- The Type C meeting with the FDA provides guidance to
strengthen QIXLEEF™ nonclinical and toxicological data package for
marketing approval.
OTTAWA, ON, March 17, 2022 /CNW/ - Tetra Bio-Pharma Inc.
("Tetra" or the "Company") (TSX: TBP) (OTCQB: TBPMF) (FRA:
JAM1), a leader in cannabinoid-derived drug discovery and
development received the response letter for a Type C meeting with
the United States Food and Drug Administration (FDA) for its
inhaled cannabinoid-based product, QIXLEEF™. The meeting was
held to discuss the nonclinical safety requirements for the
marketing approval.
Guy Chamberland, CEO and CRO of
Tetra Bio-Pharma Inc. commented, "The November 2021 news release confirmed that
QIXLEEF™ aerosol, generated by the Mighty Medic® medical device,
met the USA cGMP regulatory
requirements, including the delivered-dose uniformity (DDU)
criteria, established by the FDA for inhalation aerosols. Last
month, we announced that preliminary data from over 40 episodes of
breakthrough pain in each of the experimental and active treatment
groups suggested that QIXLEEF™ could be an effective analgesic for
pain management. This new feedback provided by the FDA is
very good and will allow the Company to refine its toxicology plan
and address the key issues that are of concern to patients who will
want to use QIXLEEF™ for a relatively long period of time. The
interactions with regulators, like the FDA, are critical for both
the Company and shareholders. The FDA guidance will pave the way
for marketing approval and allow the Company to elaborate
cost-effective strategy as part of the drug development program. To
date, our data shows that QIXLEEF™ might become an alternative
analgesic to reduce the use of opioids in patients with severe or
chronic pain. An alternative to opioids is long overdue."
The FDA provided guidance on the Company's nonclinical safety
program required to submit a marketing application. Drug metabolite
testing in animals is a prerequisite and one of the utmost
importance for the FDA is the disproportionate amount of CBD
metabolite, 7-COOH-CBD, that was found in humans treated with
Epidiolex™ compared to animals. The higher amount of 7-COOH-CBD was
correlated to hepatotoxicity raising a safety concern on CBD usage
in humans. As previously disclosed, the Company was able to
demonstrate that the CBD metabolite, 7-COOH-CBD, is only 2.5 times
higher in subjects inhaling QIXLEEF™ compared to 40 times higher in
CBD oral administration, thereby supporting a better safety profile
for inhaled QIXLEEF™. Additionally, the FDA requires a more
exhaustive assessment of brain histopathology as the inhalation
route of administration facilitates QIXLEEF™ delivery to the
brain. A carcinogenicity assessment is required as QIXLEEF™ is
intended to be administered on a chronic basis for long-term usage
in patients living with pain. Accordingly, the Company will provide
the FDA with a bridging strategy to reduce development costs. The
requirements for developmental and reproductive toxicology will
also require a bridging strategy to ensure that the risks to
patients who are pregnant, at risk of becoming pregnant, or
breastfeeding are adequately characterized. Despite the extensive
information in the literature, bridging strategies are essential to
address specific aspects of a prescription drug as well as to link
these findings to existing data. The information received from the
FDA will allow the Company to align its nonclinical safety strategy
for both the USA and European
markets.
About QIXLEEF™
QIXLEEF™ is the Company's proprietary investigational new drug
currently being studied in two FDA authorized clinical trials.
QIXLEEF™ is a botanical therapy with a fixed dosage of THC and CBD.
The drug is inhaled using a medical vaporizer and manufactured in
Canada in a licensed cGMP facility
authorized by the Canadian Health Authority.
About REBORN©1 - Clinical Trial
REBORN©1 is a Phase 2
study authorized by U.S. FDA to evaluate inhaled cannabinoids
against a class of immediate-release oral opioids for the
management of breakthrough cancer pain (BTcP). This is a
10-week proof-of concept, open-label randomized study to evaluate
the effect of inhaled QIXLEEF™ as compared to morphine sulfate or
hydromorphone or oxycodone for the treatment of BTcP in 20
patients.
About PLENITUDE© - Clinical Trial
Plenitude© is a
Phase 2 multicenter clinical trial authorized by U.S. FDA to
evaluate the safety and efficacy of inhaled cannabinoids for the
uncontrolled pain relief in 78 patients with advanced cancer. It is
a 4-week randomized, double-blind, placebo-controlled, parallel
group design trial followed by an open label period of 11
months.
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. Their
evidence-based scientific approach has enabled them 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 they 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: www.tetrabiopharma.com
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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
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Forward-looking statements are subject to a number of risks and
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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 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
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
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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
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SOURCE Tetra Bio-Pharma Inc.