The clinical development program of QIXLEEF in the USA begins with the PLENITUDE© clinical trial. This FDA authorized clinical trial assesses the clinical impact of QIXLEEF in advanced cancer patients with uncontrolled pain. A successful PLENITUDE© clinical program, allows Tetra to commercialize the world’s first dried flower botanical cannabinoid drug product for the treatment of pain in patients with an advanced refractory cancer.
The FDA validated Tetra’s nonclinical program proposed to support clinical trials in non-cancer pain indications and the New Drug Application. This guidance from FDA is critical to the success of the clinical trials and the timing to commercialization because of the costs implicated with the performance of a full nonclinical program. The FDA confirmed areas where Tetra could obtain a waiver for some of the nonclinical safety requirements based on the target patient population. “Confirmation of the waivers was critical because it confirms Tetra’s understanding of the regulatory requirements. The waivers represent a short-term savings of over 5 million dollars for the first marketing application of QIXLEEF as well as further potential savings,” stated Dr. Guy Chamberland, CEO and Chief Regulatory Officer of Tetra.
Tetra will expand the program to target patients with non-cancer pain indications, under the guidance of the FDA as the PLENTITUDE© clinical program advances. The Company would then seek approval for a non-cancer pain indication, such as a second-line or third- line therapy for a condition of uncontrolled pain. Uncontrolled pain refers to a state where the standard of care medications has not achieved adequate control of the pain. A second- or third-line therapy is only initiated once a patient has received the first-line of therapy (e.g., ibuprofen, duloxetine, pregabalin) but has not obtained enough relief.
The FDA reviewed and provided scientific validation of Tetra’s proposed approach to ensuring the quality of the botanical raw material and drug product specifications and how Tetra will ensure the comparability of the non-medicinal ingredients (i.e., volatile organic compounds) from lot-to-lot across the nonclinical and clinical programs. Tetra must demonstrate to the FDA that the QIXLEEF batches used in clinical trials will be comparable to those of the commercial lots as well as those that were used at every stage of the drug development program.
The FDA’s validation of the botanical raw material specifications and quality control was essential to ensure the acceptability of the data packages that would be used for the marketing application as well as ensuring a successful global market penetration. “There is biological variability associated with the use of any botanical raw material. Obtaining the FDA’s validation on the scientific approach used by Tetra was a significant step forward for QIXLEEF. We are now in an excellent position to bring this new drug to the market,” stated Dr. Guy Chamberland.
The expansion of the indications will allow QIXLEEF to compete in a very competitive $44.3Bn market size1 compared to the previous $2Bn market. The $44.3Bn market includes all first line therapies and self care options. Duloxetine and pregabalin, for example, at peak, were both selling $9Bn globally2.
About Tetra Bio-Pharma
Tetra Bio-Pharma (TSX-V:TBP) (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.:
LifeSci Advisors LLC
LifeSci Public Relations
514-288-8500 ext. 226
Source: Tetra Bio-Pharma
- Compuscript Data 2013 from IQVIA
- The LANCET Oncology Volume 12, Issue 5, May 2011, Pages 489-495
- DelveInsight Syndicated Report January 2020