Patient safety is primary imperative
ORLEANS, Ontario, Feb. 05, 2019 (GLOBE NEWSWIRE) — Tetra Bio-Pharma Inc. (“Tetra” or the “Company“) (TSX-V: TBP) (OTCQB: TBPMF), today announced that it has temporarily suspended its phase 3 clinical program due to impurities found in its PPP001 investigational drug being administered to patients. This suspension does not affect the timing of the European application nor the development of the second-generation inhalation products.
Quality standards and process validations are imposed by pharmaceutical Good Manufacturing Practices (GMP). Just like our food chain, botanical drugs have unique challenges because of the potential for microbial contamination known as mycotoxins. Tetra’s investigational drug is composed of raw cannabis materials. In late spring 2018, Tetra initiated a study to monitor the microbial flora in its investigational product in order to validate the storage and drying process used in the fabrication of its investigational product. On December 20th the results of this ongoing study revealed the presence of the 3 mycotoxins in the lot of the investigational drug used for the clinical trials. Tetra communicated these findings within 24-hours of discovery to regulators and acted rapidly to ensure the safety and wellness of patients. As per discussions with Health Canada and the Ethics Review Board, Tetra contacted every patient involved in the ongoing clinical trials to suspend treatment and retrieve the investigational drugs.
Cannabis products that are ultimately sold in the recreational or medical market in Canada, are cultivated, processed and sold under the Cannabis Act, which are subject to Good Production Practices. Under the Good Production Practices, there is only a requirement to test for certain mycotoxins, namely aflatoxin and total content of mycotoxins. The cannabis raw materials purchased by Tetra for use in its investigational drug met the requirements under the Cannabis Act and Good Production Practices and tested below allowable limits.
However, Tetra is administering cannabis to patients as a drug for use in clinical trials which is governed by the requirements of the Food and Drugs Act and related Regulations. The fabrication, processing, packaging and sale of the investigational drug, must be conducted in accordance with the Good Manufacturing Practices (“GMPs”). Such GMPs require the validation of the storage and drying process to ensure the cannabis drug conforms to the quality standard of a prescription drug. Tetra, having acted in accordance with the requirements of the Food and Drugs Act and GMPs, detected the presence of mycotoxins other than aflatoxin in the experimental lot used for the validation. This led to the analyses of every lot being used in its clinical trials to verify for the presence of two other types of mycotoxins (Ochratoxin A, and DON (Deoxynivalenol; Vomitoxin) and the inclusion of this testing into the product specifications.
Tetra Bio-Pharma considers patient health and well-being to be non-negotiable. Tetra will take the next 6 months to assess the situation and propose a robust quality program to Health Canada so that Canadian patients taking its PPP001 prescription cannabis-derived drug are confident in the products’ quality and safety.
Tetra Bio-Pharma CEO and CSO Guy Chamberland holds a Ph.D. in Biomedical Sciences (toxicology) among other academic designations and is a well-respected expert in the field particularly in drug safety stated, “This unexpected development will result in a 6-month delay in the submission of the Canadian New Drug Submission or Drug Identification Number (DIN) application for PPP001. Tetra strongly believes that this delay will lead to a safer and higher quality drug for patients with advanced cancer. Through our research and development efforts, Tetra’s intention is to create higher quality for all cannabis-derived medicinal products. This is Tetra’s commitment to patient safety. We will continue to provide reports to Health Canada so that the Canadian government receives Tetra’s data in a timely manner so that regulators can ensure the safety and wellness of all Canadians consuming recreational and medical cannabis.”
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 authorized, and FDA reviewed, clinical trials 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
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: the anticipated benefits of the Proposed Transaction for Tetra; completion and expected timing of the Proposed Transaction; whether the terms of the Proposed Transaction will be as described in this press release; whether the Proposed Transaction will be successful; the receipt of required regulatory approvals (including stock exchange) in respect of the Proposed Transaction)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 the success of PPP001, the applicability of the discoveries made therein, the successful and timely completion and uncertainties related to the regulatory process including the applications for Orphan Drug Designation, 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. 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.|
|Executive Vice-President Corporate Development and Licensing|
|Carol Levine||Marissa Zanti|
|514-288-8500 ext. 226||416-425-9143 ext. 204|
Source: Tetra Bio-Pharma Inc