Planning for Phase 2 Clinical Trial Underway
OTTAWA, Dec. 20, 2018 (GLOBE NEWSWIRE) — Tetra Bio-Pharma Inc. (“Tetra” or “TBP”) today announced that its Phase 1 clinical trial in healthy volunteers using vaporized PPP001 has been successfully concluded. This trial was aimed at determining the pharmacokinetics (PK) and safety of a 4-day titration followed by a single dose of vaporized PPP001 in 12 healthy volunteers. Preliminary review of the human clinical data indicates that the treatment was well tolerated. Based on these positive results, Tetra Bio-Pharma expects to move into Phase 2 clinical trials in fibromyalgia patients.
Tetra Bio-Pharma also completed a first series of analyses of the cannabis vapor generated by the Mighty Medic vaporizer manufactured by Storz & Bickel, thus providing a deeper understanding of the process of administering cannabinoids to patients. This gives health regulators like Health Canada, a detailed view of the efficiency of the delivery system.
“We are thrilled with the results of this trial which was completed both on time and on budget,” stated Dr. Guy Chamberland, CEO and CSO of Tetra Bio-Pharma. “We look forward to investigating this vaped version of PPP001 in patients who suffer from the debilitating pain of fibromyalgia. The Mighty Medic technology provides an alternative delivery method for PPP001, along with a new therapeutic indication for fibromyalgia which will give us access to a much larger patient population. According to the National Fibromyalgia Association there are more than 10 million people who suffer from this disease in the U.S. alone.”
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
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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 this trial, the ability to obtain orphan drug status, 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. While no definitive documentation has yet been signed by the parties and there is no certainty that such documentation will be signed. 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.|
|Robert (Bob) Bechard|
|Executive Vice President, Corporate Development and Licensing|
|Carol Levine||Stephanie Engel|
|514-288-8500 ext. 226||416-425-9143 ext. 209|
Source: Tetra Bio-Pharma Inc