GREY:TBPMQ - Post by User
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Humaniston Mar 10, 2023 7:51pm
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TBP: ON CEASE TRADE news of approval form health canada for.
TBP: ON CEASE TRADE news of approval form health canada for.human trial of its drug. i dont get it, if theyre moving fwd with their testing and all ok, why can't they file on time? and if becasue they don't have money, why wuld they have problem getting moeny ifthe product is super promising?
bizarre behaviour! i don't trust it at all. ut ill keep watching
Tetra Bio-Pharma Announces Health Canada Authorization to Proceed with its Oral ARDS-003 New Drug in Human Trial Montreal, QC - TheNewswire - March 10, 2023 - Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSX:TBP) (OTC:TBPMF) (FRA:JAM1), a leader in cannabinoid-derived drug discovery and development is pleased to announce Health Canada has issued the Company a No Objection Letter (NOL) to proceed with its first in human clinical trial using oral ARDS-003 to treat various immunomodulatory conditions, in Canada.
- Tetra Bio-Pharma receives approval from Health Canada of its Phase 1 Clinical Trial with oral ARDS-003.
- Oral ARDS-003 is a new therapeutic positioned to modulate acute systemic inflammation and prevent sepsis, acute respiratory distress syndrome (“ARDS”), and organ damage.
The NOL provides the acknowledgement of drug candidacy and authority to proceed with Tetra’s Phase 1 clinical trial to assess the safety, tolerability, and pharmacokinetics of a single ascending dose of oral ARDS-003 in healthy volunteers. The results will guide further development of the drug for patients with hyper inflammatory conditions such as Acute Respiratory Distress Syndrome (ARDS).
Tetra received $4.5M in support from the Government of Quebec for the clinical development of ARDS-003 in the indication of acute respiratory distress syndrome, whether or not it is caused by COVID-19, as well as in patients with sepsis. The receipt of the NOL was one of the last conditions to be met to allow the company to draw on this investment.
Dr. Guy Chamberland, CEO and Chief Regulatory Officer at Tetra, commented, “We are excited to see our novel drug candidate, oral ARDS-003, moving forward in a clinical setting. As few as 1 out of 1,000 compounds make it into Phase 1 human trials. The development of effective, out-patient, oral therapies that either directly address viral infection or treat associated complications such as inflammation, organ damage, or fibrosis, is important in a national response to future pandemics or health emergencies. With over 12 years of preclinical efficacy research in sepsis and cytokine hyperinflammatory reactions, we are very confident that oral ARDS-003 will be an effective drug with strong commercial potential.”
A Promising Treatment
Oral ARDS-003 is a novel First in Human (FIH) drug candidate containing the active pharmaceutical agent, Onternabez, a potent and selective full agonist of the type 2 cannabinoid receptor (CB2R), an essential immunomodulatory target. Oral ARDS-003 is positioned to modulate acute systemic inflammation and prevent sepsis, ARDS, and organ damage. While the clinical profile of ARDS arising from viral (COVID) or bacterial sepsis can vary, hyperinflammation involving a dysfunctional immune response is a common mediator of lung damage. Tetra's pre-clinical studies have demonstrated that its drug candidate decreases this hyperinflammatory response and slows disease progression.