Tetra Bio-Pharma getting ready to file a clinical trial application to initiate phase 3 clinical trial on terminal cancer patients in the coming weeks http://www.marketwired.com/press-release/tetra-bio-pharma-getting-ready-file-clinical-trial-application-initiate-phase-3-clinical-tsx-venture-tbp-2233957.htm
September 18, 2017 08:00 ET
Tetra Bio-Pharma getting ready to file a clinical trial application to initiate phase 3 clinical trial on terminal cancer patients in the coming weeks
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
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
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; 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.
Source: Tetra Bio-Pharma
Tetra Bio-Pharma Inc.
Vice- President Marketing & Communication
(514) 360 8040 Ext. 210