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Tetra Bio-Pharma (TSX:TBP) provides an update on its U.S. REBORN1 clinical trial
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  • Tetra Bio-Pharma Inc (TBP) has shipped the investigational new drug QIXLEEF, to the USA for the initiation of the REBORN1 study
  • REBORN1 will investigate cannabis as an alternative to morphine sulfate for the management of breakthrough cancer pain (BTcP)
  • QIXLEEF is a botanical drug product inhaled through a vaporizer
  • Tetra Bio Pharma Inc is a biopharmaceutical leader in cannabinoid-based drugs
  • Tetra Bio-Pharma Inc(TBP) is up 9.62 per cent, trading at C$0.285 per share at 10:12 am ET

Tetra Bio-Pharma (TBP) has shipped the investigational new drug QIXLEEF, to the USA for the initiation of the REBORN1 study.

The company has completed the manufacturing of QIXLEEF and has received the cannabis export permit from Health Canada.

REBORN1 will investigate cannabis as an alternative to morphine sulfate immediate release in the management of breakthrough pain.

QIXLEEF is a botanical drug product with a "fixed ratio" of THC and CBD and is inhaled through a vaporizer.

"We are committed to the fight against the opioid crisis. That is why since the authorization of the clinical trial by the FDA in late January 2021, Tetra has worked hard to prepare QIXLEEF for clinical testing. We are on track to initiate this Phase 2 proof-of-concept trial designed to demonstrate that QIXLEEF can provide pain relief faster than an immediate-release oral morphine." said Dr. Guy Chamberland, CEO and CRO of Tetra Bio-Pharma Inc.

REBORN1 is a 10-week open-label randomized study to evaluate the effect of inhaled QIXLEEF compared to morphine sulfate immediate release (MSIR) to help manage the onset of pain relief of breakthrough cancer pain (BTcP).

BTcP is a rapid onset, high intensity, and short duration pain episode, which takes place within stable background pain control. The time to peak intensity of an episode ranges from 3 to 15 minutes with a duration of 30 to 60 minutes. They occur with a frequency of 1.5 to 6 times per day.

BTcP significantly affects the quality of life of patients with cancer and their ability to function normally.

Tetra Bio Pharma Inc is a biopharmaceutical leader in cannabinoid-based drugs. It discovers and develops clinical programs aimed at delivering novel prescription drugs and treatments.

Tetra Bio-Pharma Inc(TBP) is up 9.62 per cent, trading at C$0.285 per share at 10:12 am ET.

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