OTTAWA, ONTARIO--(Marketwired - Oct. 4, 2016) - Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (CSE:TBP)(CSE:TBP.CN), through its 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 announces that it received a PRE-IND Acknowledgement and Meeting Request Granted letter from the US FDA.
According to Dr. G. Chamberland, Chief Scientific Officer, PPP submitted a request for a Type B pre-IND meeting with the USA Food and Drug Administration (FDA) for its PPP001 dried cannabis drug product. The meeting will be held in late January 2017 with the Division of Anesthesia, Analgesia, and Addiction Products (DAAAP), Center for Drug Evaluation and Research (CDER).
Dr. Chamberland further commented that the Company intends on submitting a Clinical Trial Application later this year and, if authorized by Health Canada, would initiate its Phase I trial in humans later this year. He added, "The timing of the meeting with the FDA is perfect as it will allow the corporation time to adjust its clinical development program if the Orphan Drug Indications are granted. The first clinical trial of PPP001 will be performed in healthy volunteers and provide the Company with a good understanding of the pharmacokinetics and safety of the drug product. This will then allow the Company to subsequently proceed to perform clinical studies in patient populations based on an acceptable benefit-to-risk ratio for human subjects".
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.