- Health Canada has approved its protocol for a clinical trial investigating its PPP001 drug as an alternative to the opioid fentanyl in the management of breakthrough cancer pain
- The clinical trial will be conducted by Montreal-based Sant̩ Cannabis, a medical clinic and contract research organization specialized in clinical research for cannabis Рbased therapies
Patient recruitment to begin for landmark research
ORLEANS, Ontario, Aug. 09, 2018 — Tetra Bio-Pharma Inc., a leader in cannabinoid-based drug discovery and development (TSX VENTURE: TBP) (OTCQB: TBPMF), is pleased to announce that Health Canada has approved its protocol for a clinical trial investigating its PPP001 drug as an alternative to the opioid fentanyl in the management of breakthrough cancer pain. The clinical trial will be conducted by Montreal-based Santé Cannabis, a medical clinic and contract research organization specialized in clinical research for cannabis – based therapies.
The trial will assess the time-to-relief in patients suffering from breakthrough cancer pain. Based on its clinical data, Tetra believes that the pharmacodynamic properties of PPP001 may provide a novel faster acting alternative to the opioid fentanyl. In addition, the time-to-maximal plasma concentrations of THC suggest that PPP001 will provide rapid relief to the patient’s suffering.  As a prescription drug with a Drug Identification Number (DIN) PPP001 will be eligible for insurance coverage, making the cannabis-based medication accessible in pharmacies thereby providing much easier access.
The Opioid Crisis
There have been numerous news reports in the North America media highlighting the fact that we are experiencing an opioid crisis. In June, the Canadian government asked drug makers to stop marketing opioids, but for patients suffering from uncontrolled pain, this news does not provide them with an alternative to alleviate their pain.
- There were 41,997 opioid-related deaths in the USA in 2016 contributing to the U.S. President’s declaration that the U.S. is experiencing an opioid crisis.
- 92% of the 3,987 apparent opioid-related deaths in Canada in 2017 were accidental.
- Males make up 76% of these fatalities; more than one-third among those aged 30-39.
- The percentage of these accidental deaths involving fentanyl rose from 55% in 2016 to 72% in 2017.
“Medical cannabis may help reduce the use of drugs like fentanyl for treating breakthrough and chronic pain. However, unrefuted scientific data on its safety and effectiveness that will satisfy regulators, professional groups and insurers is what’s missing,†said Dr. Guy Chamberland, Interim CEO and Chief Scientific Officer of Tetra Bio-Pharma. “Tetra is in the business of providing that evidence which would see our drug PPP001 become a complementary prescription therapy.  We’ve taken a pharmaceutical pathway of drug development involving collaborative dialogue with Health Canada and the FDA to bring cannabis and cannabinoid products to market so that physicians, who have been hesitant to recommend it, will have a new, trusted therapeutic option for their patients.â€
Cannabis versus Fentanyl Clinical Trial Recruitment
Santé Cannabis will begin recruitment for the clinical trial as of October 2018. More information on eligibility criteria as well as the details and duration of the trial can be obtained by visiting the Santé Cannabis website: www.santecannabis.ca/en/research/cannabis-clinical-trial/ or by calling 514-419-4131 and select English and press 5 to reach the research team.
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: www.tetrabiopharma.com
About Santé Cannabis
Established in Montreal, Quebec in 2014, Santé Cannabis is a Centre of Excellence in medical cannabis research, clinical practice and healthcare professional training. Since its inception, Santé Cannabis has provided medical assessment, education, monitoring and follow-up to 5,000 patients referred by more than 2,000 Quebec physicians. Santé Cannabis operates within the guidelines for the authorization of medical cannabis as set out by the Collège des médecins du Québec.  As an independently credentialed clinical trial research organization, and with unparalleled clinical experience supporting both patients and healthcare professionals, Santé Cannabis has established itself as a global leader in medical cannabis research. Santé Cannabis is currently conducting a Health Canada approved Phase 3 trial for PPP001 for advanced cancer patients suffering from uncontrolled pain and associated symptoms, as well as a Phase 2 trial for PPP005 investigating the use of oral capsules of cannabis oil for the treatment of chronic pain.
For more information visit:Â www.santecannabis.ca
Source: Tetra Bio-Pharma
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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 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 (Bob) Bechard
Executive Vice President, Corporate Development and Licensing
514-817-2514
[email protected]
Media Contact:
energi PR
Stephanie Engel
[email protected]
514-288-8500 ext. 209
416-425-9143 ext. 209
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