- Resumption of its PLENITUDE© clinical trial to bring QIXLEEF™ to market
- ReBorn© clinical trial to resume to bring CAUMZ™ to the market as an alternative to opioids for breakthrough pain
- QIXLEEF™ metabolite mapping ongoing
OTTAWA, ON / ACCESSWIRE / June 5, 2020 / Tetra Bio-Pharma Inc. (“Tetra” or the “Company”) (TSXV:TBP)(OTCQB:TBPMF), a bio-pharmaceutical company engaged in cannabinoid-derived drug discovery, today announced that the long awaited resumption of its PLENITUDE© clinical trial to bring QIXLEEF™ to market is set to commence in Q3 2020. In addition, the Company expects to resume the ReBorn© clinical trial to bring CAUMZ™ to the market as an alternative to opioids for breakthrough pain.
As disclosed in the final short form prospectus, filed on May 19, 2020, Tetra raised over CAD $9 million dollars to ensure it would have dedicated funds to start its phase 2 clinical trial in 2020 and a second pivotal trial in 2021, along with the necessary toxicology programs and regulatory submissions. The trial is being led by the Dr. Sue Sisley’s of the Scottsdale Research Institute and will be extended to nine additional sites across the United States. Site initiation to study specific procedures is expected to be underway in August 2020. Patient recruitment will begin as soon as the sites receive the GMP certified cannabis drug product from Aphria. Once recruitment is initiated, we can anticipate enrolling patients within two weeks. The first patients are expected to receive their initial drug dose by September 2020. Enrollment is expected to be completed by the end of March 2021.
On April 14, 2020, the Company announced that the lead site at which it conducts its clinical trials related to the development of its investigational therapeutic QIXLEEF™ (which is being developed for the treatment of uncontrolled pain in advanced cancer patients), received the renewal of its Schedule 1 license from the US Drug Enforcement Agency. This license permits the facility to receive shipments of cannabinoid pellets and is critical to the clinical trials related to QIXLEEF™. Since then, two additional sites with a Schedule I license have been selected to participate in the study. Seven additional sites are in the process of renewing their Schedule I license.
With the completion of the May 2020 financing and the site license renewal in April, Aphria is gearing up to provide the required GMP grade cannabis to be used in the Plenitude© trial. Aphria has been implementing new procedures as the pharmaceutical grade quality specifications are different to those of medical cannabis to ensure patient safety. Tetra had signed an exclusive supply agreement with Aphria in 2016 and was excited to learn that Aphria had received its GMP certification as this facility will be able to accommodate the supply of Cannabis needed to successfully complete the trials.
“Since late 2019, Tetra and Aphria have been working to ensure resources and supplies are in place to ensure an efficient and GMP compliant execution of this trial. This work is important as the FDA authorized Tetra’s new quality standards for cannabis. As a leader in the development of cannabinoid-based drugs, we have a responsibility to take action as uncontrolled pain in advanced cancer patients continues to cause suffering among patients and their families” said Guy Chamberland, CEO and CRO of Tetra. “In the final days when patients are with their loved ones, the time should not be spent with them in pain and agony from the effects of the advanced cancer. Rather, this time should be spent cherishing every moment, together. Aphria shares our vision that quality and patient safety is of utmost importance and we will jointly ensure that these patients receive the highest quality of flower bud the market can offer. Tetra has invested enormous energy studying the quality of cannabis and today we are ready to deliver with our partner!”
QIXLEEF™ CANNABINOID METABOLIC PROFILE STUDY IN HUMANS
On April 02, 2020, Tetra announced the launch of a study to map out the levels of cannabinoid metabolites (e.g., 7-COOH-CBD), cannabinoid precursors (e.g., CBGA) and minor cannabinoids (e.g., CBN) in the plasma of humans that had smoked or vaporized QIXLEEF™. This study was initiated after having developed and validated methods to quantify the levels of CBD, THC, cannabinoid precursors (such as THCA, CBDA and CBGA), minor cannabinoids (such as Cannabinol, Cannabichromene, Cannabigerol), and the metabolites 7-OH-CBD, 7-COOH-CBD, 11-OH-THC and 11-nor-9-carboxy-THC in the plasma of all human subjects that received QIXLEEF™. Tetra expects this study to be completed in Q3 2020.
Regulators are becoming increasingly concerned about the safety of cannabis and cannabinoid drugs due to the liver toxicity findings associated with Epidiolex. The inhalation route of administration avoids the first pass metabolism. Tetra believes that the mapping data from this study will show a better safety profile for the inhalation route of administration. This could explain why patients have purported the safe use of smoked cannabis.
Yesterday Tetra announced that they had finalized a definitive commercial sales agreement for the sale of the Mighty Medic device as part of the CAUMZ™-kit drug-device combination product. On February 13, 2020, Tetra signed a definitive manufacturing agreement with Vitiprints LLC, for the commercial production of CAUMZ™. This agreement also provided additional patent protection to CAUMZ™. Despite the current travel restrictions, Tetra is continuing to move full speed into the implementation of this commercial manufacturing technology and should be ready for commercial manufacturing in Q4 2020.
Over the last few months, Tetra has re-assessed the timelines for initiating the ReBorn© clinical trial. Tetra has prioritized accelerating ReBorn© over Serenityã to focus on speed to market. ReBorn© is designed to assess the safety and efficacy of CAUMZ™ in breakthrough cancer pain. ReBorn© is a head to head comparative study assessing CAUMZ™ as an alternative to morphine sulfate (short‐acting opioids) for breakthrough pain in cancer patients. Cancer patients suffering from breakthrough pain are highly medicated with long-acting and shortacting opioids, an opioid cocktail that affects their quality of life and their ability to function normally. The nature and route of administration of CAUMZ™ make it an ideal candidate to rapidly alleviate intolerable episodes of pain of rapid onset and may possibly reduce their occurrences through a chronic treatment. ReBorn© is a small trial composed of an open-label, cross-over proof-of concept sub-study followed by a randomized, double-blind placebo controlled sub-study. The lead site for ReBorn© has more than 20 years of experience in addiction and pain management and holds an active Schedule I license, a critical requirement to accelerate the start up phase of the ReBorn© study. Guy Chamberland, CEO and CRO of Tetra commented, “Although Serenityã represents a larger potential market, ReBorn© can potentially bring CAUMZ™ to the market faster. We believe that a statistically and clinically significant superiority in time-to-relief will have an impact on the approvability of CAUMZ™ by regulators. In the current opioid crisis, time-to-relief remains a major challenge. Based on our revised assessments, Tetra is now planning to initiate ReBorn© in Q4 2020.
“Because everyday counts when you suffer with pain, we are substantially accelerating the production of our QIXLEEF™ and CAUMZ™ drug program.” said Guy Chamberland, CEO and CRO of Tetra. “Tetra is about quality, safe and effective therapeutic solutions. Our goal is to bring these therapeutic options to families and health care professionals as fast as possible.”
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 and approved, 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 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.:
Alpha Bronze, LLC
Mr. Pascal Nigen
Phone: + 1 (646) 255-0433
Ms. Carol Levine APR, FCPRS
Phone: + 1 (416) 425-9143 ext. 226
Mobile: + 1 (514) 703-0256
SOURCE: Tetra Bio-Pharma
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