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Tetra Bio-Pharma $ Obtains Health Canada Approval to Conduct a Phase 1 Pharmacokinetic & Safety Study Using Vaporized Version of PPP001 $AERO $CBDS $CGRW $ $GBLX

Posted by AGORACOM-JC at 8:57 AM on Thursday, November 1st, 2018

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  • Announced that is has received a “No Objection Letter” (NOL) from the Therapeutic Drug Directorate at Health Canada to conduct a Phase 1 pharmacokinetic (PK) and safety study using a vaporized version of PPP001.
  • This represents the first ever human clinical trial featuring a vaporized cannabinoid drug product 

OTTAWA, Nov. 01, 2018 — Tetra Bio-Pharma Inc. (“Tetra” or “TBP”) today announced that is has received a “No Objection Letter” (NOL) from the Therapeutic Drug Directorate at Health Canada to conduct a Phase 1 pharmacokinetic (PK) and safety study using a vaporized version of PPP001.

This study aims to determine the Pharmacokinetic and safety profile of PPP001 delivered as an inhaled vapour using the Mighty Medic (see previous July 16, 2018 News Release), thus providing patients with an alternative to the smoked version of PPP001 and allowing Tetra to develop PPP001 for healthier patients suffering from uncontrolled pain.   It is anticipated that this phase 1 data, combined with Tetra’s characterization of the composition of vapor, will provide the necessary evidence to advance the development of vaporized PPP001 into more chronic and non-life-threatening diseases, such as fibromyalgia. The study is expected to begin and end in Q4 2018.

“We are pleased to announce this critical Phase 1 trial focused on the PK and safety of our PPP001 pellet delivered by vaporization,” said Dr. Guy Chamberland, CEO and CSO of Tetra Bio-Pharma Inc. “Over the last 3 months we have analyzed the composition of the vapor.  This data combined with the results of this Phase 1 will provide the critical pharmacological information required by physicians to adequately guide future efficacy studies in patients who suffer from a chronic condition such as fibromyalgia where there are limited treatment options and there is a large unmet medical need.  It may also provide an alternative mode of delivery for those patients who prefer not to smoke.”

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 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:

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 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 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 Bechard
Executive Vice-President Corporate Development and Licensing
[email protected]
Media Contact
energi PR
Carol Levine Stephanie Engel
514-288-8500 ext. 226 416-425-9143 ext. 209
[email protected] [email protected]


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