Tetra Bio-Pharma Engages Dalton Pharma for
GMP Manufacturing of ARDS-003
Significant advancement achieved with ARDS-003 sterile injectable
nano-emulsion finished drug product.
A new anti-inflammatory drug candidate.
Ottawa, August 13, 2020 (GLOBE NEWSWIRE) -- Tetra Bio-Pharma Inc. (“Tetra” or the “Company”) (TSX:TBP) (OTCQB:TBPMF), a leader in cannabinoid-derived drug discovery and development, is pleased to announce that it has awarded the contract for the manufacturing of its active pharmaceutical ingredient (API), HU-308, and of the intravenous, sterile, finished drug product ARDS-003 to Dalton Pharma Services (Dalton).
HU-308 is a synthetic small molecule new chemical entity which specifically targets the human CB2 receptors and has the potential to be a new anti-inflammatory drug. Dalton has developed and improved the synthesis process for HU-308. In preparation for moving the clinical program forward, additional activities are underway which include manufacturing drug batches of HU-308 and ARDS-003. This allowed Tetra to carry out the nonclinical safety program and studies required to generate the data needed for a clinical trial application in both Canada and the USA. The development of a GMP batch manufacturing process is ongoing along with a first scale-up to fulfill Tetra’s clinical requirements. To-date, the drug specifications and analytical quality control methods for the release of both the API and injectable formulation are completed and in the final validation stage. The placebo and active injectable formulations have been developed using FDA approved excipients for intravenous emulsions which will avoid additional toxicology testing to qualify the non-medicinal ingredients. The first injectable product batches were shown to have adequate particle size for sterile filtering and filter compatibility. Sterile filtering is the optimal method for obtaining a sterile injectable drug.
"Dalton is pleased to be working with Tetra on this important new drug to potentially treat cytokine release syndromes. Dalton will play an important role in the development of this innovative drug and we look forward to a long and productive partnership with Tetra," said Peter Pekos, CEO, Dalton Pharma Services.
Dr. Guy Chamberland, CEO and CRO commented, "We are very pleased to be working with Dalton on this high priority project to bring ARDS-003 into clinical trials. This partnership was ideal for Tetra as Dalton recognized the urgency and proposed a plan that aligns with our corporate objective to bring this investigational drug into clinical trials as soon as possible. More importantly, this plan ensured that all aspects of the regulatory requirements and GMP compliance were respected. As a pharmaceutical company, the progress achieved at this point, and within such an accelerated timeframe is significant in that we can now attest that ARDS-003 conforms to the standard quality and compatibility requirements of other injectable prescription drugs for human use".
Dalton Chemical Laboratories Inc. o/a Dalton Pharma Services is a Health Canada approved and FDA registered cGMP contract service provider of integrated chemistry, drug development and manufacturing services to the pharmaceutical and biotechnology industries. Dalton brings over 30 years of experience to their client's projects and emphasizes quality, speed and flexibility.
Dalton can accelerate a drug development program by integrating drug discovery, formulation and process development, custom synthesis, cGMP sterile fill/finish of liquids and powders, cGMP API manufacturing and/or dosage form manufacturing and Accelerated Stability Testing, all at a single location that helps Dalton to be adaptable, flexible and cost-effective.
CMO 2016, 2017 and 2018 Leadership Awards in the categories of Quality, Reliability, Capabilities, Expertise, Compatibility and Development from Life Science Leader reflects Dalton's ongoing commitment to their clients, peers and the business community. In 2017 Dalton was re-certified as "A Great Place to Work."
About Tetra Bio-Pharma
Tetra Bio-Pharma (TSX: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
Neither the TSX Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Exchange) accepts responsibility for the adequacy or accuracy of this release.
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.