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Tetra Bio-Pharma Announces the Initiation of its Phase I Trial of dried Cannabis $TBP.ca

Posted by AGORACOM-JC at 8:45 AM on Thursday, February 23rd, 2017

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  • Announces launch of its Double-Blind Phase I Study to Assess Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Single and Multiple Daily Ascending Doses of Cannabis (Delta-9-tetrahydrocannabinol/ Cannabidiol) by Smoking/Inhalation in Healthy Male and Female Volunteers
  • Phase I clinical research is a classical pharmaceutical study in the development of a new drug. The trial activities will occur over a 3 to 4-month period and involve site initiation, subject recruitment and enrolment, a single daily ascending dose phase and a 7-day multiple daily ascending dose phase, followed by study termination

OTTAWA, ONTARIO–(Feb. 23, 2017) – PhytoPain Pharma (PPP), a subsidiary of Tetra BioPharma Inc. (“Tetra” or the “Company“) (CSE:TBP)(CSE:TBP.CN)(OTC PINK:GRPOF), a pharmaceutical company focused on developing and commercializing therapeutic cannabis-based products for the treatment of pain is pleased to announce the launch of its Double-Blind Phase I Study to Assess Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Single and Multiple Daily Ascending Doses of Cannabis (Delta-9-tetrahydrocannabinol/ Cannabidiol) by Smoking/Inhalation in Healthy Male and Female Volunteers.

The Phase I clinical research is a classical pharmaceutical study in the development of a new drug. The trial activities will occur over a 3 to 4-month period and involve site initiation, subject recruitment and enrolment, a single daily ascending dose phase and a 7-day multiple daily ascending dose phase, followed by study termination. Algorithme Pharma has already begun recruiting subjects for the Phase I trial. This study is a pivotal safety trial as it will allow Tetra to understand the adverse effects of smoking Cannabis and associate the outcomes, such as cognitive function, to plasma levels of THC and CBD. The study will provide Tetra with the data necessary to discuss with Health Canada and FDA the potential risks in patient populations and discuss marketing requirements for specific indications.

The pharmacokinetic profile and safety data generated by the Phase I trial will allow Tetra to finalize the design of its Phase II-III clinical trial that will assess the safety and efficacy of PPP001 in cancer patients with uncontrolled pain. PPP001 is being developed for cancer patients with moderate-to-severe pain and that are not adequately controlled with the standard of care. Approximately 50% of cancer patients suffer from pain and more than 600,000 of these patients suffer from moderate-to-severe pain. In the USA, there are over 4 million cancer patients and this pain market is valued at over $5 billion USD.

We are very pleased to announce that the start of the Phase I clinical trial activities as this keeps the company on track in its development of PPP001″, commented Mr, Andre Rancourt. “With PPP001 and the mucoadhesive AdVersa® controlled-release tablet, Tetra is positioning itself to become a major player in the cancer pain therapy market, added Mr. Rancourt.

The Canadian Securities Exchange (“CSE”) has not reviewed this news release and does not accept responsibility for its adequacy or accuracy.

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 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.
Dr. Guy Chamberland
Chief Science Officer
(514) 220-9225

 

Tetra Bio-Pharma Announces Approval by Health Canada of its Phase I Trial of dried Cannabis $TBP.ca

Posted by AGORACOM-JC at 12:39 PM on Thursday, February 16th, 2017

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  • Therapeutic Products Directorate (TPD) of Health Canada has approved its Phase I clinical study of smoked cannabis
  • We are very pleased to announce the authorization of the Phase I clinical trial by TPD. This is an important milestone in the clinical development of smoked Cannabis in North America and we are proud to be working with Algorithme pharma, a Clinical Research Organization with many years of experience and expertise in the conduct of Phase I clinical studies,² said Dr. Chamberland, Chief Science Officer.

OTTAWA, ONTARIO–(Feb. 16, 2017) – PhytoPain Pharma Inc. (PPP), a subsidiary of Tetra Bio-Pharma Inc. (“Tetra” or the “Company“) (CSE:TBP)(CSE:TBP.CN), a pharmaceutical company focused on developing and commercializing therapeutic cannabis-based products for the treatment of pain is pleased to announce that the Therapeutic Products Directorate (TPD) of Health Canada has approved its Phase I clinical study of smoked cannabis.

Tetra has worked with Algorithme Pharma, an Altasciences company, for the preparation of the Clinical Trial Application (CTA) for the conduct of a Double-Blind Phase I Study to Assess Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Single and Multiple Daily Ascending Doses of Cannabis (Delta-9-tetrahydrocannabinol/ Cannabidiol) by Smoking/Inhalation in Healthy Male and Female Volunteers. The CTA was submitted to Health Canada and the research ethics review board in December 2016. On January 3, 2017, the clinical trial received approval from the Institutional Review Board. TPD issued a Letter of Authorization for the conduct of the Phase I clinical trial on February 16, 2017. Algorithme Pharma will be initiating the clinical trial activities in the coming weeks.

²We are very pleased to announce the authorisation of the Phase I clinical trial by TPD. This is an important milestone in the clinical development of smoked Cannabis in North America and we are proud to be working with Algorithme pharma, a Clinical Research Organization with many years of experience and expertise in the conduct of Phase I clinical studies,² said Dr. Chamberland, Chief Science Officer.

“This trial is part of Tetra’s commitment to develop medical Cannabis as a prescription drug for patients. The outcome of this trial is going to have significant implications in medical Cannabis research as it is a first pharmaceutical clinical trial assessing the effects of smoked Cannabis on cognitive function in healthy volunteers” said Mr. Rancourt, Chief Executive Officer

Earlier this month, Tetra and IntelGenx announced the co-development of Dronabinol AdVersa® Mucoadhesive controlled-release tablet for the management of Breakthrough Cancer Pain. The significant advantage of the Mucoadhesive technology was demonstrated in a Phase I clinical trial. The study demonstrated the delayed-release of THC avoids a rapid increase in the blood. ²With both of these products in clinical development, Tetra is on track with its objective to bring Cannabis-based prescription drugs to the market. Both of these products are promising alternatives in the battle for the reduction of opioids and improving quality of life in patients with chronic pain², added Dr. Chamberland.

The Canadian Securities Exchange (“CSE”) has not reviewed this news release and does not accept responsibility for its adequacy or accuracy.

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 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.
Dr. Guy Chamberland
Chief Science Officer
(514) 220-9225

Tetra Discusses Clinical Program in New Interview with CFN Media

Posted by AGORACOM-JC at 9:19 AM on Tuesday, February 14th, 2017

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  • Exclusive interview and article discussing the progress made by Tetra Bio-Pharma Inc. (OTC PINK: GRPOF) (CNSX: TBP) in its clinical trial program
  • Interview is with Dr. Guy Chamberland, Tetra’s Chief Science Officer

SEATTLE, WA–(Feb 14, 2017) – CFN Media Group (“CannabisFN”), the leading creative agency and digital media network dedicated to legal cannabis, announces publication of an exclusive interview and article discussing the progress made by Tetra Bio-Pharma Inc. (OTC PINK: GRPOF) (CNSX: TBP) in its clinical trial program. The interview is with Dr. Guy Chamberland, Tetra’s Chief Science Officer.

Medical marijuana may be legal for roughly 60% of the U.S. population, but the cost of the drug remains prohibitive for many patients in need. Tetra Bio-Pharma aims to undergo FDA-sanctioned clinical trials for dried medical marijuana to secure prescription drug coverage from insurance companies.

Tetra Bio-Pharma held a pre-Investigational New Drug (“IND”) meeting with the U.S. Food and Drug Administration (“FDA”) in late January to advance its PPP001 clinical trial. During the meeting, the FDA provided all the necessary guidance on the design of a Phase I clinical trial on healthy volunteers and its overall development program. The meeting further demonstrates the agency’s willingness to continue the clinical trial to develop a dried marijuana prescription drug.

PPP001 is a dried cannabis product with 9.5% tetrahydrocannabinol (“THC”) and 2% cannabidiol (“CBD”) that is being developed as a prescription drug that will meet the FDA’s high bar for quality and manufacturing. The company’s goal is to be the first to achieve reimbursement from insurance companies for the cost of the prescription, which could prove to be a game-changer for would-be medical marijuana patients that cannot afford the drug.

Tetra Bio-Pharma recently partnered with Sante Cannabis in Montreal to assist in developing its clinical trials. As a leading private medical marijuana clinic, the organization has years of experience in educating patients and ensuring the optimal benefits. The company aims to leverage this expertise to ensure that its clinical trials are properly designed to achieve desired outcomes while helping achieve the organization’s goal of lowering costs for patients.

Please follow the link to read the full article and see the interview: http://www.cannabisfn.com/tetra-bio-pharma-moves-closer-to-clinical-trials/

Learn how to become a CFN Media client company, brand or entrepreneur: http://www.cannabisfn.com/become-featured-company/

Download the CFN Media iOS mobile app to access the world of cannabis from the palm of your hand:https://itunes.apple.com/us/app/cannabisfn/id988009247?ls=1&mt=8

Or visit our homepage and enter your mobile number under the Apple App Store logo to receive a download link text on your iPhone:http://www.cannabisfn.com

About CFN Media

CFN Media (CannabisFN), the leading creative agency and media network dedicated to legal cannabis, helps marijuana businesses attract investors, customers (B2B, B2C), capital, and media visibility. Private and public marijuana companies and brands in the US and Canada rely on CFN Media to grow and succeed.

CFN launched in June of 2013 to initially serve the growing universe of publicly traded marijuana companies across North America. Today, CFN Media is also the digital media choice for the emerging brands in the space.

Disclaimer:

Except for the historical information presented herein, matters discussed in this release contain forward-looking statements that are subject to certain risks and uncertainties that could cause actual results to differ materially from any future results, performance or achievements expressed or implied by such statements. Emerging Growth LLC, which owns CFN Media and CannabisFN.com, is not registered with any financial or securities regulatory authority, and does not provide nor claims to provide investment advice or recommendations to readers of this release. Emerging Growth LLC may from time to time have a position in the securities mentioned herein and may increase or decrease such positions without notice. For making specific investment decisions, readers should seek their own advice. Emerging Growth LLC may be compensated for its services in the form of cash-based compensation or equity securities in the companies it writes about, or a combination of the two. For full disclosure please visit: http://www.cannabisfn.com/legal-disclaimer/.

CFN Media
Frank Lane
206-369-7050
flane@cannabisfn.com

 

Tetra Bio-Pharma Inc. Receives Notice of Authorization from Health Canada for the Conduct of its Clinical Trial with its PPTGR topical product $TBP.ca

Posted by AGORACOM-JC at 8:44 AM on Wednesday, February 1st, 2017

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  • Received a Notice of Authorization from the Therapeutic Products Directorate, Health Canada, for its planned clinical trial for PhytoPain Topical Gel Relief
  • Being developed as a locally administered therapeutic for the treatment of Chemotherapy-Induced Neuropathic Pain

OTTAWA, ONTARIO-(Feb. 1, 2017) – PhytoPain Pharma Inc. (“PPP”), a subsidiary of Tetra Bio-Pharma (“Tetra” or the “Company“) (CSE:TBP), a pharmaceutical company focused on developing and commercializing therapeutic cannabis-based products for the treatment of pain and other medical conditions announces that it has received a Notice of Authorization from the Therapeutic Products Directorate, Health Canada, for its planned clinical trial for PhytoPain Topical Gel Relief (“PPTGR”), being developed as a locally administered therapeutic for the treatment of Chemotherapy-Induced Neuropathic Pain (“CIPN”).

CIPN is a common adverse effect of cancer therapy and a frequent reason why cancer patients stop their treatment early. For some patients, the severity of the symptoms can be reduced by lowering the dose of chemotherapy or temporarily stopping it. In other patients the symptoms of CIPN may last for months or years after the cancer therapy has stopped. CIPN symptoms are managed using the same analgesics used to manage other types of neuropathic pain. Some of these analgesics also cause intolerable side effects in patients. The use of a topical counterirritant may help reduce the symptoms of CIPN and avoid exposing some patients to oral neuropathic pain analgesics.

The Canadian Securities Exchange (“CSE”) has not reviewed this news release and does not accept responsibility for its adequacy or accuracy.

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 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.
Dr. Guy Chamberland
Chief Science Officer
Phone: (514) 220-9225

Tetra Bio-Pharma Inc.
André Rancourt
Chief Executive Officer
Phone: (343) 689-0714

Tetra Bio-Pharma Inc. Completes Pre-IND Meeting with FDA on PPP001 $TBP.ca

Posted by AGORACOM-JC at 10:21 AM on Monday, January 30th, 2017

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  • Completed its pre-IND meeting with the USA Food and Drug Administration  for its PPP001 dried cannabis drug product
  • Meeting was held in January 2017 with the Division of Anesthesia, Analgesia, and Addiction Products, Center for Drug Evaluation and Research
  • FDA provided all the necessary guidance on the design of the Phase I trial in healthy volunteers and the overall product development program, including quality, nonclinical and the medical device, and on marketing requirements

OTTAWA, ONTARIO–(Jan. 30, 2017) – PhytoPain Pharma Inc. (“PPP“), a subsidiary of Tetra Bio-Pharma Inc. (“Tetra” or the “Company“) (CSE:TBP)(CSE:TBP.CN)(OTC PINK:GRPOF), a pharmaceutical company focused on developing and commercializing therapeutic cannabis-based products for the treatment of pain and other medical conditions announces that it has completed its pre-IND meeting with the USA Food and Drug Administration (“FDA”) for its PPP001 dried cannabis drug product. The meeting was held in January 2017 with the Division of Anesthesia, Analgesia, and Addiction Products (“DAAAP”), Center for Drug Evaluation and Research (“CDER”).

The FDA provided all the necessary guidance on the design of the Phase I trial in healthy volunteers and the overall product development program, including quality, nonclinical and the medical device, and on marketing requirements. Dr. Chamberland, M.Sc., Ph.D., Chief Scientific Officer and Regulatory Affairs, commented “We could not be more pleased, as the FDA guidance gave us a clear path to progress from early to late phase clinical development. Adhering to the US FDA regulations is part of Tetra Bio-Pharma’s dedication to the commercialization of Cannabis as a prescription controlled drug and the corporations plan to seek reimbursement by insurers for patients.”

The Canadian Securities Exchange (“CSE”) has not reviewed this news release and does not accept responsibility for its adequacy or accuracy.

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 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.
Dr. Guy Chamberland
Chief Science Officer
(514) 220-9225

Tetra Bio-Pharma Inc.
Andre Rancourt
Chief Executive Officer
(613) 689-0714

Tetra Bio-Pharma Inc. Announces New Appointment of Dr. Gilles Chamberland, M.D., FRCPC to its Scientific and Clinical Advisory Board $TBP.ca

Posted by AGORACOM-JC at 9:15 AM on Wednesday, January 11th, 2017

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  • Announced the nomination of Dr. Gilles Chamberland, MD, FRCPC, to its Scientific and Clinical Advisory Board
  • Board is comprised of experts in clinical research, pain management, cancer, and neurological product drug development

(TORONTO, ONTARIO  Jan. 11, 2017) – PhytoPain Pharma Inc. (“PhytoPain Pharma” or “PPP“), a subsidiary of Tetra Bio-Pharma Inc. (“Tetra” or the “Company“) (CSE:TBP)(CSE:TBP.CN)(OTC PINK:GRPOF), is pleased to announce the nomination of Dr. Gilles Chamberland, MD, FRCPC, to its Scientific and Clinical Advisory Board. The board is comprised of experts in clinical research, pain management, cancer, and neurological product drug development. The nomination of Dr. Chamberland, M.D., to its Advisory Board will provide critical guidance on PPP’s clinical development program with regards to the safety of cannabis drug products and the potential mental health risks associated with the consumption of marijuana.

“Patient safety has been a driving force since the creation of PPP. The use of cannabis has been associated with several important safety issues including potential psychiatric-related events. As a company focused on creating scientific data these risks, as well as others, must be adequately assessed and quantified in a clinical environment. The addition of Dr. Gilles Chamberland, M.D., FRCPC, to our team of accomplished scientific and clinical experts will help us ensure that these potential adverse effects of consuming cannabis will be adequately assessed in our clinical development program and these potential risks will be appropriately communicated to both physicians and patients”, stated Dr. Guy Chamberland, Chief Scientific Officer and Regulatory Affairs.

ABOUT Dr. Gilles Chamberland

Dr. Gilles Chamberland, M.D., FRCPC – Director Professional Services, Medical Psychiatrist, Associate Professor, Department of Psychiatry, Institut Philippe-Pinel de Montréal, Université de Montréal.

Dr. Chamberland received a Bachelor of Law degree from the Université de Sherbrooke, a doctorate in medicine from the Université de Montréal, a diploma in psychiatry from the Université de Montréal, and a diploma of advanced studies in biological and medical ethics of the René Descartes University in Paris. In 2012, he earned the Distinguished Fellow from the Canadian Psychiatric Association and, by 2015 the American Psychiatric Association gave him the same professional recognition. He received a diploma in the subspecialty of Forensic Psychiatry in 2013 from the Royal College of Physicians and Surgeons of Canada. Dr. Chamberland has a vast experience in clinical management of patients suffering from various psychiatric conditions including marijuana induced-psychosis. He is also a well-known author and expert witness in the field on psychiatry.

The Canadian Securities Exchange (CSE) has not reviewed this news release and does not accept responsibility for its adequacy or accuracy.

Tetra Bio-Pharma Inc.
Andre Rancourt, Chief Executive Officer, or
Ryan Brown. VP Business Development and Communications, or
Andre Audet, Executive Chairman
(343) 689-0714
Investors@tetrabiopharma.com

Tetra Bio-Pharma Inc. Announces Binding Letter of Intent for JV Co-Development and Commercialization of Health Care Products Containing Cannabinoids also Closes Private Placement $TBP.ca

Posted by AGORACOM-JC at 9:03 AM on Tuesday, January 10th, 2017

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  • Entered into a binding letter of intent to form a joint venture with Ford’s Family Pharmacy and Wellness Center (“FFP”) in Moncton, New Brunswick
  • Primary objective of this venture is the development and commercialization of cannabinoid-based products for the Canadian health care market with a special focus on CBD and THC-free cannabis products for the USA cosmetic and supplement market

OTTAWA, ONTARIO–(Jan. 10, 2017) – Tetra Bio-Pharma Inc. (“TetraBio“, “TBP“, or the “Company“) (CSE:TBP)(CSE:TBP.CN)(OTC PINK:GROPF) through its subsidiary, Agro-Tek Health Inc. (“GTK“), is pleased to announce that it has entered into a binding letter of intent to form a joint venture with Ford’s Family Pharmacy and Wellness Center (“FFP“) in Moncton, New Brunswick. The primary objective of this venture is the development and commercialization of cannabinoid-based products for the Canadian health care market with a special focus on CBD and THC-free cannabis products for the USA cosmetic and supplement market.

About Tetra Bio-Pharma

Tetra Bio-Pharma, through its subsidiaries, is engaged in the development and commercialization of cannabis-based pharmaceuticals and consumer health products. www.tetrabiopharma.com

About Agro-Tek Health

Agro-Tek Health is a subsidiary of Tetra Bio-Pharma Inc. and is focused on commercialization of over the counter consumer goods containing cannabis and other non-controlled medicinal plants.

About Ford’s Family Pharmacy

Ford’s Family Pharmacy and Wellness Center currently holds a Controlled Substance License from Health Canada for the processing, packaging, and distribution of controlled substances. https://www.fordrx.com

Since 1997, Ford’s Family Pharmacy & Wellness Centre has helped clients improve and prolong their health, wellness, and vitality by providing personalized compounding and wellness solutions. Their team consists of: four pharmacists, 14 pharmacy technicians/assistants and two registered nurses. FFP provides innovative solutions to complex medical problems and works with Canadian healthcare providers (including physicians, veterinarians, and dentists) to create well-rounded, comprehensive natural and compounding treatment plans.

To maximize the benefit of this venture, GTK will establish its health care product development and commercialization activities within the province of New Brunswick. New Brunswick is quickly positioning itself as a desired homebase for companies in the cannabis industry and GTK commends the government of New Brunswick for its assistance in establishing this project.

Dr. Peter Ford, Pharm D will work with GTK to develop cannabinoid-based skin care and wellness products for the Canadian retail markets. This joint venture will allow GTK to develop a portfolio of innovative CBD-based products for patient self-care in addition to CBD and THC-free products for the USA cosmetic and supplement market.

According to Mr. André Rancourt, Chief Executive Officer, “These products will allow GTK to commercialize cannabis-derived products for the Canadian and USA wellness market in preparation for the unveiling of Canada’s new cannabis regulations.”

Dr. Ford will also assist TetraBio with its ongoing NSERC Engage partnership grant with McGill University (see press release from October 19, 2016). Dr. Ford’s expertise will also be used for the development of the PPP001 dried cannabis pellets for upcoming phase 1 clinical trials. “The partnerships with McGill University and Dr. Ford are in line with the Company’s vision to expand its commercial operations focused on the development and sale of cannabis-derived supplements and retail products for the North American market,” commented Mr. Rancourt.

Dr. Guy Chamberland, M.Sc., Ph.D., Chief Science Officer, commented, “Ford’s Family Pharmacy and Wellness Center currently holds a Controlled Substance License from Health Canada for the processing, packaging, and distribution of controlled substances. Working with Dr. Ford will allow TBP to adhere to current regulations relating to controlled substances including cannabis. This resource allows TBP to further its ongoing projects while remaining compliant with Canadian and US narcotics regulations.” He also stated, “Dr. Ford is a renowned expert in wellness and a highly-experienced formulator and this joint venture will help the Company bring cutting edge cannabis-based health and wellness products to patients and consumers in a timely and cost effective manner.”

This project will be funded via current working capital and the previously announced NSREC research grant in collaboration with McGill University.

Closing of Non-brokered Private Placement

The Company is also pleased to announce that, on December 30, 2016, it closed a non-brokered private placement of 2,395,500 units at a price of $0.20 per unit for aggregate gross proceeds of $479,100. Each unit consists of one common share and one non-transferable warrant, with a whole warrant entitling the holder to purchase one common share at a price of $0.26 per share for a period of twelve months expiring December 30, 2017.

The securities issued pursuant to the private placement are subject to a four-month hold period from the closing date and subject to all necessary regulatory approvals, including the approval of the Exchange.

The proceeds of the private placement will be used to pursue commercialization projects in 2017 and increase scientific staff.

In Other News

Tetra Bio-Pharma is also pleased to announce that, effective December 16, 2016, TBP has been added to the Canadian Securities Exchange composite index. The index is comprised of listed companies that meet market capitalization, trading, and seasoning criteria established by the exchange.

The Canadian Securities Exchange (CSE) has not reviewed this news release and does not accept responsibility for its adequacy or accuracy.

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 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.
Andre Rancourt
Chief Executive Officer
343-689-0714

Tetra Bio-Pharma Inc.
Dr. Guy Chamberland
Chief Scientific Officer
343-689-0714
www.tetrabiopharma.com

Marijuana Company of America Has Engaged Auditing Firm to Prepare for Move to Fully Reporting Public Company $MCOA.us

Posted by AGORACOM-JC at 10:00 AM on Tuesday, December 27th, 2016

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  • Engaged L&L CPAs, PA as its independent audit firm to complete a two-year audit of the Company’s financial statements as part of the process of preparing to become a fully reporting public company with the intent of uplisting to a higher reporting exchange
  • Newly engaged auditors are working together with the Company’s legal counsel to complete the necessary procedures to file a registration statement with the Securities and Exchange Commission

BONSALL, CA–(Dec 27, 2016) – MARIJUANA COMPANY OF AMERICA INC., (“MCOA” or the “Company”) (OTC PINK: MCOA), an innovative cannabis and hemp marketing, consulting and distribution company, has engaged L&L CPAs, PA as its independent audit firm to complete a two-year audit of the Company’s financial statements as part of the process of preparing to become a fully reporting public company with the intent of uplisting to a higher reporting exchange.

The newly engaged auditors are working together with the Company’s legal counsel to complete the necessary procedures to file a registration statement with the Securities and Exchange Commission. When completed and filed with the Commission, this will represent a significant step toward our efforts to enhance long-term shareholder value, while attracting a broader and more diverse shareholder base.

“Our goal is to be a fully transparent reporting public company,” said the Company’s CEO, Donald Steinberg. “As we grow and take these major steps, we want our shareholders to be well-informed about our plans and our progress. By becoming a fully-reporting, transparent public company, we may be better positioned to enhance stock liquidity and attract institutional investors, which will fundamentally enhance the value of our Company.”

Once the audit is completed over the next several months, the Company will have a better idea which stock exchange is most appropriate for the Company. “Our goal is to be fully reporting on the most reputable exchange we qualify for, so our shareholders have all the information they need to follow our progress in detail,” said Mr. Steinberg.

L&L CPAs, PA is registered with the PCAOB and is experienced in conducting audits of public companies in the cannabis industry. Completing this audit will help ensure the accuracy and completeness of the Company’s financial information, and also help to identify and strengthen internal controls over financial reporting.

About Marijuana Company of America Inc.

Marijuana Company of America (“MCOA”) is a publicly traded company headquartered in Southern California. MCOA will distribute marijuana and products related to marijuana as well as CBD and hemp, using a variety of marketing approaches to distribute on a global basis.

SAFE HARBOR STATEMENT:

This release contains forward-looking statements that are based upon current expectations or beliefs, as well as a number of assumptions about future events. Although we believe that the expectations reflected in the forward-looking statements and the assumptions upon which they are based are reasonable, we can give no assurance or guarantee that such expectations and assumptions will prove to have been correct. Forward-looking statements are generally identifiable by the use of words like “may,” “will,” “should,” “could,” “expect,” “anticipate,” “estimate,” “believe,” “intend,” or “project” or the negative of these words or other variations on these words or comparable terminology. The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous factors and uncertainties, including but not limited to: adverse economic conditions, competition, adverse federal, state and local government regulation, international governmental regulation, inadequate capital, inability to carry out research, development and commercialization plans, loss or retirement of key executives and other specific risks. To the extent that statements in this press release are not strictly historical, including statements as to revenue projections, business strategy, outlook, objectives, future milestones, plans, intentions, goals, future financial conditions, events conditioned on stockholder or other approval, or otherwise as to future events, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The forward-looking statements contained in this release are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made.

For more information, please visit the Company’s websites at:
MarijuanaCompanyofAmerica.com
hempSMART.com
Harmoneous.com
agoracom.com/ir/MarijuanaCompanyofAmerica

Investor Relations
888-777-4362
ir@mcoa.club

More than $1 billion of marijuana sold in Colorado in 2016 $TBP.ca $MCOA.us

Posted by AGORACOM-JC at 4:23 PM on Tuesday, December 13th, 2016
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  • Last year, the marijuana industry created 18,000 full-time jobs and generated $2.39 billion in economic activity in the state.
  • Recreational and medical cannabis shops have sold more than $1 billion of marijuana and related products so far in 2016, already surpassing last year’s total of $996,184,788

(CNN) It’s always 4/20 somewhere — at least in Colorado. The state’s marijuana shops have reached a massive new milestone: $1 billion in legal, regulated sales in the first 10 months of 2016.
Voters legalized marijuana in Colorado back in 2012, but the dispensaries didn’t open until 2014Last year, the marijuana industry created 18,000 full-time jobs and generated $2.39 billion in economic activity in the state.

And the boom is still growing. According to new data from the state’s Department of Revenue, recreational and medical cannabis shops have sold more than $1 billion of marijuana and related products so far in 2016, already surpassing last year’s total of $996,184,788.

Attorney Christian Sederberg, partner at Vicente Sederberg, played an integral part in Colorado’s Amendment 64, which legalized marijuana in the state. He is estimating that sales of pot will reach $1.3 billion by the end of this year, which could have a total economic impact of over $3 billion.
Designer marijuana boosts THC potency
Designer marijuana boosts THC potency 02:24
“This milestone continues to show that the cannabis industry in Colorado is an engine of growth for the economy, a job creator, and one of the biggest industries in the state,” Sederberg told CNN. “People were consuming cannabis before, but now they are buying it from tax-regulated businesses that are benefiting the economy. This has replaced an underground, illegal market.”
Sederberg says that marijuana has become one of the largest industries in Colorado, and certainly the fastest growing.
“From 2015 to 2016, there has been a 53% increase in retail sales and a 9% increase in medical sales,” he said. “Medical sales are growing at a much slower rate, but recreational sales will continue to grow in the double digits.”

All-time high

Marijuana sales in Colorado hit an all-time high in September 2016, generating $127.8 million, according to The Cannabist, a Colorado-based news site covering the industry. But October’s numbers are still sizable: Shops sold nearly $82.8 million of recreational cannabis and $35 million of medical marijuana.
Colorado has three different taxes on recreational marijuana — a standard 2.9% sales tax, a special 10% sales tax, and a 15% excise tax on wholesale transfers, which go towards schools. The state collected just over $6 million from the excise tax, bringing the yearly total to $49.7 million, The Cannabist tallied.
Of that, the first $40 million will go towards school construction projects, and any additional tax revenue from the excise tax will go directly to the state’s public school fund.
In this past election, California, Massachusetts, Nevada, and Maine all approved legal sales of recreational marijuana. Medical marijuana is now legal in more than half of US states. In total, marijuana sales could expand the national market to $21 billion by 2020. That is up from $5.7 billion last year and an expected $7.9 billion this year.
But in the eyes of the federal government, marijuana is still an illegal substance. The Drug Enforcement Administration classifies marijuana as a Schedule 1 drug, the same as heroin, LSD, and ecstasy.
Source: http://edition.cnn.com/2016/12/13/health/colorado-marijuana-sales-trnd/

Tetra Bio-Pharma Provides USA Regulatory Update for its Cannabis Inhalation Product PPP001 $TBP.ca

Posted by AGORACOM-JC at 9:04 AM on Wednesday, November 23rd, 2016

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  • Company confirmed that, on November 8, 2016, it received a letter from the Office of Combination Products stating that the USA Food and Drug Administration had completed its review of the request for designation for the marijuana prescription drug and titanium pipe kit
  • FDA confirmed that the product is a combination product, and assigned it to the Center for Drug Evaluation and Research as the lead agency center for premarket review and regulation based on FDA’s determination of the marijuana product’s primary mode of action.

OTTAWA, ONTARIO–(Nov. 23, 2016) – PhytoPain Pharma Inc. (“PPP“), a subsidiary of Tetra Bio-Pharma Inc. (“Tetra” or the “Company“) (CSE:TBP) (CSE:TBP.CN) (OTC PINK:GRPOF), is a pharmaceutical company focused on developing and commercializing therapeutic cannabis-based products for the treatment of pain and other medical conditions announces that the development of its smoked marijuana prescription drug is on schedule.

The Company confirmed that, on November 8, 2016, it received a letter from the Office of Combination Products stating that the USA Food and Drug Administration (“FDA“) had completed its review of the request for designation for the marijuana prescription drug and titanium pipe kit. The FDA confirmed that the product is a combination product, and assigned it to the Center for Drug Evaluation and Research (“CDER“) as the lead agency center for premarket review and regulation based on FDA’s determination of the marijuana product’s primary mode of action.

The Company previously announced that it received a pre-IND (Investigational New Drug) acknowledgement and meeting request granted letter from the US FDA. This week, the company is submitting the information package required by FDA for the Type B pre-IND meeting in January 2017 with the Division of Anesthesia, Analgesia, and Addiction Products, Center for Drug Evaluation and Research. According to Dr. G. Chamberland, Chief Science Officer, “As per FDA policies, the pre-IND information package is submitted to obtain guidance from FDA on the product development and marketing requirements for the smoked marijuana prescription drug combination product”. Dr. Chamberland further commented that this regulatory filing is part of PPP’s dedication to the commercialization of marijuana as a prescription controlled drug and the corporation’s plan to seek reimbursement by insurers for patients.

The Company has been working with Algorithme Pharma, an Altasciences company, for the conduct of its Phase I clinical trial in healthy human subjects. PPP is using the services of Algorithme Pharma based on its experience and expertise in the conduct of clinical trials for the pharmaceutical industry. Later this week the project team will be submitting the Phase I clinical protocol, and related documents, to the Institutional Review Board for review. If approved, Algorithme Pharma will subsequently submit the Clinical Trial Application to the Therapeutic Products Directorate of Health Canada for approval. In parallel, Algorithme Pharma will submit an application for exemption under section 56 of the Controlled Drugs and Substances Act for its planned research on healthy subjects.

The Company stated that, subsequent to a request for classification to the Medical Devices Bureau, Health Canada, the PPP001-titanium pipe that will be used in the clinical trial is a Class I medical device. Dr. Chamberland commented: “As a Class I medical device, the PPP001-titanium pipe does not require approval for use in the clinical trial”.

About PPP001-kit product

PPP001-kit product will be sold as two separate products packaged together in a single package and is comprised of the drug PPP001 and the device PPP001-titanium pipe. The drug component and device component will be linked together by the labelling of each component.

The product PPP001-kit, once approved, could be sold in pharmacies containing the prescription controlled drug PPP001, in a blister pack, and the PPP-titanium pipe device that will be used to generate the smoke to deliver the active ingredients by inhalation.

PPP001 drug pellet blisters and a fully assembled PPP-titanium pipe for combustion and inhalation of the generated smoke are required for therapy with PPP001 and are provided in the PPP001-kit.

Each blister of PPP001 drug pellet contains marijuana with a standardized amount of delta-9-tetrahydrocannibinol and cannibidiol. A single PPP001 drug pellet is pushed out of the blister by the patient and inserted into the PPP-titanium pipe.

In Other News:

The Company has received $227,738 in exercised warrants for November 2016.

The Canadian Securities Exchange (CSE) has not reviewed this news release and does not accept responsibility for its adequacy or accuracy.

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 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.
Ryan Brown – VP Business Development and Communications
Andre Audet – Executive Chairman
Dr. Guy Chamberland – Chief Scientific Officer
(613) 421-8402