OTTAWA, ON, Nov. 29, 2021 /PRNewswire/ - Tetra Bio-Pharma
Inc. ("Tetra" or the "Company") (TSX: TBP)
(OTCQB: TBPMF) (FRA: JAM1), a leader in cannabinoid-derived drug
discovery and development today announced positive initial clinical
data from its ongoing Phase 2 clinical trials (REBORN©1
and PLENITUDE©) of QIXLEEF™ for cancer
pain. QIXLEEF™ is a botanical inhaled investigational
new drug with a fixed ratio of THC and CBD that meets USA cGMP regulatory requirements.
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The REBORN©1 trial is a head-to-head,
open-label, crossover phase 2 study against oral opioids in the
management of short and frequent episodes of incapacitating pain
(breakthrough pain) in patients with cancer. The
REBORN©1 study protocol is assessing the safety and
preliminary efficacy of QIXLEEF™ in onset of pain relief and on
pain intensity compared to three types of immediate release oral
opioids: oral morphine sulfate immediate release, oral
hydromorphone immediate release, and oral oxycodone immediate
release. The PLENITUDE© trial is a randomized
double-blind phase 2 study assessing the safety and efficacy of
QIXLEEF™ in patients with cancer who have uncontrolled pain. Both
studies are conducted across multiple clinical sites located in
the United States.
Safety data of the REBORN©1 trial collected up to now
confirm QIXLEEF™ tolerability and good safety profile in patients
with cancer with breakthrough pain; no serious adverse events have
been reported, only adverse drug reactions of mild intensity have
been recorded. Preliminary data of the PLENITUDE© trial
also confirm QIXLEEF™ tolerability and good safety profile in the
pool of subjects treated with either QIXLEEF™ or the placebo in the
randomized double-blind 4-week period and in subjects treated with
QIXLEEF™ during the open-label 11-month period. Preliminary
analysis of the data shows a positive effect on pain relief in
QIXLEEFTM-treated patients. The Company cannot disclose
further data on efficacy due to regulatory compliance.
Dr. Guy Chamberland, CEO and CRO
commented, "A safe and efficient therapeutic alternative that
allows the reduction of opioids is critical now more than ever to
support patients in their journey against pain. Preliminary data
from both REBORN©1 and
PLENITUDE© confirm the safety and pharmacodynamic
profile of QIXLEEF™ reported in the phase I trials. The
pharmacokinetic profile of QIXLEEF™ is well indicated to help
manage short episodes of pain such as breakthrough pain and will
offer patients and physicians a viable, safer, and non-opioid
option for pain management."
Lastly, Tetra's metabolite profile study in humans showed that
intake of QIXLEEF™ does not lead to significant levels of
metabolites associated with toxicity and its pharmacokinetic
profile mirrors the temporal characteristics of breakthrough cancer
pain episodes, with a transient and fast effect of action. Tetra's
Phase I trials showed that maximal plasma concentration was reached
within 5 minutes and that the drug was well tolerated with a good
safety profile.
About Breakthrough Cancer Pain
Opioids are the cornerstone of the management of cancer pain.
The opioid crisis is serious, and the number of deaths related to
overdosing remains elevated (Opioid Basics | CDC's Response to the
Opioid Overdose Epidemic | CDC). Tetra's cannabis and
cannabinoid-derived product pipeline has the potential to play a
significant role in opioid use reduction, thus addressing a
societal issue of critical proportion.
Current opioids approach to manage breakthrough pain are
inadequate to timely relieve pain in patients with cancer.
Immediate-release oral morphine produces an analgesic effect in
30-45 minutes, with peak effect at ~1 hour or more (Staahl C. et
al., Journal of Clinical Pharmacology, 2008; 48:619-631), in
contrast to episodes of breakthrough cancer pain, which typically
peak within 3-15 minutes and last ~1 hour. In addition to
inappropriate time window of efficacy, immediate-release oral
opioids affect the patient's functioning (e.g., confusion) and
quality of life (e.g., constipation, drowsiness, sleep disorders)
and may induce life-threatening side effects such as respiratory
depression in addition to multiple side effects. More potent
opioids such as fast-onset opioids have a higher risk of abuse
potential, increasing the risk of misuse and overdose. There is
currently no therapeutic solution that offers fast onset of pain
relief with an acceptable safety profile and low risk of abuse
potential.
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 visit: www.tetrabiopharma.com
Neither the TSX Exchange nor its Regulation Services Provider
(as that term is defined in the policies of the TSX Exchange)
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.