Source: Tetra Bio-Pharma
Tetra Bio-Pharma Inc. ("Tetra" or the "Company")
(CSE:TBP)(CSE:TBP.CN)(CNSX:TBP)(OTCQB:TBPMF), today announced that it
has strengthened its position on bringing marijuana to patients in the
form of a prescription drug. Tetra has become a world leader in the
field of cannabis drug development and its PPP001 dried cannabis drug
was covered in the Global Pain Management Drugs Market analysis report
published by Azoth Analytics in May 2017. According to this report,
Tetra is the only company developing dried marijuana as a drug.
One in five Canadians will live with pain in their lifetime
and one in two will be affected by cancer.
Canadian courts have ruled in
favor of patients wanting access to marijuana for relief. In response
to these decisions, the Canadian government has implemented the Access
to Cannabis for Medical Purposes Regulations (ACMPR) to help bring
marijuana to patients. Canada's Prime Minister has been very favorable
in bringing marijuana to patients but it will be up to corporations to
step in and adhere to the Canadian Food and Drug regulations to bring
marijuana medications to patients. Tetra is a world leader in the drug
development field of cannabis-based medications and is paving the road
to become the first company to commercialize a dried marijuana product
as a drug in North America.
"Canadian's are entitled to access to marijuana to treat
their pain or its co-morbidities. It is not a question of social
standing or a judgement if the act of 'smoking' is acceptable for
patients. It is a fundamental right to have access to a botanical drug
that can effectively allow patients to have a better quality of life,"
commented Dr. Guy Chamberland, CSO of Tetra Bio-Pharma. "There is
sufficient evidence suggesting that smoking marijuana is an adequate
medication to help relieve pain and improve a patient's well-being. Both
of these are important aspects to offering effective therapies to
patients. The challenge has been addressing quality and safety issues to
meet the standards of a drug."
Over the years our society has inherited an image that
'smoking' or 'vaporizing' is not associated with a healthy approach to
health care. According to the expert committee on the Health Effects of
Marijuana (National Academies Press, 2017), 'smoking cannabis does not
increase the risk for certain cancers (i.e., lung, head and neck)'. In
addition, cancer patients typically consume an amount of dried marijuana
per day, in dry weight, that is less than 1 tobacco cigarette, without
the paper, per day.
The significantly reduced amount of smoke per day is
one of the explanations supporting that smoking marijuana does not
increase the risk for these cancers. That said, these are effective
routes of delivering a complex botanical medication. "Society has to
focus on caring for all patients living with pain not just those that
want a different dosage form," commented Dr. Chamberland. He added, "In
fact our challenge is to characterize the safety and efficacy of this
therapy, ensure lot-to-lot quality, provide adequate risk information to
health professionals, demonstrate the safety and efficacy so that
physicians can adequately assess the potential efficacy and safety for
their patient, and actively pursue more tolerable dosage forms to offer
these innovative cannabis therapies to patients. In the end, a patient's
desire to smoke marijuana for relief has to be defended by Canadian
courts and politicians. We live in a democratic society and we have to
care for everyone."
"Tetra undertook the development of PPP001 as a first
prescription marijuana drug. The company is preparing its phase 3 trial
in cancer patients and will assess the safety and efficacy using both
the titanium pipe and vaporizer delivery systems. From Day 1, Tetra was
dedicated to characterizing the safety and tolerability of consuming
medical marijuana by smoking. Tetra also adopted the firm position of
working transparently with regulators because the corporation believed
it is important to bring marijuana, as traditionally used, to patients.
Tetra will continue to work with provincial and federal governments,
including physician and pharmacist professional corporations, to help
address issues associated with the development and commercialization of a
first prescription medical marijuana drug."
"Tetra already works closely with Health Canada through the
regulatory processes in place for the development of drugs and
controlled substances," commented Dr. Chamberland. He added that, "Tetra
was working closely with the province of New Brunswick whom from Day 1
was very active in preparing for the eventual legalization of marijuana
in Canada. Tetra is working with physician and pharmacist professional
associations/corporations and will be working closely with these health
professionals as the company prepares for its Phase 3 trial and the
eventual commercialization of the first dried marijuana drug."
"Tetra has performed safety, pharmacokinetic and cognitive
function studies in healthy volunteers.
The corporation has
characterized the safety of consuming marijuana and understands what the
potential risks are to consumers and patients. This information will be
made available by Tetra to Health Canada and to other government
departments on request. We believe that this safety data provides a
clear and accurate picture of what happens to people that smoke
marijuana recreationally," commented Dr. Chamberland. "We believe it is
our responsibility to provide this information to regulators to help
pave the road for the Trudeau government's legalization."
In addition, Tetra will use its clinical knowledge from its
Phase 1 and Safety clinical studies to implement effective and secure
patient care programs. This includes working with independent
professional organizations to transfer its clinical risk information and
ensure that these groups provide continued medical education to their
health professionals. Dr. Chamberland commented, "Launching the first
dried marijuana drug in Canada brings a responsibility of ensuring that
all safety risks are communicated to health professionals to ensure the
well-being of consumers. No body wants another fentanyl-type crisis; all
we want is for patients to obtain relief and an improved quality of
life when consuming marijuana that is of the same quality as any other
prescription medication."
"Tetra will be actively pursuing the development and
commercialization of PPP001 to remain a world leader in the field of
cannabis medicine," commented Andre Rancourt, CEO of Tetra Bio-Pharma.
"We are dedicated to working with distributors and pharmaceutical
companies interested in bringing medical marijuana as a prescription
drug around the world. We are focusing on bringing to patients what the
Supreme Court of Canada ruled was their right: access to marijuana."
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