OTTAWA, ONTARIO--(Marketwired - Feb. 5, 2018) - Tetra Bio-Pharma Inc. ("Tetra" or the
"Company") (TSX VENTURE:TBP)(OTCQB:TBPMF), a global leader in cannabinoid-based drug development and discovery,
is pleased to announce that it has received a No Objection Letter (NOL) from the Therapeutic Products Directorate (TPD) Health
Canada to its Clinical trial application (CTA) for the Company's PPP001 prescription smokable dried cannabis product.
Coinciding with World Cancer Day 2018, Tetra is now ready to initiate its Phase 3 clinical trial of PPP001 in
terminal cancer patients, the first registration trial in the world for smokable cannabinoid-based drug. This trial is expected
to be a landmark study, enrolling a total of 946 subjects, evaluating the therapeutic benefits of a cannabinoid prescription drug
in improving quality of life and treating pain in terminal cancer patients.
"This is an especially significant and noteworthy milestone for the lead candidate in our product pipeline," said
Bernard Fortier, Tetra's CEO, "as it positions Tetra to potentially be the first company with a Health Canada approved,
cannabinoid-based drug on the market aimed at treating breakthrough pain in cancer patients. The advanced cancer pain market is a
$2.4B market1; this is a significant and important opportunity for the Company as our drug PPP001 has the potential to
help reduce the reliance on opioids for the management of severe pain."
The first and main recruitment center of the trial will be in Montreal at Santé Cannabis, Québec's first medical
clinic and resource centre specializing in cannabis and cannabinoids for medical purposes.
The PPP001 Phase 3 trial will evaluate the effects of Tetra's smokable cannabinoid-based drug made from natural
dried cannabis. Tetra previously entered into a supply agreement with Aphria Inc., to use Aphria's unique blend of dried medical
cannabis in its PPP001 clinical trial. Aphria owns an 8.5% stake in Tetra.
As part of the clinical trial, Tetra will also collect the pharmaco-economics evidence required from insurers in
order to support the reimbursement of the first cannabis prescription drug. "Today, most private insurance plans do not cover
cannabis treatment, nor is public reimbursement available, making this therapeutic option costly for patients. It is very
important for us to bring a new therapeutic option for patients in the form of an approved prescription drug and to take action
in order to have it reimbursed for patients" commented Bernard Fortier, CEO.
The trial aims to demonstrate that PPP001 eases suffering and facilitates a more serene experience of living and
dying in terminal cancer patients. If conclusive, Tetra will submit a filing for a Drug Identification Number (DIN) to Health
Canada in 2019, thus providing a new noninvasive treatment to relieve pain for cancer patient. With this approval, Tetra expects
to be on time with its previously announced schedule with the development of PPP001, culminating in a potential launch in Canada
by Q1, 2020 and in the US by Q3, 2020.
Dr Guy Chamberland, Tetra's Chief Scientific Officer (CSO) explained that: "The development of PPP001 for patients
with advanced cancer is an important commitment for Tetra, given that cancer patients suffer from severe pain which is often
accompanied by depression and insomnia. Medical cannabis has been shown to help patients beyond the immediate benefit of pain
relief."
"With the expertise of Santé Cannabis, we expect to demonstrate the clinical benefits of PPP001 on the quality of
life of advanced cancer patients. It's important to note that our clinical program will also address the potential of PPP001 to
reduce the reliance on opioids for management of severe pain. We expect that, once it is approved as a drug under prescription,
PPP001 will be included over time ahead of opioids treatment for those patients with terminal cancer pain. The Company will
continue to maintain a transparent and direct line of communication with Health Canada and the U.S. FDA to ensure that we address
the issues required for drug approval. PPP001 is about patients first, " added Dr. Guy Chamberland.
Tetra worked with Santé Cannabis physicians to design a clinical trial that would demonstrate the safety and
efficacy of PPP001 in terminal cancer patients and have focused the clinical development on a first indication in patients with
advanced cancer. The Phase III clinical trial will be performed by the medical team of Santé Cannabis.
"Throughout my clinical experience assessing and following more than 600 medical cannabis patients, cannabis
inhalation remains a critical option to provide rapid relief from a wide variety of symptoms associated with advanced cancer, "
said Dr. Antonio Vigano, Principal Investigator of the trial and Research Director of Santé Cannabis. "We will rigorously assess
the safety, efficacy and tolerability of PPP001 to support the population of cancer patients by bringing an important therapeutic
tool to the same standard of prescription drugs It is great to be celebrating World Cancer Day 2018 with the first large scale
clinical study to prove that medical cannabis can ease the suffering and improve quality of life of many cancer patients,
particularly when they most need it."
About Cancer Pain:
In the USA, 1,5 million patients suffer from cancer pain2. Pain is one of the most frightening of all
cancer symptoms for patients and their families3. According to statistics published by the American Cancer Society in
20024, 50% to 70% of people with cancer experience some degree of pain, with a quarter of them actually dying in pain.
Without adequate relief of their pain, their quality of life is negatively impacted. Furthermore, the incidence of pain in
advanced stages of invasive cancer approaches 80% and it is 90% in patients with bone metastases5.
- https://decisionresourcesgroup.com/report/141466-biopharma-cancer-pain-2015
- Melnikova I. Pain market 2010 ;, doi:10.1038/nrd3226
- Winslow M, Seymour J, Clark D. 2005. Stories of cancer pain: a historical perspective. J Pain Symptom Manage,
29:22-31.
- American Cancer Society. 2002. Cancer facts and figures 2002
- Pharo GH, Zhou L. 2005. Pharmacologic Management of Cancer Pain. JAOA, 105:S21-28.
About PPP001:
PPP001 aims to be the first smokable marihuana for advanced cancer pain under prescription. It is a dried cannabis
pellet designed to be smoked in an inhalation device specifically developed for this product. PPP001 is a unique blend of 3
strains of standardized dried cannabis, creating a drug substance with 9,5% THC and 2,5% CBD.
About Aphria:
Aphria Inc., one of Canada's lowest cost producers, produces, supplies and sells medical cannabis. Located in
Leamington, Ontario, the greenhouse capital of Canada, Aphria is truly powered by sunlight, allowing for the most natural growing
conditions available. Aphria is committed to providing pharma-grade medical cannabis, superior patient care while balancing
patient economics and returns to shareholders.
About Tetra Bio-Pharma:
Tetra Bio-Pharma (TSX VENTURE:TBP)(OTCQB:TBPMF) is a biopharmaceutical leader in cannabinoid-based drug discovery
and clinical development. Tetra is focusing on three core business pillars: clinical research, pharmaceutical promotion and
retail commercialization of cannabinoid-based products.
More information at: www.tetrabiopharma.com
Source: Tetra Bio-Pharma
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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 (including, without limitation, statements regarding potential acquisitions and financings) 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
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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, through its wholly-owned subsidiary, GrowPros MMP Inc., to obtain a license for the production of medical marijuana;
failure to obtain sufficient financing to execute the Company's business plan; competition; regulation and anticipated and
unanticipated costs and delays, the success of the Company's research strategies, the applicability of the discoveries made
therein, the successful and timely completion and 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
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