Theratechnologies Announces All U.S. Oncology Clinical Sites Now Enrolling for Phase 1 Trial of Sudocetaxel Zendusortide
30 August 2023 - 4:34PM
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.
About Theratechnologies
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.
Forward-Looking Information 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.
Investor Contact:Philippe Dubuc
Senior Vice President and Chief Financial Officer
pdubuc@theratech.com438-315-6608
Media
inquiries:Julie SchneidermanSenior Director,
Communications & Corporate
Affairscommunications@theratech.com1-514-336-7800
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