OTTAWA, ON / ACCESSWIRE / January 29, 2021 /Tetra Bio-Pharma Inc. ("Tetra" or the "Company")(TSX:TBP) (OTCQB:TBPMF), a leader in cannabinoid-derived drug discovery and development announced today that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application, allowing Tetra to initiate its QIXLEEFTM Reborn1TM clinical trial in cancer patients with breakthrough pain.
"This is really good news for all of us and in particular for the cancer patients that suffer from breakthrough pain. We aim to initiate this proof-of-concept trial designed to demonstrate that QIXLEEFTM can provide pain relief faster than an immediate-release oral morphine," said Guy Chamberland, CEO and CRO of Tetra Bio-Pharma Inc.
Reborn1TM is a 10-week open-label randomized study to evaluate the effect of inhaled QIXLEEFTM compared to morphine sulfate immediate release (MSIR) to improve fast 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 and the majority are moderate to severe in intensity (Portenoy and Hagen 1990; Portenoy et al. 1999; Davies et al. 2011). It significantly affects the quality of life of patients with cancer and their ability to function normally (Zeppetella and Davies 2013).
The study's primary endpoint is the time weighted Sum of Pain Intensity Differences (SPID) from pre-dose to 30 minutes (SPID30) after the first inhalation or after taking MSIR. The SPID30 is based on a visual analog scale (VAS) score and is calculated for each BTcP episode that is treated with either study drug. The pain intensity is to be recorded by the patient in his/her diary. Secondary endpoints include difference in pain intensity and onset of pain relief at 5, 10, 15, 30 and 60 minutes, which will give insight to the timing of the onset of symptom relief for both treatments.
The study design includes a screening and titration period of up to 2 weeks followed by an open-label crossover comparison study where each patient will receive the investigational drug and active comparator for a 7-week treatment period, during which the groups will switch treatments at week 3.
The rationale to use inhaled QIXLEEFTM in cancer patients with BTcP is supported by a strong body of evidence demonstrating the fast onset of action of an inhaled drug and the pharmacological action of THC on the perception of pain (Ruiz M.E., Scioli Montoto S. (2018); Stockings E, Campbell G, Hall WD, et al (2018); Blanton HL, Brelsfoard J, DeTurk N, et al (2019).