Tetra Bio-Pharma Inc. - TBPMF STOCK NEWS

Tetra Bio-Pharma announced the receipt of a positive Scientific Advice Assessment (SAA) Report from the Malta Medicines Authority for its inhaled drug QIXLEEF™. The report endorses the company's nonclinical safety and quality programs, paving the way for a Marketing Authorization Application (MAA) submission in Europe. The SAA Report offers guidance on clinical requirements and highlights the REBORN2© trial as pivotal for MAA approval. Tetra's CEO expressed optimism regarding this endorsement, indicating alignment with regulatory expectations for global clinical development.

Tetra Bio-Pharma has filed a PCT patent application for Cannabis Plant Residue (PCT/CA2021/050886), dated June 28, 2021. The application aims to protect its use as a prebiotic supplement alongside a partnership with Thorne HealthTech for FDA GRAS status, which would expand its applications in food and dietary supplements. Research shows that cannabis residue enhances beneficial gut microbes, making it a promising candidate for gastrointestinal health. This development aligns with Tetra's commitment to cannabinoid-based drug discovery and innovation.

Tetra Bio-Pharma Inc. has appointed Christine Caron as its first Patient Partner to enhance collaboration and engagement in research focused on pain management and Sepsis. Caron, a triple amputee who advocates for Sepsis awareness, will assist in reviewing clinical trial materials and translating knowledge to key audiences. Tetra aims to develop patient-centric approaches in its clinical programs, with a focus on improving quality of life and pain management through cannabinoid-based therapies. CEO Guy Chamberland expressed confidence in Caron's contributions towards prioritizing patient outcomes.

The Central Ethics Committee has approved an amendment to the REBORN1© study protocol, enabling Tetra Bio-Pharma to compare its cannabinoid-based drug QIXLEEF™ against three immediate-release oral opioids for treating breakthrough cancer pain. This phase 2 proof-of-concept study aims to demonstrate the efficacy of QIXLEEF™ as a potential alternative to traditional opioids. The amendment is expected to accelerate patient enrollment once the Drug Enforcement Administration approves the new protocol.

Tetra Bio-Pharma announced promising results for its investigational drug ARDS-003, which, when combined with antiviral drugs, significantly reduced viral replication in studies. Conducted in collaboration with Targeted Pharmaceuticals and George Mason University, the research highlighted ARDS-003's potential in treating hyperinflammatory conditions associated with COVID-19 and sepsis. CEO Dr. Guy Chamberland emphasized the unique study method using neuro-organoid spheres, which allows for advanced research without live animals. These findings may open new market opportunities and impact the development of cannabinoid-based therapies.

Tetra Bio-Pharma has announced that Health Canada has accepted its New Drug Submission (NDS) for REDUVO™, a treatment for chemotherapy-induced nausea and vomiting (CINV). This marks a significant milestone as the company transitions from pre-revenue to revenue-generating status. If approved, REDUVO™ will receive a Notice of Compliance (NOC) and a Drug Identification Number (DIN), allowing Tetra to market the drug in Canada. The company anticipates reimbursement for REDUVO™ from provincial and private healthcare plans, addressing a critical need for alternative therapies in CINV management.

Tetra Bio-Pharma has accelerated its Phase 2 clinical trial, PLENITUDE, for QIXLEEF, an investigational cannabis medication targeting uncontrolled cancer pain. The trial aims to assess QIXLEEF's safety and efficacy over four weeks, with potential eligibility for an additional 48 weeks. Market analysis suggests the advanced cancer pain market could exceed USD $900 million by 2030. Tetra is committed to providing a safer alternative to opioids for cancer patients.

Tetra Bio-Pharma has initiated its first Phase 2 clinical trial, REBORN1, evaluating the inhaled drug QIXLEEF against oral morphine for cancer pain management. Conducted in the U.S. with the Hassman Research Institute, this trial aims to enroll 20 patients experiencing breakthrough cancer pain. QIXLEEF, containing both THC and CBD, seeks to provide a safer alternative to opioids. With cancer pain affecting up to 70% of patients, the potential impact of this drug on pain relief could be significant, indicating a transformative shift in pain management.

Tetra Bio-Pharma has entered into a Definitive Agreement with DanCann Pharma for the exclusive distribution of its cannabinoid-derived products in several European countries. This deal is projected to generate over 47.5M CAD in revenue, including upfront and milestone payments of 1.5M CAD and cumulative royalties exceeding 46M CAD through 2028. Key products include Reduvo™ Adversa®, QIXLEEF™, and ENJOUCA™, targeting pain management and chemotherapy-induced nausea. The collaboration is anticipated to commence in the first half of 2022.