- 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.
/NOT FOR DISTRIBUTION TO UNITED STATES NEWSWIRE SERVICES OR
DISSEMINATION IN THE UNITED
STATES/
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-François 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
ecm@cgf.com.
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.
About Tetra Bio-Pharma Inc.:
Tetra Bio-Pharma (TSX: TBP) (OTCQB: TBPMF) (FRA:JAM1) is a
leader in cannabinoid-derived drug discovery and development with a
FDA and a Health Canada cleared clinical program aimed at bringing
novel prescription drugs and treatments to patients and their
healthcare providers. Its evidence-based scientific approach has
enabled us to develop a pipeline of cannabinoid-based drug products
for a range of medical conditions, including pain, inflammation,
and oncology. With patients at the core of what we do, Tetra
Bio-Pharma is focused on providing rigorous scientific validation
and safety data required for inclusion into the existing biopharma
industry by regulators, physicians and insurance companies.
For more information visit: www.tetrabiopharma.com
Forward-looking statements
Some statements in this release may contain forward-looking
information. All statements, other than of historical fact, that
address activities, events or developments that the Company
believes, expects or anticipates will or may occur in the future
are forward-looking statements. Forward-looking statements are
generally identifiable by use of the words "may", "will", "should",
"continue", "expect", "anticipate", "estimate", "believe",
"intend", "plan" or "project" or the negative of these words or
other variations on these words or comparable terminology.
Forward-looking statements contained in this news release include,
but are not limited to, statements regarding the enrollment of
patients in the REBORN1© study, expected timeline of
such enrollment, expected results of the REBORN1© study,
the conduct of further studies on ARDS-003 and the expected
benefits of ARDS-003 on the immune system in Acute Respiratory
Distress Syndrome or Sepsis patients, the conduct of Phase
1a/1b studies and the location of
such studies, the obtention of an IND from the FDA in connection
with ARDS-003, the issuance of Common Shares under the ATM Program,
as well as the expected use of the proceeds of the ATM Program.
Forward-looking statements are subject to a number of risks and
uncertainties, many of which are beyond the Company's ability to
control or predict, that may cause the actual results of the
Company to differ materially from those discussed in the
forward-looking statements. Factors that could cause actual results
or events to differ materially from current expectations include,
among other things, without limitation, the inability of the
Company to obtain sufficient financing to execute the Company's
business plan; competition; regulation and anticipated and
unanticipated costs and delays, the potential lack of success of
the Company's research and development strategies, including the
success of the products mentioned in this news release or any other
product, the lack of applicability of the discoveries made therein,
the uncertainties related to the regulatory process, the timing of
clinical trials, the timing and outcomes of regulatory or
intellectual property decisions and other risks disclosed in the
Company's public disclosure record on file with the relevant
securities regulatory authorities. Although the Company has
attempted to identify important factors that could cause actual
results or events to differ materially from those described in
forward-looking statements, there may be other factors that cause
results or events not to be as anticipated, estimated or intended.
Readers should not place undue reliance on forward-looking
statements. The forward-looking statements included in this news
release are made as of the date of this news release and the
Company does not undertake an obligation to publicly update such
forward-looking statements to reflect new information, subsequent
events or otherwise unless required by applicable securities
legislation.
SOURCE Tetra Bio-Pharma Inc.