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PhytoPain Pharma Reports Successful Pre-CTA Consultation With Health Canada for Its Phase I Trial With Cannabis $GCI.ca

Posted by AGORACOM-JC at 8:50 AM on Tuesday, June 28th, 2016

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  • Successful pre-CTA (Clinical Trial Application) consultation with the Therapeutic Products Directorate of Health Canada
  • Proposed Phase I clinical study of smoked cannabis
  • “This is the first step in establishing a key clinical research program aimed at developing the use of inhaled Cannabis as a prescription drug and will provide physicians with evidence on the safety and efficacy of inhaled Cannabis which remains the most commonly preferred form of ingestion by Medical Cannabis Patients,” stated Dr. Chamberland, Chief Scientific Officer and Regulatory Affairs.

OTTAWA, ONTARIO–(June 28, 2016) – PhytoPain Pharma Inc. (“PhytoPain Pharma” or “PPP“), a subsidiary of GrowPros Cannabis Ventures Inc. (“GrowPros” or the “Company“) (CSE:GCI), is pleased to announce a successful pre-CTA (Clinical Trial Application) consultation with the Therapeutic Products Directorate (“TPD“) of Health Canada regarding its proposed Phase I clinical study of smoked cannabis. PhytoPain Pharma submitted for review by the regulators, a pre-CTA information package to brief TPD on the planned clinical study and the investigational drug and its comparator (placebo). Health Canada provided feedback and guidance on the Phase I trial’s study population, placebo material, and neurological and cognitive assessment measures.

PhytoPain Pharma is on track to finalize the clinical protocol and submit the CTA application to TPD. PPP will meet with its Clinical Advisory Board to discuss the guidance from Health Canada and work with a Phase I Clinical Research Organization to implement the recommendations. In addition, PhytoPain Pharma will submit an application for exemption under section 56 of the Controlled Drugs and Substances Act for its planned research on healthy subjects.

“This is the first step in establishing a key clinical research program aimed at developing the use of inhaled Cannabis as a prescription drug and will provide physicians with evidence on the safety and efficacy of inhaled Cannabis which remains the most commonly preferred form of ingestion by Medical Cannabis Patients,” stated Dr. Chamberland, Chief Scientific Officer and Regulatory Affairs.

“I am encouraged at the speed and efficiency displayed by our team in achieving this measurable milestone in the development of our cannabis inhalation drug product. This further validates our belief that, as the regulatory environment surrounding cannabis prohibition continues to evolve, the need for standardised pharmaceutical style products will become the standard in Medicinal Cannabis for physicians, insurers, and regulators. This will position PhytoPain Pharma and GrowPros very favourably as the consumer market continues to develop.”

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.

GrowPros Cannabis Ventures Inc.
Ryan Brown
Chief Executive Officer
(613) 421-8402

GrowPros Cannabis Ventures Inc.
Andre Audet
Executive Chairman
(613) 421-8402

GrowPros Cannabis Ventures Inc.
Dr. Guy Chamberland
Chief Scientific Officer and Regulatory Affairs
(514) 220-9225

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