Tetra Bio-Pharma Provides Management Update on COVID-19
Regulatory activities have not slowed down despite the COVID-19 crisis. These activities are now performed by Tetra’s employees from their home offices. Tetra confirms that it will continue all planned Clinical Trial Applications (CTA), DIN (Drug Identification Number applications), veterinary drug clinical trial applications (Experimental Studies Certificate; ESC) and Pre-Submission meetings in Canada and Investigational New Drug Applications (IND), veterinary IND applications, Pre-IND meetings (PIND) (including Type B and C meetings), Orphan Drug Designation (ODD) applications in the United States. European regulatory activities will also continue.
Tetra’s clinical research team is working to increase the number of clinical sites in Canada and the USA so that it can accelerate the enrolment of patients when the crisis is over. To date the ophthalmic clinical trial has been moving along as per expected timelines. Half of the patient dogs have completed the treatment phase of the study. There was no treatment related adverse events. Tetra expects to complete this trial in this fiscal quarter (end of April) or early in fiscal Q3 and will then report the key outcomes of the study. The corporation has already begun planning the second trial for the treatment of canine indolent corneal ulcers. This second trial will involve regulatory filings in both Canada and the USA. The IND-enabling toxicology studies with HU308 for the human ocular trials are continuing as planned.
During this crisis period, Tetra will be submitting both an IND and CTA to initiate a clinical trial in Canada and the USA for its Orphan Drug HCC011. The corporation will continue forward with its PIND meeting request to discuss with the FDA the marketing requirements for this Orphan Drug that would benefit from FDA’s expedited programs as well as the 505(b)(2) NDA (New Drug Application) regulatory pathway.
Serenity and Reborn activities will be slowed by the crisis. However, the extent of any delays in the clinical activities will be a result of the ultimate effect that this crisis has on factors such as availability of physicians, clinics and enrolment. This is fully understandable as hospital-based physicians have been mobilized to treat individuals infected by the COVID-19 virus, which we all consider to be urgent. That is why Company immediately began procedures to increase the number of clinical sites. Tetra has prioritized obtaining critical clinical research data during this period that had previously been planned for late 2020. The clinical outcomes from these studies will provide important scientific and medical information on CAUMZTD and HCC011. This information is required for the marketing application for any new drug.
Tetra has communicated with all of its drug suppliers, including those that produce THC, CBD, HU308 and PPP001. Current assessment by these firms is that the COVID-19 crisis will not significantly affect supply of the clinical research medications. Tetra’s main QIXLEEF clinical site should be minimally affected by the crisis as it is a private clinic and not a hospital.
Panag Pharma and TALLC research and development activities will be moving along as planned. CB2 Therapeutics pre-commercialization activities will also continue as planned.
“We are extremely relieved that majority of our employees will be able to work from their home offices. Tetra’s virtual environment is well established and is now proving to be a great advantage in ensuring the health and safety of our team and the continuity of our priority projects during this unprecedented time. Special working conditions currently allow Tetra’s manufacturing staff to work in a safe environment. If required to ensure the safety of employees, the corporation also implemented plans that could allow these employees to work from their home and continue to advance Tetra priority projects. We are fortunate that the recent financing allows us to move forward during these difficult times. Tetra’s business model allowed the company to rapidly implement safe working policies without affecting our productivity.” said Dr. Guy Chamberland, CEO and Chief Regulatory Officer of Tetra Bio-Pharma.
About Tetra Bio-Pharma
Tetra Bio-Pharma (TBP.V) (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. Could we work in “existing regulatory standards of safety and clinical evidence for pharmaceutical products”.
For more information visit: www.tetrabiopharma.com
Source: Tetra Bio-Pharma
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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 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.:
Investor Contact:
Pascal Nigen
Alpha Bronze LLC
Phone : + 1 (646) 255-0433
tetra@alphabronze.net
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