Tetra Bio-Pharma Inc. (“Tetra” or the “Corporation”) (TSX VENTURE:TBP) (TBPMF), a global leader in cannabinoid-based drug development and discovery, is pleased to provide a Corporate Update on its programs and upcoming milestones in the development of its bio-pharmaceutical and natural health products that address large markets with significant unmet medical needs.
- In Q3 of this year, TBP will file a request to commence a Phase 1 clinical trial for PPP004 our topical product indicated for General Neuropathic Pain, conservatively estimated as a billion-dollar market. Neuropathic pain can be caused by injury or disease and can be associated with such common conditions as shingles, diabetic neuropathy, multiple sclerosis, spinal stenosis and sciatica among other conditions.
- In Q3, we anticipate filing a request to commence a Phase 1 clinical trial for PPP003 an ocular treatment for eye pain and inflammation and dry eye. The company has identified one lead compound that is a non-scheduled 1 cannabinoid which would significantly reduce time to market as is it not considered a controlled substance. TBP is also exploring conducting a study focused on Dry-Eye, in the USA.
- Tetra-Bio-Pharma anticipates launching its Rx Oil capsules for the treatment of chronic pain and cancer pain in Q3 of this year. The company is presently conducting a Phase IV study expected to be completed in Q3 and we expect the launch to occur in Q3.
- We expect to complete our Phase III trial for PPP001 in Q4/2018, Q1/2019 and will file for approval in Q1 of 2019. Tetra will seek additional indications for this product and we will announce our intentions soon.
- In Q3, we expect to launch our bioavailability study for PPP0002, and if we prove equivalence to the referenced product, Tetra anticipates filing for approval under the 505 (B) 2 route in the USA in Q4 2018. In addition, Tetra expects to commence a Phase II study in chronic pain with PPP002 in Q3 of this year.
- Legalization of recreational cannabis is expected to take place in Q3/Q4 of this year following which Tetra Bio-Pharma will launch no fewer than 7 cannabinoid based Natural Health products in the Canadian market. We will also look to license these products worldwide.
“Tetra Bio-Pharma has come a long way in the last 12 months and the momentum is building as we advance our products through various phases of clinical development, thereby answering the need for rigorous scientific evidence. We believe our independently credentialed clinical development work, in combination with the launch of our natural health products will be instrumental in building shareholder value,” stated Guy Chamberland Interim CEO and CSO for Tetra Bio-Pharma.
About Tetra Bio-Pharma:
Tetra Bio-Pharma (TBP.V) (TBPMF) is a biopharmaceutical leader in cannabinoid-based drug discovery and development with a clinical program aimed at bringing novel drugs and treatments to patients and their healthcare providers. The Company has several subsidiaries that are engaged in the development of Bio Pharmaceuticals and Natural Health Products containing Cannabis and other medicinal plant-based elements. Tetra Bio-Pharma is focused on combining the traditional methods of medicinal cannabis use with the supporting scientific validation and safety data required for inclusion into the existing bio pharma industry by regulators, physicians and insurance companies.
More information at: www.tetrabiopharma.com
Source: Tetra Bio-Pharma
For further information, please contact Tetra Bio-Pharma Inc.
Robert (Bob) Béchard
Executive Vice President, Corporate Development & Licensing
For investors information, please contact:
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
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 Corporation 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 Corporation’s ability to control or predict, that may cause the actual results of the Corporation 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 failure to obtain sufficient financing to execute the Corporation’s business plan; the success of the Rx PrincepsTM product offering and inhalation device; guidance on expected sales volumes associated with the Rx PrincepsTM product offering and inhalation device; competition; regulation and anticipated and unanticipated costs and delays, and other risks disclosed in the Corporation’s public disclosure record on file with the relevant securities regulatory authorities. Although the Corporation 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 Corporation 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.