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TBP: FIRST PATIENT HAS ENTERED THE REBORN1 CLINICAL TRIAL

[Humanist]

Tetra Bio-Pharma Announces Clinical Advancements and Establishment of At-the-Market Equity Program
 
by @newswire on 28 May 2021, 06:55
 

• First REBORN1© patient enters clinical trial.
• Positive results of first study in Sars-CoV-2 infected mice.
• Filing of IND for ARDS-003 Adaptive Phase 1a/1b clinical trial.

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OTTAWA, ON, May 28, 2021 /CNW/ - Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSX: TBP) (OTCQB: TBPMF) (FRA: JAM1), a leader in cannabinoid-derived drug discovery and development is pleased to announce that the first patient has entered the REBORN1© clinical trial; the first study of mice infected with Sars-CoV-2 virus demonstrates ARDS-003's potential to reduce clinical signs of infection; and that the Company is in the process of filing an Investigational New Drug application with the U.S. Food and Drug Administration (FDA) for ARDS-003.

REBORN1©
The REBORN1© trial is designed to evaluate the effect of the Company's inhaled proprietary drug formulation, QIXLEEF™, against immediate release oral morphine sulfate on onset of pain relief in people living with cancer. QIXLEEF™ is a botanical drug product with a "fixed ratio" of THC and CBD and is inhaled through a Class 2 medical device vaporizer.

Dr. Hassman and the clinical staff have been trained on the study procedures and received the green light to start enrolling patients following the Site Initiation Visit. Patient enrolment is a multistep process that can last up to two weeks to determine the eligibility of the patient and leads to random allocation of the patient to either the comparator (immediate release morphine) or QIXLEEF™ arm of the cross-over designed trial.

According to medical expert and Principal Investigator Dr. David Hassman "We are excited to be part of this revolutionary trial which may help improve the quality of life of patients experiencing breakthrough cancer pain. Dosing the first patient is an important milestone and none of this would have been possible without the contribution of our dedicated team and study participants."

In the REBORN1© study, the screening process also requires that the eligible patient completes a questionnaire for seven continuous days to assess the intensity of his/her background chronic pain, the number of episodes of breakthrough cancer pain and opioid use. Chronic pain is common in patients suffering from breakthrough pain and should be adequately controlled with long-acting opioids to prevent any confusion in the analysis of the efficacy of QIXLEEF™ on breakthrough pain. Similarly, the clinical staff verifies that the use of long-acting opioid is stable, and that the patient will not change his/her medication during study conduct. Such assessments before dispensing QIXLEEF™ to the patient ensure data quality and reliability. Several patients have been identified as eligible to the REBORN1© study and a first visit has been performed launching this 7-day assessment.


Dr. Chamberland, Chief Executive Office (CEO) and Chief Regulatory Officer (CRO) further commented, "We are very pleased to announce that the screening process has been initiated and eligible patients identified. The first REBORN1© patient is being monitored to ensure a stable background chronic pain treatment. As soon as this 7-day period is over, this patient with breakthrough pain will be the first patient to receive QIXLEEF™. Over the next months, the trial will provide data on the outcome of the cannabis treatment versus immediate-release morphine."

Positive results of first study in Sars-CoV-2 infected mice
Pre-clinical studies are ongoing to examine ARDS-003 in Sars-CoV-2 infected mice (hACE2) to generate initial data on the dosing and efficacy of ARDS-003 for mitigating clinical disease. SARS-CoV-2 enters the human body via binding to human angiotensin-converting enzyme 2 (ACE2). The hACE2 mouse is a transgenic mouse strain carrying a human ACE2 coding sequence that results in hACE2 expression in epithelial cells, including airway epithelial cells. This generates a robust model of COVID-19 that recapitulates clinical features of the human disease, including moderate to severe pneumonia and acute respiratory distress syndrome following intranasal virus inoculation.

Daily Health Scores (DHS) were assessed in ACE2 mice treated with vehicle (no drug) or ARDS-003 at Day 7 post infection/treatment compared to sham animals (no infection, no treatment). The DHS were scored on clinical signs including overall appearance, mobility, signs of COVID-19 including respiratory distress and body condition, in order to generate an overall composite health score. Higher scores are indicative of poor clinical prognosis. Infected animals dosed with ARDS-003 (10 mg/kg) resulted in lower DHS scores at 7 days compared to no-treatment (vehicle) with some of the ARDS-003 treated mice having a DHS score comparable to the no-infection control group animals. A lower dose of 3 mg/kg ARDS-003 did not result in any significant benefit to infected animals. Additional studies are planned to further determine the dose range and treatment regimen that provides optimal clinical benefit in SARS-CoV-2 infected mice as well as to describe the underlying mechanisms contributing to this benefit.

"The severity of Sars-CoV-2 infection in a patient has significant impacts on our health care system. ARDS-003 can become a valuable therapeutic if clinical trials demonstrate a reduction in the severity of the infection. Tetra is also studying the benefits of ARDS-003 on the immune system response to establish advantages over the use of dexamethasone in Acute Respiratory Distress Syndrome or Sepsis patients. We believe a broad action immunomodulator that does not result in pronounced immune suppression will play a more significant role," commented Dr. Chamberland CEO and CRO.

ARDS-003 – Adaptative Phase 1a/1b Clinical Status
Tetra completed a consultation process with both the U.S. FDA and Health Canada (HC) for ARDS-003, an investigational drug to treat COVID-19 patients. This mandatory regulatory process included the review of Tetra's nonclinical safety data package as well as the clinical trial protocols. Based on feedback from HC, the Phase 1a and 1b protocols were modified to a single protocol with an adaptive study design. The Phase 1a will be performed in healthy volunteers and the Phase 1b in hospitalized COVID-19 patients with severe pneumonia. As an adaptive study design, the Phase 1b will be initiated concurrently to the Phase 1a and involves Safety Review Committee and Data Safety Monitoring Board oversight. The study will be initiated at 6 sites across the USA, Canada, and Brazil. Batches of ARDS-003 have been manufactured over the last several months allowing Tetra to create the chemistry, manufacturing and controls information required to submit the USA Investigational New Drug (IND).
"Many investors have been waiting for the submission of the IND to the FDA. As with any new molecular entity drug, Tetra had to develop the data required by the FDA and we can now say that the IND is being filed," commented Dr. Chamberland CEO and CRO.
At-the-Market Equity Program
Tetra is also pleased to announce that it has established an at–the–market equity program (the "ATM Program") that allows the Company to issue up to $10,000,000 of common shares of the Company (the "Common Shares") from treasury to the public from time to time, at the Company's discretion. Any Common Shares sold as "at-the-market distributions" (as defined in National Instrument 44–102 – Shelf Distributions) in the ATM Program will be sold through the Toronto Stock Exchange (the "TSX") or any other recognized Canadian marketplace on which the Common Shares are listed, quoted or otherwise traded from time to time, at the prevailing market price at the time of sale. The establishment of the ATM Program constitutes a material change (within the meaning of applicable securities legislation) for Tetra.
Distributions of the Common Shares under the ATM Program will be made pursuant to the terms of an equity distribution agreement (the "Equity Distribution Agreement") dated May 28, 2021 with Canaccord Genuity Corp. (the "Agent").
"Having recently completed two bought deal offerings (including the exercise of the over-allotment option in each of these offerings) for aggregate gross proceeds of $25.9 million, we have also witnessed an increased rate of exercise of outstanding warrants to purchase our Common Shares. The net proceeds from these offerings and warrants exercises will primarily go towards the advancement of our ARDS-003, REBORN1^© and PLENITUDE^© clinical trials. We believe the ATM Program will provide us with an opportunity to firmly solidify our balance sheet. We expect that the ATM Program will serve both Tetra and our shareholders very well, as it will constitute an additional tool to raise funds on an "as-needed" basis, without the expenses and fees associated with larger-scale financings." said Jean-Franois Boily, Chief Financial Officer of Tetra.
The volume and timing of distributions under the ATM Program, if any, will be determined at the Company's sole discretion. The ATM Program will be effective until the earlier of April 30, 2022 and the sale of all the Common Shares issuable under the ATM Program, unless terminated prior to such date by the Company or the Agent. Tetra intends to use the net proceeds from the ATM Program, if any, principally to fund research and development activities, general and administrative expenses, working capital requirements and other general corporate purposes. As Common Shares sold in the ATM Program will be distributed at the prevailing market price at the time of the sale, prices may vary among purchasers during the period of the distribution.
The ATM Program is being established pursuant to a prospectus supplement dated May 28, 2021 (the "Prospectus Supplement") to the Company's short form base shelf prospectus dated April 1, 2020 (the "Base Shelf Prospectus"), filed with the securities regulatory authorities in each of the provinces of Canada. The Equity Distribution Agreement, the Prospectus Supplement and the Base Shelf Prospectus will be available under the Company's profile on SEDAR at www.sedar.com. Alternatively, copies of the Equity Distribution Agreement, the Prospectus Supplement and the Base Shelf Prospectus can be obtained upon request by contacting the Agent at [e-mail].
No securities regulatory authority has either approved or disapproved of the contents of this press release. This press release is for information purposes only and does not constitute an offer to sell or a solicitation of any offer to buy the securities in the United States, in any province or territory of Canada or in any other jurisdiction. There shall be no sale of the securities in any jurisdiction in which an offer to sell, a solicitation of an offer to buy or sale would be unlawful.
The securities mentioned herein have not been and will not be registered under the U.S. Securities Act of 1933, as amended (the "U.S. Securities Act") or any U.S. state securities laws and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the U.S. Securities Act and applicable U.S. state securities laws.
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