Tetra Biopharma Survey Validates Primary Endpoint of SERENITY Clinical Trial

Survey respondents are Patients and Physicians from the US and Canada

OTTAWA, March 26, 2020 (GLOBE NEWSWIRE) -- Tetra Bio-Pharma Inc. (“Tetra” or the “Company”) (TSX-V:TBP) (OTCQB: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 ...

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%).