18 September, 2017
OTTAWA, ONTARIO--(Marketwired - Sept. 18, 2017) - Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSX VENTURE:TBP)(OTCQB:TBPMF), today announces that it will be filing a clinical trial application (CTA) in the coming weeks to therapeutic products directorate (TPD) to initiate its Phase 3 clinical trial of PPP001 in terminal cancer patients. With this filing, Tetra expects to be on time with its previously announced schedule with the development of PPP001. The corporation worked with physicians of Sante Cannabis to design a clinical trial that would demonstrate the safety and efficacy of PPP001 in terminal cancer patients. In addition, as part of the clinical trial, Tetra will collect the pharmacoeconomics evidence required from provincial insurers in order to support the reimbursement of the first cannabis prescription drug.
A significant percentage of patients placed on a cannabis treatment suffer from side effects that are not tolerable. This can lead to patients stopping a potentially effective therapy. As part of its early phase clinical research, Tetra developed dosing strategies to minimize moderate and severe side effects in patients. This dosing strategy was developed in healthy volunteers over the last few months and has shown to be effective in reducing the severity of the side effects and preventing certain serious ones. This allows TBP to initiate its Phase 3 trial based on clinical data proposing a more tolerable approach to consuming smoked cannabis and to assess PPP001 in terminal cancer patients. This is a significant step in the development of a safe, tolerable and effective new drug for the management of chronic pain in terminal cancer patients with co-morbidities.
This will be the first Phase 3 clinical trial studying the therapeutic benefits of a smoked dried cannabis prescription drug in terminal cancer patients. Due to the status of cannabis under the Controlled Drugs and Substances Act in Canada, over the last four months the corporation developed procedures and methods that would both satisfy the Narcotic Controls Regulations and ensure the protection of patients consuming the cannabis. The corporation is confident that these procedures will be well received by Health Canada as they ensure compliance with both the Food and Drug Act and Controlled Drugs and Substances Act.
Tetra also reports that it has restructured its investors and public relation functions to integrate them with the marketing and communication functions. Mr. Edward Miller is leaving the Corporation effective as of today. We want to thank Mr. Miller for the work he has done for the Corporation over the last months and wish him all the success he deserves for his new professional projects.
PPP001 aims to be the first smokable marihuana for advanced cancer pain under prescription. It is a dried cannabis pellet designed to be smoked in an inhalation device specifically developed for this product.
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 has three core expertise: clinical research, pharmaceutical promotion and retail commercialization of cannabinoid-based drugs.
More information at: www.tetrabiopharma.com