- SAA Report endorsed Tetra Bio-Pharma's proposed nonclinical
development and quality programs for QIXLEEF™.
- SAA Report provides clarity on clinical requirements for
registration in Europe.
OTTAWA, ON, Sept. 2, 2021 /CNW/ - Tetra Bio-Pharma
Inc. ("Tetra" or the "Company") (TSX: TBP)
(OTCQB: TBPMF) (FRA: JAM1), a leader in cannabinoid-derived drug
discovery and development is pleased to announce that it received
the Scientific Advice Assessment (SAA) Report from the Malta
Medicines Authority. Overall, the SAA Report provided
positive feedback on Tetra's drug development plan for
QIXLEEF™ and eligibility for submitting a Marketing
Authorization Application (MAA) under Directive 2001/83/EC
(Directive). QIXLEEF™ is the Company's inhaled proprietary drug
which has a fixed ratio of THC and CBD. The medication is inhaled
through a Class II medical vaporizer.
The SAA Report endorses Tetra's proposed plan to address the
nonclinical safety requirements for submitting a MAA for QIXLEEF™.
Similarly, the SAA Report endorses the Company's quality program
for QIXLEEF™ as a medicine. In both cases, the SAA Report
provides guidance on requirements for MAA approval.
The SAA Report discusses the assessment of both the PLENITUDE©
and REBORN© clinical programs with regards to a MAA. The SAA
Report provides guidance on the endpoints and other aspects of the
protocol. The REBORN2© trial was identified as pivotal for the MAA
because of its dose-response endpoint requirements of the
Directive. Depending on the outcome in the REBORN1© and
REBORN2© clinical trials, full Marketing Authorization would
require confirmation of the outcome of REBORN1©.
Dr. Guy Chamberland, Chief
Executive Officer and Chief Regulatory Officer of Tetra Bio-Pharma
said "the endorsement of the proposed nonclinical and
quality programs is an exciting achievement that affirms the
robustness of our drug development approach. The Medicine
Authority's response confirms that our development strategy,
adjusted with their guidance on the clinical program, could allow
QIXLEEF™ to satisfy the requirements of article 8 of the Directive.
The timing of this news is important for us as we try to
finalize a single global clinical program for bringing QIXLEEF™ to
patients."
About Tetra Bio-Pharma
Tetra Bio-Pharma (TSX:
TBP) (OTCQB: TBPMF) (FRA:JAM1) is a leader in cannabinoid-derived
drug discovery and development with a FDA and a Health Canada
cleared clinical program aimed at bringing novel prescription drugs
and treatments to patients and their healthcare providers. Our
evidence-based scientific approach has enabled us to develop a
pipeline of cannabinoid-based drug products for a range of medical
conditions, including pain, inflammation, and oncology. 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 biopharma industry by regulators,
physicians and insurance companies.
For more information visit: www.tetrabiopharma.com
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Company to obtain sufficient financing to execute the Company's
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research and development strategies, including the success of this
product or any other product, the applicability of the
discoveries made therein, the successful and timely completion and
uncertainties related to the regulatory process, the timing of
clinical trials, the timing and outcomes of regulatory or
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Company's public disclosure record on file with the relevant
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results or events not to be as anticipated, estimated or intended.
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SOURCE Tetra Bio-Pharma Inc.