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tbp receives US FDA oprhan drug designation for THC DRUG

[Humanist]

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

December 04, 2019 08:00 ET | Source: Tetra Bio-Pharma

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