- Ethics Committee approves REBORN1© protocol amendment allowing
for the addition of two immediate release oral opioids to be
compared against QIXLEEF™.
- REBORN1© is the first of its kind proof-of-concept phase 2
study comparing a cannabinoid-based drug, QIXLEEF™, to immediate
release oral opioid for the treatment of breakthrough cancer
pain.
- QIXLEEF™ has the potential to transform the pain market,
offering an alternative to prescribed opioids in the management of
breakthrough pain.
OTTAWA, ON, July 12, 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 announced today that the Central Ethics
Committee has approved the proposed protocol modifications allowing
additional immediate release oral opioids to be used as comparators
in the REBORN1© study. Expanding to three (3) immediate
release oral opioids will allow for the acceleration of patient
enrolment in the REBORN1© trial.
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. The
approved amended protocol opens 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. This amendment will allow the
Company to demonstrate the potential efficacy of QIXLEEF™ against a
class of immediate relief oral opioids. Well-designed clinical
evidence is required to demonstrate to physicians that QIXLEEF™ can
be an alternative to the class of immediate release oral opioids.
The amended protocol will be implemented at the clinical site upon
approval of the Drug Enforcement Administration (DEA) and amendment
of the study-specific Schedule I license.
QIXLEEF™ is the Company's inhaled proprietary drug formulation
which has a fixed ratio of THC and CBD. The medication is inhaled
through a Class II medical vaporizer. When pharmaceutical grade
cannabis is vaporized rather than smoked, the beneficial components
can be inhaled without the generation of smoke and combusted
by-products.
Dr. Guy Chamberland, CEO and CRO
commented, "The amended protocol allows QIXLEEF™ to be studied
against three types of immediate release oral opioids instead of
just one. It will facilitate the recruitment of patients who can
benefit from QIXLEEF™ to treat their breakthrough pain as it
broadens the pool of qualified patients. Once the Schedule I
license is approved, a process that usually takes a couple of
weeks, the amended protocol will enhance the recruitment rate,
thereby accelerating the study conduct. The approval by the DEA is
a formality as the amendment does not modify the amount of
controlled substance at the clinical site. Further, there have been
numerous news reports recently of drug makers exiting the opioid
business, however for patients suffering from uncontrolled pain,
this news does not provide them with an alternative to alleviate
their pain. Tetra is in the business of providing the evidence
which would see QIXLEEF™ become an alternative prescription therapy
to opioids".
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
(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.
View original content to download
multimedia:https://www.prnewswire.com/news-releases/tetra-bio-pharma-accelerates-reborn1-trial-301331210.html
SOURCE Tetra Bio-Pharma Inc.