Tetra Bio-Pharma Inc. - TBPMF STOCK NEWS

Tetra Bio-Pharma has received a Drug Establishment License from Health Canada to distribute REDUVO soft gel capsules, a synthetic THC product aimed at treating severe nausea from chemotherapy. As part of the regulatory process, Tetra is also applying for a Cannabis Drug License. This development positions Tetra favorably in the estimated $80M CDN Canadian market. The company confirmed plans to launch REDUVO in late 2021 and completed a compliant GMP inspection.

Tetra Bio-Pharma Inc. (OTCQB: TBPMF) has submitted a request to the Malta Medicines Authority for a Scientific Opinion on its investigational new drug, QIXLEEF, which is intended for clinical trials in Europe. This drug aims to provide rapid relief for severe acute pain, offering a potential alternative to opioids. The REBORN2 trial will compare QIXLEEF with morphine for treating breakthrough cancer pain. The company is focusing on global commercialization of QIXLEEF, as it prepares to address significant needs in pain management.

Tetra Bio-Pharma Inc. has announced the completion of manufacturing its investigational drug QIXLEEF for the REBORN1 clinical trial aimed at evaluating cannabis as an alternative to morphine for treating breakthrough cancer pain (BTcP). The company received an export permit from Health Canada allowing the shipment of QIXLEEF to the USA. The 10-week open-label study seeks to assess whether inhaled QIXLEEF offers faster pain relief than morphine sulfate immediate release. The trial is part of Tetra's commitment to addressing the opioid crisis.

Tetra Bio-Pharma Inc. has received a new patent from the U.S. Patent and Trademark Office, enhancing its intellectual property portfolio. This patent is for a method to treat Interstitial Cystitis (IC), a chronic bladder condition affecting up to 12% of women. Current treatments are limited, prompting research into cannabinoid therapies, which have shown promise in reducing inflammation and pain associated with IC. Tetra plans to commercialize its product in Q2 2022, through a partnership.

Tetra Bio-Pharma has advanced the New Drug Submission (NDS) for its REDUVO soft gel capsules, responding to Health Canada’s request for additional information. A successful application will grant Canada's only Drug Identification Number (DIN) for a THC-based prescription drug, expected to enter the market in the second half of 2021. The Canadian market for such drugs is estimated at $80M CDN by 2022. REDUVO aims to treat chemotherapy-induced nausea and vomiting as well as AIDS-related anorexia.

The FDA has favorably reviewed Tetra Bio-Pharma's preclinical data for ARDS-003, a therapeutic aimed at treating hospitalized COVID-19 patients at risk of developing ARDS. This review, part of the Coronavirus Treatment Acceleration Program, confirms the drug's safety for human use and endorses the clinical trial's design. The upcoming trial will evaluate ARDS-003's safety and efficacy in combination with dexamethasone in COVID-19 patients. Current ARDS conditions have a significant mortality rate, indicating a critical unmet medical need that ARDS-003 aims to address.

Tetra Bio-Pharma has received a Notice of Compliance for its Drug Establishment License (DEL) from Health Canada, a key milestone for the commercialization of its Reduvo soft gel capsules. This follows a successful inspection confirming Tetra's compliance with pharmaceutical distribution regulations. The DEL is essential for the ongoing Drug Identification Number (DIN) review process. Tetra aims to bring Reduvo to market in 2021 as part of its wider strategy to provide cannabinoid-based treatments for various medical conditions.

Tetra Bio-Pharma announced that Health Canada has approved the filing of a Clinical Trial Application for their drug candidate ARDS-003 to treat hospitalized COVID-19 patients at risk of developing Acute Respiratory Distress Syndrome (ARDS). This condition is a leading cause of mortality in COVID-19, affecting 20-67% of critically ill patients. The trial will be the first worldwide to use an injectable synthetic cannabinoid for this purpose. The company aims to finalize the study protocol for testing the drug's safety and efficacy in combination with dexamethasone.

Tetra Bio-Pharma has entered an agreement with Targeted Pharmaceuticals to collaborate on the Antiviral Central Nervous System Program. This partnership aims to advance the research of ARDS-003, focusing on its potential in treating neuroinflammation and other antiviral applications. The global market for central nervous system drugs is projected to grow from $125.28 billion in 2020 to $163.05 billion by 2025, highlighting significant opportunities in this field. CEO Dr. Guy Chamberland emphasizes the importance of this collaboration for expanding investment returns on ARDS-003.