Tetra Biopharma Survey Validates Primary Endpoint of SERENITY© Clinical Trial
Tetra Bio-Pharma Inc. (“Tetra” or the “Company”) (TBP.V) (TBPMF), a leader in cannabinoid-derived drug discovery and development, today announced the results of a survey conducted among US and Canadian patients and physicians which validated the primary endpoint of the SERENITY© pivotal trial. The results confirm that the primary endpoint in the SERENITY© clinical trial is accurate
About Cancer Cachexia
Fifty to 80% of cancer patients experience cachexia during their disease1 Cachexia is defined as “multifactorial syndrome characterized by an ongoing loss of skeletal muscle mass (with or without loss of fat mass) that cannot be fully reversed by conventional nutritional support and leads to progressive functional impairment”2. The most intense symptoms reported by the cachectic patients are lack of appetite, fatigue, wellbeing, sleep, and increase in pain.
Secondary symptoms impact nutrition, such as nausea, depression, and pain, which can further decrease caloric intake and add a ‘‘starvation’’ component to the catabolic processes associated with cachexia.
Survey Methodology
During February and March 2020 Tetra conducted a survey in the United States and Canada in order to gather patient and physician feedback about the most bothersome symptoms in advanced cancer patients with cachexia.
Patients and physicians received identical questionnaires, however the instructions to each group were different. Patients were asked to describe their personal experience with cancer cachexia, whereas physician responses were based on their perception of their patients with cancer cachexia.
The patient survey was distributed to patients at the SERENITY© study clinical sites. A total of 33 American and Canadian patients responded to the survey. According to the surveyed patients, pain (66.7%), fatigue (57.6%), and lack of appetite (45.5%) are the three most bothersome symptoms. Nausea/vomiting (39.4%), worrying (33.3%), feeling irritable (33.3%), change in the way food tastes (30.3%) and difficulty sleeping (27.3%), were also often identified by patients as bothersome.
Figure 1 is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/83b07703-8abf-49c2-82ca-9bef70cfc3ef
In the attached chart, for each symptom, the number on the bar represents the number of patients who rated that symptom among most bothersome symptoms for them.
In addition, patients reported that the most bothersome or distressing functional impacts of the disease were that they are “unable to work /or to do chores at home” (54.5%), that they are “unable to enjoy life” (45.5%), and that they have “trouble doing strenuous activities (e.g. carrying a heavy shopping bag)” (39.4%).
Figure 2 is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/b4e1efb5-2b49-431c-8eb2-7f44c16c5c73
In the attached chart, for each symptom, the number on the bar represents the number of patients who rated that impact among most bothersome or distressing functional impact for them.
The Physician Perspective
The physician survey was distributed to the Principal and Co-Principal Investigators at the clinical sites of the SERENITY© study. A total of 18 American and Canadian physicians participated in the survey. According to the those surveyed pain (88.9%), fatigue (83.3%), lack of appetite (72.2%), weight loss (55.6%), nausea/vomiting (61.1%), and difficulty sleeping (33.3%) are the most bothersome symptoms they perceive to be experienced by their patients with advanced cancer and cachexia.
Figure 3 is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/c3e30eac-c3ae-4490-9976-43658b183918
In the attached chart, for each symptom, the number on the bar represents the number of physicians who rated that symptom among the most bothersome symptoms for their patients.
In addition, the physicians reported that the most bothersome or distressing functional impacts of the disease were that the patients were “unable to enjoy life” (83.3%), that “because of their physical condition, they have trouble meeting the needs of their family” (61.1%) and that they were “unable to work /or to do chores at home” (55.6%).
Figure 4 is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/f17599df-42dc-4284-a948-64ae4b06f9d7
In the above chart, for each functional impact, the number on the bar represents the number of physicians who rated that impact among the three most bothersome functional impacts for their patients.
“Tetra is pleased to report that the survey results corroborate our understanding of Cancer Cachexia symptoms. This confirms that the selected primary endpoint in the SERENITY© clinical trial is accurate. As discussed in Tetra’s news release issued on March 23rd, our team is advancing this protocol on many fronts. This patient and physician feedback further strengthens our belief that CAUMZ may bring significant clinical benefit to patients,” said Dr. Guy Chamberland, CEO and Chief Regulatory Officer of Tetra Bio-Pharma.
References:
1=(Argilés et al. 2014; Badowski and Yanful 2018; Kasvis et al. 2019).
2=(Fearon et al. 2011; Bar-Sela et al. 2019b)
About Tetra Bio-Pharma
Tetra Bio-Pharma (TSX-V:TBP) (TBPMF) is a biopharmaceutical leader in cannabinoid-based drug discovery and development with a Health Canada approved, and FDA reviewed and approved, 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. Could we work in “existing regulatory standards of safety and clinical evidence for pharmaceutical products”.
For more information visit: www.tetrabiopharma.com
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 the success of this product or any other product, 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. 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.:
Investor Contact:
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917-385-2160
pnigen@alphabronzellc.com
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