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     561  0 Kommentare Tetra Bio-Pharma Clinical Study on Cannabis Oil Capsules for Patients Suffering from Chronic Pain should be completed by Fall 2018

    OTTAWA, ONTARIO--(Marketwired - April 12, 2018) - Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSX VENTURE:TBP) (OTCQB:TBPMF), provides a status report on its encapsulated cannabis oils (PPP005) clinical trials and that these cannabis products are ready to commercialize in the retail market post-legalization.

    Natural health products and OTC medications

    The authorization from the Office of Controlled Substances marks the initiation of the treatment phase of the Phase 2 clinical trial that will be used to support Product License Applications post legalization. Tetra is performing this clinical study to obtain safety and efficacy data to support modern claims for the use of encapsulated cannabis oils in the treatment of chronic pain. Tetra's program is designed to build a leading position in the development and commercialization of cannabis-based natural health products. Tetra's products are being developed to be compliant with standards expected for pharmaceutical products which will be supported by scientific and clinical evidence.

    PPP005 Phase 1 Clinical trial

    Phase 1 clinical trial to assess safety, tolerability and pharmacokinetics of single and multiple dose of encapsulated cannabis oil (10 mg THC with 10 mg CBD) will be completed soon. "This study will provide cardiovascular safety data to ensure that the oil formulations can be safely used by consumers. The pharmacokinetic data will provide the data required to define the frequency of dosing needed to avoid inappropriate use that could lead to accumulation of cannabinoids in the body," said Dr. Guy Chamberland, M.Sc., Ph.D., interim CEO and Chief Scientific Officer.

    PPP005 Phase 2 Clinical trial

    On March 22, 2018, Santé Cannabis, the Montreal-based clinic that is conducting the Phase 2 clinical trial for Tetra, received authorization from the Office of Controlled Substances to use the cannabis oil capsules of PPP005 (controlled substance).

    This authorization allowed the Principal Investigator of the trial, Dr. Antonio Vigano, to proceed with the clinical trial of PPP005 in chronic pain patients. This exemption allows Santé Cannabis to prescribe the blinded study medication and for Aphria Inc to ship blinded products to patient's home under the jurisdiction of the ACMPR. The screening and enrolment is proceeding faster than expected and will allow Tetra to meet its corporate objectives.

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    Tetra Bio-Pharma Clinical Study on Cannabis Oil Capsules for Patients Suffering from Chronic Pain should be completed by Fall 2018 OTTAWA, ONTARIO--(Marketwired - April 12, 2018) - Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSX VENTURE:TBP) (OTCQB:TBPMF), provides a status report on its encapsulated cannabis oils (PPP005) clinical trials and that these cannabis products …