natural pharmaceuticals derived From Cannabis and other medicinal plants
Company Receives Health Canada Phase 3 Clinical Trial Approval For Smokable Dried Cannabis Prescription Drug
AGORACOM NEWS FLASH
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Message: Tetra Bio-Pharma Strengthens its Position on Bringing Marijuana to Patients in a Form Acceptable to Health Care Professionals
OTTAWA, ONTARIO--(July 5, 2017) - 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."
About Tetra Bio-Pharma:
Tetra Bio-Pharma is a multi subsidiary publicly traded company (CSE:TBP)(CSE:TBP.CN)(CNSX:TBP)(OTCQB:TBPMF) engaged in the development of Bio Pharmaceuticals and Natural Health Products containing Cannabis and other medicinal plant based elements.
Tetra Bio-Pharma is focused on combining the traditional methods of medicinal cannabis use with the supporting scientific validation and safety data required for inclusion into the existing bio pharma industry by regulators physicians and insurance companies. More information is available about the company at: www.tetrabiopharma.com.
Source: Tetra Bio-Pharma
The Canadian Securities Exchange ("CSE") has not reviewed this news release and does not accept responsibility for its adequacy or accuracy.
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 or other variations on these words or comparable terminology. 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, through its wholly-owned subsidiary, GrowPros MMP Inc., to obtain a licence 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, 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.
Tetra Bio-Pharma Inc.
Vice President, IR & Corporate Communications
(514) 360-8040 Ext. 203
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