OTTAWA, ONTARIO--(Marketwired - Sept. 29, 2016) - Tetra Brio-Pharma Inc. ("Tetra" or the "Company") (CSE:TBP)(CSE:TBP.CN), through its wholly-owned subsidiary, PhytoPain Pharma Inc. ("PPP"), a pharmaceutical company focused on developing and commercializing therapeutic cannabis-based products for the treatment of pain and other medical conditions, has selected 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.
According to Dr. G. Chamberland, Chief Scientific Officer, "Adequately evaluating the safety of inhaled marijuana requires well-equipped clinical research facilities and investigational teams experienced in handling the administration of investigational drugs by inhalation to human volunteers. A fully assembled medical device, PPP001-titanium pipe, will be used for combustion of the marijuana and subsequent inhalation of the generated smoke."
"We are proud to have been selected by PPP for their Phase I trial. We have partnered closely with PPP to design a unique Phase I trial in healthy human subjects to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple daily ascending doses of the company's PPP001 inhalation marijuana investigational drug product." explained Dr. Graham Wood, Executive Vice President, Phase I Clinical Development, at Algorithme Pharma.
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 Company's plan to seek reimbursement by insurers for patients. He added that this Phase I trial will only begin after approval of the Clinical Trial Application (CTA) by the Therapeutic Products Directorate, Health Canada, Research Ethics Board approval, and obtaining an exemption from the Office of Controlled Substances for the conduct of the study.
Altasciences Clinical Research encompasses Algorithme Pharma and Vince & Associates Clinical Research, making it one of the largest early phase clinical CROs in North America. With over 25 years' experience, Altasciences provides clinical development services to biopharmaceutical companies worldwide, including study conduct, medical writing, biostatistics, data management, and bioanalysis.
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.