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Tetra Bio-Pharma Receives FDA Orphan Drug Designation for Hepatocellular Carcinoma

19:00 EST 3 Dec 2019 | Globe Newswire

Tetra to launch Phase 2 trial for treatment of hepatocellular carcinoma in Q1 2020       

      Tetra leverages Caumz™-kit technology to provide a new drug for cancer treatment

OTTAWA, Dec. 04, 2019 (GLOBE NEWSWIRE) --  Tetra Bio-Pharma Inc. (“Tetra” or the “Company”) (TSX-V:TBP) (OTCQB:TBPMF), a leader in cannabinoid-derived drug discovery and development, today announced it has received U.S. Food and Drug Administration (FDA) Orphan Drug Designation for delta-9-tetrahydrocannabinol (THC) in the treatment of hepatocellular carcinoma.

“We are very pleased to have received Orphan Drug Designation (ODD) from the FDA for THC. This second ODD for cannabinoids demonstrates our innovation and successful drug development program that will soon include hepatocellular carcinoma," said Dr. Guy Chamberland, CEO and Chief Regulatory Officer of Tetra Bio-Pharma. “We intend to bring a modified formulation of Caumz™ for hepatocellular carcinoma into clinical trials in Q1 2020. As previously announced, we in-licensed the formulation technology and the intellectual property rights for the selective distribution of cannabinoids to brain cancers that overexpress CD44.”

Tetra will leverage the pharmacokinetic and safety data from its Caumz™ Phase 1 clinical trials to support its Phase 2 trial of a modified formulation Caumz™ in patients with advanced hepatocellular carcinoma. Tetra intends to initiate this new trial in the first quarter of 2020. 

“We are thrilled that we can bring this new cancer therapy to Phase 2 clinical trials with no additional drug development costs to Tetra’s shareholders,” Dr. Chamberland noted. “The Caumz™-kit technology already exists, so we will maximize our investment in the development of inhaled cannabinoid drugs to bring another drug to the market."

Arrangements with Respect to Promotional and Investor Relations Activities

Finally, pursuant to Policy 3.4 – Investor Relations, Promotional and Market-Making Activities of the TSX Venture Exchange (the “Exchange”), Tetra wishes to disclose certain past arrangements with respect to promotional activities and “Investor Relation Activities” (within the meaning of the policies of the Exchange) made by Tetra with consultants.

In March 2019, Tetra entered into an agreement with MaisonBrison Communications (“MaisonBrison”) whereby MaisonBrison provided investor relations services for Tetra. MaisonBrison, an arm’s length company based in Montreal, Quebec, provides investor relations services for numerous large and medium-sized publicly-listed Canadian corporations. Tetra terminated the agreement with MaisonBrison in August 2019. Prior to the termination of the agreement, MaisonBrison provided services customary for investor relations consultants, including corporate strategy and key messaging development, quarterly earnings process, drafting press releases, communications and relations with the financial community, preparing investor presentations, communications and relations with financial media, and other ancillary activities. Under the terms of the agreement, MaisonBrison was paid $10,500 per month, plus taxes and out-of-pocket disbursements for their services. Maison Brison did not have an interest, directly or indirectly, in Tetra or its securities, or any right or intent to acquire such an interest.

In November 2017, Tetra entered into a consulting agreement with Mr. Edward Miller, whereby Mr. Miller, an arm’s length individual, provided promotional services for Tetra, including marketing, publicity and other ordinary course communications to promote the business and products of Tetra and its subsidiaries, and to promote awareness of Tetra. During the course of the agreement, Mr. Miller was paid on an hourly basis at the rate of $45 per hour, plus all applicable sales taxes. In addition, Mr. Miller was granted 110,000 stock options at market price.

As disclosed by Tetra on August 12, 2019, Tetra has engaged LifeSci Advisors LLC, a leading investor relations consultancy serving life science companies, and LifeSci Public Relations LLC, a corporate communications firm helping clients engage their corporate audiences and achieve their business objectives via a broad array of traditional, social and digital media tools.

About Tetra Bio-Pharma
Tetra Bio-Pharma (TSX-V:TBP) (OTCQB:TBPMF) is a biopharmaceutical leader in cannabinoid-based drug discovery and development with a Health Canada approved, and FDA reviewed, clinical program aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers. The Company has several subsidiaries engaged in the development of an advanced and growing pipeline of Bio Pharmaceuticals, Natural Health and Veterinary Products containing cannabis and other medicinal plant-based elements. With patients at the core of what we do, Tetra Bio-Pharma is focused on providing rigorous scientific validation and safety data required for inclusion into the existing bio pharma industry by regulators, physicians and insurance companies.

For more information visit: www.tetrabiopharma.com

Source: Tetra Bio-Pharma

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.

Forward-looking statements
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 to obtain sufficient financing to execute the Company's business plan; competition; regulation and anticipated and unanticipated costs and delays, the success of the Company's research and development strategies, including the success of this product  or any other product, the applicability of the discoveries made therein, the successful and timely completion and uncertainties related to the regulatory process, the timing of clinical trials, the timing and outcomes of regulatory or intellectual property decisions 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.

For further information, please contact Tetra Bio-Pharma Inc.:

Investor Contact:
Bruce Mackle
LifeSci Advisors LLC
646-889-1200
Tetrainvestors@LifeSciAdvisors.com           

Media Contact: 
Andrew Mielach
LifeSci Public Relations
646-876-5868
amielach@lifescipublicrelations.com

Canada:
Carol Levine 
Energi PR 
514-288-8500 ext. 226 
carol.levine@energipr.com 

 

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