Tetra Successfully Completes Phase 1 Study With Vaporized Version of PPP001
December 20 2018 - 4:00PM
Tetra Bio-Pharma Inc.
(“
Tetra” or “
TBP”) today
announced that its Phase 1 clinical trial in healthy volunteers
using vaporized PPP001 has been successfully concluded. This trial
was aimed at determining the pharmacokinetics (PK) and safety of a
4-day titration followed by a single dose of vaporized PPP001 in 12
healthy volunteers. Preliminary review of the human
clinical data indicates that the treatment was well tolerated.
Based on these positive results, Tetra Bio-Pharma expects to move
into Phase 2 clinical trials in fibromyalgia patients.
Tetra Bio-Pharma also completed a first series
of analyses of the cannabis vapor generated by the Mighty Medic
vaporizer manufactured by Storz & Bickel, thus providing a
deeper understanding of the process of administering cannabinoids
to patients. This gives health regulators like Health Canada, a
detailed view of the efficiency of the delivery system.
“We are thrilled with the results of this trial
which was completed both on time and on budget,” stated Dr. Guy
Chamberland, CEO and CSO of Tetra Bio-Pharma. “We look forward to
investigating this vaped version of PPP001 in patients who suffer
from the debilitating pain of fibromyalgia. The Mighty Medic
technology provides an alternative delivery method for PPP001,
along with a new therapeutic indication for fibromyalgia which will
give us access to a much larger patient population. According to
the National Fibromyalgia Association there are more than 10
million people who suffer from this disease in the U.S. alone.”
About Tetra
Bio-PharmaTetra Bio-Pharma (TSX-V: TBP) (OTCQB: TBPMF) is
a biopharmaceutical leader in cannabinoid-based drug discovery and
development with a Health Canada approved, and FDA reviewed,
clinical program 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
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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 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
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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 this trial, the
ability to obtain orphan drug status, 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. While no definitive documentation has yet been signed
by the parties and there is no certainty that such documentation
will be signed. 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 |
|
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Media
Contact |
|
energi PR |
|
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Stephanie Engel |
Carol.Levine@energipr.com |
stephanie.engel@energipr.com |
514-288-8500 ext.
226 |
416-425-9143 ext.
209 |
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