onternabez injectable (ARDS-003) / Tetra Bio-Pharma - LARVOL DELTA

Significant Discovery Reveals New Antiviral Properties of Tetra Bio-Pharma's Innovative Drug ARDS-003 (PRNewswire) - "Combining ARDS-003 with antiviral drugs significantly decreased viral replication compared to antiviral treatment alone....Tetra Bio-Pharma Inc....announced today that its investigational new drug ARDS-003 has been studied in a viral infected organoid model as part of a research collaboration between Targeted Pharmaceuticals ('Targeted') and George Mason University....A preliminary study on HIV using the HU-308 molecule, the Active Pharmaceutical Ingredient used in our Covid-19 therapeutic ARDS-003, determined that viral replication is significantly decreased...Targeted stated in its news release 'These studies are significant in that cannabinoids may provide a protective effect by alleviating the pathogenic effects of EVs in HIV-1 and CNS-related infections'..."

Preclinical • Infectious Disease • Novel Coronavirus Disease

FDA Provides Positive Feedback on Tetra Bio-Pharma's Application for ARDS-003 Clinical Development in COVID-19 Patients (Yahoo Finance) - "...the U.S. Food and Drug Administration (FDA) has favorably reviewed the preclinical data package and clinical development plan of ARDS-003 to treat COVID-19 patients. The review was conducted within the framework of the Coronavirus Treatment Acceleration Program (CTAP)....FDA agreed with the animal toxicology and safety data to ensure that ARDS-003 is safe for human use, and approved the sample size, safety procedures and duration of treatment in severe COVID-19 patients. As a result of this feedback, the Company looks forward to filing an Investigational New Drug Application to initiate the clinical trial."

Cytokine release syndrome • FDA event • IND • Acute Respiratory Distress Syndrome • Novel Coronavirus Disease

Health Canada Provides Positive Feedback on Tetra Bio-Pharma’s Application for ARDS-003 to be Studied in COVID-19 Patients at Risk of Developing Acute Respiratory Distress Syndrome (BioSpace) - "...Health Canada supports the filing of a Clinical Trial Application for assessing their novel drug candidate, ARDS-003, in patients with COVID-19....Tetra will use this study to demonstrate that its ARDS-003 drug can help prevent the acute respiratory distress seen in serious complications of COVID-19. The proposed study is a randomized, double-blind, placebo-controlled trial to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ascending doses of ARDS-003 in hospitalized COVID-19 patients with pneumonia and at risk of developing acute respiratory distress syndrome."

Cytokine release syndrome • New trial • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease

"Tetra Bio-Pharma Initiates Additional Studies of ARDS-003 in Neuroinflammation and Antiviral Diseases @Pharmashot @TetraBioPharma https://t.co/iGGKxuEWPw" (@Pharmashot)

Acute Respiratory Distress Syndrome • Immunology • Infectious Disease • Inflammation

"Great breakdown on ARDS003 and the promise it holds as a therapeutic in treating #ARDS and #sepsis $TBP #pharma #drugdevelopment @SepsisUK @UKSepsisTrust @SepsisCanada @PhRMA @endpts @BioWorld @FP_Champagne" (@DianeReardon33)

Acute Respiratory Distress Syndrome • Infectious Disease • Septic Shock

A novel treatment for cytokine storm (Health Europa) - "...Tetra Bio-Pharma has received the green light from the US Food and Drug Administration (FDA) to begin a Phase 1 trial with human subjects for its investigational therapeutic drug ARDS-003, after successfully completing safety studies....Based on the safety data, both the active ingredient and the sterile injectable drug product ARDS-003 are both considered safe for use in humans. These plateaus are also required to submit a Clinical Trial Application in Canada and an Investigational New Drug (IND) application in the USA for a Phase 1 trial."

Cytokine storm • New P1 trial • Infectious Disease • Novel Coronavirus Disease

"@Forbes @JoeBiden @StockDayPodcast @BioStocks Someone sees the value in $tbp $tbpmf #covid treatment ARDS-003. Check out the million share purchase! @JustinTrudeau you snooze you will lose!" (@michaelvalli77)

Acute Respiratory Distress Syndrome

Tetra Bio-Pharma provides update on PPP003 inflammatory cytokine reduction drug program (Streetinsider.com) - "Management believes that under an accelerated timeline, a potential drug for CRS could be ready for conditional approval by Health Canada during the third quarter of 2021....Only $4.7 million of the announced $18 million will be designated to the Phase II trial in COVID-19 infected patients suffering from CRS. Tetra has applied to the Federal Government's Strategic Innovation Fund for a grant which would cover approximately 75% of this budget and would allow the Company to meet the accelerated timeline to complete the Phase II clinical trial in the first half of fiscal 2021 and submit for conditional drug approval."

Canadian regulatory • Cytokine release syndrome • Grant • Infectious Disease • Novel Coronavirus Disease

FDA Provides Positive Feedback on Tetra Bio-Pharma’s Pre-Investigational New Drug Application for ARDS-003 to Be Studied in COVID-19 Patients at Risk of Developing Acute Respiratory Distress Syndrome (ARDS) (Yahoo Finance) - "Tetra Bio-Pharma Inc....is excited to announce that the U.S. Food and Drug Administration (FDA) has favorably reviewed the company's Pre-Investigational New Drug (PIND) application for ARDS-003....FDA agreed with Tetra's proposed active substance and finished product specifications as well as the stability programs. The FDA stated that the nonclinical program was appropriate to support initiating phase 1 study....In addition, Tetra is planning to initiate a study in COVID-19 patients in parallel to conducting the phase 1 trial in healthy volunteers. Tetra expects to start the Phase 1 trial in late September 2020. The treatment phase of the study should be completed within the two months followed by the analysis and reporting phase."

Cytokine release syndrome • FDA event • New P1 trial • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease

Tetra Bio-Pharma provides PPP003 inflammatory cytokine reduction drug program (Tetra Bio-Pharma Press Release) - "Tetra Bio-Pharma Inc....is pleased to announce that it has now completed the modifications to the nonclinical safety program of PPP003 to ensure the launch of a Phase 1 trial in healthy volunteers later this year and subsequently be able to initiate a Phase 2 trial in patients with COVID-19 immediately after....The phase I study will enroll approximately 100 healthy volunteers....The study will include standard safety assessments, pharmacokinetics and cardiovascular evaluations. The phase II study will enroll approximately 100 covid-19 infected patients in several hospitals."

New P1 trial • New P2 trial • Infectious Disease • Novel Coronavirus Disease