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PhytoPain Pharma Provides USA Regulatory Update for Its Cannabis Inhalation Product PPP001 $GCI.ca

Posted by AGORACOM-JC at 8:41 AM on Monday, September 26th, 2016

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  • PPP had filed a RFD for PPP001 to be classified as a drug and assigned to the Center for Drug Evaluation and Research
  • RFD enables the FDA to determine the product type and appropriate lead center.

OTTAWA, ONTARIO–(Sept. 26, 2016) - PhytoPain Pharma (“PPP“), a subsidiary of GrowPros Cannabis Ventures Inc. (“GrowPros” or the “Company” or “GCI“) (CSE:GCI), a pharmaceutical company focused on developing and commercializing therapeutic cannabis-based products for the treatment of pain and other medical conditions, received an Acknowledgement Letter from the U.S. Food and Drug Administration (“FDA“) after submitting a Request for Designation (“RFD“). PPP had filed a RFD for PPP001 to be classified as a drug and assigned to the Center for Drug Evaluation and Research (“CDER“). The RFD enables the FDA to determine the product type and appropriate lead center. If the FDA has not issued a designation letter within 60 calendar days of the filing of the RFD, PPP’s recommendation will become the designated classification and assignment.

According to Dr. G. Chamberland, Chief Scientific Officer, the RFD was submitted to establish the lead review for the PPP001-kit. He stated, “PPP recommended that the product PPP001-kit (PPP001 drug component and PPP-titanium pipe device component) be regulated as a Combination Product and that based on the Primary Mode of Action (PMOA) that primary jurisdiction be granted to CDER.” 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.

About PPP001-kit product

PPP001-kit product will be prescribed by physicians and available in pharmacies as two separate products packaged together in a single package and is comprised of the prescription controlled drug PPP001 (dried standardized cannabis sativa in a blister pack) and the fully assembled device PPP001-titanium pipe. The titanium pipe will be used to generate the smoke by combustion to deliver the active ingredients via inhalation. The drug component and device component will be linked together by the labelling of each component. Each blister of PPP001 drug pellet contains cannabis sativa with a standardized amount of delta-9-tetrahydrocannibinol. A single PPP001 drug pellet is pushed out of the blister by the patient and inserted into the PPP-titanium pipe for combustion and inhalation of the smoke.

About RFD

An RFD is also referred to as an applicant’s letter of request to the FDA (see 21 Code of Federal Regulations (“CFR”) 3.2(j)). It is a written submission to the Office of Combination Products (“OCP”). RFDs generally request a determination of (1) the regulatory identity or classification of a product as a drug, device, biological product, or combination product, and/or (2) either the component of FDA that will regulate the product if it is a non-combination product, or which Agency Center will have primary jurisdiction for premarket review and regulation if it is a combination product. A letter of designation, see 21 CFR 3.2(i), (alternatively referred to as a designation letter) is FDA’s formal response to an RFD and is a binding determination with respect to classification and/or center assignment that may be changed under conditions specified in Section 563 of the FD&C Act and 21 CFR 3.9 in the regulations.” For further information regarding the RFD process, please visit the FDA website, www.fda.gov. Text was taken from FDA’s Guidance for Industry – How to write a Request for Designation (RFD).

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

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

GrowPros MMP
Ryan Brown
President
(613) 421-8402

Clinical trials high on list for medical marijuana community

Posted by AGORACOM-JC at 2:42 PM on Tuesday, February 17th, 2015

The medical marijuana movement is asking the scientific community to make examining the therapeutic potential of cannabis in much more depth a priority, cannabis experts from North America and the UK declared on 14 February at the American Association for the Advancement of Science (AAAS) annual meeting in California. But the drug’s controlled status is continuing to slow efforts to investigate the myriad compounds in the plant.

The panellists said the evidence is clear that cannabinoids can treat different types of pain effectively. In addition, they cited some evidence that cannabinoids help with neurological conditions like epilepsy. There is also very early clinical trial data suggesting that the molecule cannabidiol (CBD) has an antipsychotic effect and some evidence that it could help with anxiety disorders.

Although cannabis use is associated with things like short-term memory loss and learning problems, the experts presented data showing that once use is stopped those effects disappear within a few days. They also said there is no proof of any long-term neurocognitive effects of chronic marijuana use on the adult brain, although there is some cause for concern about heavy use by adolescents.

The question of whether the compounds have untoward effects remains unclear due to insufficient research. The field is stalled because large clinical trials require the deep pockets of the pharmaceutical sector, but a major barrier is the lack of intellectual property around some of these compounds. ‘They are old drugs, they are hard to lock in patents, and that makes it difficult for someone to invest significantly into these kinds of research studies that might not have the long-term payback,’ explained Mark Ware, who runs the pain research unit at McGill University, Canada.

However, possession of cannabis is still illegal in most US states making it a difficult drug to work with in the clinic. Igor Grant, a neuropsychiatrist who directs the cannabis research centre at the University of California, San Diego, US, has conducted seven clinical trials that involved smoked or inhaled cannabis and all required that he obtain regulatory approvals from three separate agencies before he could even acquire the cannabis for the studies.

Research marijuana for the US is grown by University of Mississippi under government licence. Once investigators clear all of the approvals, they can request the study drug from the NIH in the form of cigarettes containing different concentrations of tetrahydrocannabinol or THC – the main psychoactive constituent of cannabis.

Cannabis in Canada

Cannabis research is far easier to pursue in Canada where there is a regulated government programme. The country controls cannabis differently to other drugs, arguing that it fits neither under natural health product regulations that govern the use of herbal medicines, nor under the pharmaceutical drug regulations.

Some of the Canadian companies that grow cannabis under licence are now funding clinical trials to try and develop a drug, according to Ware. ‘The money is out there, but the trick is to get these kinds of pilot studies – proof-of-concept studies – done that encourage people to do larger-scale trials,’ he said.

The experts agreed that more information is needed about therapeutic use of cannabis. To help fill this gap, the provincial ethics committee in Quebec recently directed that all patients cleared to use cannabis for medical reasons must agree to be part on an ongoing study. Ware has been tapped to help set up a Quebec-wide registry that will allow these patients to be tracked anonymously for adverse events, as well as for things like pain, spasticity, appetite level and mood. The registry is expected to go live by the end of March.

In the US, there has been much media and public interest in a strain of medical marijuana first developed to treat a child suffering from repeated seizures, dubbed Charlotte’s Web, which is high in CBD but does not contain any psychoactive compounds. But Ware is troubled by the phenomenon of parents and patients seeking out CBD therapeutics. ‘We don’t know where the cannabidiol is coming from; there is a tremendous kind of mythology about the stuff coming from eastern Europe or China,’ he said. Hemp farmers in Canada are being approached to produce CBD and are charging huge amounts of money, he added.

The development of such medicinal products is complicated by the fact that cannabis contains over 100 different ingredients that may be bioactive. This flies in the face of the model followed by regulatory agencies like the US Food and Drug Administration that are set up to deal with single molecules rather than complex mixtures.

Source: http://www.rsc.org/chemistryworld/2015/02/clinical-trials-high-list-medical-marijuana-community

Mazorro Announces Results of Meeting, Management Changes, and Effective Date of Name Change and Amalgamation

Posted by AGORACOM-JC at 8:40 AM on Wednesday, December 31st, 2014

OTTAWA, ONTARIO–(Dec. 31, 2014) - Mazorro Resources Inc. (the “Company“) (CSE:MZO) (FRANKFURT:JAM) is pleased to announce that the following matters were approved by the Company’s shareholders at the special meeting of shareholders held on December 29, 2014:

(i) a change of business from mineral resource exploration to the medical marijuana industry upon completion of the Company’s previously announced acquisition of GrowPros MMP Inc. (the “GrowPros Sub“) pursuant to a three-cornered amalgamation between the Company, its wholly-owned subsidiary 9048073 Canada Inc., and the GrowPros Sub (the “Amalgamation“);
(ii) a change of name to “GrowPros Cannabis Ventures Inc.” (the “Name Change“) upon completion of the Amalgamation; and
(iii) an amended fixed share option plan (the “Plan“), which increases the maximum number of common shares reserved for issuance under the Plan to 5,807,048, representing 10% of the number of issued and outstanding common shares of the Company upon completion of the Amalgamation.

The Amalgamation was previously approved by the shareholders of GrowPros Sub at a special meeting of its shareholders held on December 22, 2014.

The Company has now completed the necessary corporate filings and has received certificates of amalgamation and amendment confirming January 1, 2015 as the effective date of the Amalgamation and the Name Change (the “Effective Date“). The Company expects to begin trading on the Canadian Securities Exchange (the “CSE“) under its new name and new trading symbol “GCI” on or about January 5, 2015, subject to the filing of all required documentation with the CSE. The new CUSIP and ISIN numbers for the Company’s common shares will be 39985Y102 and CA39985Y1025.

As of the Effective Date, the issued and outstanding capital of the Company will consist of 58,070,487 common shares, 15,463,000 common share purchase warrants, 501,300 agent compensation options, and 1,225,000 stock options.

The Company is further pleased to confirm, as previously announced, that as of the Effective Date, Mr. Ryan Brown will join the Company’s board of directors and will be appointed as the Company’s new President and CEO and Mr. Sabino Di Paola will be appointed as the Company’s new CFO and Corporate Secretary. Mr. Brown will be replacing Mr. Léo Côté, who will be resigning from the Company’s board of directors, and Messrs. Brown and Di Paola will assume the senior officer roles currently held by Mr. André Audet who will remain on the board of directors as Chairman but will resign as the Company’s Interim President, CEO, and CFO.

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 to complete the Amalgamation and Change of Business, failure to obtain sufficient financing, and other risks disclosed in the Company’s public disclosure record on file with the relevant securities regulatory authorities. Any forward-looking statement speaks only as of the date on which it is made and except as may be required by applicable securities laws. The Company disclaims any intent or obligation to update any forward-looking statement.

Andre Audet
Director
Phone: (613) 241-2332

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Mazorro Provides Update on GrowPros MMP Activities

Posted by AGORACOM-JC at 8:36 AM on Wednesday, December 17th, 2014

OTTAWA, ONTARIO–(Dec. 17, 2014) - Mazorro Resources Inc. (the “Company“) (CSE:MZO)(FRANKFURT:JAM) announces that, further to its press release November 6, 2014 announcing the signature of a definitive agreement with GrowPros MMP Inc. (“GrowPros“) and in anticipation of a successful closing of the proposed amalgamation (“Amalgamation“), management of GrowPros has provided the following update on its activities.

GrowPros is finalizing the second revision to its application for a license under the Marihuana for Medical Purposes Regulations (“MMPR“). These revisions are part of the normal review process and GrowPros is impressed by the expediency with which its file has been reviewed by Health Canada. In addition, GrowPros will be closing the previously-announced transaction for the purchase of 190 acres of agricultural land located 45 minutes North of Ottawa, Ontario which will house a 50,000 sq. ft. production facility with unlimited room for expansion. As a result, management of GrowPros advises that it expects to receive a ready to build authorization from Health Canada in the second quarter of 2015.

GrowPros also reports that it is currently in preliminary negotiations with companies in various service and supply segments of the cannabis production industry. Management of GrowPros advises that merging main stream business into the cannabis industry will be a major focus of GrowPros going forward. Accordingly, these opportunities should provide a higher return on investment for GrowPros and, ultimately, a quicker route to profitability than solely being an applicant or licensed MMPR producer. This is in line with GrowPros‘ philosophy as a medical marihuana consultation and acquisition firm.

As previously announced on December 3, 2014, the Company would like to remind shareholders that the special meeting of the Company’s shareholders to approve the (i) proposed change of business from mineral resource exploration to the medical marijuana industry and (ii) change of name to “GrowPros Cannabis Inc. / Entreprise GrowPros cannabis inc.” will be held on December 29, 2014 (the “Special Meeting“). A notice of meeting, management information circular, and form of proxy in respect of the Special Meeting has been sent to shareholders and is available under the Company’s profile on the CSE website and on SEDAR.

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 to complete the Amalgamation and change of business, failure to obtain sufficient financing, and other risks disclosed in the Company’s public disclosure record on file with the relevant securities regulatory authorities. Any forward-looking statement speaks only as of the date on which it is made and except as may be required by applicable securities laws. The Company disclaims any intent or obligation to update any forward-looking statement.

Mazorro Resources Inc.
André Audet
Interim President, CEO, and CFO
(613) 241-2332

Mazorro Receives Conditional Approval of Change of Business and Name Change

Posted by AGORACOM-JC at 4:36 PM on Wednesday, December 3rd, 2014

OTTAWA, ONTARIO–(Dec. 3, 2014) - Mazorro Resources Inc. (the “Company“) (CSE:MZO)(FRANKFURT:JAM) announces that it has received the conditional approval of the Canadian Securities Exchange (the “CSE“) for its proposed change of business from mineral resource exploration to the medical marijuana industry (the “Change of Business“) and its change of name to “GrowPros Cannabis Inc. / Entreprise GrowPros cannabis inc.” (the “Name Change“) upon receipt of necessary shareholder approval in respect thereof and completion of the three-cornered amalgamation with GrowPros MMP Inc., previously announced on November 6, 2014 (the “Amalgamation“).

The Company has filed an updated Form 2A listing statement under its profile on the CSE website and on SEDAR at www.sedar.com that provides additional disclosure of the terms of the Amalgamation, the Company’s proposed new business, and the related risk factors.

The Company expects that the CSE will publish a bulletin shortly to announce the resumption of trading of the Company’s common shares (the “Common Shares“) on the CSE at the opening of trading on December 4, 2014. The trading symbol “MZO” will remain the same until completion of the Amalgamation and the Name Change, following which the Common Shares will trade on the CSE under the symbol “GCI”.

Completion of the Amalgamation, the Change of Business, and the Name Change, remain subject to a number of conditions, including, but not limited to, receipt of necessary shareholder approvals in respect thereof and satisfaction of standard closing conditions for transactions of this nature.

The special meeting of the Company’s shareholders that was called to seek the requisite approval for the Change of Business and the Name Change, among other items, has been postponed and will now be held on December 29, 2014 (the “Special Meeting“). A notice of meeting, management information circular, and form of proxy in respect of the Special Meeting will be sent to shareholders and is available under the Company’s profile on the CSE website and on SEDAR.

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 to complete the Amalgamation and Change of Business, failure to obtain sufficient financing, and other risks disclosed in the Company’s public disclosure record on file with the relevant securities regulatory authorities. Any forward-looking statement speaks only as of the date on which it is made and except as may be required by applicable securities laws. The Company disclaims any intent or obligation to update any forward-looking statement.

Mazorro Resources Inc.
Andre Audet
Interim President, CEO, and CFO
(613) 241-2332