Tetra Bio-Pharma Resumes its Phase 3 Clinical Trial Program
09 April 2019 - 12:30PM
Tetra Bio-Pharma Inc. ("
Tetra" or
the "
Company") (TSX-V: TBP) (OTCQB: TBPMF),
today announced it is ready to resume its Phase 3 clinical program
in advanced cancer pain patients with the objective to assess
Health- Related Quality of Life (HrQoL).
The SERENITY© Study will use a
vaporizer, a Health Canada approved Class 2 medical device as a
delivery mechanism which is more acceptable to hospitals and
palliative care centers. Tetra’s new drug formerly referred to as
PPP-001 will be investigated in the SERENITY ©
Study under the commercial trademark of CAUMZ. In
preparation for commercialization, Tetra has decided to brand its
investigational drug name for regulatory filing purposes.
In addition, the significant expansion of
clinical trial sites to 20 in both Canada and the United States,
will accelerate patient recruitment and help expedite Tetra’s
submission to regulatory agencies.
“I am extremely pleased with Tetra’s ability to
quickly resolve the problem that required us to suspend our
clinical trial in advanced cancer pain. With great challenge comes
great opportunity and what we are now able to deliver is a better
and more reliable product,” said Dr. Guy Chamberland, CEO and CSO
of Tetra Bio-Pharma. “The continuation of our research is excellent
news, not only for those suffering with advanced cancer pain and
other symptoms but also for our investors. I look forward to the
day when Tetra’s cannabinoid-derived drugs will help reduce, if not
eliminate the reliance on drugs like Fentanyl®, Oxycodone® or
morphine and that hopefully the study drug will be able to bring
serenity to patients in their difficult journey through the
disease.”
About Tetra Bio-Pharma:
Tetra Bio-Pharma (TSX-V: TBP) (OTCQB: TBPMF) is
a biopharmaceutical leader in cannabinoid-based drug discovery and
development with a Health Canada authorized, and FDA reviewed,
clinical trials aimed at bringing novel prescription drugs and
treatments to patients and their healthcare providers. The Company
has several subsidiaries engaged in the development of an advanced
and growing pipeline of Bio Pharmaceuticals, Natural Health and
Veterinary Products containing cannabis and other medicinal
plant-based elements. With patients at the core of what we do,
Tetra Bio-Pharma is focused on providing rigorous scientific
validation and safety data required for inclusion into the existing
bio pharma industry by regulators, physicians and insurance
companies.
For more information visit: www.tetrabiopharma.com
Source: Tetra Bio-Pharma
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the adequacy or accuracy of this release.
Forward-looking statements
Some statements in this release may contain
forward-looking information. All statements, other than of
historical fact, that address activities, events or developments
that the Company believes, expects or anticipates will or may occur
in the future (including, without limitation, statements regarding
potential acquisitions and financings) are forward-looking
statements. Forward-looking statements are generally identifiable
by use of the words "may", "will", "should", "continue", "expect",
"anticipate", "estimate", "believe", "intend", "plan" or "project"
or the negative of these words or other variations on these words
or comparable terminology. Forward-looking statements are subject
to a number of risks and uncertainties, many of which are beyond
the Company's ability to control or predict, that may cause the
actual results of the Company to differ materially from those
discussed in the forward-looking statements. Factors that could
cause actual results or events to differ materially from current
expectations include, among other things, without limitation, the
inability of the Company to obtain sufficient financing to execute
the Company's business plan; competition; regulation and
anticipated and unanticipated costs and delays, the success of the
Company's research and development strategies, including the
success of CAUMZ and its other drug candidates, the applicability
of the discoveries made therein, the successful and timely
completion and uncertainties related to the regulatory process
including the applications for Orphan Drug Designation, the timing
of clinical trials, the timing and outcomes of regulatory or
intellectual property decisions and other risks disclosed in the
Company's public disclosure record on file with the relevant
securities regulatory authorities. Although the Company has
attempted to identify important factors that could cause actual
results or events to differ materially from those described in
forward-looking statements, there may be other factors that cause
results or events not to be as anticipated, estimated or intended.
Readers should not place undue reliance on forward-looking
statements. The forward-looking statements included in this news
release are made as of the date of this news release and the
Company does not undertake an obligation to publicly update such
forward-looking statements to reflect new information, subsequent
events or otherwise unless required by applicable securities
legislation.
Tetra Bio-Pharma Contact: Steeve NéronSr VP
Marketing and Medical Affairs sneron@tetrabiopharma.com
Investor Contact: Maison
Brison Pierre Boucher, CPA, CMA Partner, Executive
Vice-President 514-731-0000 ext. 237
Investors@tetrabiopharma.com
Media Contact : energi PR
Carol Levine, APR, FCPRS CEO 514-288-8500 ext. 226
Carol.levine@energipr.com
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