OTTAWA, ONTARIO – PhytoPain Pharma Inc. (“PhytoPain Pharma” or “PPP“), a subsidiary of GrowPros Cannabis Ventures Inc. (“GrowPros” or the “Company“) (CSE:GCI), today announces the submission to the US Food and Drug Administration (FDA) Office of Orphan Products Development, two applications for Orphan Drug Designation for delta-9-tetrahydrocannibinol and cannabidiol for the treatment of patients with Complex Regional Pain Syndrome Type 1 (CRPS1) and patients with Central PostStroke Pain (CPSP).
The decision to proceed with these Orphan Drug Designation submissions is part of PPP’s plan to move forward with the development of a cannabis prescription drug product for the treatment of neuropathic pain associated with CRPS1 and CPSP. If successful, the designation of delta-9-tetrahydrocannibinol and cannabidiol as an Orphan Drug will open the door for many opportunities most notably tax credits on clinical research reduction of the waiting period and reduced registration fees. It also provides PPP with a 7-year period of market exclusivity in the U.S.
Dr. Guy Chamberland, M.Sc., Ph.D., Chief Scientific Officer of PhytoPain Pharma, commented:
“Our Orphan Drug Designation submissions, announced today, are part of our corporate strategy to develop and commercialize delta-9-tetrahydrocannibinol and cannabidiol prescription drug products for the management of neuropathic pain associated with cancer, HIV, CPSP, and CRPS1 and uncontrolled pain within the United States.” He continued: “I am also very pleased to report that PPP and its collaborators are on track to finalize the Clinical Trial Application (CTA) and submit the clinical protocol to the US Food & Drug Administration (FDA) for review. PPP is developing these prescription drug products for both the Canadian and USA market and intends on obtaining marketing approval from Health Canada and the US FDA. Our medical research team headed by Apical Science Inc. principals Dr. Randy Ringuette, Ph.D. and Dr. Charles Campbell, Ph.D. has been tasked with finalizing these documents for the regulatory agencies.
“This important step positions PPP at the forefront of North American cannabis based consumer drug product development. PPP intends to engage industry partners operating under Canada’s ACMPR (Access to Cannabis for Medical Purposed Regulation) to participate in various aspects of the development process. Being able to leverage this federally legal infrastructure will allow PPP many benefits not available in other jurisdictions”, commented GrowPros CEO Ryan Brown.
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.
GrowPros Cannabis Ventures Inc.
Chief Executive Officer
(613) 421-8402GrowPros Cannabis Ventures Inc.
GrowPros Cannabis Ventures Inc.
Dr. Guy Chamberland
Chief Scientific Officer and Regulatory Affairs