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”, “promising”, “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, statements regarding the enrollment, recruitment and dosing of patients in the Company’s Phase 1 clinical trial studying sudocetaxel zendusortide. Although the Forward-Looking Statements contained in this press release are based upon what the Company believes are reasonable assumptions in light of the information currently available, investors are cautioned against placing undue reliance on this information since actual results may vary from the forward-looking information. Certain assumptions made in preparing the Forward-Looking Statements include that: clinical trial site will be able to recruit patients who meet the inclusion criteria of the study protocol, no untoward side effects from the use of sudocetaxel zendusortide will be discovered and strong signs of efficacy from the use of sudocetaxel zendusortide will be observed. Forward-Looking Statements 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 Statements. These risks and uncertainties include, but are not limited to, those related to or arising from: difficulties in the recruitment of patients, competition from other investigational drugs in the field of oncology and negative results that can be observed from the use of sudocetaxel zendusortide leading to a halt in the development of this investigative peptide drug product. We refer current and potential investors to the “Risk Factors” section of our Annual Information Form dated February 27, 2023, available on SEDAR at www.sedarplus.ca and on EDGAR at www.sec.gov as an exhibit to our report on Form 40-F dated February 28, 2023, under Theratechnologies’ public filings for additional risks involved in our business. 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
Senior Director, Communications & Corporate Affairs