BriaCell Receives Green-Light from Data Safety Monitoring Board for its Phase 3 Study in Metastatic Breast Cancer
02 Dezember 2024 - 1:50PM
BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT)
(“BriaCell” or the “Company”), a clinical-stage biotechnology
company that develops novel immunotherapies to transform cancer
care, announces that the Data Safety Monitoring Board (DSMB), an
independent group of experts who review and monitor safety data of
a clinical study to determine if a study should continue, be
modified, or be halted early, has completed its first review of
safety events in patients enrolled in BriaCell’s pivotal randomized
Phase 3 study of Bria-IMT™ plus an immune checkpoint inhibitor
(CPI) combination regimen (NCT06072612). The DSMB issued a
statement recommending continuation of the study in metastatic
breast cancer patients. BriaCell’s pivotal Phase 3 study is
currently being conducted under Fast Track Designation with the
Food and Drug Administration (FDA).
“We are pleased with the DSMB’s recommendation
for the continuation of BriaCell’s Phase 3 study without any
protocol modification as a significant milestone towards clinical
advancement of our novel immunotherapy as a safe and effective
treatment option for metastatic breast cancer patients,” stated Dr.
William V. Williams, BriaCell’s President & CEO.
“We strongly believe in the potential of our
novel immunotherapy to transform cancer care for metastatic breast
cancer patients, and the positive DSMB review reinforces our
confidence in the potential use of the combination regimen in
metastatic breast cancer patients,” noted Giuseppe Del Priore, MD,
MPH, BriaCell’s Chief Medical Officer.
About BriaCell Therapeutics
Corp.
BriaCell is a clinical-stage biotechnology
company that develops novel immunotherapies to transform cancer
care. More information is available at https://briacell.com/.
Safe Harbor
This press release contains “forward-looking
statements” that are subject to substantial risks and
uncertainties. All statements, other than statements of historical
fact, contained in this press release are forward-looking
statements. Forward-looking statements contained in this press
release may be identified by the use of words such as “anticipate,”
“believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,”
“seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,”
“target,” “aim,” “should,” “will,” “would,” or the negative of
these words or other similar expressions, although not all
forward-looking statements contain these words. Forward-looking
statements, including those about BriaCell’s clinical advancement
of Bria-IMT™ as a safe and effective treatment option for
metastatic cancer patients; the ability of Bria-IMT™ to transform
cancer care in metastatic breast cancer patients; and the potential
use of the combination regimen for metastatic breast cancer
patients are based on BriaCell’s current expectations and are
subject to inherent uncertainties, risks, and assumptions that are
difficult to predict. Further, certain forward-looking statements,
such as those are based on assumptions as to future events that may
not prove to be accurate. These and other risks and uncertainties
are described more fully under the heading “Risks and
Uncertainties” in the Company’s most recent Management’s Discussion
and Analysis, under the heading “Risk Factors” in the Company’s
most recent Annual Information Form, and under “Risks and
Uncertainties” in the Company’s other filings with the Canadian
securities regulatory authorities and the U.S. Securities and
Exchange Commission, all of which are available under the Company's
profiles on SEDAR+ at www.sedarplus.ca and on
EDGAR at www.sec.gov. Forward-looking statements
contained in this announcement are made as of this date, and
BriaCell Therapeutics Corp. undertakes no duty to update such
information except as required under applicable law.
Neither the Toronto Stock Exchange nor its
Regulation Services Provider (as that term is defined in the
policies of the Toronto Stock Exchange) accepts responsibility for
the adequacy or accuracy of this release.
Contact Information
Company Contact:William V.
Williams, MDPresident &
CEO1-888-485-6340info@briacell.com
Media Relations:Jules AbrahamCORE
IRjulesa@coreir.com
Investor Relations Contact:CORE
IRinvestors@briacell.com
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