OTTAWA, ONTARIO–(Marketwired – Apr 12, 2018) – Tetra Bio-Pharma Inc. (“Tetra” or the “Company”) (TSX VENTURE:TBP) (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.
“We are performing this Phase 2 clinical trial to obtain safety and efficacy data to help drive the sales of encapsulated cannabis oil products for the treatment of chronic pain,” added Dr. Guy Chamberland. “We expect chronic pain patients to use cannabis oils, but many of these patients will also be taking opioids or other prescription medications. The capability of different doses and ratios of medical cannabis oil to change the amount and type of concomitant medications, such as opioids, used for pain, and the need for rescue pain medication to control chronic non-cancer and cancer pain is evaluated. The use of measures that quantify different pain drug regimens used by the patients will help us understand the potential of cannabis oils to be used for opioid sparing. The trial should be completed by fall 2018.”
About Tetra Bio-Pharma:
Tetra Bio-Pharma (TSX VENTURE:TBP) (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. Tetra Bio-Pharma is currently developing a pipeline of five cannabinoid-based products using different delivery systems such as smokable pellets, oral tablets, eye drops and topical ointments.
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 license for the production of medical marijuana; failure 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 strategies, 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.