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Planning for Phase 2 Clinical Trial Underway

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12yearplan Member Level  Thursday, 12/20/18 04:06:02 PM
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Planning for Phase 2 Clinical Trial Underway

OTTAWA, Dec. 20, 2018 (GLOBE NEWSWIRE) -- Tetra Bio-PharmaInc. (“Tetra” or “TBP”) today announced that its Phase 1 clinical trial in healthy volunteers using vaporized PPP001 has been successfully concluded. This trial was aimed at determining the pharmacokinetics (PK) and safety of a 4-day titration followed by a single dose of vaporized PPP001 in 12 healthy volunteers. Preliminary review of the human clinical data indicates that the treatment was well tolerated. Based on these positive results, Tetra Bio-Pharma expects to move into Phase 2 clinical trials in fibromyalgia patients.

Tetra Bio-Pharma also completed a first series of analyses of the cannabis vapor generated by the Mighty Medic vaporizer manufactured by Storz & Bickel, thus providing a deeper understanding of the process of administering cannabinoids to patients. This gives health regulators like Health Canada, a detailed view of the efficiency of the delivery system.

“We are thrilled with the results of this trial which was completed both on time and on budget,” stated Dr. Guy Chamberland, CEO and CSO of Tetra Bio-Pharma. “We look forward to investigating this vaped version of PPP001 in patients who suffer from the debilitating pain of fibromyalgia. The Mighty Medic technology provides an alternative delivery method for PPP001, along with a new therapeutic indication for fibromyalgia which will give us access to a much larger patient population. According to the National Fibromyalgia Association there are more than 10 million people who suffer from this disease in the U.S. alone.”

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 approved, and FDA reviewed, 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.

For more information visit: www.tetrabiopharma.com

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