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     1143  0 Kommentare Tetra Bio-Pharma provides update on status of its Phase 3 Clinical Trial Application of Lead Drug Candidate PPP001

    OTTAWA, ONTARIO--(Marketwired - Dec. 9, 2017) - Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSX VENTURE:TBP)(OTCQB:TBPMF), a global leader in cannabinoid-based drug development, announced today that the Company has accepted the suggestion of Health Canada to change the order of its clinical trial application (CTA) review process. As such, the quality certification for the manufacturing of PPP001 will take place prior to the approval of its clinical trial protocol as Health Canada assesses its partner Aphria's operations for Good Manufacturing Practices (GMP) for pharmaceutical products. Tetra agrees to this change from Health Canada because it is in the best interest of patients.

    This change in the usual CTA approval process is expected to potentially extend the review process by 30 days. Tetra continues to expect PPP001 to become the first cannabis-derived inhalation drug to receive a drug identification number (DIN) from Health Canada, as well as pharmaceutical drug status from the FDA. The phase 3 trial should therefore begin in early 2018. The Company expects this change to have only a minor impact on time to market for PPP001.

    Tetra received approval for the ethics review board on November 6th and subsequently submitted a Clinical Trial Application (CTA) for its Phase 3 clinical trial in cancer patients. This trial is expected to be a landmark clinical trial and is the first of its kind, enrolling a total of 946 subjects. Dr Guy Chamberland, Tetra's Chief Scientific Officer (CSO) commented that: "a GMP certification from Health Canada's drug inspectorate is welcome as this certification will signal to the company that its manufacturing partners comply with GMP requirements for drug approval and increases the measures put in place to ensure patients' safety." Once the trial is initiated, The Company will accelerate enrolment by expanding the number of clinical sites as it aims to adhere to its target date for filing PPP001 as a prescription drug (with a drug identification number - DIN) to Health Canada.

    About Tetra Bio-Pharma:

    Tetra Bio-Pharma (TSX VENTURE:TBP)(OTCQB:TBPMF) is a biopharmaceutical leader in cannabinoid-based drug discovery and clinical development. Tetra is focusing on three core business pillars: clinical research, pharmaceutical promotion and retail commercialization of cannabinoid-based products.

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    Tetra Bio-Pharma provides update on status of its Phase 3 Clinical Trial Application of Lead Drug Candidate PPP001 OTTAWA, ONTARIO--(Marketwired - Dec. 9, 2017) - Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSX VENTURE:TBP)(OTCQB:TBPMF), a global leader in cannabinoid-based drug development, announced today that the Company has accepted the suggestion of …