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Tetra Bio-Pharma Provides Additional Information on CAUMZ Following Type B Meeting with USA FDA
Tetra Bio-Pharma Provides Additional Information on CAUMZ Following Type B Meeting with USA FDA.
About this update from Tetra Bio-pharma Inc.
[{"type":"text","content":"\n CAUMZ targeting survival indications in advanced incurable cancer. Eligible for Fast Track designation and Accelerated Approval regulatory program.505(b)(2) NDA pathway provides significant cost savings.    OTTAWA, Feb. 25, 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, is pleased to provide additional information on the drug development program for CAUMZ™ following the previously announced Type B meeting with the US Food and Drug Administration (FDA). The first indication for CAUMZ™ will be the treatment of cancer cachexia patients.  To ensure minimal time to market, the first target patient population will be cancer cachexia patients that have an incurable and malignant cancer that is refractory to treatment.  CAUMZ is designed to prolong survival and improve quality of life and the patient's day-to-day functioning.  Providing these types of benefits to a cancer patient with cachexia would provide an important contribution to the care of these patients and their wellbeing.  Cancer cachexia is a multifactorial syndrome defined 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. Its pathophysiology is characterised by a negative protein and energy balance driven by a variable combination of reduced food intake and abnormal metabolism. The agreed diagnostic criterion for cachexia was weight loss greater than 5%, or weight loss greater than 2% in individuals already showing depletion according to current bodyweight and height (body-mass index [BMI] <20 kg/m2) or skeletal muscle mass (sarcopenia).3 A key aspect to Tetra’s technology is the selective delivery of cannabinoids to the central nervous system using the CAUMZ™-kit technology.  Avoiding the first pass metabolism that occurs with the oral or sublingual route of administration is important to minimize the formation of metabolites associated with some of the side effects.  The highly purified cannabinoid molecules are also an important element in the future success of CAUMZ™.  CAUMZ™-kit results in the inha...