OTTAWA, ONTARIO--(Marketwired - Nov. 2, 2016) - Tetra Bio-Pharma Inc. ("TetraBio" or the "Company") (CSE:TBP) through its subsidiary, PhytoPain Pharma Inc. ("PPP"), is pleased to announce that it held its Scientific and Clinical Advisory Board ("CAB") meeting on October 29th. The CAB reviewed the development program of PPP's inhalation cannabis product PPP001. PPP001 is a medical marijuana product that the company is developing as a prescription controlled drug for inhalation using a fully assembled titanium pipe.
The Board, which is comprised of experts in clinical research, pain management as well as cancer, and neurological product drug development (ref: news release August 26, 2016), met to review and discuss the development program to date, the study design of the Phase I trial and the overall clinical development plan of PPP001. This included the exclusion and inclusion criteria of the proposed Phase I trial, the Phase 1a and 1b dosing scheme, and the pharmacokinetic and pharmacodynamic assessments. The CAB also examined the clinical rationale for the selection of the delta-9-tetrahydrocannibinol (THC) and Cannabidiol (CBD) dose levels for use in PPP001.
The CAB also reviewed the salient elements of future PPP's Phase II and III clinical trials for the development of PPP001 in various medical conditions, including the use of medical marijuana as a second or third line therapy for cancer and HIV patients with uncontrolled pain. The CAB reports directly to the Board of Directors of the Company and will be submitting a report on the outcome of the CAB meeting in the near future.
Currently, there is only limited safety or efficacy information, if any, derived from well-controlled clinical trials available to physicians to adequately assess the benefits and risks of prescribing medical marijuana. Dr. Luc Vachon, President of the CAB commented: ²the members of the CAB are very pleased and excited to be participating in a full pharmaceutical approach on the development of medical marijuana as a prescription drug. The members expressed that the clinical development plan used by PPP - supported by a formal regulatory path - will help generate the type of clinical information required by physicians.²
"This team of scientific and clinical experts provided us with excellent guidance on the development program. We are pleased to recommend to the Board of Directors that PPP is ready to submit the Clinical Trial Application (CTA) for the conduct of its Phase I trial in healthy human volunteers," stated Dr. Chamberland, Chief Scientific Officer and Regulatory Affairs.
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.