OTTAWA, ON / ACCESSWIRE / May 11, 2020 / Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSX-V:TBP) (OTCQB:TBPMF), a leader in cannabinoid-derived drug discovery and development, is pleased to announce that its Chief Operating Officer Steeve Néron participated in an interview on Saturday to discuss the Company's development of a drug program to treat certain symptoms of COVID-19.
As mentioned in previous press releases, the Company is developing its already existing initial PPP003 program as a potential intravenous drug as well as a second PPP003 indication for Cytokine Release Syndrome ("CRS") to treat certain symptoms of COVID-19. The CRS program, as mentioned in previous press releases, is intended to treat symptoms from patients who have tested positive for COVID-19. However, the drug is not intended as a vaccine for the prevention of the disease. Management believes that under an accelerated timeline, a potential drug for CRS could be ready for conditional approval by Health Canada during the third quarter of 2021. This estimated accelerated timeline is based on Health Canada's policy to expedite the review of a drug product shown to improve the outcome of life-threatening conditions, such as COVID-19.
The Company designed the nonclinical safety program and Phase I clinical trial to support Phase II trials in either CRS or ophthalmic disease patient populations. Tetra estimates that this combined program will cost approximately $13.3 million. Only $4.7 million of the announced $18 million will be designated to the Phase II trial in COVID-19 infected patients suffering from CRS.
Tetra has applied to the Federal Government's Strategic Innovation Fund for a grant which would cover approximately 75% of this budget and would allow the Company to meet the accelerated timeline to complete the Phase II clinical trial in the first half of fiscal 2021 and submit for conditional drug approval. The grant application was submitted last week and the process is in early stages with no certainty that a governmental grant will be awarded to the Company. Even if a grant were to be awarded to Tetra, there is no certainty that it would be sufficient to cover 75% of the program as requested by Tetra. Should the Company fail to secure the necessary funding through the Strategic Innovation Fund, the Company would need to raise funds via equity or debt financing, or via other government grants to support the development of the PPP003 Program, which are sources of financing that the Company is exploring at this stage.
The Company is not making any express or implied claims that its product has the ability to eliminate, cure or contain the COVID-19 (or SARS-2 Coronavirus) at this time. As with any new drug candidate, PPP003 has not been shown to be safe or effective in the prevention or treatment of inflammatory cytokine conditions.
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
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Some statements in this release may contain forward-looking information, including the timeline for approval of the PPP003 indication for ICR, the estimated budget for the PPP003 programs described in this release and the receipt of any governmental grants related to the PPP003 programs. 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