Tetra Bio-Pharma and Santé Cannabis Announce Completion of the First Phase 2 Cannabis Oil Trial in Cancer and Non-Cancer Pat...
March 04 2019 - 6:30AM
Tetra Bio-Pharma Inc. ("
Tetra" or
the "
Company") (TSX-V: TBP) (OTCQB: TBPMF), a
global leader in cannabinoid-derived drug development and
discovery, is pleased to announce completion of the first
double-blind, randomized and placebo-controlled Phase 2 clinical
trial of cannabis oil capsules. The trial evaluated the safety and
efficacy of different doses and ratios of medical cannabis oil
comprised of THC and CBD, for the treatment of uncontrolled chronic
pain in cancer and non-cancer patients.
The Phase 2 trial was conducted by
Montreal-based Santé Cannabis, Quebec's first clinical
research organization specializing in cannabis and cannabinoids for
medical purposes. Dr. Antonio Vigano, and his colleagues at
Santé Cannabis, designed this study to obtain clinical data on the
safety and potential efficacy of various cannabis oils used in the
practice of medicine under the Cannabis regulations.
During the next 3 months, Santé Cannabis will study the data and
submit a scientific manuscript for publication addressing key
outcomes from the trial:
- Safety and tolerability data, such as side effects, associated
with the approach used in this study;
- Preliminary efficacy data on the three different ratios of THC
and CBD used; and
- Preliminary data on the minimal effective dose of each cannabis
oil.
"This study will provide evidence-based data on
medical cannabis for chronic pain," said Dr. Antonio Vigano,
Research Director of Santé Cannabis and McGill
University Associate Professor in the Department of Oncology.
"For many patients, under careful monitoring, cannabis oil can
potentially reduce or even eliminate the need for other
pharmacological medications. The outcome of this study will support
clinicians to better understand dosing and titration of medical
cannabis in cancer and non-cancer patients. Our data will encourage
researchers to pursue deeper studies to quantify real benefits and
potential risks of natural cannabinoids as a complementary
therapeutic approach across larger populations."
According to Dr. Guy Chamberland, Tetra's
CEO and CSO, "This study is the first to investigate encapsulated
medical cannabis oil for the management of chronic pain. The
analysis of key outcomes will provide Tetra Bio-Pharma with
important scientific data on the optimal effective dose range for
patients suffering from these conditions. We are pleased to
continue to support university-based studies such as this, which
will help guide some of Tetra’s key drug development programs in
chronic pain, oncology and ophthalmic. The Corporation is
dedicated to developing prescription cannabinoid-derived drugs for
the treatment of uncontrolled cancer and non-cancer pain and to
reduce the need for opioids.”
About Tetra Bio-Pharma:Tetra Bio-Pharma
(TSX-V: TBP) (OTCQB: TBPMF) is a biopharmaceutical leader in
cannabinoid-based drug discovery and development with a Health
Canada authorized, and FDA reviewed, clinical trials aimed at
bringing novel prescription drugs and treatments to patients and
their healthcare providers. The Company has several subsidiaries
engaged in the development of an advanced and growing pipeline of
Bio Pharmaceuticals, Natural Health and Veterinary Products
containing cannabis and other medicinal plant-based elements. 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 bio pharma industry by regulators,
physicians and insurance companies.
For more information visit: www.tetrabiopharma.com
Source: Tetra Bio-Pharma
Neither the TSX Venture Exchange nor its
Regulation Services Provider (as that term is defined in the
policies of the TSX Venture Exchange) accepts responsibility for
the adequacy or accuracy of this release.
Forward-looking statementsSome
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: the anticipated benefits
of the Proposed Transaction for Tetra; completion and expected
timing of the Proposed Transaction; whether the terms of the
Proposed Transaction will be as described in this press release;
whether the Proposed Transaction will be successful; the receipt of
required regulatory approvals (including stock exchange) in respect
of the Proposed Transaction)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 product
mentioned in this release, the success of the Company's research
and development strategies, the applicability of the discoveries
made therein, the successful and timely completion and
uncertainties related to the regulatory process including the
applications for Orphan Drug Designation, 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.
For further information, please contact Tetra Bio-Pharma
Inc.Robert (Bob) Bechard
Executive Vice President, Corporate Development and Licensing
514-817-2514 Investors@tetrabiopharma.com
Media Contact: Carol
LevineCarol.levine@energipr.com514-288-8500 ext. 226
Marissa ZantiMarissa.zanti@energipr.com416-425-9143 ext. 204
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