OTTAWA, ON, Oct. 14, 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 today provided an update on the progress and
significant achievements of its lead investigational drug,
QIXLEEF™.
QIXLEEF™ is a botanical inhaled drug product with a fixed ratio
of THC and CBD that meets USA cGMP
regulatory requirements. The drug will be first indicated in
patients with cancer suffering of uncontrolled breakthrough pain
(REBORN© trials) then in patients with advanced cancer with
inadequately controlled pain (PLENITUDE© trials). QIXLEEF™, with
its innovative and proprietary dosing data, provides fast acting
relief from pain, offering patients a viable, safer, and non-opioid
option for pain management.
The Company began regulatory discussions on QIXLEEF™ with both
the U.S. Food and Drug Administration (FDA) and Health Canada in
mid-2016. This included obtaining a product jurisdiction
decision for the regulation of QIXLEEF™ as a drug-device
combination product. This type of decision is binding and
defines the regulatory path to marketing approval for a combination
product. Pre-Investigational New Drug (pre-IND or Type B
meetings) and pre-Clinical Trial Application type meetings were
held with the regulators to discuss the regulatory requirements to
bring QIXLEEF™ to the market as a prescription drug and seek
guidance and approval on the drug development strategy.
Since the beginning of the clinical development program in
late-2016, QIXLEEF™ strictly adhered to and complied with the
regulatory requirements of a prescription drug. The Company
completed two Phase 1 clinical trials in healthy volunteers to
assess the safety profile, including cardiovascular,
pharmacodynamics and pharmacokinetics, of smoked and vaporized
QIXLEEF™.
Results of these studies demonstrated the safety of QIXLEEF™ and
addressed critical concerns such as the potential for QT
prolongation when used in combination with other medications.
For patients, the 7-day multiple dosing studies revealed that
QIXLEEF™ could be used without functionally impairing the human
subject.
From an efficacy point of view, the pharmacodynamic and
pharmacokinetic studies demonstrated that QIXLEEF™ could deliver
significantly high levels of cannabinoids to the brain within the
first 5 minutes of initiating inhalation. The
pharmacodynamics confirmed the desired target response in human
subjects. The Company believes that these two characteristics
of its drug-device combination product are critical for an
effective drug in the management of breakthrough pain.
In parallel to the above Phase 1 studies, the Company initiated
a major research program on the qualitative and quantitative
composition of the aerosols generated by smoking and vaporizing
QIXLEEF™. This research began in mid-2017 and continues to be
part of the Company's routine analysis of QIXLEEF™ and its raw
materials to ensure consistent delivery of cannabinoids to the
patients between production lots. This research program led
to the development of composition of matter intellectual
property.
In November 2019, the Company
announced that the FDA had authorized the initiation of our
PLENITUDE© trial after demonstrating new quality standards for
mitigating the risk of mycotoxins to patients. PLENITUDE© is
a 4-week double-blind, randomized, placebo-controlled trial to
evaluate the safety and efficacy of inhaled QIXLEEF™ on
uncontrolled pain related to cancer in 78 adult patients with
advanced incurable cancer. The Company received the raw
materials for fabricating QIXLEEF™ in September 2020 thereby allowing the start of the
in-life phase of the trial.
In August 2020, the Company shared
data on its CBD Metabolite Study in Humans. This milestone had a
major positive impact on Tetra's inhaled product portfolio, as the
data demonstrated very low level of CBD metabolites in humans
exposed to inhaled QIXLEEF™. This evidence corroborated the
absence of liver toxicity when QIXLEEF™ is inhaled and strengthened
the safety profile of our drug product.
In 2020, the Company expanded its regulatory activities to
ensure the nonclinical safety strategy, manufacturing and quality,
and a global clinical trial program for the marketing approval of
QIXLEEF™ in Europe. Subsequently,
Tetra created a subsidiary in Europe, called Tetra Bio-Pharma Europe LTD.
The former was important so that the regulatory requirements for
QIXLEEF™ would be similar for Europe, United
States and Canada. Having a global drug development
strategy ensures economy of scale and lower cost of drug
development to shareholders. As part of the regulatory
achievements, in September 2021, the
Company received its first Scientific Advice Assessment Report from
a European Medicines Authority. This Report provided positive
feedback on the drug development plan and eligibility for
submitting a Marketing Authorization Application (MAA) under
Directive 2001/83/EC (Directive).
In January 2021, the FDA
authorized the initiation of the REBORN1© trial with
QIXLEEF™. The REBORN1© trial is a head-to-head phase 2 study
against an opioid treatment in the management of short and frequent
episodes of incapacitating pain (breakthrough pain) requesting
immediate release opioid treatment in patients living with cancer.
The initial protocol was assessing a direct safety and efficacy
comparison between QIXLEEF™ and oral morphine sulfate immediate
release on the onset of pain relief in this population. In
June 2021, an approved amended
protocol opened the recruitment to cancer patients with
breakthrough pain who are treated with either oral morphine sulfate
immediate release, oral hydromorphone immediate release, or oral
oxycodone immediate release. REBORN1©, if successful, is
expected to provide proof of concept evidence that QIXLEEF™ can be
an alternative to the class of immediate release oral opioids in
the management of breakthrough cancer pain.
With a supportive outcome of the REBORN1© trial, the Company
will be on a path to bring QIXLEEF™ as a novel, safe, and effective
treatment for the management of breakthrough pain. The
Company will leverage the long-term safety data gathered in the
PLENITUDE© trial to supplement the safety and efficacy data for the
REBORN© trials. The REBORN© clinical strategy provides the
fastest and lowest cost development program to bring QIXLEEF™ to
the market.
The Company is finalizing its raw material global supply plans
and is in partnering discussions as it prepares to initiate the
last stage of its drug development of QIXLEEF™ for an indication in
breakthrough pain as an alternative to immediate-release oral
opioids.
Dr. Guy Chamberland, CEO and CRO
commented, "Our team has made significant progress in bringing
QIXLEEF™ to a late clinical development stage. We are
dedicated to bringing this novel medication to patients and
physicians as an alternative to opioids. It has been a
challenging, but exciting journey to develop the first Rx inhaled
cannabinoid-based drug."
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
Neither the TSX Exchange nor its Regulation Services Provider
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accepts responsibility for 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 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
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.
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SOURCE Tetra Bio-Pharma Inc.