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.
More information at: www.tetrabiopharma.com
Source: Tetra Bio-Pharma
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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, through its wholly-owned subsidiary, GrowPros MMP Inc., to obtain a licence for the production of medical marijuana; failure to obtain sufficient financing to execute the Company’s business plan; the success of the Rx Princeps™ product offering and inhalation device; guidance on expected sales volumes associated with the Rx Princeps™ product offering and inhalation device; competition; regulation and anticipated and unanticipated costs and delays, 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.
Dr. Anne-Sophie Courtois, DVM
Vice President, Marketing & Communications
(514) 360-8040 Ext. 210