OTTAWA -
The clinical development program of QIXLEEF in the
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
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
The expansion of the indications will allow QIXLEEF to compete in a very competitive
About
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 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.
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